Sun Pharmaceutical Industries, Inc.
This study evaluates the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.
The efficacy and safety of deuruxolitinib in adolescent subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects 12 to \<18 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, participants from the Treatment Period will receive deuruxolitinib for 52 weeks.
Inclusion Criteria: * Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years. * Between 12 to \<18 years of age * At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50. * Willing to comply with the study visits and requirements of the study protocol Exclusion Criteria: * Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untr…
Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
Deuruxolitinib matching placebo will be dosed orally as tablets