Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
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
3 other identifiers
interventional
142
3 countries
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2016
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedStudy Start
First participant enrolled
December 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2019
CompletedResults Posted
Study results publicly available
May 26, 2020
CompletedMay 26, 2020
May 1, 2020
2.4 years
November 23, 2016
May 6, 2020
May 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
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).
Baseline, Week24
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period
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.
Week 28 up to Week 52
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period
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.
COE day 1 up to end of study
Number of Participants With Laboratory Abnormalities During SBE Period
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.
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)
Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period
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.
COE day 1 up to end of study
Secondary Outcomes (19)
Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants
Baseline, Week 24
Percentage of Participants Achieving SALT 30 at Week 24
Baseline, Week 24
Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
Baseline, Weeks 2,4,6,8,12,16,20,24
Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
Baseline, Weeks 2,4,6,8,12,16,20,24
Percentage of Participants Achieving SALT 30 Across Time (Treatment Period)
Baseline, Weeks 2,4,6,8,12,16,20,24
- +14 more secondary outcomes
Study Arms (3)
Cohort 1
EXPERIMENTALPF-06651600
Cohort 2
EXPERIMENTALPF-06700841
Cohort placebo
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
- Must have moderate to severe alopecia areata:
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (55)
University of Alabama at Birmingham, Dermatology at the Whitaker Clinic
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, 35233, United States
Southern California Dermatology, Inc.
Santa Ana, California, 92701, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Office of F. Monte Purcelli
Santa Monica, California, 90404, United States
Tower Saint John's Imaging
Santa Monica, California, 90404, United States
University of Colorado Hospital Clinical and Translational Research Center, Inpatient Unit
Aurora, Colorado, 80045, United States
University of Colorado Hospital Clinical and Translational Research Center, Outpatient Clinic
Aurora, Colorado, 80045, United States
University of Colorado Hospital, Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Investigational Drug Services
New Haven, Connecticut, 06511, United States
Church Street Research Unit
New Haven, Connecticut, 06519, United States
Yale Hearing and Balance Center
New Haven, Connecticut, 06519, United States
Yale New Haven Hospital
New Haven, Connecticut, 06519, United States
Park Avenue Dermatology Administrative Annex
Orange Park, Florida, 32073, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
Edward B. Kampsen, MD
Tampa, Florida, 33609, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
Rose Radiology
Tampa, Florida, 33609, United States
Forward Clinical Trials, Inc
Tampa, Florida, 33624, United States
MedaPhase Inc.
Newnan, Georgia, 30263, United States
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, 60077, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, 46256, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital Clinical Unit for Research Trials in Skin (CURTIS)
Boston, Massachusetts, 02114, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Mount Sinai Department of Otolaryngology
New York, New York, 10029, United States
Rockefeller University Hospital
New York, New York, 10065, United States
Investigational Drug Service
Rochester, New York, 14642, United States
University of Rochester Audiology
Rochester, New York, 14642, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of Rochester Radiology
Rochester, New York, 14642, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
University of Utah MidValley Dermatology
Murray, Utah, 84107, United States
University of Utah Medical Center
Salt Lake City, Utah, 84132, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502, United States
Hearing Life
Hurstville, New South Wales, 2220, Australia
Dr. Glen and Partners Medical Imaging
Kogarah, New South Wales, 2217, Australia
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, 2217, Australia
St. George Hearing and Balance Clinic
Kogarah, New South Wales, 2217, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
Veracity Clinical Research
Woolloongabba, Queensland, 4102, Australia
Skin & Cancer Foundation Inc.
Carlton, Victoria, 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Bridge Road Imag ing
Richmond, Victoria, 3121, Australia
Richmond Audiology
Richmond, Victoria, 3121, Australia
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X2, Canada
Research by ICLS
Oakville, Ontario, L6J 7W5, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5, Canada
York Dermatology Center
Richmond Hill, Ontario, L4C 9M7, Canada
Related Publications (7)
Xi L, Peeva E, Yamaguchi Y, Ye Z, Lejeune A, Hyde C, Guttman-Yassky E. Multiomics Analysis of the Response to Ritlecitinib in Alopecia Areata Subtypes and Correlation With Efficacy. Allergy. 2025 Aug;80(8):2348-2360. doi: 10.1111/all.16659. Epub 2025 Jul 14.
PMID: 40654284DERIVEDKing B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Mesinkovska NA, Paul C, Gong Y, Anway SD, Tran H, Wolk R, Zwillich SH, Lejeune A. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program. Am J Clin Dermatol. 2024 Mar;25(2):299-314. doi: 10.1007/s40257-024-00846-3. Epub 2024 Jan 23.
PMID: 38263353DERIVEDWojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
PMID: 37917289DERIVEDHughes 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.
PMID: 36045513DERIVEDPeeva 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.
PMID: 34915057DERIVEDGuttman-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.
PMID: 34863853DERIVEDFensome 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.
PMID: 30113844DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2016
First Posted
November 29, 2016
Study Start
December 15, 2016
Primary Completion
May 15, 2019
Study Completion
May 15, 2019
Last Updated
May 26, 2020
Results First Posted
May 26, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
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.