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NCT06163326 · ClinicalTrials.gov registry record · Phase 3
A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
A Phase 3 study of Vitiligo, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06163326: Recruiting Phase 3 study of Vitiligo, sponsored by Pfizer.
NCT06163326 is a Phase 3 study of Vitiligo that is actively recruiting participants, run by Pfizer. The registered enrollment target is 400 participants, below the 1,098-participant average among 15 other Vitiligo trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06163326, a Phase 3 study of Vitiligo, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study 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 a
Primary Outcome
To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ritlecitinib 100 mg
- DRUG Ritlecitinib
Study Locations (20)
North Carolina
- University of North Carolina Medical Center - Chapel Hill
- Clinical & Translational Research Center (CTRC) - Chapel Hill
- Accellacare - Wilmington - Wilmington
- Wilmington Health, PLLC - Wilmington
California
- California Dermatology & Clinical Research Institute - Encinitas
- Marvel Clinical Research - Huntington Beach
- Wallace Medical Group, Inc - Los Angeles
Florida
- Encore Medical Research of Boynton Beach - Boynton Beach
- Skin Care Research - Hollywood
- ForCare Clinical Research - Tampa
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- Remington-Davis, Inc - Columbus
Indiana
- Dawes Fretzin Clinical Research Group, LLC - Indianapolis
Louisiana
- DelRicht Research - Baton Rouge
Maryland
- Lawrence J. Green, MD LLC - Rockville
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-01-19 |
| Est. Completion | 2027-04-23 |
| Phase | Phase 3 |
What NCT06163326 shows while recruiting
NCT06163326 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,098-participant average among 15 other Vitiligo trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Vitiligo appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06163326 names 20 study sites across 12 states, led by North Carolina, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06163326 about?
NCT06163326 is a clinical study titled "A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo". 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-...
What is the current status of trial NCT06163326?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2024-01-19. Estimated completion is 2027-04-23.
What conditions does trial NCT06163326 study?
This clinical trial studies the following conditions: Vitiligo.
What interventions are being tested in trial NCT06163326?
The interventions under investigation include: Placebo (DRUG), Ritlecitinib 100 mg (DRUG), Ritlecitinib (DRUG).
Who is sponsoring clinical trial NCT06163326?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06163326 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Vitiligo
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06163326's enrollment target sits among peer trials
400 3rd of 15 higher than 13 of 15 other Vitiligo trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vitiligo trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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