CompletedPhase 3

A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo

United States, Australia, Bulgaria607 participantsStarted 2022-12-01

Plain-language summary

A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental Vitiligo (Active and Stable) Tranquillo

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants ≥18 years of age at Screening. Adolescents (12 to \<18 years of age) are also eligible for this study, but only if approved by the local IRB/EC and regulatory health authority. Where these approvals have not been granted, only participants ≥18 years of age will be enrolled.
. Eligible participants must have at both Screening and Baseline:
. If receiving concomitant medications for any reason other than vitiligo, participant must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study.
. Must agree to stop all other treatments for vitiligo from Screening through the final follow-up visit.

Exclusion criteria

. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:
. Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin:
. General Infection History:
. Specific Viral Infection History:
. Medical Conditions, Other:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and T-VASI50 at Week 52

Timeframe: Week 52

Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52

Timeframe: Week 52

Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities

Timeframe: Baseline through Week 52

Trial details

NCT IDNCT05583526

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-05

View on ClinicalTrials.gov More Stable Nonsegmental Vitiligo trials

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants ≥18 years of age at Screening. Adolescents (12 to \<18 years of age) are also eligible for this study, but only if approved by the local IRB/EC and regulatory health authority. Where these approvals have not been granted, only participants ≥18 years of age will be enrolled.
. Eligible participants must have at both Screening and Baseline:
. If receiving concomitant medications for any reason other than vitiligo, participant must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study.
. Must agree to stop all other treatments for vitiligo from Screening through the final follow-up visit.

Exclusion criteria

. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:
. Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin:
. General Infection History:
. Specific Viral Infection History:
. Medical Conditions, Other:

What they're measuring

US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and T-VASI50 at Week 52

Timeframe: Week 52

Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52

Timeframe: Week 52

Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities

Timeframe: Baseline through Week 52