A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo (NCT06163326)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: California Dermatology & Clinical Research Institute — Encinitas, California
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (73 Sites)
Showing the first 25 of 73 sites.
- California Dermatology & Clinical Research Institute — Encinitas, California
- Marvel Clinical Research — Huntington Beach, California
- Wallace Medical Group, Inc — Los Angeles, California
- Encore Medical Research of Boynton Beach — Boynton Beach, Florida
- Skin Care Research — Hollywood, Florida
- ForCare Clinical Research — Tampa, Florida
- Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana
- DelRicht Research — Baton Rouge, Louisiana
- Lawrence J. Green, MD LLC — Rockville, Maryland
- University of Michigan — Ann Arbor, Michigan
- University of New Mexico Health Sciences Center — Albuquerque, New Mexico
- SUNY Downstate Health Sciences University — Brooklyn, New York
- University of North Carolina Medical Center — Chapel Hill, North Carolina
- Clinical & Translational Research Center (CTRC) — Chapel Hill, North Carolina
- Accellacare - Wilmington — Wilmington, North Carolina
- Wilmington Health, PLLC — Wilmington, North Carolina
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Remington-Davis, Inc — Columbus, Ohio
- Medical University of South Carolina — Charleston, South Carolina
- Modern Research Associates, PLLC — Dallas, Texas
- Alpesh D. Desai, DO PLLC — Houston, Texas
- Austin Institute for Clinical Research — Houston, Texas
- The Skin Hospital — Darlinghurst, New South Wales
- North Eastern Health Specialists — Campbelltown, South Australia
- Skin Health Institute Inc. — Carlton, Victoria
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Vitiligo
- Daily Topical Rapamycin for Vitiligo — Charleston, South Carolina
- A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo — Glendale, Arizona
- A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo — Birmingham, Alabama
- A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo — Scottsdale, Arizona
- An Observational Study of Patients With Dermatologic Disease — Winston-Salem, North Carolina
Explore by condition: All Vitiligo clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.