NCT04530344

Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	ruxolitinib	ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.
DRUG	Vehicle	Vehicle cream is a topical formulation applied as a thin film to affected areas.

Timeline

• Start date: 2020-09-24
• Primary completion: 2022-11-14
• Completion: 2022-11-14
• First posted: 2020-08-28
• Last updated: 2025-08-14
• Results posted: 2023-07-19

Locations

84 sites across 8 countries: United States, Bulgaria, Canada, France, Germany, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study