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Recruiting Phase 3

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

NCT07617597 · tracked via the Priya Life Science Japan tracker
Sponsor
Sun Pharma Japan Limited
Phase
Phase 3
Started
2026-06-19
Last updated
2026-10-15

Condition(s) studied

Alopecia Areata

Investigational drug(s) / intervention(s)

Deuruxolitinib →Placebo

Deuruxolitinib: Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg

Placebo: Deuruxolitinib matching placebo will be dosed orally as tablets for up to 24 weeks and then deuruxolitinib will be dosed for up to 52 weeks

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percentage of subjects achieving an absolute SALT score of 20 or less — Week 24
    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).

Trial sites (18)

FacilityCityRegionStatus
Study Site 102 Asahikawa Japan Recruiting
Study Site 117 Bunkyō City Japan Recruiting
Study Site 119 Ebina Japan Recruiting
Study Site 101 Hamamatsu Japan Recruiting
Study Site 116 Ishikawa Japan Recruiting
Study Site 112 Kitakyushu Japan Recruiting
Study Site 118 Kōtoku Japan Recruiting
Study Site 110 Kurashiki Japan Recruiting
Study Site 113 Kurume Japan Recruiting
Study Site 107 Kyoto Japan Recruiting
Study Site 106 Mitaka-shi Japan Recruiting
Study Site 114 Miyagi-gun Japan Not Yet Recruiting
Study Site 104 Niigata Japan Recruiting
Study Site 109 Osaka Japan Recruiting
Study Site 108 Osaka Japan Recruiting
Study Site 103 Sapporo Japan Recruiting
Study Site 105 Shinjuku-Ku Japan Recruiting
Study Site 111 Ube Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07617597 on ClinicalTrials.gov ↗ ← All trials in Japan