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

Conditions

• Vitiligo

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ruxolitinib — DRUG
  ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.
• Vehicle — DRUG
  Vehicle cream is a topical formulation applied as a thin film to affected areas.

Study Details

The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.

Key Dates

Start date

Sep 24, 2020

Status verified

Aug 2025

Primary completion

Nov 14, 2022

Completion

Nov 14, 2022

Study Design

Enrollment

458 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A : ruxolitinib cream
  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.
• Placebo Comparator: Cohort A : Vehicle
  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.
• Experimental: Cohort B : roxolitinib cream
  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.

Primary Outcome Measure

Time to Relapse (Defined as <F-VASI75) [ Time Frame: from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) ]

Locations (44)

Find similar trials in Hoover, AL

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