NCT05583526

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

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NON SEGMENTAL VITILIGO

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Study B7981040 is a Phase 3 randomized, double-blind, 52-week placebo-controlled, multi center study investigating the efficacy, safety, and tolerability of ritlecitinib in adult and adolescent participants with nonsegmental vitiligo (both active and stable vitiligo).

Conditions

• Stable Nonsegmental Vitiligo
• Active Nonsegmental Vitiligo

Interventions

Type	Name	Description
DRUG	Ritlecitinib	50 mg capsule
DRUG	Placebo	Matching capsule

Timeline

• Start date: 2022-12-01
• Primary completion: 2026-02-05
• Completion: 2026-02-05
• First posted: 2022-10-17
• Last updated: 2026-02-27

Locations

115 sites across 15 countries: United States, Australia, Bulgaria, Canada, China, Germany, Italy, Japan, Mexico, Poland, South Africa, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study