Overview
This study evaluates the efficacy and safety of deuruxolitinib in Japanese Adults between 18 and 65 years of age who have 50% or greater scalp hair loss.
Description
The efficacy and safety of deuruxolitinib in adult 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 between 18 and 65 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, all participants from the Treatment Period will receive deuruxolitinib for 52 weeks.
Eligibility
Inclusion Criteria:
- Written informed consent has been obtained.
- Japanese subjects with severe alopecia areata who are between 18 and 65 years of age, inclusive, at the time of informed consent.
- Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months.
- SALT score of 50 or more at both Screening and Baseline.
Exclusion Criteria:
- Treatment with systemic immunosuppressive medications or agents, including Janus kinase inhibitors, within 4 months prior to randomization.
- Treatment with biologics within 6 months prior to Screening.
- Positive test results for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus at Screening.
- History of active tuberculosis, a positive interferon gamma release assay at Screening, or evidence of tuberculosis-related lesions on chest radiography.
- Clinically significant hematologic abnormalities, hepatic impairment, or renal impairment at Screening.
