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NCT07617597
Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata
Conditions: Alopecia Areata
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 78
Sponsor: Sun Pharma Japan Limited
Location: Study Site 102 Asahikawa
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07617597). StuddyBuddy aggregates publicly available trial information.