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

Incyte

Status and phase: Completed; Phase 3

Conditions: Vitiligo

Treatments: Drug: Vehicle; Drug: ruxolitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04530344

INCB 18424-308

Details and patient eligibility

About

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.

Enrollment: 458 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently enrolled and receiving treatment in INCB 18424-306 (NCT04052425) or INCB 18424-307 (NCT04057573) studies evaluating ruxolitinib cream in participants with vitiligo.
• Currently tolerating ruxolitinib cream in the parent study and no safety concerns per investigators judgment.
• Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
• Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
• Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child.
• Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and written assent from the participant when possible.

Exclusion criteria

• Has been permanently discontinued from study treatment in the parent study for any reason.
• Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
• Pregnant or breastfeeding woman.
• Participants who live with anyone participating in any current Incyte-sponsored ruxolitinib cream study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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458 participants in 3 patient groups, including a placebo group

Cohort A : ruxolitinib cream

Experimental group

Description:

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.

Treatment:

Drug: ruxolitinib

Cohort A : Vehicle

Placebo Comparator group

Description:

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:

Drug: Vehicle

Cohort B : roxolitinib cream

Experimental group

Description:

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.

Treatment:

Drug: ruxolitinib