CompletedPhase 3

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

United States607 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 range12 Years

SexALL

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:
✕. Have received any of the prohibited treatment regimens specified.
✕. Previous administration with an investigational drug or vaccine that do not affect vitiligo within 4 weeks of Day 1 \[Baseline\] or within 5 half-lives, whichever is longer.
✕. Any of the following abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:

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 range12 Years

SexALL

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:
✕. Have received any of the prohibited treatment regimens specified.
✕. Previous administration with an investigational drug or vaccine that do not affect vitiligo within 4 weeks of Day 1 \[Baseline\] or within 5 half-lives, whichever is longer.
✕. Any of the following abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:

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