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.
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.
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.
Parallel
Deuruxolitinib
DrugDeuruxolitinib will be dosed orally as tablets at a dose of 8 mg
Placebo
DrugDeuruxolitinib matching placebo will be dosed orally as tablets for up to 24 weeks and then deuruxolitinib will be dosed for up to 52 weeks
Percentage of subjects achieving an absolute SALT score of 20 or less
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.
Percentage of subjects achieving an absolute SALT score of 20 or less
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Relative change in SALT scores from baseline
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I
The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders will defined as participants with responses of 6 (much improved) or 7 (very much improved).
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