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RECRUITING
NCT06163326
PHASE3

A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

Sponsor: Pfizer

View on ClinicalTrials.gov

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

DRUG

Ritlecitinib

Ritlecitinib 50 mg capsule once daily

DRUG

Ritlecitinib 100 mg

Ritlecitinib 100 mg capsule once daily

DRUG

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