Study to Evaluate Treatment of Ruxolitinib Cream in Children (6 to < 12) With Nonsegmental Vitiligo
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
IRAS ID
1011562
Contact name
Fiona Lee
Contact email
Sponsor organisation
Incyte Corporation
Clinicaltrials.gov Identifier
Research summary
This study is being done to learn how well a cream containing a drug called ruxolitinib, works in treating vitiligo on the face and body of children aged over 6 years but under 12 years. Vitiligo is a condition that causes loss of pigment (skin colour) in patches of skin.
Ruxolitinib cream is currently approved in the US, EU, UK and Canada for the treatment of nonsegmental vitiligo in adults and adolescents aged 12 and older. However, there are no approved treatments for children under 12.
Participants may be in the study for up to 14 months, attending a total of 13 visits to the study site. The study includes:
• Screening period: Lasts up to 30 days and involves initial tests and assessments.
• Treatment period: 52 weeks in total (24-week “vehicle-controlled period” and 28-week “Extension period”)
• Follow-up: 30 days after the last application of the study cream
During the first 24 weeks of the treatment period (vehicle-controlled period), participants will be randomly assigned to receive one of the following:
• 0.75% ruxolitinib cream
• 1.5% ruxolitinib cream
• Vehicle cream (called a placebo) that does not have any active ingredients
Participants who complete 24 weeks of treatment without side effects will proceed to the 28-week extension period. During this period, all participants will receive ruxolitinib cream. Participants who previously received ruxolitinib cream will continue with the same strength of cream in the extension period. Those who received the vehicle cream will transition to either 0.75% or 1.5% ruxolitinib cream, as no vehicle cream will be used during this phase.
At least 250 children are expected to participant in this study.
This is a double-blinded study, meaning neither participants, parents, nor study doctors will know which cream is being used during the vehicle-controlled and treatment extension periods.REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0103
Date of REC Opinion
1 Apr 2026
REC opinion
Further Information Favourable Opinion