Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata

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ClinicalTrials.gov Identifier: NCT02974868

Recruitment Status : Completed

First Posted : November 29, 2016

Results First Posted : May 26, 2020

Last Update Posted : May 26, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Pfizer

Study Description

Brief Summary:

This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 113 weeks. This includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind) Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension Period and a 4 week Follow up Period.

Condition or disease	Intervention/treatment	Phase
Alopecia Areata	Drug: PF-06651600 Drug: PF-06700841 Drug: Placebo	Phase 2

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	142 participants
Allocation:	Randomized
Intervention Model Description:	The first 24 weeks are parallel. The single-blind extension period will have a segment for non-responder and a withdrawal/retreatment segment for responder. The cross-over extension period is parallel for non-responders.
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A PHASE 2A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE ALOPECIA AREATA WITH A SINGLE-BLIND EXTENSION PERIOD AND A CROSS-OVER OPEN LABEL EXTENSION PERIOD
Actual Study Start Date :	December 15, 2016
Actual Primary Completion Date :	May 15, 2019
Actual Study Completion Date :	May 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Alopecia areata

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1 PF-06651600	Drug: PF-06651600 200 mg QD during induction and 50 mg QD during Maintenance
Experimental: Cohort 2 PF-06700841	Drug: PF-06700841 60 mg QD during induction and 30 mg QD during maintenance
Placebo Comparator: Cohort placebo placebo	Drug: Placebo Placebo

Outcome Measures

Primary Outcome Measures :

Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 [ Time Frame: Baseline, Week24 ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. Score range: 0-100%. Higher score indicates more severe disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline signifies an improvement. Baseline is defined as the last measurement prior to first dosing (Day 1).
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period [ Time Frame: Week 28 up to Week 52 ]
An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators. Arms end with "withdrawal Segment" and "retreatment segment" described the same population while in different treatment segment .The reason why count on PF-06700841 differ by 1 participant is that 1 responder directly entered the retreatment segment and skipped the withdrawal segment.
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period [ Time Frame: COE day 1 up to end of study ]
An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.
Number of Participants With Laboratory Abnormalities During SBE Period [ Time Frame: Week 28 up to Week 52 for non-responders and responders in the withdrawal segment, AT day 1 up to AT Week 24 for retreatment segment (AT=active treatment) ]
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.
Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period [ Time Frame: COE day 1 up to end of study ]
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.

Secondary Outcome Measures :

Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants [ Time Frame: Baseline, Week 24 ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Alopecia totalis (AT): derived as SALT score = 100% at baseline only. Alopecia universalis (AU): derived as SALT score = 100% and both eyelash and eyebrow assessments were "none" at baseline.
Percentage of Participants Achieving SALT 30 at Week 24 [ Time Frame: Baseline, Week 24 ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The 90% CI was calculated using Chan and Zhang method.
Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period) [ Time Frame: Baseline, Weeks 2,4,6,8,12,16,20,24 ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.
Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period) [ Time Frame: Baseline, Weeks 2,4,6,8,12,16,20,24 ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Percent change from baseline is defined as SALT baseline value minus SALT value at a specific visit divided by baseline and multiplying by 100. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.
Percentage of Participants Achieving SALT 30 Across Time (Treatment Period) [ Time Frame: Baseline, Weeks 2,4,6,8,12,16,20,24 ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 50 Across Time (Treatment Period) [ Time Frame: Baseline, Weeks 2,4,6,8,12,16,20,24 ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 75 Across Time (Treatment Period) [ Time Frame: Baseline, Weeks 2,4,6,8,12,16,20,24 ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 90 Across Time (Treatment Period) [ Time Frame: Baseline, Weeks 2,4,6,8,12,16,20,24 ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 100 Across Time (Treatment Period) [ Time Frame: Baseline, Weeks 2,4,6,8,12,16,20,24 ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Number of Participants With the IGA Score Change (Treatment Period) [ Time Frame: baseline, Week 2,4,6,8,12,16,20,24 ]
The clinical evaluator of alopecia areata (AA) will perform an assessment of the overall improvement of AA and assign an Investigator Global Assessment (IGA) score(ranging from 0 to 5) with higher score representing higher regrowth rate. Baseline is defined as the last measurement prior to first dosing (Day 1).
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Treatment Period [ Time Frame: baseline up to Week 24 ]
An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.
Number of Participants With Laboratory Abnormalities During Treatment Period [ Time Frame: Baseline up to Week 24 ]
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.
Time to Achieve the Retreatment Criteria During the Withdrawal/Retreatment Part of the Extension Period Among Subjects Who Achieved Primary Endpoint at Week 24 (SBE Period) [ Time Frame: Week 24 up to Week 52 ]
Time to re-treatment (weeks) = (date of re-treatment criteria met - date at Week 24 +1)/7. The calendar time to retreatment was calculated. Baseline is defined as Week 24 measurement. The duration in Drug Holiday #1 (ranging from 2-6 weeks) is counted in the Kaplan-Meier analysis. One subject directly entered the re-treatment period and hence is censored at baseline in the Kaplan-Meier analysis.
Change From Baseline in SALT Across Time (SBE Period) [ Time Frame: Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment) ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% confidence interval in this outcome measurement is the LSM and 90%CI for difference from initial 24-week treatment period placebo respectively.
Percentage of Participants Achieving SALT 30 Across Time (SBE Period) [ Time Frame: Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment) ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 50 Across Time (SBE Period) [ Time Frame: Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment) ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 75 Across Time (SBE Period) [ Time Frame: Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment) ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 90 Across Time (SBE Period) [ Time Frame: Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment) ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Percentage of Participants Achieving SALT 100 Across Time (SBE Period) [ Time Frame: Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment) ]
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
Must have moderate to severe alopecia areata:

Exclusion Criteria:

History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
Infected with hepatitis B or hepatitis C viruses.
Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Have received any of the following treatment regiments specified in the timeframes outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal medications with unknown properties or known beneficial effects for AA.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974868

Locations

Show 55 study locations

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United States, Alabama
University of Alabama at Birmingham, Dermatology at the Whitaker Clinic
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, United States, 35233
United States, California
Southern California Dermatology, Inc.
Santa Ana, California, United States, 92701
Clinical Science Institute
Santa Monica, California, United States, 90404
Office of F. Monte Purcelli
Santa Monica, California, United States, 90404
Tower Saint John's Imaging
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Hospital Clinical and Translational Research Center, Inpatient Unit
Aurora, Colorado, United States, 80045
University of Colorado Hospital Clinical and Translational Research Center, Outpatient Clinic
Aurora, Colorado, United States, 80045
University of Colorado Hospital, Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Investigational Drug Services
New Haven, Connecticut, United States, 06511
Church Street Research Unit
New Haven, Connecticut, United States, 06519
Yale Hearing and Balance Center
New Haven, Connecticut, United States, 06519
Yale New Haven Hospital
New Haven, Connecticut, United States, 06519
United States, Florida
Park Avenue Dermatology Administrative Annex
Orange Park, Florida, United States, 32073
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
Edward B. Kampsen, MD
Tampa, Florida, United States, 33609
Olympian Clinical Research
Tampa, Florida, United States, 33609
Rose Radiology
Tampa, Florida, United States, 33609
Forward Clinical Trials, Inc
Tampa, Florida, United States, 33624
United States, Georgia
MedaPhase Inc.
Newnan, Georgia, United States, 30263
United States, Illinois
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, United States, 60077
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Clinical Unit for Research Trials in Skin (CURTIS)
Boston, Massachusetts, United States, 02114
United States, New York
Weill Cornell Medicine
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Mount Sinai Department of Otolaryngology
New York, New York, United States, 10029
Rockefeller University Hospital
New York, New York, United States, 10065
Investigational Drug Service
Rochester, New York, United States, 14642
University of Rochester Audiology
Rochester, New York, United States, 14642
University of Rochester Medical Center
Rochester, New York, United States, 14642
University of Rochester Radiology
Rochester, New York, United States, 14642
United States, Oklahoma
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States, 74136
United States, South Dakota
Health Concepts
Rapid City, South Dakota, United States, 57702
United States, Utah
University of Utah MidValley Dermatology
Murray, Utah, United States, 84107
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23502
Australia, New South Wales
Hearing Life
Hurstville, New South Wales, Australia, 2220
Dr. Glen and Partners Medical Imaging
Kogarah, New South Wales, Australia, 2217
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, Australia, 2217
St. George Hearing and Balance Clinic
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
The Skin Centre
Benowa, Queensland, Australia, 4217
Veracity Clinical Research
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Skin & Cancer Foundation Inc.
Carlton, Victoria, Australia, 3053
Sinclair Dermatology
East Melbourne, Victoria, Australia, 3002
Bridge Road Imag ing
Richmond, Victoria, Australia, 3121
Richmond Audiology
Richmond, Victoria, Australia, 3121
Canada, Manitoba
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada, R3M 3Z4
Canada, Ontario
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1X2
Research by ICLS
Oakville, Ontario, Canada, L6J 7W5
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 5K2
The Centre for Dermatology
Richmond Hill, Ontario, Canada, L4B 1A5
York Dermatology Center
Richmond Hill, Ontario, Canada, L4C 9M7

Sponsors and Collaborators

Pfizer

Investigators

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Study Director:	Pfizer CT.gov Call Center	Pfizer

Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol [PDF] June 6, 2018

Statistical Analysis Plan [PDF] June 12, 2018

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.

Peeva E, Guttman-Yassky E, Banerjee A, Sinclair R, Cox LA, Zhu L, Zhu H, Vincent M, King B. Maintenance, withdrawal, and re-treatment with ritlecitinib and brepocitinib in patients with alopecia areata in a single-blind extension of a phase 2a randomized clinical trial. J Am Acad Dermatol. 2022 Aug;87(2):390-393. doi: 10.1016/j.jaad.2021.12.008. Epub 2021 Dec 13. No abstract available.

Guttman-Yassky E, Pavel AB, Diaz A, Zhang N, Del Duca E, Estrada Y, King B, Banerjee A, Banfield C, Cox LA, Dowty ME, Page K, Vincent MS, Zhang W, Zhu L, Peeva E. Ritlecitinib and brepocitinib demonstrate significant improvement in scalp alopecia areata biomarkers. J Allergy Clin Immunol. 2022 Apr;149(4):1318-1328. doi: 10.1016/j.jaci.2021.10.036. Epub 2021 Dec 1.

Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.

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Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT02974868
Other Study ID Numbers:	B7931005 2016-004048-13 ( EudraCT Number ) ALLEGRO ( Other Identifier: Alias Study Number )
First Posted:	November 29, 2016 Key Record Dates
Results First Posted:	May 26, 2020
Last Update Posted:	May 26, 2020
Last Verified:	May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL:	https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Pfizer:


Phase 2 randomized double-blind placebo alopecia areata safety	efficacy JAK janus kinase moderate severe

Additional relevant MeSH terms:

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Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases	Pathological Conditions, Anatomical PF-06700841 Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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