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TRuE-VIP1 Study - Ruxolitinib cream for children ages 2-11 with vitiligo
Official title: A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
Status: Recruiting now
Description:
This Phase 3 study is evaluating the safety and efficacy of ruxolitinib 1.5% cream in children ages 2–11 with nonsegmental vitiligo.
During the first 24 weeks, participants receive ruxolitinib cream or a matching cream (called "vehicle") with no active medicine. Study cream is applied twice daily.
Participation continues for up to 52 weeks, followed by a safety follow-up.
Basic eligibility includes measurable nonsegmental vitiligo on the face and body: at least 0.5% of body surface area on the face and at least 2% on nonfacial areas, with no more than 10% total body involvement. Other criteria apply, including requirements concerning current and recent vitiligo treatments.
Sites are located in the United States and Canada. The research site determines eligibility.
Use of ruxolitinib cream for vitiligo in this age group is investigational.
🔎 See if your child is eligible here
Related pediatric study: View the study for children ages 6–11 in Argentina and Europe (recruitment closed)
Start date: January 24, 2025
Completion date: March 13, 2027
Organizer: Incyte Corporation
Contact: Incyte Corporation Call Center (US)
Tel.: +1-855-463-3463
Email: medinfo@incyte.com
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