A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 WITH A PARTIALLY BLINDED EXTENSION PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH ACTIVE NON-SEGMENTAL VITILIGO
2 other identifiers
interventional
366
10 countries
92
Brief Summary
This is a Phase 2b, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 60 weeks. This includes an up to 4 weeks Screening Period, a 24 week dose ranging period, an up to 24 week extension period and a 8 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 Nov 2018
92 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
October 19, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedStudy Start
First participant enrolled
November 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2021
CompletedResults Posted
Study results publicly available
March 25, 2022
CompletedMarch 25, 2022
March 1, 2022
2.2 years
October 19, 2018
January 10, 2022
March 1, 2022
Conditions
Outcome Measures
Primary Outcomes (9)
Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period
Central read F-VASI was assessed based on the facial photographs taken at the site. Central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ \[Affected Facial Surface Area\] × 4 × \[Depigmentation Rates\]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. The higher score of F-VASI signified severer symptoms of non-segmental vitiligo. Percent change from baseline in central read F-VASI = ((post-baseline central read F-VASI - baseline central read F-VASI)/baseline central read F-VASI)×100. A negative percent change from baseline in central read F-VASI signified an improvement.
Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period
Adverse Event (AE) was defined as any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; or that was considered to be an important medical event. Causality to study treatment was determined by the investigator.
24 weeks
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. The abnormal test findings, clinically significant signs and symptoms of anaemia, neutropenia, thrombocytopenia and lymphopenia were reported as AEs. The clinical significance was determined by the investigator. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline up to Week 24
Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period
Participants had to abstain from all food and drink (except water and non-investigational products) for an 8-hour overnight fast prior to fasting lipid profile panel collection. Fasting lipid assessment included total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. The clinical meaningfulness was determined by the investigator. Baseline was defined as the last measurement prior to first dosing (Day 1).
Baseline up to Week 24
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period
Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.
24 weeks
Number of Participants With TEAEs and SAEs - Extension (Ext) Period
AE was defined as any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; or that was considered to be an important medical event. Causality to study treatment was determined by the investigator.
24 weeks
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. The abnormal test findings, clinically significant signs and symptoms of anaemia, neutropenia, thrombocytopenia and lymphopenia were reported as AEs. The clinical significance was determined by the investigator. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
24 weeks
Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period
Participants had to abstain from all food and drink (except water and non-investigational products) for an 8-hour overnight fast prior to fasting lipid profile panel collection. Fasting lipid assessment included total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. The clinical meaningfulness was determined by the investigator.
24 Weeks
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period
Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.
24 weeks
Secondary Outcomes (24)
Percentage of Participants Achieving Central F-VASI75 at Week 24 - DR Period
Week 24
Percentage of Participants Achieving T-VASI50 at Week 24 - DR Period
Week 24
Percent Change From Baseline in T-VASI at Designated Time Points - DR Period
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period
Baseline, Weeks 4, 8, 16 and 24
Percent Change From Baseline in Local F-VASI at Designated Time Points - DR Period
Baseline, Weeks 4, 8, 12, 16, 20 and 24
- +19 more secondary outcomes
Study Arms (12)
Cohort 1
EXPERIMENTALInduction dose 1 given once a day(QD) for 4 weeks followed by maintenance dose A given QD for 20 weeks
Cohort 2
EXPERIMENTALInduction dose 2 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
Cohort 3
EXPERIMENTALMaintenance dose A given QD for 24 weeks
Cohort 4
EXPERIMENTALMaintenance dose B given QD for 24 weeks
Cohort 5
EXPERIMENTALMaintenance dose C given QD for 24 weeks
Cohort 6
PLACEBO COMPARATORPlacebo given QD for 24 weeks
Extension Cohort 1
EXPERIMENTAL4 week drug holiday (no drug given) followed by PF-06700841 oral tablet QD for 20 weeks
Extension Cohort 2
EXPERIMENTALInduction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks in conjunction with narrow band UVB phototherapy
Extension Cohort 3
EXPERIMENTALInduction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
Extension Cohort 4
EXPERIMENTALMaintenance dose A given QD for 24 weeks
Extension Cohort 5
EXPERIMENTALMaintenance dose B given QD for 24 weeks
Extension Cohort 6
NO INTERVENTIONObservation period for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects between 18-65 years of age, inclusive, at time of informed consent.
- Must have moderate to severe active non-segmental vitiligo.
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (92)
Marvel Research, LLC
Huntington Beach, California, 92647, United States
University of California, Irvine, Dermatology Clinical Research Center
Irvine, California, 92697, United States
Vitiligo and Pigmentation Institute Of Southern California
Los Angeles, California, 90036, United States
Dermatology Specialist, Inc.
Murrieta, California, 92562, United States
Dermatology Specialists, Inc.
Oceanside, California, 92056, United States
UC Davis Health
Sacramento, California, 95816, United States
Brookside Dermatology Associates
Bridgeport, Connecticut, 06606, United States
New England Research Associates, LLC
Bridgeport, Connecticut, 06606, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Advanced Skin and MOHS Surgery Center, c/o TrialSpark, Inc.
Chicago, Illinois, 60657, United States
Chevy Chase Dermatology Center (TrialSpark, Inc.)
Chevy Chase, Maryland, 20815, United States
TrialSpark - Samantha Toerge, MD
Chevy Chase, Maryland, 20815, United States
TrialSpark - Ronald Shore, MD
Rockville, Maryland, 20852, United States
Tobias & Battite, Inc.
Boston, Massachusetts, 02111, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
UMass Memorial Medical Center, Hahnemann Campus
Worcester, Massachusetts, 01605, United States
Investigational Drug Service Pharmacy
Worcester, Massachusetts, 01655, United States
UMass Memorial Medical Center Ear Nose and Throat
Worcester, Massachusetts, 01655, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital Department of Dermatology
Detroit, Michigan, 48202, United States
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55455, United States
The Dermatology Group, P.C.
Verona, New Jersey, 07044, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10003, United States
Upper West Side Dermatology c/o TrialSpark, Inc
New York, New York, 10023, United States
MDCS: Medical Dermatology & Cosmetic Surgery (TrialSpark, Inc.)
New York, New York, 10065, United States
South Nassau Dermatology
Oceanside, New York, 11572, United States
TrialSpark, Inc. - Russell W. Cohen, MD
Oceanside, New York, 11572, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28411, United States
Remington-Davis, Inc. Clinical Research
Columbus, Ohio, 43215, United States
ForeFront Dermatology
Columbus, Ohio, 43220, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136, United States
University Physicians Group
Austin, Texas, 78701, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9191, United States
Pickens Academic Tower
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, 23502, United States
Tamjidi Skin Institute (TrialSpark, Inc.)
Vienna, Virginia, 22182, United States
The Skin Hospital
Darlinghurst, New South Wales, 2010, Australia
Premier Specialists Pty Ltd
Kogarah, New South Wales, 2217, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102, Australia
Skin Health Institute
Carlton, Victoria, 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3052, Australia
Hôpital Erasme Dermatology
Brussels, 1070, Belgium
UZ Brussel - Dermatology
Brussels, 1090, Belgium
UZ Gent - Dermatology
Ghent, 9000, Belgium
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7, Canada
Enverus Medical Research
Surrey, British Columbia, V3V 0C6, Canada
University of British Columbia
Vancouver, British Columbia, V5Z 4E8, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
CCA Medical Research
Ajax, Ontario, L1S 7K8, Canada
Guenther Research Inc.
London, Ontario, N6A 3H7, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X3, Canada
DermEdge Research
Mississauga, Ontario, L5H 1G9, Canada
North York Research Inc.
North York, Ontario, M2M 4J5, Canada
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5, Canada
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5, Canada
K.Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, Quebec, G1V 4X7, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, G1W 4R4, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, G1W1S2, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie, Dermatologische Ambulanz
Bad Bentheim, 48455, Germany
Universitaetsklinikum Erlangen Hautklinik Studienambulanz
Erlangen, 91054, Germany
Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt am Main, 60590, Germany
Universitaetsklinikum Schleswig-Holstein, Campus Luebeck CCIM
Lübeck, 23538, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Istituti Fisioterapici Ospitalieri, Istituto di Ricovero e Cura a Carattere Scientifico,
Roma, RM, 00144, Italy
Nagoya City University Hospital - Dermatology
Nagoya, Aichi-ken, 467-8602, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506, Japan
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Related Publications (4)
Yamaguchi Y, Peeva E, Duca ED, Facheris P, Bar J, Shore R, Cox LA, Sloan A, Thaci D, Ganesan A, Han G, Ezzedine K, Ye Z, Guttman-Yassky E. Ritlecitinib, a JAK3/TEC family kinase inhibitor, stabilizes active lesions and repigments stable lesions in vitiligo. Arch Dermatol Res. 2024 Jul 18;316(7):478. doi: 10.1007/s00403-024-03182-y.
PMID: 39023568DERIVEDWojciechowski 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: 37917289DERIVEDGuttman-Yassky E, Del Duca E, Da Rosa JC, Bar J, Ezzedine K, Ye Z, He W, Hyde C, Hassan-Zahraee M, Yamaguchi Y, Peeva E. Improvements in immune/melanocyte biomarkers with JAK3/TEC family kinase inhibitor ritlecitinib in vitiligo. J Allergy Clin Immunol. 2024 Jan;153(1):161-172.e8. doi: 10.1016/j.jaci.2023.09.021. Epub 2023 Sep 28.
PMID: 37777018DERIVEDEzzedine K, Peeva E, Yamaguchi Y, Cox LA, Banerjee A, Han G, Hamzavi I, Ganesan AK, Picardo M, Thaci D, Harris JE, Bae JM, Tsukamoto K, Sinclair R, Pandya AG, Sloan A, Yu D, Gandhi K, Vincent MS, King B. Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial. J Am Acad Dermatol. 2023 Feb;88(2):395-403. doi: 10.1016/j.jaad.2022.11.005. Epub 2022 Nov 9.
PMID: 36370907DERIVED
Related Links
MeSH Terms
Interventions
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
- Masking Details
- Dose ranging period is blinded. The partially blinded extension period includes open arms and blinded arms.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2018
First Posted
October 23, 2018
Study Start
November 26, 2018
Primary Completion
February 5, 2021
Study Completion
February 5, 2021
Last Updated
March 25, 2022
Results First Posted
March 25, 2022
Record last verified: 2022-03
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.