Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo

Summary

Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo. Adverse effects and change in disease activity will be assessed. Upadacitinib is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 160 participants aged 18-65 with non-segmental vitiligo in 5 treatment arms across 35 sites worldwide. Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. 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.

Timeline

Start

2021-06-30

Primary completion

2023-01-13

Completion

2023-08-29

Publications

• Ezzedine K, Soliman AM, Camp HS, Ladd MK, Pokrzywinski R, Coyne KS, Sen R, Schlosser BJ, Bae JM, Hamzavi I. Psychometric Properties and Meaningful Change Thresholds of the Vitiligo Area Scoring Index. JAMA Dermatol. 2025 Jan 1;161(1):39-46. doi: 10.1001/jamadermatol.2024.4534.
• Passeron T, Ezzedine K, Hamzavi I, van Geel N, Schlosser BJ, Wu X, Huang X, Soliman AM, Rosmarin D, Harris JE, Camp HS, Pandya AG. Once-daily upadacitinib versus placebo in adults with extensive non-segmental vitiligo: a phase 2, multicentre, randomised, double-blind, placebo-controlled, dose-ranging study. EClinicalMedicine. 2024 May 31;73:102655. doi: 10.1016/j.eclinm.2024.102655. eCollection 2024 Jul.

Drugs

Indications