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History of Changes for Study: NCT03732807
PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)
Latest version (submitted February 1, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 5, 2018 None (earliest Version on record)
2 December 12, 2018 Recruitment Status, Study Status, Contacts/Locations, Oversight and Study Identification
3 January 8, 2019 Study Status, IPDSharing, Contacts/Locations and Study Identification
4 January 15, 2019 Study Status and Contacts/Locations
5 February 18, 2019 Contacts/Locations and Study Status
6 March 25, 2019 Contacts/Locations, Study Status and Study Identification
7 April 15, 2019 Contacts/Locations and Study Status
8 May 7, 2019 Contacts/Locations and Study Status
9 June 4, 2019 Contacts/Locations and Study Status
10 June 25, 2019 Contacts/Locations and Study Status
11 July 1, 2019 Contacts/Locations and Study Status
12 July 30, 2019 Contacts/Locations and Study Status
13 August 27, 2019 Contacts/Locations, Study Status and References
14 September 26, 2019 Contacts/Locations and Study Status
15 October 24, 2019 Contacts/Locations and Study Status
16 November 13, 2019 Contacts/Locations and Study Status
17 December 9, 2019 Contacts/Locations and Study Status
18 January 13, 2020 Contacts/Locations and Study Status
19 February 4, 2020 Contacts/Locations and Study Status
20 February 27, 2020 Contacts/Locations and Study Status
21 March 19, 2020 Contacts/Locations and Study Status
22 March 30, 2020 Contacts/Locations and Study Status
23 April 7, 2020 Study Status and Contacts/Locations
24 April 24, 2020 Contacts/Locations and Study Status
25 April 28, 2020 Contacts/Locations and Study Status
26 June 17, 2020 Contacts/Locations and Study Status
27 July 2, 2020 Study Status and Contacts/Locations
28 July 30, 2020 Contacts/Locations and Study Status
29 August 10, 2020 Outcome Measures, Study Status and Conditions
30 September 8, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
31 October 19, 2020 Contacts/Locations and Study Status
32 November 23, 2020 Contacts/Locations, Study Status and Study Design
33 December 15, 2020 Contacts/Locations and Study Status
34 February 3, 2021 Study Status, Contacts/Locations and Study Design
35 March 8, 2021 Study Status, Contacts/Locations and Study Design
36 March 10, 2021 Contacts/Locations and Study Status
37 March 17, 2021 Contacts/Locations and Study Status
38 April 2, 2021 Contacts/Locations, Study Status and Study Design
39 April 20, 2021 Contacts/Locations, Study Design and Study Status
40 May 4, 2021 Study Status, Contacts/Locations and Study Design
41 May 14, 2021 Outcome Measures and Study Status
42 June 2, 2021 Contacts/Locations and Study Status
43 July 26, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
44 August 3, 2021 Contacts/Locations and Study Status
45 August 17, 2021 Contacts/Locations, Study Design and Study Status
46 September 23, 2021 Contacts/Locations and Study Status
47 October 5, 2021 Contacts/Locations and Study Status
48 December 16, 2021
Quality Control Review has not concluded Returned: January 13, 2022
Outcome Measures, Study Status, Document Section and Study Design
49 February 1, 2022 Study Status, Outcome Measures
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Study NCT03732807
Submitted Date:  February 1, 2022 (v49)

Open or close this module Study Identification
Unique Protocol ID: B7981015
Brief Title: PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)
Official Title: A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS
Secondary IDs: 2018-001714-14 [EudraCT Number]
ALLEGRO 2B/3 [Alias Study Number]
Open or close this module Study Status
Record Verification: February 2022
Overall Status: Completed
Study Start: December 3, 2018
Primary Completion: December 31, 2020 [Actual]
Study Completion: June 24, 2021 [Actual]
First Submitted: November 5, 2018
First Submitted that
Met QC Criteria:
November 5, 2018
First Posted: November 7, 2018 [Actual]
Results First Submitted: December 16, 2021
Results First Submitted that
Met QC Criteria:
February 1, 2022
Results First Posted: February 24, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
February 1, 2022
Last Update Posted: February 24, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Pfizer
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.
Detailed Description:
Open or close this module Conditions
Conditions: Alopecia Areata
Keywords: Alopecia
Alopecia totalis
Alopecia universalis
Patchy hair loss
Diffuse hair loss
Hair loss
Hair disease
PF-06651600
Ritlecitinib
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 7
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 718 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Sequence A
Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
Drug: PF-06651600 Induction Dose
Oral tablets taken once daily (QD)
Drug: PF-06651600 Maintenance Dose #1
Oral tablets taken QD
Experimental: Sequence B
Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
Drug: PF-06651600 Induction Dose
Oral tablets taken once daily (QD)
Drug: PF-06651600 Maintenance Dose #2
Oral tablets taken QD
Experimental: Sequence C
Maintenance dose #1 given QD for 48 weeks
Drug: PF-06651600 Maintenance Dose #1
Oral tablets taken QD
Experimental: Sequence D
Maintenance dose #2 given QD for 48 weeks
Drug: PF-06651600 Maintenance Dose #2
Oral tablets taken QD
Experimental: Sequence E
Maintenance dose #3 given QD for 48 weeks
Drug: PF-06651600 Maintenance Dose #3
Oral tablets taken QD
Experimental: Sequence F
Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks
Drug: PF-06651600 Induction Dose
Oral tablets taken once daily (QD)
Drug: PF-06651600 Maintenance Dose #1
Oral tablets taken QD
Drug: Placebo
Oral tablets taken QD
Experimental: Sequence G
Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
Drug: PF-06651600 Maintenance Dose #1
Oral tablets taken QD
Drug: Placebo
Oral tablets taken QD
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24
[ Time Frame: Week 24 ]

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (<=) 20 at week 24 were reported.
Secondary Outcome Measures:
1. Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4
[ Time Frame: Week 24 ]

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.
2. Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1
[ Time Frame: Week 24 ]

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.
3. Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24
[ Time Frame: Week 24 ]

PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
4. Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 20 at Week 24: Maximum Effect (Emax) Model
[ Time Frame: Week 24 ]

The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=20 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=20 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
5. Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 10 at Week 24: Maximum Effect (Emax) Model
[ Time Frame: Week 24 ]

The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=10 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=10 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
6. Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48
[ Time Frame: Week 4, 8, 12, 18, 28, 34, 40, and 48 ]

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
7. Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48
[ Time Frame: Week 4, 8, 12, 18, 28, 34, 40, and 48 ]

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <=10 were reported.
8. Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
[ Time Frame: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score.
9. Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24
[ Time Frame: Baseline (Day 1), Week 4, 8, 12, 18, and 24 ]

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
10. Change From Baseline in SALT Score at Week 28, 34, 40, and 48
[ Time Frame: Baseline (Day 1), Week 28, 34, 40, and 48 ]

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
11. Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
[ Time Frame: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]

EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows.
12. Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
[ Time Frame: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]

ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash.
13. Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48
[ Time Frame: Week 4, 8, 12, 18, 24, 34, 40, and 48 ]

PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
14. Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations
[ Time Frame: Baseline (Day 1), Week 4, 8, 12, 18, and 24 ]

AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
15. Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations
[ Time Frame: Baseline (Day 1), Week 34, 40, and 48 ]

AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
16. Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48
[ Time Frame: Week 4, 8, 12, 18, 24, 34, 40, and 48 ]

AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on a scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss', where higher scores indicated more hair loss.
Other Outcome Measures:
1. Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24
[ Time Frame: Baseline (Day 1), Week 4, 8, 12, and 24 ]

HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1.
2. Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48
[ Time Frame: Baseline (Day 1), Week 48 ]

HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1.
3. Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24
[ Time Frame: Baseline (Day 1), Week 4, 8, 12, and 24 ]

HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.
4. Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48
[ Time Frame: Baseline (Day 1), Week 48 ]

HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.
5. Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48
[ Time Frame: Week 4, 8, 12, 24 and 48 ]

HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms.
6. Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48
[ Time Frame: Week 4, 8, 12, 24 and 48 ]

HADS is a validated 14-item PRO measure used to assessed states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms.
Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Clinical diagnosis of alopecia areata with no other cause of hair loss
  • ≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months
  • Current episode of hair loss ≤10 years

Exclusion Criteria:

  • Other types of alopecia or other diseases that can cause hair loss
  • Other scalp diseases that could interfere with assessment of hair loss/regrowth
  • Subjects with shaved heads must not enter the study until hair has grown back & is considered stable by the investigator
  • Any previous use of any Janus kinase (JAK) inhibitor
Open or close this module Contacts/Locations
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations: United States, Alabama
The University of Alabama at Birmingham Hospital Outreach Lab
Birmingham, Alabama, United States, 35233
The University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, United States, 35233
The University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, United States, 35294
United States, California
Mosaic Dermatology
Beverly Hills, California, United States, 90211
University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center
Irvine, California, United States, 92697
Dermatology Specialists, Inc.
Murrieta, California, United States, 92562
University of California, San Francisco
San Francisco, California, United States, 94115
Kaiser Permanente Clinical Trials Unit
San Francisco, California, United States, 94118
Southern California Dermatology, Inc.
Santa Ana, California, United States, 92701
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
University of Colorado Hospital Clinical and Translational Research Center
Aurora, Colorado, United States, 80045
University of Colorado Hospital Outpatient Pavillion
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Church Street Research Unit
New Haven, Connecticut, United States, 06519
United States, District of Columbia
Medstar Georgetown University Hospital Center-Department of Otolaryngology
Washington, District of Columbia, United States, 20007
Medstar Washington Hospital Center-Claude Nogay Research Pharmacy
Washington, District of Columbia, United States, 20010
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
Medstar Georgetown University Hospital Center-Department of Pediatrics
Washington, District of Columbia, United States, 20016
United States, Florida
Siperstein Dermatology Group
Boynton Beach, Florida, United States, 33472
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
ForCare Clinical Research
Tampa, Florida, United States, 33613
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Illinois
Northwestern Medical Group
Chicago, Illinois, United States, 60611
Northwestern Medicine Diagnostic Testing Center
Chicago, Illinois, United States, 60611
Northwestern Medicine
Chicago, Illinois, United States, 60611
Northwestern Memorial Hospital, Investigational Research Pharmacy
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60611
NorthShore University HealthSystem
Skokie, Illinois, United States, 60077
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
United States, Iowa
University of Iowa Hospitals and Clinics; Department of Pharmacy-IDS;
Iowa City, Iowa, United States, 52242
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Medstar Georgetown University Hospital - Department of Dermatology
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, United States, 55455
University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, New Jersey
The Dermatology Group, P.C.
Verona, New Jersey, United States, 07044
United States, New York
NYU School of Medicine, The Ronald O. Perelman Department of Dermatology
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, North Carolina
UNC CTRC
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals, Investigational Drug Service
Chapel Hill, North Carolina, United States, 27514
UNC Dermatology Clinical Trials Unit
Chapel Hill, North Carolina, United States, 27516
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Vital Prospects Clinical Research Institute, P.C
Tulsa, Oklahoma, United States, 74136
United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Argentina
Psoriahue Medicina Interdisciplinaria
Caba, Argentina, C1425DKG
Argentina, Buenos Aires
CINME Centro de Investigaciones Metabolicas
Caba, Buenos Aires, Argentina, C1027AAP
Australia, New South Wales
Premier Specialists Pty Ltd
Kogarah, New South Wales, Australia, 2217
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
The Skin Centre
Benowa, Queensland, Australia, 4217
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Skin Health Institute
Carlton, Victoria, Australia, 3053
Sinclair Dermatology
East Melbourne, Victoria, Australia, 3002
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Royal Park Campus
Parkville, Victoria, Australia, 3052
Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Quebec, Canada, G1V 4X7
Canada, Manitoba
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada, R3M 3Z4
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, Canada, B3H 1Z2
Canada, Ontario
Guenther Research Inc
London, Ontario, Canada, N6A 3H7
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1X3
The Centre for Clinical Trials
Oakville, Ontario, Canada, L6J 7W5
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 5K2
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, Canada, L4C 9M7
Medicor Research Inc
Sudbury, Ontario, Canada, P3A1W8
Sudbury Skin Clinique
Sudbury, Ontario, Canada, P3C 1X8
Research Toronto
Toronto, Ontario, Canada, M4W 2N4
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2X 2V1
Chile, Recoleta
Centro Internacional de Estudios Clinicos, CIEC
Santiago, Recoleta, Chile, 8420383
Chile, Región Metropolitana
Centro Medico Skin Med
Santiago, Región Metropolitana, Chile, 7580206
Clinica Dermacross S.A.
Santiago, Región Metropolitana, Chile, 7640881
Chile, Valparaiso
Medical Skin Center
Vina del Mar, Valparaiso, Chile, 2530900
China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025
China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Peking University Third Hospital
Beijing, Beijing, China, 100191
China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China, 518053
China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
China, Jiangsu
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
China, Shanghai
Huashan Hospital, Fudan University/Dermatology Department
Shanghai, Shanghai, China, 200040
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
The Second Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology Dept
Hangzhou, Zhejiang, China, 310009
Colombia, Antioquia
Fundacion Centro de Investigacion Clinica CIC
Medellin, Antioquia, Colombia, 050001
Fundacion Hospitalaria San Vicente de Paul
Medellin, Antioquia, Colombia, 050010
Colombia, D.c.
Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS
Bogota, D.c., Colombia, 110221
Czechia
DERMAMEDICA s.r.o.
Nachod, Czechia, 54701
Fakultni nemocnice Olomouc
Olomouc, Czechia, 779 00
Sanatorium profesora Arenbergera
Praha 1, Czechia, 11000
Clintrial s.r.o.
Praha 10, Czechia, 100 00
Nemocnice Na Bulovce
Praha 8- Liben, Czechia, 180 81
Germany
Fachklinik Bad Bentheim
Bad Bentheim, Germany, 48455
Emovis GmbH
Berlin, Germany, 10629
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
University Hospital Frankfurt
Frankfurt am Main, Germany, 60590
University Hospital Schleswig-Holstein
Luebeck, Germany, 23538
University Hospital Muenster
Muenster, Germany, 48149
Hungary
Semmelweis Egyetem
Budapest, Hungary, 1085
Debreceni Egyetem
Debrecen, Hungary, 4032
Bugat Pal Korhaz, Borgyogyaszat
Gyongyos, Hungary, 3200
Szegedi Tudományegyetem Altalanos Orvostudomanyi Kar
Szeged, Hungary, 6720
Japan
Osaka City University Hospital
Osaka, Japan, 545-8586
Japan, Aichi
Nagoya City University Hospital - Dermatology
Nagoya, Aichi, Japan, 467-8602
Japan, Miyagi
Tohoku University hospital
Sendai, Miyagi, Japan, 980-8574
Japan, Shizuoka
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan, 431-3192
Japan, Tokyo
Juntendo Tokyo Koto Geriatric Medical Center
Koto-ku, Tokyo, Japan, 136-0075
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
Korea, Republic of
Pusan National University Hospital
Busan, Korea, Republic of, 49241
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Mexico
Sociedad de Metabolismo y Corazon S.C.
Veracruz, Mexico, C.P. 91900
Hospital D'Maria
Veracruz, Mexico, CP. 91910
Poland
Centermed Krakow Sp.z o.o.
Krakow, Poland, 31-530
Medicover Sp.z.o.o
Lodz, Poland, 90-368
Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Poland, 90-436
Sanova Audiological Care Polska Sp.z.o.o
Lodz, Poland, 91-867
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, Poland, 71-434
RCMed Oddzial Warszawa
Warszawa, Poland, 02-657
Royalderm Agnieszka Nawrocka
Warszawa, Poland, 02-962
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Poland, 50-566
Russian Federation
State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Dermatovenerologic Dispensary
Chelyabinsk, Russian Federation, 454092
University Clinic of Kirov SMU
Kirov, Russian Federation, 610035
Clinical Medical Center of A.I. Yevdokimov MSMSU
Moscow, Russian Federation, 111398
Federal State Autonomous Institution National Medical Research Centre of Childrens Health
Moscow, Russian Federation, 119991
State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"
Rostov-on-Don, Russian Federation, 344002
Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)
Saint Petersburg, Russian Federation, 191123
Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -
Saint Petersburg, Russian Federation, 194021
Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"
Saint Petersburg,, Russian Federation, 191123
State Autonomous Healthcare Institution of the Yaroslavl Region Clinical Emergency Hospital
Yaroslavl, Russian Federation, 150003
Spain
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitario Reina Sofía, Servicio Dermatologia
Cordoba, Spain, 14004
Servicio Otorrinolaringologia, Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
Servicio Radiologia, Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Hospital Universitario La Paz
Madrid, Spain, 28046
Servicio de Dermatologia, Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Servicio de Otorrinolaringologia, Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Servicio de Radiologia, Hospital Universitario y Politecnico Le Fe
Valencia, Spain, 46026
Spain, Barcelona
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch
Kaohsiung City, Taiwan, 83301
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan, 23561
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Chung-Shan Medical University Hospital
Taichung, Taiwan, 40201
National Taiwan University Hospital
Taipei, Taiwan, 100
Chang Gung Memorial Hospital-Linkou Branch
Taoyuan City, Taiwan, 333
United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom, BN2 5BE
NHS Tayside Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G51 4TF
Southampton University Hospital NHS Foundation Trust, University Hospital Southampton
Hampshire, United Kingdom, SO16 6YD
Harley Grove Medical Centre
London, United Kingdom, E3 2AT
Guy's and St.Thomas' Hospitals NHS Foundation Trust, St.Thomas' Hospital,
London,, United Kingdom, SE1 7EH
Guy's and St.Thomas' Hospitals NHS Foundation Trust, Guy's Hospital,
London,, United Kingdom, SE1 9RT
United Kingdom, EAST Sussex
Brighton and Sussex University Hospitals NHS Trust
Brighton, EAST Sussex, United Kingdom, BN2 5BE
United Kingdom, Hampshire
Southampton University Hospital NHS Foundation Trust, Royal South Hants Hospital
Southampton, Hampshire, United Kingdom, SO14 0YG
Open or close this module IPDSharing
Plan to Share IPD: Yes
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Supporting Information:
Time Frame:
Access Criteria:
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Open or close this module References
Citations:
Links: Description: To obtain contact information for a study center near you, click here.
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: April 14, 2021
Uploaded: 12/16/2021 08:26
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: April 23, 2021
Uploaded: 12/16/2021 08:26
File Name: SAP_001.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details Total 1097 participants signed the informed consent form. Out of which 379 participants were screen failures, 718 actually enrolled into the study and were assigned to study treatments.
 
Arm/Group Title Ritlecitinib (PF-06651600) 200 mg Then 50 mg Ritlecitinib (PF-06651600) 200 mg Then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group Description Participants aged 12 years or above with moderate to severe alopecia areata (AA) with greater than or equal to (>=) 50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 milligram (mg) tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug . Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Period Title: Treatment Period (up to Week 24)
Started 132 130 130 132 63 65 66
Completed 122 124 121 117 58 63 61
Not Completed 10 6 9 15 5 2 5
Reason Not Completed
Adverse Event 3 0 2 4 2 0 1
Lost to Follow-up 1 0 1 2 1 0 0
Physician Decision 0 1 2 5 0 0 1
Pregnancy 1 0 0 0 1 0 1
Protocol Violation 1 1 0 0 0 0 0
Withdrawal by Subject 4 4 4 4 1 1 2
Lack of Efficacy 0 0 0 0 0 1 0
Period Title: Treatment Extension (Week 25 up to 48)
Started 113 [1] 111 [1] 108 [1] 106 [1] 49 [1] 59 [1] 57 [1]
Completed 107 100 103 97 44 56 53
Not Completed 6 11 5 9 5 3 4
Reason Not Completed
Adverse Event 0 2 2 1 0 0 2
Lack of Efficacy 2 1 0 3 3 0 1
Lost to Follow-up 0 0 2 1 1 2 0
Non-Compliant with study drug 0 1 0 0 0 0 0
Physician Decision 0 1 0 1 1 0 0
Withdrawal by Subject 3 2 1 1 0 1 1
Other 1 4 0 2 0 0 0
[1]Participants continued dosing according to their assigned sequence in the preceding period.
Open or close this module Baseline Characteristics
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mgTotal
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Total of all reporting groups
Overall Number of Baseline Participants 132 130 130 132 63 65 66 718
Baseline Analysis Population Description
Age, Continuous
Mean (Standard Deviation)
Unit of measure: Years
Number Analyzed132 Participants130 Participants130 Participants132 Participants63 Participants65 Participants66 Participants718 Participants
34.5(14.98)33.7(13.75)32.4(13.36)33.7(14.83)34.3(13.88)33.0(14.01)35.0(15.89)33.8(14.33)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed132 Participants130 Participants130 Participants132 Participants63 Participants65 Participants66 Participants718 Participants
Female
81
61.36%
85
65.38%
71
54.62%
80
60.61%
43
68.25%
46
70.77%
40
60.61%
446
62.12%
Male
51
38.64%
45
34.62%
59
45.38%
52
39.39%
20
31.75%
19
29.23%
26
39.39%
272
37.88%
Ethnicity (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed132 Participants130 Participants130 Participants132 Participants63 Participants65 Participants66 Participants718 Participants
Hispanic or Latino
18
13.64%
16
12.31%
11
8.46%
23
17.42%
8
12.7%
7
10.77%
4
6.06%
87
12.12%
Not Hispanic or Latino
113
85.61%
114
87.69%
116
89.23%
109
82.58%
55
87.3%
58
89.23%
61
92.42%
626
87.19%
Unknown or Not Reported
1
0.76%
0
0%
3
2.31%
0
0%
0
0%
0
0%
1
1.52%
5
0.7%
Race (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed132 Participants130 Participants130 Participants132 Participants63 Participants65 Participants66 Participants718 Participants
American Indian or Alaska Native
0
0%
1
0.77%
0
0%
2
1.52%
0
0%
0
0%
0
0%
3
0.42%
Asian
33
25%
28
21.54%
43
33.08%
34
25.76%
17
26.98%
14
21.54%
17
25.76%
186
25.91%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
1
1.59%
0
0%
0
0%
1
0.14%
Black or African American
6
4.55%
7
5.38%
5
3.85%
3
2.27%
2
3.17%
2
3.08%
2
3.03%
27
3.76%
White
92
69.7%
90
69.23%
79
60.77%
91
68.94%
42
66.67%
47
72.31%
47
71.21%
488
67.97%
More than one race
0
0%
3
2.31%
1
0.77%
2
1.52%
0
0%
2
3.08%
0
0%
8
1.11%
Unknown or Not Reported
1
0.76%
1
0.77%
2
1.54%
0
0%
1
1.59%
0
0%
0
0%
5
0.7%
Open or close this module Outcome Measures
1. Primary Outcome:
Title Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24
Description SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (<=) 20 at week 24 were reported.
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Participants with missing SALT scores due to coronavirus disease-19 related reasons were excluded from this analysis, while participants with missing data due to other reasons were considered as non-responders. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
 
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed124 121 124 119 59 130
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
30.65(22.53 to 38.76) 22.31(14.90 to 29.73) 23.39(15.94 to 30.84) 14.29(8.00 to 20.57) 1.69(0.00 to 4.99) 1.54(0.00 to 3.65)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 200 mg Then 50 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.000001
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value29.11
Confidence Interval(2-sided) 95%
21.17 to 37.91
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 200 mg Then 30 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.000001
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value20.78
Confidence Interval(2-sided) 95%
13.65 to 29.18
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 50 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.000001
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value21.85
Confidence Interval(2-sided) 95%
14.65 to 30.23
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 30 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.000154
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value12.75
Confidence Interval(2-sided) 95%
6.69 to 20.36
Estimation Comments[Not specified]
2. Secondary Outcome:
Title Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4
Description SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Analysis 4: Data imputed by using a missing at random (MAR) mechanism for participants with missing data due to COVID-19. Missing data due to reasons not related to COVID-19 were consider as non-responders.
 
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed118 119 119 114 55 125
Measure Type: Number
Unit of Measure: Percentage of participants
21.29 12.87 13.42 10.62 1.65 1.54
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 200 mg Then 50 mg, Placebo
CommentsA generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.000001
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value19.75
Confidence Interval(2-sided) 95%
11.91 to 27.59
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 200 mg Then 30 mg, Placebo
CommentsA generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.000526
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value11.33
Confidence Interval(2-sided) 95%
4.93 to 17.74
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 50 mg, Placebo
CommentsA generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.000311
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value11.88
Confidence Interval(2-sided) 95%
5.42 to 18.33
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 30 mg, Placebo
CommentsA generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.002922
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value9.09
Confidence Interval(2-sided) 95%
3.10 to 15.07
Estimation Comments[Not specified]
3. Secondary Outcome:
Title Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1
Description SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Analysis 1: Participants with missing SALT score at Week 24 due to COVID-19 related reasons excluded from analysis at that time point, participants with missing SALT scores due to other reasons counted as non-responders at that time point.
 
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed124 121 124 119 59 130
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
21.77(14.51 to 29.04) 13.22(7.19 to 19.26) 13.71(7.66 to 19.76) 10.92(5.32 to 16.53) 1.69(0.00 to 4.99) 1.54(0.00 to 3.65)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 200 mg Then 50 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.000001
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value20.24
Confidence Interval(2-sided) 95%
13.23 to 28.49
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 200 mg Then 30 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.000337
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value11.68
Confidence Interval(2-sided) 95%
5.82 to 19.07
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 50 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.000228
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value12.17
Confidence Interval(2-sided) 95%
6.27 to 19.53
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 30 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.001875
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value9.39
Confidence Interval(2-sided) 95%
3.86 to 16.46
Estimation Comments[Not specified]
4. Secondary Outcome:
Title Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24
Description PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
 
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed120 119 120 116 55 125
Measure Type: Number
Unit of Measure: Percentage of participants
52.19 45.40 49.17 41.95 11.36 9.23
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 200 mg Then 50 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.000001
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value42.96
Confidence Interval(2-sided) 95%
31.68 to 54.25
Estimation Comments[Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 200 mg Then 30 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.000001
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value36.18
Confidence Interval(2-sided) 95%
25.22 to 47.14
Estimation Comments[Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 50 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.000001
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value39.96
Confidence Interval(2-sided) 95%
28.85 to 51.06
Estimation Comments[Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group SelectionRitlecitinib (PF-06651600) 30 mg, Placebo
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.000001
Comments[Not specified]
MethodMiettinen and Nurminen method
Comments[Not specified]
Method of EstimationEstimation ParameterEstimate of difference
Estimated Value32.72
Confidence Interval(2-sided) 95%
21.95 to 43.50
Estimation Comments[Not specified]
5. Secondary Outcome:
Title Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 20 at Week 24: Maximum Effect (Emax) Model
Description The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=20 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=20 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
 
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed124 121 124 119 59 130
Measure Type: Number
Unit of Measure: Percentage of participants
32.37 20.57 22.52 13.58 4.81 1.63
6. Secondary Outcome:
Title Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 10 at Week 24: Maximum Effect (Emax) Model
Description The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=10 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=10 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
 
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed124 121 124 119 59 130
Measure Type: Number
Unit of Measure: Percentage of participants
21.29 13.76 14.43 9.02 3.88 1.66
7. Secondary Outcome:
Title Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48
Description SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
Time Frame Week 4, 8, 12, 18, 28, 34, 40, and 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 65 66
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
 
Week 4
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
0.78(0.00 to 2.29) 0.00(NA to NA) [1] 0.00(NA to NA) [2] 0.00(NA to NA) [2] 0.00(NA to NA) [2] 0.00(NA to NA) [2] 0.00(NA to NA) [2]
Week 8
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
5.47(1.53 to 9.41) 4.13(0.59 to 7.68) 2.46(0.00 to 5.21) 0.00(NA to NA) [2] 0.00(NA to NA) [2] 0.00(NA to NA) [2] 0.00(NA to NA) [2]
Week 12
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
11.90(6.25 to 17.56) 8.87(3.87 to 13.88) 6.35(2.09 to 10.61) 3.28(0.12 to 6.44) 3.39(0.00 to 8.01) 1.64(0.00 to 4.83) 1.59(0.00 to 4.67)
Week 18
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
19.83(12.73 to 26.94) 13.22(7.19 to 19.26) 13.11(7.12 to 19.10) 9.40(4.11 to 14.69) 3.33(0.00 to 7.88) 1.67(0.00 to 4.91) 1.61(0.00 to 4.75)
Week 28
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
34.17(25.68 to 42.65) 23.53(15.91 to 31.15) 26.05(18.16 to 33.94) 20.49(13.33 to 27.65) 5.00(0.00 to 10.51) 1.75(0.00 to 5.16) 6.35(0.33 to 12.37)
Week 34
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
38.40(29.87 to 46.93) 27.64(19.74 to 35.55) 33.87(25.54 to 42.20) 28.69(20.66 to 36.71) 5.08(0.00 to 10.69) 19.67(9.70 to 29.65) 9.23(2.19 to 16.27)
Week 40
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
39.06(30.61 to 47.51) 33.33(25.00 to 41.66) 39.34(30.68 to 48.01) 30.00(21.80 to 38.20) 6.78(0.36 to 13.19) 23.08(12.83 to 33.32) 15.38(6.61 to 24.16)
Week 48
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
39.53(31.10 to 47.97) 34.43(26.00 to 42.86) 43.20(34.52 to 51.88) 31.15(22.93 to 39.37) 9.84(2.36 to 17.31) 33.85(22.34 to 45.35) 18.75(9.19 to 28.31)
[1]NA Explanation: 95% confidence interval (CI) could not be calculated as there were no participants with SALT score <=20.
[2]NA Explanation: 95% CI could not be calculated as there were no participants with SALT score <=20.
8. Secondary Outcome:
Title Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48
Description SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <=10 were reported.
Time Frame Week 4, 8, 12, 18, 28, 34, 40, and 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 65 66
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
 
Week 4
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
0.78(0.00 to 2.29) 0.00(NA to NA) [1] 0.00(NA to NA) [1] 0.00(NA to NA) [1] 0.00(NA to NA) [1] 0.00(NA to NA) [1] 0.00(NA to NA) [1]
Week 8
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
2.34(0.00 to 4.96) 0.83(0.00 to 2.44) 0.82(0.00 to 2.42) 0.00(NA to NA) [1] 0.00(NA to NA) [1] 0.00(NA to NA) [1] 0.00(NA to NA) [1]
Week 12
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
6.35(2.09 to 10.61) 5.65(1.58 to 9.71) 5.56(1.56 to 9.56) 0.82(0.00 to 2.42) 1.69(0.00 to 4.99) 0.00(NA to NA) [1] 1.59(0.00 to 4.67)
Week 18
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
12.40(6.52 to 18.27) 7.44(2.76 to 12.11) 6.56(2.16 to 10.95) 5.13(1.13 to 9.12) 1.67(0.00 to 4.91) 1.67(0.00 to 4.91) 1.61(0.00 to 4.75)
Week 28
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
29.17(21.03 to 37.30) 16.81(10.09 to 23.53) 18.49(11.51 to 25.46) 16.39(9.82 to 22.96) 3.33(0.00 to 7.88) 1.75(0.00 to 5.16) 3.17(0.00 to 7.50)
Week 34
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
30.40(22.34 to 38.46) 18.70(11.81 to 25.59) 23.39(15.94 to 30.84) 22.13(14.76 to 29.50) 3.39(0.00 to 8.01) 13.11(4.64 to 21.59) 4.62(0.00 to 9.72)
Week 40
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
31.25(23.22 to 39.28) 25.20(17.53 to 32.88) 27.05(19.17 to 34.93) 25.00(17.25 to 32.75) 3.39(0.00 to 8.01) 18.46(9.03 to 27.89) 9.23(2.19 to 16.27)
Week 48
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
33.33(25.20 to 41.47) 27.87(19.91 to 35.82) 31.20(23.08 to 39.32) 25.41(17.68 to 33.14) 6.56(0.35 to 12.77) 24.62(14.14 to 35.09) 14.06(5.55 to 22.58)
[1]NA Explanation: 95% CI could not be calculated as there were no participants with SALT score <=10.
9. Secondary Outcome:
Title Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Description SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score.
Time Frame Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 65 66
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
 
Week 4
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
0.78(0.00 to 2.29) 0.00(NA to NA) [1] 0.00(NA to NA) [1] 0.00(NA to NA) [1] 0.00(NA to NA) [1] 0.00(NA to NA) [1] 0.00(NA to NA) [1]
Week 8
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
4.69(1.03 to 8.35) 3.31(0.12 to 6.49) 1.64(0.00 to 3.89) 0.83(0.00 to 2.44) 0.00(NA to NA) [1] 1.59(0.00 to 4.67) 0.00(NA to NA) [1]
Week 12
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
11.90(6.25 to 17.56) 8.06(3.27 to 12.86) 6.35(2.09 to 10.61) 2.46(0.00 to 5.21) 1.69(0.00 to 4.99) 1.64(0.00 to 4.83) 1.59(0.00 to 4.67)
Week 18
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
20.66(13.45 to 27.88) 14.88(8.54 to 21.22) 9.84(4.55 to 15.12) 11.11(5.42 to 16.81) 1.67(0.00 to 4.91) 1.67(0.00 to 4.91) 1.61(0.00 to 4.75)
Week 24
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
31.45(23.28 to 39.62) 20.66(13.45 to 27.88) 22.58(15.22 to 29.94) 13.45(7.32 to 19.57) 1.69(0.00 to 4.99) 1.54(0.00 to 4.53) 3.08(0.00 to 7.28)
Week 28
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
34.17(25.68 to 42.65) 24.37(16.66 to 32.08) 27.73(19.69 to 35.77) 21.31(14.04 to 28.58) 5.00(0.00 to 10.51) 3.51(0.00 to 8.29) 4.76(0.00 to 10.02)
Week 34
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
38.40(29.87 to 46.93) 32.52(24.24 to 40.80) 38.71(30.14 to 47.28) 28.69(20.66 to 36.71) 5.08(0.00 to 10.69) 21.31(11.03 to 31.59) 10.77(3.23 to 18.31)
Week 40
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
39.84(31.36 to 48.33) 34.96(26.53 to 43.39) 42.62(33.85 to 51.40) 30.00(21.80 to 38.20) 5.08(0.00 to 10.69) 23.08(12.83 to 33.32) 15.38(6.61 to 24.16)
Week 48
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
39.53(31.10 to 47.97) 36.07(27.54 to 44.59) 46.40(37.66 to 55.14) 31.15(22.93 to 39.37) 9.84(2.36 to 17.31) 32.31(20.94 to 43.68) 21.88(11.75 to 32.00)
[1]NA Explanation: 95% CI could not be calculated as there were no participants with at least 75% improvement in SALT score.
10. Secondary Outcome:
Title Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24
Description SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
Time Frame Baseline (Day 1), Week 4, 8, 12, 18, and 24
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
 
Change at Week 4
Number Analyzed Participants Participants Participants Participants Participants Participants
-2.3(-3.64 to -1.01) -2.7(-4.03 to -1.35) -1.8(-3.16 to -0.50) -1.3(-2.60 to 0.06) -1.3(-3.19 to 0.69) -0.9(-2.17 to 0.46)
Change at Week 8
Number Analyzed Participants Participants Participants Participants Participants Participants
-12.8(-15.56 to -10.05) -12.5(-15.28 to -9.71) -6.3(-9.10 to -3.50) -5.0(-7.82 to -2.21) -1.7(-5.74 to 2.34) -1.2(-3.99 to 1.50)
Change at Week 12
Number Analyzed Participants Participants Participants Participants Participants Participants
-22.7(-26.47 to -18.97) -20.1(-23.87 to -16.30) -12.4(-16.18 to -8.61) -10.3(-14.11 to -6.47) -3.5(-9.00 to 1.98) -2.4(-6.12 to 1.35)
Change at Week 18
Number Analyzed Participants Participants Participants Participants Participants Participants
-31.2(-35.63 to -26.83) -25.0(-29.41 to -20.55) -22.5(-26.94 to -18.07) -17.5(-22.02 to -13.02) -2.4(-8.87 to 3.97) -3.9(-8.31 to 0.43)
Change at Week 24
Number Analyzed Participants Participants Participants Participants Participants Participants
-36.5(-41.54 to -31.53) -29.2(-34.21 to -24.15) -33.3(-38.33 to -28.25) -23.6(-28.72 to -18.45) -4.2(-11.50 to 3.13) -5.1(-10.03 to -0.13)
11. Secondary Outcome:
Title Change From Baseline in SALT Score at Week 28, 34, 40, and 48
Description SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
Time Frame Baseline (Day 1), Week 28, 34, 40, and 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.
 
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 65 66
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline
90.3(15.05) 90.5(14.28) 90.3(14.69) 90.0(15.07) 88.3(16.87) 94.4(9.31) 91.5(13.22)
Change at Week 28
-44.1(36.35) -33.3(33.85) -36.1(33.42) -29.2(32.56) -5.6(23.15) -11.5(22.75) -5.0(18.51)
Change at Week 34
-48.2(36.16) -35.5(35.50) -43.6(34.35) -33.5(35.01) -7.6(23.61) -27.5(32.78) -12.6(24.47)
Change at Week 40
-49.3(36.11) -38.5(37.14) -46.9(35.68) -35.9(35.90) -11.4(26.01) -36.5(34.56) -23.0(30.64)
Change at Week 48
-49.4(36.09) -40.5(37.27) -48.9(36.63) -40.1(35.87) -13.3(30.13) -46.3(35.51) -32.2(32.39)
12. Secondary Outcome:
Title Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Description EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows.
Time Frame Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 65 66
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
 
Week 4
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
1.87(0.00 to 4.44) 2.88(0.00 to 6.10) 0.00(NA to NA) [1] 0.93(0.00 to 2.76) 1.96(0.00 to 5.77) 0.00(NA to NA) [1] 3.85(0.00 to 9.07)
Week 8
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
10.28(4.53 to 16.03) 13.86(7.12 to 20.60) 2.97(0.00 to 6.28) 4.90(0.71 to 9.09) 3.85(0.00 to 9.07) 3.77(0.00 to 8.90) 0.00(NA to NA) [1]
Week 12
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
22.86(14.83 to 30.89) 17.48(10.14 to 24.81) 9.62(3.95 to 15.28) 7.62(2.54 to 12.69) 6.25(0.00 to 13.10) 0.00(NA to NA) [1] 4.00(0.00 to 9.43)
Week 18
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
29.70(20.79 to 38.61) 18.81(11.19 to 26.43) 17.82(10.36 to 25.29) 12.87(6.34 to 19.40) 10.20(1.73 to 18.68) 0.00(NA to NA) [1] 8.16(0.50 to 15.83)
Week 24
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
33.98(24.83 to 43.13) 25.49(17.03 to 33.95) 29.00(20.11 to 37.89) 16.67(9.43 to 23.90) 8.33(0.51 to 16.15) 3.64(0.00 to 8.58) 5.77(0.00 to 12.11)
Week 28
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
37.00(27.54 to 46.46) 29.00(20.11 to 37.89) 27.27(18.50 to 36.05) 24.76(16.51 to 33.02) 12.24(3.07 to 21.42) 4.17(0.00 to 9.82) 6.00(0.00 to 12.58)
Week 34
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
41.35(31.88 to 50.81) 30.77(21.90 to 39.64) 34.65(25.37 to 43.93) 31.43(22.55 to 40.31) 14.58(4.60 to 24.57) 15.69(5.71 to 25.67) 13.46(4.18 to 22.74)
Week 40
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
43.40(33.96 to 52.83) 30.39(21.47 to 39.32) 39.00(29.44 to 48.56) 33.65(24.57 to 42.74) 16.00(5.84 to 26.16) 20.00(9.43 to 30.57) 26.92(14.87 to 38.98)
Week 48
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
42.99(33.61 to 52.37) 32.67(23.53 to 41.82) 43.56(33.89 to 53.23) 33.33(24.32 to 42.35) 16.00(5.84 to 26.16) 30.91(18.70 to 43.12) 31.37(18.64 to 44.11)
[1]NA Explanation: 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in EBA.
13. Secondary Outcome:
Title Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Description ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash.
Time Frame Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 65 66
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
 
Week 4
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
3.03(0.00 to 6.41) 1.08(0.00 to 3.17) 5.38(0.79 to 9.96) 1.03(0.00 to 3.04) 4.55(0.00 to 10.70) 2.04(0.00 to 6.00) 0.00(NA to NA) [1]
Week 8
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
9.09(3.43 to 14.75) 4.44(0.19 to 8.70) 8.79(2.97 to 14.61) 4.35(0.18 to 8.51) 2.22(0.00 to 6.53) 2.04(0.00 to 6.00) 0.00(NA to NA) [1]
Week 12
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
16.49(9.11 to 23.88) 10.99(4.56 to 17.41) 11.70(5.20 to 18.20) 7.37(2.11 to 12.62) 4.76(0.00 to 11.20) 0.00(NA to NA) [1] 0.00(NA to NA) [1]
Week 18
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
25.53(16.72 to 34.35) 20.00(11.74 to 28.26) 20.00(11.74 to 28.26) 12.09(5.39 to 18.79) 6.98(0.00 to 14.59) 2.17(0.00 to 6.39) 0.00(NA to NA) [1]
Week 24
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
30.21(21.02 to 39.39) 21.35(12.84 to 29.86) 28.89(19.52 to 38.25) 26.09(17.11 to 35.06) 4.88(0.00 to 11.47) 9.80(1.64 to 17.97) 0.00(NA to NA) [1]
Week 28
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
29.79(20.54 to 39.03) 25.00(15.95 to 34.05) 36.78(26.65 to 46.91) 24.21(15.60 to 32.82) 4.76(0.00 to 11.20) 6.82(0.00 to 14.27) 4.55(0.00 to 10.70)
Week 34
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
34.02(24.59 to 43.45) 26.37(17.32 to 35.43) 38.89(28.82 to 48.96) 26.32(17.46 to 35.17) 7.32(0.00 to 15.29) 16.67(6.12 to 27.21) 6.52(0.00 to 13.66)
Week 40
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
39.80(30.10 to 49.49) 28.09(18.75 to 37.43) 38.20(28.11 to 48.30) 27.66(18.62 to 36.70) 18.60(6.97 to 30.24) 25.49(13.53 to 37.45) 17.39(6.44 to 28.34)
Week 48
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
38.38(28.80 to 47.96) 29.55(20.01 to 39.08) 40.00(29.88 to 50.12) 30.53(21.27 to 39.79) 20.93(8.77 to 33.09) 37.25(23.99 to 50.52) 35.56(21.57 to 49.54)
[1]NA Explanation: 95% CI could not be calculated as there were no participants with at least a 2-grade improvement or a score of 3 in ELA.
14. Secondary Outcome:
Title Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48
Description PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
Time Frame Week 4, 8, 12, 18, 24, 34, 40, and 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 65 66
Measure Type: Number
Unit of Measure: Percentage of participants
 
Week 4: greatly improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
5.43 4.03 2.36
0
0
0
0
Week 4: moderately improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
3.10 11.29 4.72 7.87 1.61 1.59 1.54
Week 8: greatly improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
17.19 14.88 8.13 4.13 1.64 1.59 1.56
Week 8: moderately improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
13.28 21.49 7.32 16.53 4.92 3.17 4.69
Week 12: greatly improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
22.83 22.58 13.60 12.20 3.39
0
3.17
Week 12: moderately improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
18.11 19.35 14.40 14.63 3.39 10.00 7.94
Week 18: greatly improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
27.64 22.31 18.03 19.33 1.64 1.67 3.28
Week 18: moderately improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
23.58 23.97 27.87 15.13 6.56 10.00 4.92
Week 24: greatly improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
36.51 26.45 28.80 28.93 1.67 1.54 4.62
Week 24: moderately improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
16.67 20.66 20.80 13.22 10.00 9.23 3.08
Week 34: greatly improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
43.20 35.54 37.40 31.97 5.08 18.64 7.81
Week 34: moderately improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
12.00 17.36 15.45 15.57 6.78 22.03 20.31
Week 40: greatly improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
43.75 34.68 37.70 30.00 6.78 30.77 13.85
Week 40: moderately improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
15.63 14.52 14.75 19.17 11.86 24.62 15.38
Week 48: greatly improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
44.96 33.33 42.40 31.15 6.56 42.19 26.56
Week 48: moderately improved
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
13.18 18.70 13.60 18.03 9.84 17.19 17.19
15. Secondary Outcome:
Title Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations
Description AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
Time Frame Baseline (Day 1), Week 4, 8, 12, 18, and 24
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specified time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
 
Change at Week 4: emotional symptoms
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.37(-0.49 to -0.25) -0.22(-0.34 to -0.10) -0.33(-0.45 to -0.21) -0.31(-0.44 to -0.19) -0.29(-0.47 to -0.11) -0.28(-0.40 to -0.16)
Change at Week 8: emotional symptoms
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.50(-0.62 to -0.38) -0.46(-0.58 to -0.34) -0.50(-0.62 to -0.37) -0.36(-0.48 to -0.23) -0.45(-0.62 to -0.27) -0.39(-0.51 to -0.27)
Change at Week 12: emotional symptoms
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.53(-0.66 to -0.40) -0.54(-0.67 to -0.41) -0.48(-0.61 to -0.34) -0.49(-0.63 to -0.36) -0.50(-0.69 to -0.31) -0.36(-0.49 to -0.23)
Change at Week 18: emotional symptoms
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.64(-0.78 to -0.51) -0.57(-0.71 to -0.44) -0.60(-0.74 to -0.46) -0.54(-0.68 to -0.40) -0.44(-0.63 to -0.24) -0.43(-0.56 to -0.29)
Change at Week 24: emotional symptoms
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.61(-0.75 to -0.46) -0.61(-0.76 to -0.47) -0.69(-0.83 to -0.54) -0.58(-0.72 to -0.43) -0.49(-0.70 to -0.28) -0.47(-0.61 to -0.33)
Change at Week 4: activity limitations
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.19(-0.29 to -0.08) -0.04(-0.15 to 0.07) -0.16(-0.27 to -0.05) -0.13(-0.24 to -0.02) -0.20(-0.36 to -0.04) -0.18(-0.29 to -0.07)
Change at Week 8: activity limitations
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.24(-0.34 to -0.13) -0.25(-0.36 to -0.14) -0.18(-0.29 to -0.07) -0.09(-0.20 to 0.02) -0.21(-0.37 to -0.05) -0.20(-0.31 to -0.09)
Change at Week 12: activity limitations
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.27(-0.38 to -0.17) -0.22(-0.32 to -0.11) -0.21(-0.32 to -0.11) -0.24(-0.35 to -0.13) -0.27(-0.42 to -0.11) -0.21(-0.32 to -0.11)
Change at Week 18: activity limitations
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.35(-0.45 to -0.24) -0.26(-0.36 to -0.15) -0.23(-0.34 to -0.12) -0.23(-0.34 to -0.12) -0.28(-0.44 to -0.13) -0.26(-0.36 to -0.15)
Change at Week 24: activity limitations
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.30(-0.40 to -0.20) -0.30(-0.40 to -0.20) -0.31(-0.41 to -0.21) -0.28(-0.38 to -0.18) -0.31(-0.45 to -0.16) -0.29(-0.39 to -0.19)
16. Secondary Outcome:
Title Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations
Description AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
Time Frame Baseline (Day 1), Week 34, 40, and 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specified time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 65 66
Mean (Standard Deviation)
Unit of Measure: Units on a scale
 
Change at Week 34: emotional symptoms
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
-0.78(0.95) -0.72(1.00) -0.72(0.93) -0.71(1.06) -0.62(0.83) -0.77(0.92) -0.64(0.91)
Change at Week 40: emotional symptoms
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
-0.84(1.04) -0.80(1.02) -0.81(0.98) -0.83(1.11) -0.62(0.96) -0.83(1.01) -0.66(1.00)
Change at Week 48: emotional symptoms
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
-0.96(0.99) -0.84(1.07) -0.85(1.04) -0.72(1.15) -0.50(0.89) -0.98(1.05) -0.68(1.03)
Change at Week 34: activity limitations
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
-0.37(0.71) -0.31(0.78) -0.26(0.73) -0.37(0.78) -0.33(0.76) -0.36(0.59) -0.42(0.78)
Change at Week 40: activity limitations
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
-0.44(0.76) -0.33(0.84) -0.25(0.68) -0.42(0.81) -0.23(0.71) -0.40(0.66) -0.39(0.84)
Change at Week 48: activity limitations
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
-0.43(0.79) -0.39(0.84) -0.29(0.76) -0.36(0.85) -0.26(0.90) -0.44(0.71) -0.36(0.81)
17. Secondary Outcome:
Title Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48
Description AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on a scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss', where higher scores indicated more hair loss.
Time Frame Week 4, 8, 12, 18, 24, 34, 40, and 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specified time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 65 66
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
 
Week 4: current hair loss on scalp
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
11.38(5.77 to 16.99) 9.76(4.51 to 15.00) 4.17(0.59 to 7.74) 4.84(1.06 to 8.62) 1.69(0.00 to 4.99) 6.35(0.33 to 12.37) 3.17(0.00 to 7.50)
Week 8: current hair loss on scalp
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
11.48(5.82 to 17.13) 16.67(10.00 to 23.33) 7.76(2.89 to 12.63) 8.47(3.45 to 13.50) 1.72(0.00 to 5.07) 4.76(0.00 to 10.02) 8.06(1.29 to 14.84)
Week 12: current hair loss on scalp
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
20.66(13.45 to 27.88) 19.51(12.51 to 26.52) 12.71(6.70 to 18.72) 13.33(7.25 to 19.42) 3.57(0.00 to 8.43) 6.67(0.35 to 12.98) 4.92(0.00 to 10.34)
Week 18: current hair loss on scalp
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
27.35(19.27 to 35.43) 25.00(17.25 to 32.75) 13.79(7.52 to 20.07) 16.38(9.64 to 23.11) 8.62(1.40 to 15.84) 8.33(1.34 to 15.33) 6.78(0.36 to 13.19)
Week 24: current hair loss on scalp
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
35.83(27.25 to 44.41) 30.00(21.80 to 38.20) 26.27(18.33 to 34.21) 24.58(16.81 to 32.34) 5.26(0.00 to 11.06) 10.77(3.23 to 18.31) 6.35(0.33 to 12.37)
Week 34: current hair loss on scalp
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
42.02(33.15 to 50.89) 34.45(25.92 to 42.99) 29.31(21.03 to 37.59) 30.25(22.00 to 38.51) 7.14(0.40 to 13.89) 22.03(11.46 to 32.61) 11.29(3.41 to 19.17)
Week 40: current hair loss on scalp
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
41.80(33.05 to 50.56) 36.59(28.07 to 45.10) 35.65(26.90 to 44.41) 32.48(23.99 to 40.96) 8.93(1.46 to 16.40) 29.23(18.17 to 40.29) 19.05(9.35 to 28.74)
Week 48: current hair loss on scalp
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
42.28(33.55 to 51.01) 33.61(25.22 to 41.99) 42.37(33.46 to 51.29) 32.77(24.34 to 41.21) 8.62(1.40 to 15.84) 33.85(22.34 to 45.35) 20.97(10.83 to 31.10)
Week 4: current hair loss on eyebrows
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
9.09(3.43 to 14.75) 7.14(2.04 to 12.24) 7.45(2.14 to 12.75) 4.17(0.17 to 8.16) 4.35(0.00 to 10.24) 6.25(0.00 to 13.10) 8.70(0.55 to 16.84)
Week 8: current hair loss on eyebrows
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
17.35(9.85 to 24.84) 21.05(12.85 to 29.25) 11.96(5.33 to 18.59) 10.99(4.56 to 17.41) 6.52(0.00 to 13.66) 4.17(0.00 to 9.82) 11.11(1.93 to 20.29)
Week 12: current hair loss on eyebrows
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
27.84(18.92 to 36.75) 27.84(18.92 to 36.75) 18.09(10.30 to 25.87) 15.96(8.55 to 23.36) 11.63(2.05 to 21.21) 11.11(1.93 to 20.29) 6.82(0.00 to 14.27)
Week 18: current hair loss on eyebrows
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
27.66(18.62 to 36.70) 33.68(24.18 to 43.19) 27.47(18.30 to 36.64) 19.78(11.60 to 27.96) 13.33(3.40 to 23.27) 11.11(1.93 to 20.29) 7.14(0.00 to 14.93)
Week 24: current hair loss on eyebrows
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
32.29(22.94 to 41.65) 32.98(23.47 to 42.48) 30.43(21.03 to 39.84) 29.35(20.04 to 38.65) 6.82(0.00 to 14.27) 12.00(2.99 to 21.01) 10.87(1.87 to 19.86)
Week 34: current hair loss on eyebrows
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
42.71(32.81 to 52.60) 38.71(28.81 to 48.61) 38.89(28.82 to 48.96) 31.91(22.49 to 41.34) 16.28(5.24 to 27.31) 22.73(10.34 to 35.11) 13.33(3.40 to 23.27)
Week 40: current hair loss on eyebrows
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
42.27(32.44 to 52.10) 36.84(27.14 to 46.54) 38.89(28.82 to 48.96) 38.04(28.12 to 47.96) 20.00(8.31 to 31.69) 32.00(19.07 to 44.93) 23.91(11.59 to 36.24)
Week 48: current hair loss on eyebrows
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
44.90(35.05 to 54.75) 34.04(24.46 to 43.62) 43.96(33.76 to 54.15) 39.36(29.49 to 49.24) 15.56(4.97 to 26.14) 38.00(24.55 to 51.45) 33.33(19.56 to 47.11)
Week 4: current hair loss on eyelashes
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
11.49(4.79 to 18.20) 4.60(0.20 to 9.00) 7.59(1.75 to 13.44) 9.30(3.16 to 15.44) 5.26(0.00 to 12.36) 8.89(0.57 to 17.20) 5.26(0.00 to 12.36)
Week 8: current hair loss on eyelashes
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
17.44(9.42 to 25.46) 17.65(9.54 to 25.75) 12.82(5.40 to 20.24) 14.81(7.08 to 22.55) 7.89(0.00 to 16.47) 6.67(0.00 to 13.95) 8.11(0.00 to 16.90)
Week 12: current hair loss on eyelashes
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
29.41(19.73 to 39.10) 26.74(17.39 to 36.10) 16.46(8.28 to 24.63) 19.05(10.65 to 27.44) 8.33(0.00 to 17.36) 14.63(3.82 to 25.45) 8.33(0.00 to 17.36)
Week 18: current hair loss on eyelashes
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
31.33(21.35 to 41.30) 37.65(27.35 to 47.95) 21.05(11.89 to 30.22) 22.22(13.17 to 31.28) 7.89(0.00 to 16.47) 12.20(2.18 to 22.21) 2.94(0.00 to 8.62)
Week 24: current hair loss on eyelashes
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
31.40(21.59 to 41.20) 42.17(31.54 to 52.79) 31.17(20.82 to 41.51) 28.05(18.33 to 37.77) 8.33(0.00 to 17.36) 13.04(3.31 to 22.78) 2.63(0.00 to 7.72)
Week 34: current hair loss on eyelashes
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
40.00(29.59 to 50.41) 36.59(26.16 to 47.01) 37.33(26.39 to 48.28) 34.52(24.36 to 44.69) 11.43(0.89 to 21.97) 21.43(9.02 to 33.84) 13.51(2.50 to 24.53)
Week 40: current hair loss on eyelashes
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
43.02(32.56 to 53.49) 39.29(28.84 to 49.73) 32.89(22.33 to 43.46) 36.59(26.16 to 47.01) 10.81(0.81 to 20.82) 28.26(15.25 to 41.27) 13.16(2.41 to 23.91)
Week 48: current hair loss on eyelashes
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
41.86(31.43 to 52.29) 37.35(26.94 to 47.76) 38.16(27.24 to 49.08) 34.52(24.36 to 44.69) 8.11(0.00 to 16.90) 39.13(25.03 to 53.23) 28.95(14.53 to 43.37)
Week 4: current hair loss on body
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
11.46(5.09 to 17.83) 9.28(3.50 to 15.05) 10.42(4.31 to 16.53) 6.38(1.44 to 11.32) 2.13(0.00 to 6.25) 4.26(0.00 to 10.03) 11.36(1.99 to 20.74)
Week 8: current hair loss on body
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
14.74(7.61 to 21.86) 15.96(8.55 to 23.36) 13.98(6.93 to 21.03) 10.11(3.85 to 16.38) 2.17(0.00 to 6.39) 6.38(0.00 to 13.37) 11.63(2.05 to 21.21)
Week 12: current hair loss on body
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
17.02(9.42 to 24.62) 19.15(11.19 to 27.10) 14.89(7.70 to 22.09) 14.29(7.10 to 21.48) 4.44(0.00 to 10.47) 11.36(1.99 to 20.74) 7.14(0.00 to 14.93)
Week 18: current hair loss on body
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
19.78(11.60 to 27.96) 25.00(16.15 to 33.85) 15.05(7.79 to 22.32) 15.91(8.27 to 23.55) 10.64(1.82 to 19.45) 9.09(0.60 to 17.59) 7.50(0.00 to 15.66)
Week 24: current hair loss on body
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
25.81(16.91 to 34.70) 27.96(18.84 to 37.08) 20.43(12.24 to 28.62) 22.22(13.63 to 30.81) 6.67(0.00 to 13.95) 16.33(5.98 to 26.68) 11.36(1.99 to 20.74)
Week 34: current hair loss on body
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
33.33(23.75 to 42.91) 33.70(24.04 to 43.35) 31.52(22.03 to 41.02) 26.09(17.11 to 35.06) 11.36(1.99 to 20.74) 22.73(10.34 to 35.11) 9.30(0.62 to 17.98)
Week 40: current hair loss on body
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
35.11(25.46 to 44.76) 36.17(26.46 to 45.88) 30.77(21.29 to 40.25) 25.56(16.54 to 34.57) 8.70(0.55 to 16.84) 22.45(10.77 to 34.13) 11.36(1.99 to 20.74)
Week 48: current hair loss on body
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
34.74(25.16 to 44.31) 34.41(24.75 to 44.06) 36.56(26.77 to 46.35) 30.43(21.03 to 39.84) 10.87(1.87 to 19.86) 34.69(21.37 to 48.02) 20.45(8.54 to 32.37)
18. Other Pre-specified Outcome:
Title Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24
Description HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1.
Time Frame Baseline (Day 1), Week 4, 8, 12, and 24
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
 
Change at Week 4
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.1(-0.54 to 0.26) -0.4(-0.82 to -0.01) -0.1(-0.48 to 0.33) -0.1(-0.48 to 0.33) -0.3(-0.86 to 0.32) -0.3(-0.73 to 0.07)
Change at Week 8
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.5(-0.89 to -0.06) -0.3(-0.71 to 0.12) -0.2(-0.58 to 0.26) 0.2(-0.25 to 0.59) -0.2(-0.79 to 0.43) -0.3(-0.73 to 0.10)
Change at Week 12
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.6(-1.04 to -0.21) -0.4(-0.81 to 0.03) 0.0(-0.45 to 0.39) 0.1(-0.32 to 0.53) -0.5(-1.07 to 0.15) -0.1(-0.53 to 0.30)
Change at Week 24
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.4(-0.79 to 0.07) -0.8(-1.21 to -0.35) -0.3(-0.70 to 0.16) -0.2(-0.66 to 0.21) -0.4(-1.04 to 0.21) 0.0(-0.46 to 0.39)
19. Other Pre-specified Outcome:
Title Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48
Description HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1.
Time Frame Baseline (Day 1), Week 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 65 66
Mean (Standard Deviation)
Unit of Measure: Units on a scale
 
Baseline
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
2.7(2.60) 3.0(3.16) 2.9(3.00) 2.8(2.99) 2.8(2.80) 3.2(3.36) 3.3(3.54)
Change at Week 48
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
-0.7(2.13) -0.4(3.15) -0.3(2.67) -0.6(2.44) -0.5(2.53) -0.9(3.25) -0.4(3.28)
20. Other Pre-specified Outcome:
Title Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24
Description HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.
Time Frame Baseline (Day 1), Week 4, 8, 12, and 24
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed132 130 130 132 63 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
 
Change at Week 4
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.3(-0.78 to 0.08) -0.4(-0.79 to 0.08) -0.4(-0.79 to 0.08) -0.5(-0.97 to -0.10) -0.6(-1.25 to 0.02) -0.1(-0.54 to 0.32)
Change at Week 8
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.8(-1.25 to -0.31) -0.4(-0.88 to 0.07) -0.8(-1.27 to -0.31) -0.3(-0.79 to 0.17) -0.9(-1.59 to -0.20) -0.5(-0.96 to -0.03)
Change at Week 12
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.7(-1.22 to -0.28) -0.9(-1.40 to -0.46) -0.7(-1.22 to -0.27) -0.3(-0.77 to 0.19) -0.9(-1.55 to -0.17) -0.4(-0.84 to 0.09)
Change at Week 24
Number Analyzed Participants Participants Participants Participants Participants Participants
-0.8(-1.26 to -0.25) -0.7(-1.19 to -0.18) -0.8(-1.28 to -0.27) -0.3(-0.76 to 0.26) -1.0(-1.69 to -0.21) -0.6(-1.06 to -0.07)
21. Other Pre-specified Outcome:
Title Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48
Description HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.
Time Frame Baseline (Day 1), Week 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time point.
 
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed130 130 130 131 63 65 66
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline
4.6(3.84) 4.5(3.18) 4.9(3.31) 4.3(3.42) 5.2(3.38) 5.3(4.20) 5.3(3.70)
Change at Week 48
-1.0(2.92) -0.8(3.10) -0.8(3.09) -0.5(3.40) -1.2(2.89) -1.3(3.31) -0.5(4.53)
22. Other Pre-specified Outcome:
Title Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48
Description HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms.
Time Frame Week 4, 8, 12, 24 and 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time point.
   
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed7 11 13 14 5 5 10
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
 
Week 4
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
42.86(6.20 to 79.52) 60.00(29.64 to 90.36) 53.85(26.75 to 80.95) 42.86(16.93 to 68.78) 40.00(0.00 to 82.94) 60.00(17.06 to 100.00) 50.00(19.01 to 80.99)
Week 8
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
66.67(28.95 to 100.00) 45.45(16.03 to 74.88) 58.33(30.44 to 86.23) 33.33(6.66 to 60.01) 20.00(0.00 to 55.06) 50.00(1.00 to 99.00) 40.00(9.64 to 70.36)
Week 12
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
50.00(9.99 to 90.01) 63.64(35.21 to 92.06) 66.67(39.99 to 93.34) 30.77(5.68 to 55.86) 20.00(0.00 to 55.06) 60.00(17.06 to 100.00) 62.50(28.95 to 96.05)
Week 24
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
71.43(37.96 to 100.00) 63.64(35.21 to 92.06) 41.67(13.77 to 69.56) 42.86(16.93 to 68.78) 50.00(1.00 to 99.00) 50.00(1.00 to 99.00) 50.00(19.01 to 80.99)
Week 48
Number Analyzed Participants Participants Participants Participants Participants Participants Participants
50.00(9.99 to 90.01) 63.64(35.21 to 92.06) 58.33(30.44 to 86.23) 46.15(19.05 to 73.25) 80.00(44.94 to 100.00) 60.00(17.06 to 100.00) 60.00(29.64 to 90.36)
23. Other Pre-specified Outcome:
Title Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48
Description HADS is a validated 14-item PRO measure used to assessed states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms.
Time Frame Week 4, 8, 12, 24 and 48
Outcome Measure Data
Analysis Population Description
FAS included all participants who were randomized, regardless of whether they received study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time point.
 
Arm/Group TitleRitlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group DescriptionParticipants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug .Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug.Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
Overall Number of Participants Analyzed29 22 26 16 15 19 13
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 4
51.72(33.54 to 69.91) 45.45(24.65 to 66.26) 34.62(16.33 to 52.90) 37.50(13.78 to 61.22) 40.00(15.21 to 64.79) 31.58(10.68 to 52.48) 30.77(5.68 to 55.86)
Week 8
46.43(27.96 to 64.90) 50.00(28.09 to 71.91) 68.00(49.71 to 86.29) 41.67(13.77 to 69.56) 71.43(47.76 to 95.09) 33.33(11.56 to 55.11) 46.15(19.05 to 73.25)
Week 12
50.00(31.48 to 68.52) 57.89(35.69 to 80.10) 38.46(19.76 to 57.16) 56.25(31.94 to 80.56) 42.86(16.93 to 68.78) 47.37(24.92 to 69.82) 41.67(13.77 to 69.56)
Week 24
51.85(33.01 to 70.70) 65.00(44.10 to 85.90) 50.00(30.78 to 69.22) 46.67(21.42 to 71.91) 57.14(31.22 to 83.07) 44.44(21.49 to 67.40) 38.46(12.02 to 64.91)
Week 48
53.85(34.68 to 73.01) 66.67(44.89 to 88.44) 60.00(40.80 to 79.20) 50.00(23.81 to 76.19) 61.54(35.09 to 87.98) 57.89(35.69 to 80.10) 58.33(30.44 to 86.23)
Open or close this module Adverse Events
 
Time Frame Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53)
Adverse Event Reporting Description Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
 
Arm/Group Title Ritlecitinib (PF-06651600) 200 mg Then 50 mg Ritlecitinib (PF-06651600) 200 mg Then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
Arm/Group Description Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug . Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
All-Cause Mortality
  Ritlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 0 / 131 (0%)0 / 129 (0%)0 / 130 (0%)0 / 132 (0%)0 / 62 (0%)0 / 65 (0%)0 / 66 (0%)
Serious Adverse Events
  Ritlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 4 / 131 (3.05%)2 / 129 (1.55%)2 / 130 (1.54%)1 / 132 (0.76%)2 / 62 (3.23%)0 / 65 (0%)3 / 66 (4.55%)
Infections and infestations
Appendicitis ∗ A 1 / 131 (0.76%)1 / 129 (0.78%)0 / 130 (0%)0 / 132 (0%)0 / 62 (0%)0 / 65 (0%)0 / 66 (0%)
Diverticulitis ∗ A 0 / 131 (0%)0 / 129 (0%)0 / 130 (0%)1 / 132 (0.76%)0 / 62 (0%)0 / 65 (0%)0 / 66 (0%)
Empyema ∗ A 1 / 131 (0.76%)0 / 129 (0%)0 / 130 (0%)0 / 132 (0%)0 / 62 (0%)0 / 65 (0%)0 / 66 (0%)
Sepsis ∗ A 1 / 131 (0.76%)0 / 129 (0%)0 / 130 (0%)0 / 132 (0%)0 / 62 (0%)0 / 65 (0%)0 / 66 (0%)
Injury, poisoning and procedural complications
Chemical poisoning ∗ A 0 / 131 (0%)1 / 129 (0.78%)0 / 130 (0%)0 / 132 (0%)0 / 62 (0%)0 / 65 (0%)0 / 66 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer ∗ A 0 / 131 (0%)0 / 129 (0%)1 / 130 (0.77%)0 / 132 (0%)0 / 62 (0%)0 / 65 (0%)0 / 66 (0%)
Invasive lobular breast carcinoma ∗ A 1 / 131 (0.76%)0 / 129 (0%)0 / 130 (0%)0 / 132 (0%)0 / 62 (0%)0 / 65 (0%)0 / 66 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous ∗ A 1 / 131 (0.76%)0 / 129 (0%)0 / 130 (0%)0 / 132 (0%)0 / 62 (0%)0 / 65 (0%)1 / 66 (1.52%)
Psychiatric disorders
Conversion disorder ∗ A 0 / 131 (0%)0 / 129 (0%)0 / 130 (0%)0 / 132 (0%)0 / 62 (0%)0 / 65 (0%)1 / 66 (1.52%)
Suicidal behaviour ∗ A 0 / 131 (0%)1 / 129 (0.78%)0 / 130 (0%)0 / 132 (0%)1 / 62 (1.61%)0 / 65 (0%)0 / 66 (0%)
Reproductive system and breast disorders
Heavy menstrual bleeding ∗ A 0 / 131 (0%)0 / 129 (0%)0 / 130 (0%)0 / 132 (0%)0 / 62 (0%)0 / 65 (0%)1 / 66 (1.52%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism ∗ A 0 / 131 (0%)0 / 129 (0%)1 / 130 (0.77%)0 / 132 (0%)0 / 62 (0%)0 / 65 (0%)0 / 66 (0%)
Skin and subcutaneous tissue disorders
Eczema ∗ A 0 / 131 (0%)0 / 129 (0%)0 / 130 (0%)0 / 132 (0%)1 / 62 (1.61%)0 / 65 (0%)0 / 66 (0%)
Indicates events were collected by non-systematic methods.
ATerm from vocabulary, MedDRA v24.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
  Ritlecitinib (PF-06651600) 200 mg Then 50 mgRitlecitinib (PF-06651600) 200 mg Then 30 mgRitlecitinib (PF-06651600) 50 mgRitlecitinib (PF-06651600) 30 mgRitlecitinib (PF-06651600) 10 mgPlacebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mgPlacebo, Ritlecitinib (PF-06651600) 50 mg
 Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)Affected / At Risk (%)
Total 84 / 131 (64.12%)76 / 129 (58.91%)81 / 130 (62.31%)77 / 132 (58.33%)32 / 62 (51.61%)39 / 65 (60%)39 / 66 (59.09%)
Gastrointestinal disorders
Abdominal pain upper ∗ A 1 / 131 (0.76%)5 / 129 (3.88%)5 / 130 (3.85%)3 / 132 (2.27%)0 / 62 (0%)4 / 65 (6.15%)0 / 66 (0%)
Constipation ∗ A 1 / 131 (0.76%)0 / 129 (0%)1 / 130 (0.77%)7 / 132 (5.3%)1 / 62 (1.61%)1 / 65 (1.54%)0 / 66 (0%)
Diarrhoea ∗ A 9 / 131 (6.87%)4 / 129 (3.1%)12 / 130 (9.23%)8 / 132 (6.06%)0 / 62 (0%)4 / 65 (6.15%)1 / 66 (1.52%)
Nausea ∗ A 11 / 131 (8.4%)3 / 129 (2.33%)3 / 130 (2.31%)12 / 132 (9.09%)3 / 62 (4.84%)8 / 65 (12.31%)1 / 66 (1.52%)
Vomiting ∗ A 6 / 131 (4.58%)7 / 129 (5.43%)2 / 130 (1.54%)5 / 132 (3.79%)1 / 62 (1.61%)2 / 65 (3.08%)3 / 66 (4.55%)
General disorders
Fatigue ∗ A 4 / 131 (3.05%)6 / 129 (4.65%)6 / 130 (4.62%)6 / 132 (4.55%)4 / 62 (6.45%)3 / 65 (4.62%)2 / 66 (3.03%)
Infections and infestations
Folliculitis ∗ A 11 / 131 (8.4%)11 / 129 (8.53%)8 / 130 (6.15%)5 / 132 (3.79%)4 / 62 (6.45%)4 / 65 (6.15%)4 / 66 (6.06%)
Influenza ∗ A 8 / 131 (6.11%)1 / 129 (0.78%)3 / 130 (2.31%)3 / 132 (2.27%)3 / 62 (4.84%)1 / 65 (1.54%)0 / 66 (0%)
Nasopharyngitis ∗ A 19 / 131 (14.5%)21 / 129 (16.28%)18 / 130 (13.85%)21 / 132 (15.91%)7 / 62 (11.29%)7 / 65 (10.77%)4 / 66 (6.06%)
Upper respiratory tract infection ∗ A 18 / 131 (13.74%)12 / 129 (9.3%)11 / 130 (8.46%)16 / 132 (12.12%)2 / 62 (3.23%)7 / 65 (10.77%)6 / 66 (9.09%)
Urinary tract infection ∗ A 11 / 131 (8.4%)3 / 129 (2.33%)1 / 130 (0.77%)5 / 132 (3.79%)0 / 62 (0%)4 / 65 (6.15%)2 / 66 (3.03%)
Musculoskeletal and connective tissue disorders
Arthralgia ∗ A 4 / 131 (3.05%)5 / 129 (3.88%)2 / 130 (1.54%)4 / 132 (3.03%)2 / 62 (3.23%)2 / 65 (3.08%)6 / 66 (9.09%)
Myalgia ∗ A 6 / 131 (4.58%)3 / 129 (2.33%)3 / 130 (2.31%)5 / 132 (3.79%)6 / 62 (9.68%)0 / 65 (0%)1 / 66 (1.52%)
Nervous system disorders
Dizziness ∗ A 9 / 131 (6.87%)8 / 129 (6.2%)4 / 130 (3.08%)8 / 132 (6.06%)1 / 62 (1.61%)0 / 65 (0%)2 / 66 (3.03%)
Headache ∗ A 17 / 131 (12.98%)14 / 129 (10.85%)16 / 130 (12.31%)24 / 132 (18.18%)12 / 62 (19.35%)8 / 65 (12.31%)8 / 66 (12.12%)
Psychiatric disorders
Insomnia ∗ A 3 / 131 (2.29%)0 / 129 (0%)2 / 130 (1.54%)1 / 132 (0.76%)1 / 62 (1.61%)1 / 65 (1.54%)4 / 66 (6.06%)
Respiratory, thoracic and mediastinal disorders
Cough ∗ A 6 / 131 (4.58%)0 / 129 (0%)3 / 130 (2.31%)3 / 132 (2.27%)0 / 62 (0%)4 / 65 (6.15%)2 / 66 (3.03%)
Nasal congestion ∗ A 1 / 131 (0.76%)1 / 129 (0.78%)2 / 130 (1.54%)3 / 132 (2.27%)4 / 62 (6.45%)1 / 65 (1.54%)1 / 66 (1.52%)
Oropharyngeal pain ∗ A 4 / 131 (3.05%)6 / 129 (4.65%)6 / 130 (4.62%)1 / 132 (0.76%)0 / 62 (0%)2 / 65 (3.08%)5 / 66 (7.58%)
Skin and subcutaneous tissue disorders
Acne ∗ A 6 / 131 (4.58%)10 / 129 (7.75%)12 / 130 (9.23%)12 / 132 (9.09%)3 / 62 (4.84%)5 / 65 (7.69%)8 / 66 (12.12%)
Pruritus ∗ A 4 / 131 (3.05%)7 / 129 (5.43%)1 / 130 (0.77%)3 / 132 (2.27%)1 / 62 (1.61%)1 / 65 (1.54%)1 / 66 (1.52%)
Rash ∗ A 5 / 131 (3.82%)3 / 129 (2.33%)7 / 130 (5.38%)1 / 132 (0.76%)0 / 62 (0%)1 / 65 (1.54%)1 / 66 (1.52%)
Urticaria ∗ A 9 / 131 (6.87%)9 / 129 (6.98%)7 / 130 (5.38%)5 / 132 (3.79%)1 / 62 (1.61%)4 / 65 (6.15%)4 / 66 (6.06%)
Indicates events were collected by non-systematic methods.
ATerm from vocabulary, MedDRA v24.0
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact:
Name/Official Title:
Pfizer ClinicalTrials.gov Call Center
Organization:
Pfizer Inc.
Phone:
1-800-718-1021
Email:
ClinicalTrials.gov_Inquiries@pfizer.com

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