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PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03732807
Recruitment Status : Completed
First Posted : November 7, 2018
Results First Posted : February 24, 2022
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alopecia Areata
Interventions Drug: PF-06651600 Induction Dose
Drug: PF-06651600 Maintenance Dose #1
Drug: PF-06651600 Maintenance Dose #2
Drug: PF-06651600 Maintenance Dose #3
Drug: Placebo
Enrollment 718
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
Hide 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.
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 Total
Hide 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. Total of all reporting groups
Overall Number of Baseline Participants 132 130 130 132 63 65 66 718
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who were randomized, regardless of whether they received study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants 130 participants 130 participants 132 participants 63 participants 65 participants 66 participants 718 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 Analyzed 132 participants 130 participants 130 participants 132 participants 63 participants 65 participants 66 participants 718 participants
Female
81
  61.4%
85
  65.4%
71
  54.6%
80
  60.6%
43
  68.3%
46
  70.8%
40
  60.6%
446
  62.1%
Male
51
  38.6%
45
  34.6%
59
  45.4%
52
  39.4%
20
  31.7%
19
  29.2%
26
  39.4%
272
  37.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 130 participants 130 participants 132 participants 63 participants 65 participants 66 participants 718 participants
Hispanic or Latino
18
  13.6%
16
  12.3%
11
   8.5%
23
  17.4%
8
  12.7%
7
  10.8%
4
   6.1%
87
  12.1%
Not Hispanic or Latino
113
  85.6%
114
  87.7%
116
  89.2%
109
  82.6%
55
  87.3%
58
  89.2%
61
  92.4%
626
  87.2%
Unknown or Not Reported
1
   0.8%
0
   0.0%
3
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.5%
5
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 130 participants 130 participants 132 participants 63 participants 65 participants 66 participants 718 participants
American Indian or Alaska Native
0
   0.0%
1
   0.8%
0
   0.0%
2
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
3
   0.4%
Asian
33
  25.0%
28
  21.5%
43
  33.1%
34
  25.8%
17
  27.0%
14
  21.5%
17
  25.8%
186
  25.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.6%
0
   0.0%
0
   0.0%
1
   0.1%
Black or African American
6
   4.5%
7
   5.4%
5
   3.8%
3
   2.3%
2
   3.2%
2
   3.1%
2
   3.0%
27
   3.8%
White
92
  69.7%
90
  69.2%
79
  60.8%
91
  68.9%
42
  66.7%
47
  72.3%
47
  71.2%
488
  68.0%
More than one race
0
   0.0%
3
   2.3%
1
   0.8%
2
   1.5%
0
   0.0%
2
   3.1%
0
   0.0%
8
   1.1%
Unknown or Not Reported
1
   0.8%
1
   0.8%
2
   1.5%
0
   0.0%
1
   1.6%
0
   0.0%
0
   0.0%
5
   0.7%
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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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 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 Analyzed 124 121 124 119 59 130
Measure Type: Number
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 200 mg Then 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.000001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 29.11
Confidence Interval (2-Sided) 95%
21.17 to 37.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 200 mg Then 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.000001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 20.78
Confidence Interval (2-Sided) 95%
13.65 to 29.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.000001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 21.85
Confidence Interval (2-Sided) 95%
14.65 to 30.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000154
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 12.75
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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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 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 Analyzed 118 119 119 114 55 125
Measure Type: Number
Unit of Measure: Percentage of participants
21.29 12.87 13.42 10.62 1.65 1.54
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 200 mg Then 50 mg, Placebo
Comments A 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 Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.000001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 19.75
Confidence Interval (2-Sided) 95%
11.91 to 27.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 200 mg Then 30 mg, Placebo
Comments A 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 Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000526
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 11.33
Confidence Interval 95%
4.93 to 17.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 50 mg, Placebo
Comments A 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 Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000311
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 11.88
Confidence Interval 95%
5.42 to 18.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 30 mg, Placebo
Comments A 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 Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002922
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 9.09
Confidence Interval 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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 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 Analyzed 124 121 124 119 59 130
Measure Type: Number
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 200 mg Then 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.000001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 20.24
Confidence Interval 95%
13.23 to 28.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 200 mg Then 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000337
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 11.68
Confidence Interval 95%
5.82 to 19.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000228
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 12.17
Confidence Interval 95%
6.27 to 19.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001875
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 9.39
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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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 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 Analyzed 120 119 120 116 55 125
Measure Type: Number
Unit of Measure: Percentage of participants
52.19 45.40 49.17 41.95 11.36 9.23
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 200 mg Then 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.000001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 42.96
Confidence Interval (2-Sided) 95%
31.68 to 54.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 200 mg Then 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.000001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 36.18
Confidence Interval (2-Sided) 95%
25.22 to 47.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.000001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 39.96
Confidence Interval (2-Sided) 95%
28.85 to 51.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ritlecitinib (PF-06651600) 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.000001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 32.72
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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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 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 Analyzed 124 121 124 119 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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 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 Analyzed 124 121 124 119 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 132 130 130 132 63 65 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 4 Number Analyzed 129 participants 124 participants 127 participants 127 participants 62 participants 63 participants 66 participants
0.78
(0.00 to 2.29)
0.00 [1] 
(NA to NA)
0.00 [2] 
(NA to NA)
0.00 [2] 
(NA to NA)
0.00 [2] 
(NA to NA)
0.00 [2] 
(NA to NA)
0.00 [2] 
(NA to NA)
Week 8 Number Analyzed 128 participants 121 participants 122 participants 121 participants 62 participants 63 participants 64 participants
5.47
(1.53 to 9.41)
4.13
(0.59 to 7.68)
2.46
(0.00 to 5.21)
0.00 [2] 
(NA to NA)
0.00 [2] 
(NA to NA)
0.00 [2] 
(NA to NA)
0.00 [2] 
(NA to NA)
Week 12 Number Analyzed 126 participants 124 participants 126 participants 122 participants 59 participants 61 participants 63 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 121 participants 121 participants 122 participants 117 participants 60 participants 60 participants 62 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 120 participants 119 participants 119 participants 122 participants 60 participants 57 participants 63 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 125 participants 123 participants 124 participants 122 participants 59 participants 61 participants 65 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 128 participants 123 participants 122 participants 120 participants 59 participants 65 participants 65 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 129 participants 122 participants 125 participants 122 participants 61 participants 65 participants 64 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]
95% confidence interval (CI) could not be calculated as there were no participants with SALT score <=20.
[2]
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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 132 130 130 132 63 65 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 4 Number Analyzed 129 participants 124 participants 127 participants 127 participants 62 participants 63 participants 66 participants
0.78
(0.00 to 2.29)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 8 Number Analyzed 128 participants 121 participants 122 participants 121 participants 62 participants 63 participants 64 participants
2.34
(0.00 to 4.96)
0.83
(0.00 to 2.44)
0.82
(0.00 to 2.42)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 12 Number Analyzed 126 participants 124 participants 126 participants 122 participants 59 participants 61 participants 63 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 [1] 
(NA to NA)
1.59
(0.00 to 4.67)
Week 18 Number Analyzed 121 participants 121 participants 122 participants 117 participants 60 participants 60 participants 62 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 120 participants 119 participants 119 participants 122 participants 60 participants 57 participants 63 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 125 participants 123 participants 124 participants 122 participants 59 participants 61 participants 65 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 128 participants 123 participants 122 participants 120 participants 59 participants 65 participants 65 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 129 participants 122 participants 125 participants 122 participants 61 participants 65 participants 64 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]
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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 132 130 130 132 63 65 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 4 Number Analyzed 129 participants 124 participants 127 participants 127 participants 62 participants 63 participants 66 participants
0.78
(0.00 to 2.29)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 8 Number Analyzed 128 participants 121 participants 122 participants 121 participants 62 participants 63 participants 64 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 [1] 
(NA to NA)
1.59
(0.00 to 4.67)
0.00 [1] 
(NA to NA)
Week 12 Number Analyzed 126 participants 124 participants 126 participants 122 participants 59 participants 61 participants 63 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 121 participants 121 participants 122 participants 117 participants 60 participants 60 participants 62 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 124 participants 121 participants 124 participants 119 participants 59 participants 65 participants 65 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 120 participants 119 participants 119 participants 122 participants 60 participants 57 participants 63 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 125 participants 123 participants 124 participants 122 participants 59 participants 61 participants 65 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 128 participants 123 participants 122 participants 120 participants 59 participants 65 participants 65 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 129 participants 122 participants 125 participants 122 participants 61 participants 65 participants 64 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]
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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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 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 Analyzed 132 130 130 132 63 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Change at Week 4 Number Analyzed 127 participants 121 participants 124 participants 124 participants 58 participants 127 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 124 participants 119 participants 117 participants 115 participants 57 participants 124 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 121 participants 120 participants 121 participants 115 participants 56 participants 122 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 117 participants 119 participants 117 participants 112 participants 56 participants 119 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 118 participants 119 participants 119 participants 114 participants 55 participants 125 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 132 130 130 132 63 65 66
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 132 participants 130 participants 130 participants 132 participants 63 participants 65 participants 66 participants
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 Number Analyzed 109 participants 113 participants 111 participants 115 participants 55 participants 54 participants 59 participants
-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 Number Analyzed 113 participants 118 participants 117 participants 115 participants 54 participants 59 participants 61 participants
-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 Number Analyzed 116 participants 118 participants 113 participants 109 participants 54 participants 61 participants 60 participants
-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 Number Analyzed 114 participants 112 participants 116 participants 107 participants 53 participants 60 participants 59 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 132 130 130 132 63 65 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 4 Number Analyzed 107 participants 104 participants 104 participants 107 participants 51 participants 53 participants 52 participants
1.87
(0.00 to 4.44)
2.88
(0.00 to 6.10)
0.00 [1] 
(NA to NA)
0.93
(0.00 to 2.76)
1.96
(0.00 to 5.77)
0.00 [1] 
(NA to NA)
3.85
(0.00 to 9.07)
Week 8 Number Analyzed 107 participants 101 participants 101 participants 102 participants 52 participants 53 participants 51 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 [1] 
(NA to NA)
Week 12 Number Analyzed 105 participants 103 participants 104 participants 105 participants 48 participants 51 participants 50 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 [1] 
(NA to NA)
4.00
(0.00 to 9.43)
Week 18 Number Analyzed 101 participants 101 participants 101 participants 101 participants 49 participants 50 participants 49 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 [1] 
(NA to NA)
8.16
(0.50 to 15.83)
Week 24 Number Analyzed 103 participants 102 participants 100 participants 102 participants 48 participants 55 participants 52 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 100 participants 100 participants 99 participants 105 participants 49 participants 48 participants 50 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 104 participants 104 participants 101 participants 105 participants 48 participants 51 participants 52 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 106 participants 102 participants 100 participants 104 participants 50 participants 55 participants 52 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 107 participants 101 participants 101 participants 105 participants 50 participants 55 participants 51 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]
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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 132 130 130 132 63 65 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 4 Number Analyzed 99 participants 93 participants 93 participants 97 participants 44 participants 49 participants 46 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 [1] 
(NA to NA)
Week 8 Number Analyzed 99 participants 90 participants 91 participants 92 participants 45 participants 49 participants 45 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 [1] 
(NA to NA)
Week 12 Number Analyzed 97 participants 91 participants 94 participants 95 participants 42 participants 47 participants 44 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 [1] 
(NA to NA)
0.00 [1] 
(NA to NA)
Week 18 Number Analyzed 94 participants 90 participants 90 participants 91 participants 43 participants 46 participants 43 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 [1] 
(NA to NA)
Week 24 Number Analyzed 96 participants 89 participants 90 participants 92 participants 41 participants 51 participants 46 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 [1] 
(NA to NA)
Week 28 Number Analyzed 94 participants 88 participants 87 participants 95 participants 42 participants 44 participants 44 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 97 participants 91 participants 90 participants 95 participants 41 participants 48 participants 46 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 98 participants 89 participants 89 participants 94 participants 43 participants 51 participants 46 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 99 participants 88 participants 90 participants 95 participants 43 participants 51 participants 45 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]
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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 132 130 130 132 63 65 66
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4: greatly improved Number Analyzed 129 participants 124 participants 127 participants 127 participants 62 participants 63 participants 65 participants
5.43 4.03 2.36 0 0 0 0
Week 4: moderately improved Number Analyzed 129 participants 124 participants 127 participants 127 participants 62 participants 63 participants 65 participants
3.10 11.29 4.72 7.87 1.61 1.59 1.54
Week 8: greatly improved Number Analyzed 128 participants 121 participants 123 participants 121 participants 61 participants 63 participants 64 participants
17.19 14.88 8.13 4.13 1.64 1.59 1.56
Week 8: moderately improved Number Analyzed 128 participants 121 participants 123 participants 121 participants 61 participants 63 participants 64 participants
13.28 21.49 7.32 16.53 4.92 3.17 4.69
Week 12: greatly improved Number Analyzed 127 participants 124 participants 125 participants 123 participants 59 participants 60 participants 63 participants
22.83 22.58 13.60 12.20 3.39 0 3.17
Week 12: moderately improved Number Analyzed 127 participants 124 participants 125 participants 123 participants 59 participants 60 participants 63 participants
18.11 19.35 14.40 14.63 3.39 10.00 7.94
Week 18: greatly improved Number Analyzed 123 participants 121 participants 122 participants 119 participants 61 participants 60 participants 61 participants
27.64 22.31 18.03 19.33 1.64 1.67 3.28
Week 18: moderately improved Number Analyzed 123 participants 121 participants 122 participants 119 participants 61 participants 60 participants 61 participants
23.58 23.97 27.87 15.13 6.56 10.00 4.92
Week 24: greatly improved Number Analyzed 126 participants 121 participants 125 participants 121 participants 60 participants 65 participants 65 participants
36.51 26.45 28.80 28.93 1.67 1.54 4.62
Week 24: moderately improved Number Analyzed 126 participants 121 participants 125 participants 121 participants 60 participants 65 participants 65 participants
16.67 20.66 20.80 13.22 10.00 9.23 3.08
Week 34: greatly improved Number Analyzed 125 participants 121 participants 123 participants 122 participants 59 participants 59 participants 64 participants
43.20 35.54 37.40 31.97 5.08 18.64 7.81
Week 34: moderately improved Number Analyzed 125 participants 121 participants 123 participants 122 participants 59 participants 59 participants 64 participants
12.00 17.36 15.45 15.57 6.78 22.03 20.31
Week 40: greatly improved Number Analyzed 128 participants 124 participants 122 participants 120 participants 59 participants 65 participants 65 participants
43.75 34.68 37.70 30.00 6.78 30.77 13.85
Week 40: moderately improved Number Analyzed 128 participants 124 participants 122 participants 120 participants 59 participants 65 participants 65 participants
15.63 14.52 14.75 19.17 11.86 24.62 15.38
Week 48: greatly improved Number Analyzed 129 participants 123 participants 125 participants 122 participants 61 participants 64 participants 64 participants
44.96 33.33 42.40 31.15 6.56 42.19 26.56
Week 48: moderately improved Number Analyzed 129 participants 123 participants 125 participants 122 participants 61 participants 64 participants 64 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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 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 Analyzed 132 130 130 132 63 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Change at Week 4: emotional symptoms Number Analyzed 127 participants 121 participants 123 participants 122 participants 58 participants 124 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 122 participants 119 participants 117 participants 115 participants 56 participants 123 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 122 participants 120 participants 119 participants 116 participants 56 participants 121 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 118 participants 119 participants 116 participants 114 participants 57 participants 118 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 120 participants 118 participants 119 participants 116 participants 55 participants 125 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 127 participants 121 participants 123 participants 122 participants 58 participants 125 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 122 participants 119 participants 117 participants 115 participants 56 participants 123 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 122 participants 120 participants 119 participants 116 participants 56 participants 121 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 118 participants 119 participants 116 participants 114 participants 57 participants 118 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 120 participants 118 participants 119 participants 115 participants 55 participants 125 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 132 130 130 132 63 65 66
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 34: emotional symptoms Number Analyzed 112 participants 116 participants 114 participants 113 participants 53 participants 57 participants 60 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 115 participants 119 participants 112 participants 110 participants 54 participants 62 participants 60 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 114 participants 112 participants 115 participants 107 participants 53 participants 60 participants 59 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 112 participants 116 participants 114 participants 115 participants 53 participants 57 participants 60 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 115 participants 119 participants 112 participants 110 participants 54 participants 62 participants 60 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 114 participants 112 participants 115 participants 107 participants 53 participants 60 participants 59 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 132 130 130 132 63 65 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 4: current hair loss on scalp Number Analyzed 123 participants 123 participants 120 participants 124 participants 59 participants 63 participants 63 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 122 participants 120 participants 116 participants 118 participants 58 participants 63 participants 62 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 121 participants 123 participants 118 participants 120 participants 56 participants 60 participants 61 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 117 participants 120 participants 116 participants 116 participants 58 participants 60 participants 59 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 120 participants 120 participants 118 participants 118 participants 57 participants 65 participants 63 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 119 participants 119 participants 116 participants 119 participants 56 participants 59 participants 62 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 122 participants 123 participants 115 participants 117 participants 56 participants 65 participants 63 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 123 participants 122 participants 118 participants 119 participants 58 participants 65 participants 62 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 99 participants 98 participants 94 participants 96 participants 46 participants 48 participants 46 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 98 participants 95 participants 92 participants 91 participants 46 participants 48 participants 45 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 97 participants 97 participants 94 participants 94 participants 43 participants 45 participants 44 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 94 participants 95 participants 91 participants 91 participants 45 participants 45 participants 42 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 96 participants 94 participants 92 participants 92 participants 44 participants 50 participants 46 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 96 participants 93 participants 90 participants 94 participants 43 participants 44 participants 45 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 97 participants 95 participants 90 participants 92 participants 45 participants 50 participants 46 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 98 participants 94 participants 91 participants 94 participants 45 participants 50 participants 45 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 87 participants 87 participants 79 participants 86 participants 38 participants 45 participants 38 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 86 participants 85 participants 78 participants 81 participants 38 participants 45 participants 37 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 85 participants 86 participants 79 participants 84 participants 36 participants 41 participants 36 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 83 participants 85 participants 76 participants 81 participants 38 participants 41 participants 34 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 86 participants 83 participants 77 participants 82 participants 36 participants 46 participants 38 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 85 participants 82 participants 75 participants 84 participants 35 participants 42 participants 37 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 86 participants 84 participants 76 participants 82 participants 37 participants 46 participants 38 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 86 participants 83 participants 76 participants 84 participants 37 participants 46 participants 38 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 96 participants 97 participants 96 participants 94 participants 47 participants 47 participants 44 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 95 participants 94 participants 93 participants 89 participants 46 participants 47 participants 43 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 94 participants 94 participants 94 participants 91 participants 45 participants 44 participants 42 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 91 participants 92 participants 93 participants 88 participants 47 participants 44 participants 40 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 93 participants 93 participants 93 participants 90 participants 45 participants 49 participants 44 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 93 participants 92 participants 92 participants 92 participants 44 participants 44 participants 43 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 94 participants 94 participants 91 participants 90 participants 46 participants 49 participants 44 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 95 participants 93 participants 93 participants 92 participants 46 participants 49 participants 44 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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 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 Analyzed 132 130 130 132 63 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Change at Week 4 Number Analyzed 126 participants 120 participants 123 participants 121 participants 58 participants 125 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 124 participants 119 participants 118 participants 114 participants 56 participants 124 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 121 participants 119 participants 119 participants 114 participants 56 participants 120 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 120 participants 118 participants 120 participants 116 participants 56 participants 124 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 132 130 130 132 63 65 66
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 131 participants 130 participants 130 participants 131 participants 63 participants 65 participants 66 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 118 participants 118 participants 117 participants 111 participants 55 participants 59 participants 60 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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 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 Analyzed 132 130 130 132 63 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Change at Week 4 Number Analyzed 125 participants 119 participants 123 participants 121 participants 58 participants 125 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 123 participants 119 participants 118 participants 114 participants 56 participants 123 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 120 participants 119 participants 119 participants 114 participants 56 participants 121 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 119 participants 118 participants 120 participants 115 participants 56 participants 124 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 130 130 130 131 63 65 66
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 130 participants 130 participants 130 participants 131 participants 63 participants 65 participants 66 participants
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 Number Analyzed 117 participants 118 participants 117 participants 111 participants 55 participants 59 participants 60 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 7 11 13 14 5 5 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 4 Number Analyzed 7 participants 10 participants 13 participants 14 participants 5 participants 5 participants 10 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 6 participants 11 participants 12 participants 12 participants 5 participants 4 participants 10 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 6 participants 11 participants 12 participants 13 participants 5 participants 5 participants 8 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 7 participants 11 participants 12 participants 14 participants 4 participants 4 participants 10 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 6 participants 11 participants 12 participants 13 participants 5 participants 5 participants 10 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
Hide 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
Hide Outcome Measure Data
Hide 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 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
Hide 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.
Overall Number of Participants Analyzed 29 22 26 16 15 19 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 4 Number Analyzed 29 participants 22 participants 26 participants 16 participants 15 participants 19 participants 13 participants
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 Number Analyzed 28 participants 20 participants 25 participants 12 participants 14 participants 18 participants 13 participants
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 Number Analyzed 28 participants 19 participants 26 participants 16 participants 14 participants 19 participants 12 participants
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 Number Analyzed 27 participants 20 participants 26 participants 15 participants 14 participants 18 participants 13 participants
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 Number Analyzed 26 participants 18 participants 25 participants 14 participants 13 participants 19 participants 12 participants
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)
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
Hide 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 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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/129 (0.00%)   0/130 (0.00%)   0/132 (0.00%)   0/62 (0.00%)   0/65 (0.00%)   0/66 (0.00%) 
Hide Serious Adverse Events
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
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 (0.00%)   3/66 (4.55%) 
Infections and infestations               
Appendicitis * 1  1/131 (0.76%)  1/129 (0.78%)  0/130 (0.00%)  0/132 (0.00%)  0/62 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Diverticulitis * 1  0/131 (0.00%)  0/129 (0.00%)  0/130 (0.00%)  1/132 (0.76%)  0/62 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Empyema * 1  1/131 (0.76%)  0/129 (0.00%)  0/130 (0.00%)  0/132 (0.00%)  0/62 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Sepsis * 1  1/131 (0.76%)  0/129 (0.00%)  0/130 (0.00%)  0/132 (0.00%)  0/62 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Injury, poisoning and procedural complications               
Chemical poisoning * 1  0/131 (0.00%)  1/129 (0.78%)  0/130 (0.00%)  0/132 (0.00%)  0/62 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Breast cancer * 1  0/131 (0.00%)  0/129 (0.00%)  1/130 (0.77%)  0/132 (0.00%)  0/62 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Invasive lobular breast carcinoma * 1  1/131 (0.76%)  0/129 (0.00%)  0/130 (0.00%)  0/132 (0.00%)  0/62 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Pregnancy, puerperium and perinatal conditions               
Abortion spontaneous * 1  1/131 (0.76%)  0/129 (0.00%)  0/130 (0.00%)  0/132 (0.00%)  0/62 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Psychiatric disorders               
Conversion disorder * 1  0/131 (0.00%)  0/129 (0.00%)  0/130 (0.00%)  0/132 (0.00%)  0/62 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Suicidal behaviour * 1  0/131 (0.00%)  1/129 (0.78%)  0/130 (0.00%)  0/132 (0.00%)  1/62 (1.61%)  0/65 (0.00%)  0/66 (0.00%) 
Reproductive system and breast disorders               
Heavy menstrual bleeding * 1  0/131 (0.00%)  0/129 (0.00%)  0/130 (0.00%)  0/132 (0.00%)  0/62 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Respiratory, thoracic and mediastinal disorders               
Pulmonary embolism * 1  0/131 (0.00%)  0/129 (0.00%)  1/130 (0.77%)  0/132 (0.00%)  0/62 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Skin and subcutaneous tissue disorders               
Eczema * 1  0/131 (0.00%)  0/129 (0.00%)  0/130 (0.00%)  0/132 (0.00%)  1/62 (1.61%)  0/65 (0.00%)  0/66 (0.00%) 
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
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 (60.00%)   39/66 (59.09%) 
Gastrointestinal disorders               
Abdominal pain upper * 1  1/131 (0.76%)  5/129 (3.88%)  5/130 (3.85%)  3/132 (2.27%)  0/62 (0.00%)  4/65 (6.15%)  0/66 (0.00%) 
Constipation * 1  1/131 (0.76%)  0/129 (0.00%)  1/130 (0.77%)  7/132 (5.30%)  1/62 (1.61%)  1/65 (1.54%)  0/66 (0.00%) 
Diarrhoea * 1  9/131 (6.87%)  4/129 (3.10%)  12/130 (9.23%)  8/132 (6.06%)  0/62 (0.00%)  4/65 (6.15%)  1/66 (1.52%) 
Nausea * 1  11/131 (8.40%)  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 * 1  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 * 1  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 * 1  11/131 (8.40%)  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 * 1  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 (0.00%) 
Nasopharyngitis * 1  19/131 (14.50%)  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 * 1  18/131 (13.74%)  12/129 (9.30%)  11/130 (8.46%)  16/132 (12.12%)  2/62 (3.23%)  7/65 (10.77%)  6/66 (9.09%) 
Urinary tract infection * 1  11/131 (8.40%)  3/129 (2.33%)  1/130 (0.77%)  5/132 (3.79%)  0/62 (0.00%)  4/65 (6.15%)  2/66 (3.03%) 
Musculoskeletal and connective tissue disorders               
Arthralgia * 1  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 * 1  6/131 (4.58%)  3/129 (2.33%)  3/130 (2.31%)  5/132 (3.79%)  6/62 (9.68%)  0/65 (0.00%)  1/66 (1.52%) 
Nervous system disorders               
Dizziness * 1  9/131 (6.87%)  8/129 (6.20%)  4/130 (3.08%)  8/132 (6.06%)  1/62 (1.61%)  0/65 (0.00%)  2/66 (3.03%) 
Headache * 1  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 * 1  3/131 (2.29%)  0/129 (0.00%)  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 * 1  6/131 (4.58%)  0/129 (0.00%)  3/130 (2.31%)  3/132 (2.27%)  0/62 (0.00%)  4/65 (6.15%)  2/66 (3.03%) 
Nasal congestion * 1  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 * 1  4/131 (3.05%)  6/129 (4.65%)  6/130 (4.62%)  1/132 (0.76%)  0/62 (0.00%)  2/65 (3.08%)  5/66 (7.58%) 
Skin and subcutaneous tissue disorders               
Acne * 1  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 * 1  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 * 1  5/131 (3.82%)  3/129 (2.33%)  7/130 (5.38%)  1/132 (0.76%)  0/62 (0.00%)  1/65 (1.54%)  1/66 (1.52%) 
Urticaria * 1  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%) 
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators 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
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03732807    
Other Study ID Numbers: B7981015
2018-001714-14 ( EudraCT Number )
ALLEGRO 2B/3 ( Other Identifier: Alias Study Number )
First Submitted: November 5, 2018
First Posted: November 7, 2018
Results First Submitted: December 16, 2021
Results First Posted: February 24, 2022
Last Update Posted: February 24, 2022