88 listed sites: Canada (19); United States (69) - 01 Oct `26TRuE-VIP1 Study - Ruxolitinib cream for children ages 2-11 with vitiligo

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.


Related pediatric study: View the study for children ages 6–11 in Argentina and Europe

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

Link: https://clinicaltrials.gov/study/NCT06548360

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FAQOther Questions

  • Which therapy has minimal side-effects?

    Dead Sea climatotherapy is a unique and highly effective treatment option for vitiligo, offering a top-tier safety profile and natural therapeutic benefits. Its combination of p...

  • What is vitiligo?

    Vitiligo (pronounced vit-ill-EYE-go) is a generally unpredictable skin disease that causes a gradual loss of skin color and overlying hair on different parts of the body. Contr...

  • How long does it take to treat vitiligo?

    Vitiligo, a condition characterized by the loss of skin pigment, can be unpredictable in both progression and treatment. The time it takes to treat vitiligo varies significantly...