A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
NCT ID: NCT03715829
Last Updated: 2022-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
366 participants
INTERVENTIONAL
2018-11-26
2021-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
Induction dose 1 given once a day(QD) for 4 weeks followed by maintenance dose A given QD for 20 weeks
PF-06651600
Induction dose 1. Oral tablet taken QD
PF-06651600
Maintenance dose A. Oral tablet taken QD
Cohort 2
Induction dose 2 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
PF-06651600
Induction dose 2. Oral tablet taken QD
PF-06651600
Maintenance dose A. Oral tablet taken QD
Cohort 3
Maintenance dose A given QD for 24 weeks
PF-06651600
Maintenance dose A. Oral tablet taken QD
Cohort 4
Maintenance dose B given QD for 24 weeks
PF-06651600
Maintenance Dose B. Oral tablet taken QD
Cohort 5
Maintenance dose C given QD for 24 weeks
PF-06651600
Maintenance Dose C. Oral tablet taken QD
Cohort 6
Placebo given QD for 24 weeks
placebo
placebo
Extension Cohort 1
4 week drug holiday (no drug given) followed by PF-06700841 oral tablet QD for 20 weeks
PF06700841
Oral tablet taken QD
Extension Cohort 2
Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks in conjunction with narrow band UVB phototherapy
PF-06651600
Induction dose 1. Oral tablet taken QD
PF-06651600
Maintenance dose A. Oral tablet taken QD
narrow-band UVB phototherapy
Phototherapy will be combined with PF-06651600
Extension Cohort 3
Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
PF-06651600
Induction dose 1. Oral tablet taken QD
PF-06651600
Maintenance dose A. Oral tablet taken QD
Extension Cohort 4
Maintenance dose A given QD for 24 weeks
PF-06651600
Maintenance dose A. Oral tablet taken QD
Extension Cohort 5
Maintenance dose B given QD for 24 weeks
PF-06651600
Maintenance Dose B. Oral tablet taken QD
Extension Cohort 6
Observation period for 24 weeks
No interventions assigned to this group
Interventions
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PF-06651600
Induction dose 1. Oral tablet taken QD
PF-06651600
Induction dose 2. Oral tablet taken QD
PF-06651600
Maintenance dose A. Oral tablet taken QD
PF-06651600
Maintenance Dose B. Oral tablet taken QD
PF-06651600
Maintenance Dose C. Oral tablet taken QD
placebo
placebo
PF06700841
Oral tablet taken QD
narrow-band UVB phototherapy
Phototherapy will be combined with PF-06651600
Eligibility Criteria
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Inclusion Criteria
* Must have moderate to severe active non-segmental vitiligo.
Exclusion Criteria
* Infected with hepatitis B or hepatitis C viruses.
* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Marvel Research, LLC
Huntington Beach, California, United States
University of California, Irvine, Dermatology Clinical Research Center
Irvine, California, United States
Vitiligo and Pigmentation Institute Of Southern California
Los Angeles, California, United States
Dermatology Specialist, Inc.
Murrieta, California, United States
Dermatology Specialists, Inc.
Oceanside, California, United States
UC Davis Health
Sacramento, California, United States
Brookside Dermatology Associates
Bridgeport, Connecticut, United States
New England Research Associates, LLC
Bridgeport, Connecticut, United States
New Horizon Research Center
Miami, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Advanced Skin and MOHS Surgery Center, c/o TrialSpark, Inc.
Chicago, Illinois, United States
Chevy Chase Dermatology Center (TrialSpark, Inc.)
Chevy Chase, Maryland, United States
TrialSpark - Samantha Toerge, MD
Chevy Chase, Maryland, United States
TrialSpark - Ronald Shore, MD
Rockville, Maryland, United States
Tobias & Battite, Inc.
Boston, Massachusetts, United States
Tufts Medical Center
Boston, Massachusetts, United States
UMass Memorial Medical Center, Hahnemann Campus
Worcester, Massachusetts, United States
Investigational Drug Service Pharmacy
Worcester, Massachusetts, United States
UMass Memorial Medical Center Ear Nose and Throat
Worcester, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Henry Ford Hospital Department of Dermatology
Detroit, Michigan, United States
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, United States
The Dermatology Group, P.C.
Verona, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Upper West Side Dermatology c/o TrialSpark, Inc
New York, New York, United States
MDCS: Medical Dermatology & Cosmetic Surgery (TrialSpark, Inc.)
New York, New York, United States
South Nassau Dermatology
Oceanside, New York, United States
TrialSpark, Inc. - Russell W. Cohen, MD
Oceanside, New York, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Remington-Davis, Inc. Clinical Research
Columbus, Ohio, United States
ForeFront Dermatology
Columbus, Ohio, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
University Physicians Group
Austin, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Pickens Academic Tower
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, United States
Tamjidi Skin Institute (TrialSpark, Inc.)
Vienna, Virginia, United States
The Skin Hospital
Darlinghurst, New South Wales, Australia
Premier Specialists Pty Ltd
Kogarah, New South Wales, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Skin Health Institute
Carlton, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Hôpital Erasme Dermatology
Brussels, , Belgium
UZ Brussel - Dermatology
Brussels, , Belgium
UZ Gent - Dermatology
Ghent, , Belgium
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
CCA Medical Research
Ajax, Ontario, Canada
Guenther Research Inc.
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
North York Research Inc.
North York, Ontario, Canada
The Centre for Clinical Trials
Oakville, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
K.Papp Clinical Research
Waterloo, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie, Dermatologische Ambulanz
Bad Bentheim, , Germany
Universitaetsklinikum Erlangen Hautklinik Studienambulanz
Erlangen, , Germany
Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt am Main, , Germany
Universitaetsklinikum Schleswig-Holstein, Campus Luebeck CCIM
Lübeck, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Istituti Fisioterapici Ospitalieri, Istituto di Ricovero e Cura a Carattere Scientifico,
Roma, RM, Italy
Nagoya City University Hospital - Dermatology
Nagoya, Aichi-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Inha University Hospital
Incheon, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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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.
Wojciechowski 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.
Guttman-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.
Ezzedine 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2018-001271-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7981019
Identifier Type: -
Identifier Source: org_study_id
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