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Janus Kinase (JAK) Inhibitor

ruxolitinib for Vitiligo

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
Currently enrolled and receiving treatment in INCB 18424-306 (NCT04052425) or INCB 18424-307 (NCT04057573) studies evaluating ruxolitinib cream in participants with vitiligo.
Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 80 (predose); week 104 (any time post-dose) (week 52 was the first visit of this treatment extension study.)
Awards & highlights

Study Summary

This trial is evaluating the safety and efficacy of ruxolitinib cream in people who have completed another study using the cream for 28 to 52 weeks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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People currently taking part in two studies of ruxolitinib cream for vitiligo.
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The willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
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Both male and female participants must be willing to take precautions to avoid pregnancy, either through using contraception or abstaining from sex.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 80 (predose); week 104 (any time post-dose) (week 52 was the first visit of this treatment extension study.)
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 80 (predose); week 104 (any time post-dose) (week 52 was the first visit of this treatment extension study.) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Relapse (Defined as <F-VASI75)
Secondary outcome measures
Change From Baseline in F-BSA During the Extension Treatment Period
Change From Baseline in F-VASI Scores During the Extension Treatment Period
Change From Baseline in T-BSA During the Extension Treatment Period
+21 more

Side effects data

From 2022 Phase 3 trial • 458 Patients • NCT04530344
13%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib 1.5% Cream BID
Total
Vehicle Cream BID

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort B : roxolitinib creamExperimental Treatment1 Intervention
Participants who did not achieve ≥ F-VASI90 at Week 52 of the parent studies will be assigned to Cohort B and will continue ruxolitinib cream.
Group II: Cohort A : ruxolitinib creamExperimental Treatment1 Intervention
Participants who achieve complete or almost complete facial repigmentation (achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to ruxolitinib cream.
Group III: Cohort A : VehiclePlacebo Group1 Intervention
Participants who achieve complete or almost complete facial repigmentation (ie, achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to vehicle cream.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ruxolitinib
2017
Completed Phase 3
~600

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
361 Previous Clinical Trials
54,592 Total Patients Enrolled
9 Trials studying Vitiligo
2,035 Patients Enrolled for Vitiligo
Kathleen Butler, MDStudy ChairIncyte Corporation
14 Previous Clinical Trials
1,232 Total Patients Enrolled
3 Trials studying Vitiligo
831 Patients Enrolled for Vitiligo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
Minnesota
Pennsylvania
Other
How old are they?
18 - 65
What site did they apply to?
University of California San Francisco
Minnesota Clinical Study Center
The Dermatology Specialists Greenwich
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

~102 spots leftby Mar 2025