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Active, not recruitingPhase 3

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

Key facts

Who runs it
Pfizer
Where
Albuquerque, Ann Arbor, Baton Rouge, Boynton Beach, Brooklyn, Chapel Hill, Charleston, Cleveland, Columbus, Dallas, Encinitas, Hollywood, Houston, Huntington Beach, Indianapolis, Los Angeles, Rockville, Tampa, and Wilmington, United StatesSee the 22 sitesAlso in 13 other countries, 53 sites
Status
Active, not recruiting
Phase
Phase 3
People taking part
394 people enrolled
Started
19 Jan 2024
Expected to end
31 Mar 2027
Type of study
Interventional, 2 groups
Treatments tested
  • Ritlecitinib
  • Ritlecitinib 100 mg
  • Placebo
Record updated
28 September 2026

Who can take part

Age
12 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to <18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority
  • Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040
  • The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040

Who cannot take part

  • Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation
  • Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event

Where in United States

Also in 13 other countries, 53 sites

  • University of New Mexico Health Sciences CenterAlbuquerque, United StatesNo longer taking part
  • University of MichiganAnn Arbor, United StatesNo longer taking part
  • DelRicht ResearchBaton Rouge, United StatesNo longer taking part
  • Encore Medical Research of Boynton BeachBoynton Beach, United StatesNo longer taking part
  • SUNY Downstate Health Sciences UniversityBrooklyn, United StatesNo longer taking part
  • Clinical & Translational Research Center (CTRC)Chapel Hill, United StatesNo longer taking part
  • University of North Carolina Medical CenterChapel Hill, United StatesNo longer taking part
  • Medical University of South CarolinaCharleston, United StatesNo longer taking part
  • University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
  • Remington Davis, Inc.Columbus, United StatesNo longer taking part
  • Modern Research Associates PllcDallas, United StatesNo longer taking part
  • California Dermatology & Clinical Research InstituteEncinitas, United StatesNo longer taking part
  • Skin Care ResearchHollywood, United StatesNo longer taking part
  • Alpesh D. Desai, DO PLLCHouston, United StatesNo longer taking part
  • Austin Institute for Clinical ResearchHouston, United StatesNo longer taking part
  • Marvel Clinical ResearchHuntington Beach, United StatesNo longer taking part
  • Dawes Fretzin Clinical Research Group, LLCIndianapolis, United StatesNo longer taking part
  • Wallace Medical Group, IncLos Angeles, United StatesNo longer taking part
  • Lawrence J. Green, MD, LLCRockville, United StatesNo longer taking part
  • ForCare Clinical ResearchTampa, United StatesNo longer taking part
  • Accellacare - WilmingtonWilmington, United StatesNo longer taking part
  • Wilmington Health, PLLCWilmington, United StatesNo longer taking part

About the trial

What the trial wants to find out

This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV).

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Arm 1Treatment being tested

    Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040. Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned.

    Treatment: Ritlecitinib, Ritlecitinib 100 mg, and Placebo

  • Arm 2Treatment being tested

    Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned

    Treatment: Ritlecitinib, Ritlecitinib 100 mg, and Placebo

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Publications
Record updated
28 September 2026