Evaluating Deuruxolitinib for Safety and Effectiveness in Japanese Adults with Severe Alopecia Areata Including 24-Week Placebo-Controlled and 52-Week Open-Label Phases

What this Trial Is About

Researchers are evaluating the efficacy and safety of deuruxolitinib in Japanese adults aged 18 to 65 years with severe alopecia areata, characterized by 50% or greater scalp hair loss. The study includes a double-blind, randomized, placebo-controlled treatment period followed by an open-label extension, focusing on hair regrowth and patient satisfaction. Participants will be randomly assigned to receive either deuruxolitinib 8 mg orally twice daily or a matching placebo for 24 weeks. After this period, all participants will receive deuruxolitinib 8 mg twice daily during a 52-week open-label extension. The study compares the effects of the active drug against placebo initially, then monitors all participants on the active treatment. Throughout the study, participants will be assessed using the Severity of Alopecia Tool SALT score to measure hair loss, along with patient-reported outcomes on hair satisfaction and quality. Clinical evaluations include changes in eyebrow and eyelash appearance, anxiety and depression scales, and other related measures. Safety and treatment response will be monitored over the entire 76-week participation period.

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata