NCT04927975

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Non-Segmental Vitiligo

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Segmental Vitiligo

Interventions

Type	Name	Description
DRUG	Upadacitinib	Oral tablets
DRUG	Placebo	Oral tablets

Timeline

• Start date: 2021-06-30
• Primary completion: 2023-01-13
• Completion: 2023-08-29
• First posted: 2021-06-16
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

35 sites across 4 countries: United States, Canada, France, Japan

Regulatory

• FDA-regulated drug study