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Evaluating the safety and effects of ritlecitinib for non-segmental vitiligo

A PHASE 3 OPEN-LABEL, MULTI-CENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Phase 3 Interventional Pfizer · NCT06163326

This study is testing if a new medication called ritlecitinib can help people with non-segmental vitiligo regain their skin color and how safe it is over a year.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages12 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsritlecitinib
Locations78 sites (Encinitas, California and 77 other locations)
Trial IDNCT06163326 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of ritlecitinib in individuals with non-segmental vitiligo, an autoimmune skin condition characterized by loss of pigmentation. Participants who have previously received ritlecitinib will continue treatment or switch to a placebo to determine the long-term effects on skin repigmentation. The study will compare the outcomes of those receiving a lower dose of ritlecitinib, a higher dose, or a placebo over a 52-week period. The goal is to understand how well the treatment maintains or improves skin pigmentation.

Who should consider this trial

Good fit: Ideal candidates are adults and adolescents aged 12 and older who have non-segmental vitiligo and have previously participated in a related study.

Not a fit: Patients who have experienced safety-related discontinuation from the parent study or have active suicidal ideation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from non-segmental vitiligo.

How similar studies have performed: Other studies have shown promise with similar treatments for vitiligo, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

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

Where this trial is running

Encinitas, California and 77 other locations

+28 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions VitiligoStable vitiligoActive vitiligoAdultsAdolescents
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.