NCT04052425

Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

Conditions

• Non-segmental Vitiligo

Interventions

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

Timeline

• Start date: 2019-09-20
• Primary completion: 2021-03-18
• Completion: 2021-10-21
• First posted: 2019-08-09
• Last updated: 2025-08-22
• Results posted: 2022-09-21

Locations

57 sites across 8 countries: United States, Bulgaria, Canada, France, Germany, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study