A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Conditions

• NonSegmental Vitiligo

Eligibility Criteria

Sex

ALL

Age

2 Years - 11 Years

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib Cream — DRUG
  Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
• Vehicle Cream — DRUG
  Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Study Details

The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.

Key Dates

Start date

Jan 24, 2025

Status verified

Dec 2025

Primary completion

Aug 10, 2026

Completion

Mar 13, 2027

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib 1.5 % Cream
  Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
• Placebo Comparator: Vehicle Cream
  Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

Primary Outcome Measure

Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) [ Time Frame: Week 24 ]

Central Contacts

• Incyte Corporation Call Center (US)
  1.855.463.3463
  [email protected]
• Incyte Corporation Call Center (ex-US)
  +800 00027423
  [email protected]

Locations (80)

Find similar trials in Birmingham, AL

Related Studies

• A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
  PHASE2 · Recruiting · Takeda · Bryant, Arkansas