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A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
Sponsor: Pfizer
Summary
This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV). Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin. Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show: * if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo) * Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study * Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study. This study is seeking for participants who: * have non-segmental vitiligo (either active or stable) and * received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it. All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. On study visit days, you must take the medication at the study site, and not at home. Participants may receive the study medicine or placebo for up to 52 weeks. The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo. Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study. Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.
Official title: A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2024-01-19
Completion Date
2027-04-23
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
Interventions
Ritlecitinib
Ritlecitinib 50 mg capsule once daily
Ritlecitinib 100 mg
Ritlecitinib 100 mg capsule once daily
Placebo
Matching capsule once daily
Locations (74)
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Wallace Medical Group, Inc
Los Angeles, California, United States
Encore Medical Research of Boynton Beach
Boynton Beach, Florida, United States
Skin Care Research
Hollywood, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
DelRicht Research
Baton Rouge, Louisiana, United States
Lawrence J. Green, MD LLC
Rockville, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
SUNY Downstate Health Sciences University
Brooklyn, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Wilmington Health, PLLC
Wilmington, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Remington-Davis, Inc
Columbus, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Modern Research Associates, PLLC
Dallas, Texas, United States
Alpesh D. Desai, DO PLLC
Houston, Texas, United States
Austin Institute for Clinical Research
Houston, Texas, United States
The Skin Hospital
Darlinghurst, New South Wales, Australia
North Eastern Health Specialists
Campbelltown, South Australia, Australia
Skin Health Institute Inc.
Carlton, Victoria, Australia
Dr Rodney Sinclair Pty Ltd
East Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Medical Centre "Asklepiy"
Dupnitsa, Kyustendil, Bulgaria
Diagnostic Consultative Center Aleksandrovska
Sofia, Sofia (stolitsa), Bulgaria
UMHAT "Prof. Dr. Stoyan Kirkovich"AD
Stara Zagora, Bulgaria
Dermatology Research Institute
Calgary, Alberta, Canada
CaRe Clinic
Red Deer, Alberta, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
North York Research Inc
Toronto, Ontario, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, Canada
Centre de Recherche Saint-Louis inc.
Québec, Canada
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The First Hospital of Wuhan
Wuhan, Hubei, China
The First Hospital of China Medical University/Dermatology and STD Department
Shenyang, Liaoning, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Praxis Leitz und Kollegen
Stuttgart, Baden-Wurttemberg, Germany
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Hospital Infantil de Mexico Federico Gomez
Mexico City, Mexico City, Mexico
Centro de Dermatologia de Monterrey
Monterrey, Nuevo León, Mexico
Arké SMO S.A de C.V
Veracruz, Mexico
Sociedad de Metabolismo y Corazon S.C.
Veracruz, Mexico
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
Osielsko, Kuyavian-Pomeranian Voivodeship, Poland
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, Poland
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, Poland
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
The Catholic University Of Korea St. Vincent's Hospital
Suwon, Kyǒnggi-do, South Korea
Ajou University Hospital
Suwon, Kyǒnggi-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
AUDIKA
Córdoba, Spain
Istanbul Universitesi Cerrahpasa
Istanbul- Fatih, Istanbul, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Istanbul, İ̇stanbul, Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri
Kayseri, Turkey (Türkiye)
Celal Bayar University Hafsa Sultan Hospital
Manisa, Turkey (Türkiye)
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom