Study to Assess the Safety and Effectiveness of Deuruxolitinib for Treating Severe Hair Loss in Adolescents with Alopecia Areata

What this Trial Is About

This research aims to assess the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have severe alopecia areata, characterized by 50% or greater scalp hair loss. The study includes a double-blind, randomized, placebo-controlled treatment phase followed by an open-label extension. The goal is to better understand how well deuruxolitinib works and how safe it is for this age group with significant hair loss. Participants will be randomly assigned to receive either deuruxolitinib tablets or matching placebo tablets taken orally twice daily for 24 weeks during the initial treatment period. Following this, all participants will have the opportunity to receive deuruxolitinib for an additional 52 weeks in an open-label extension phase. This design allows comparison of the drug to placebo and longer-term evaluation of the drugs effects. Throughout the study, participants will have regular assessments of their hair loss using the Severity of Alopecia Tool SALT at multiple time points up to week 24 and beyond. Safety will be closely monitored by tracking side effects, vital signs, heart tests, lab results, and physical exams. Additional measurements include patient and clinician impressions of improvement, quality of life, and mental health assessments. The total study duration can extend up to 76 weeks of treatment plus safety follow-up to fully evaluate outcomes and tolerability.

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