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Janus Kinase (JAK) Inhibitor

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

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

Pivotal Trial

Summary

This trial is studying how long the effects last after stopping or continuing the use of a medicated cream called ruxolitinib. It focuses on people who have already used the cream for some time to see if it remains safe and effective. Ruxolitinib has been used in the treatment of myelofibrosis and polycythemia vera, showing benefits in symptom relief and quality of life improvements.

Eligible Conditions

Vitiligo

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 80 (predose); week 104 (any time post-dose) (week 52 was the first visit of this treatment extension study.)

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

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

Primary study objectives

Time to Relapse (Defined as <F-VASI75)

Secondary study objectives

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%

Study treatment Arm

Ruxolitinib 1.5% Cream BID

Vehicle Cream BID

Total

Awards & Highlights

Pivotal Trial

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

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

~660

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