Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)

Phase 3

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the completion of the week 24 assessments until at least 30 days after the last application of study drug (up to week 52 + 30 days)

Awards & highlights

Pivotal Trial

Summary

This trial will test whether ruxolitinib cream can improve the appearance of vitiligo. The cream will be applied to participants with vitiligo all over their body, but mostly on their face and non-facial areas, up to 10% of their total body surface area.

Eligible Conditions

Vitiligo

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the completion of the week 24 assessments until at least 30 days after the last application of study drug (up to week 52 + 30 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the completion of the week 24 assessments until at least 30 days after the last application of study drug (up to week 52 + 30 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the completion of the week 24 assessments until at least 30 days after the last application of study drug (up to week 52 + 30 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24

Secondary study objectives

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) During the Treatment Period (Double-Blind and Treatment-Extension Periods)

Change From Baseline in DLQI at Week 52

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24

+20 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment-Extension Period: Vehicle cream to Ruxolitinib cream 1.5% BIDExperimental Treatment2 Interventions

Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period.

Group II: Treatment-Extension Period: Ruxolitinib cream 1.5% BIDExperimental Treatment1 Intervention

Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.

Group III: Double-Blind Period: Ruxolitinib cream 1.5% BIDExperimental Treatment1 Intervention

Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.

Group IV: Double-Blind Period: Vehicle cream BIDPlacebo Group1 Intervention

Participants applied matching vehicle cream BID for 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib cream

2022

Completed Phase 3

~1850