CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 344 enrolled
Drug / intervention
Ruxolitinib cream +1 moredrug
Likely dose
Ruxolitinib cream applied as a thin film to affected areasAI-extracted
Key inclusion· 3
  • ✓Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥0.5% BSA on the face, ≥0.5 F-VASI
  • ✓≥3% BSA on nonfacial areas, ≥3 T-VASI, and total body vitiligo area (facial and nonfacial) not exceeding 10% BSA
  • ✓Agree to discontinue all agents used to treat vitiligo from screening through final safety follow-up visit
Key exclusion· 3
  • ✕No pigmented hair within any of the vitiligo areas on the face
  • ✕Other forms of vitiligo (e.g., segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders
  • ✕Prior use of depigmentation treatments (e.g., monobenzone) for vitiligo or other pigmented areas

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04057573
NCT04057573Phase 3Completed
CompareCT.gov

Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

Incyte Corporation·interventional·Posted Aug 15, 2019·Updated Aug 22, 2025

In Brief

A Phase 3 clinical trial evaluating Ruxolitinib cream and Vehicle for Non-segmental Vitiligo. Completed, enrolled 344 participants across 76 sites in 9 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-segmental Vitiligo
CountriesBulgaria, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 15, 2019
Enrollment StartOct 3, 2019
Primary CompletionMar 15, 2021
Study CompletionOct 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.9 years ago

Interventions

Ruxolitinib creamdrug

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

Vehicledrug

Vehicle cream is a topical formulation applied as a thin film to affected areas.