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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pfizer
Study ID
NCT05583526
Phase
PHASE3
Status
Completed

Conditions

  • Active Nonsegmental Vitiligo
  • Stable Nonsegmental Vitiligo

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ritlecitinib — DRUG
    50 mg capsule
  • Placebo — DRUG
    Matching capsule

Study Details

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

Key Dates

Start date
Dec 1, 2022
Status verified
Feb 2026
Primary completion
Feb 5, 2026
Completion
Feb 5, 2026

Study Design

Enrollment
607 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ritlecitinib 50 mg
    Ritlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)
  • Placebo Comparator: Placebo
    Placebo (placebo arm; approximately 200 participants)

Primary Outcome Measure

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 [ Time Frame: Week 52 ]

Locations (46)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
University of Alabama at Birmingham Faculty Office Towers (RegulatoryBirminghamAlabama35294-
California Dermatology & Clinical Research InstituteEncinitasCalifornia92024-
Marvel Clinical ResearchHuntington BeachCalifornia92647-
Wallace Medical Group, IncLos AngelesCalifornia90056-
AudiologyWashington D.C.District of Columbia20007-
Center for Dermatology and Dermatologic SurgeryWashington D.C.District of Columbia20037-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
Encore Medical Research of Boynton BeachBoynton BeachFlorida33436-
Skin Care ResearchHollywoodFlorida33021-
Clever Medical ResearchMiamiFlorida33126-
Ziaderm Research LLCNorth Miami BeachFlorida33162-
Olympian Clinical ResearchSt. PetersburgFlorida33709-
ForCare Clinical ResearchTampaFlorida33613-
Advanced Medical Research, PC.Sandy SpringsGeorgia30328-
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46250-
DelRicht ResearchBaton RougeLouisiana70809-
The NeuroMedical Center (XRay)Baton RougeLouisiana70810-
Velocity Clinical Research at The Dermatology Clinic, Baton RougeBaton RougeLouisiana70808-
DelRicht ResearchNew OrleansLouisiana70115-
Prairieville Family Hospital (XRay)PrairievilleLouisiana70769-
Visage Dermatology and Aesthetic CenterBowieMaryland20716-
Lawrence J Green, MD LLCRockvilleMaryland20850-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Hamzavi Dermatology - CantonCantonMichigan48187-
Skin Specialists, PCOmahaNebraska68144-
University of New Mexico Health Sciences CenterAlbuquerqueNew Mexico87102-
SUNY Downstate Health Sciences UniversityBrooklynNew York11203-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Clinical & Translational Research Center (CTRC)Chapel HillNorth Carolina27599-
University of North Carolina Medical CenterChapel HillNorth Carolina27516-
AccellacareWilmingtonNorth Carolina28411-
Accellacare - WilmingtonWilmingtonNorth Carolina28411-
PMG Research of Wilmington, LLCWilmingtonNorth Carolina28411-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Remington Davis Clinical ResearchColumbusOhio43215-
Remington-Davis, IncColumbusOhio43215-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Bellaire Dermatology AssociatesBellaireTexas77401-
Modern Research Associates, PLLCDallasTexas75231-
Alpesh D. Desai, DO PLLC - ResearchHoustonTexas77008-
Austin Institute for Clinical ResearchHoustonTexas77056-
Dermatology Clinical Research Center of San AntonioSan AntonioTexas78229-
Progressive Clinical ResearchSan AntonioTexas78213-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-

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