Clinical Research Directory

A Study to Learn How Effective, Safe, and Tolerable Upadacitinib is for Young Participants With Non-segmental Vitiligo

Sponsor: AbbVie

Summary

Vitiligo is a common, long-lasting disease that happens when the immune system attacks melanocytes (skin cells that produce the skin-coloring pigment melanin) in the skin leading to loss of color. Non-segmental vitiligo (NSV) occurs when patches of color loss appear on both sides of the body, such as both knees or both hands. This study is to evaluate how effective, safe and tolerable upadacitinib is for the treatment of non-segmental vitiligo in pediatric participants ages 6 to 11 years old. This study will have two periods: Period A and Period B. In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will receive placebo. Participants who complete Period A will continue into Period B and remain on blinded treatment. In Studies 1 and 2: Period A, participants will receive oral tablets (or oral solution) of upadacitinib or placebo once a day for 48 weeks. In Period B,participants who complete Period A will continue into Period B and remain on blinded treatment for 112 weeks. Participants will be followed up for 30 days. This study will enroll approximately 154 pediatric participants at 110 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Pediatric Subjects 6 to <12 Years Old With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy

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