Deuruxolitinib in Japanese Adults With Severe Alopecia Areata

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized, double-blind, placebo-controlled trial in Japanese adults with severe alopecia areata (SAL T score ≥50). Participants are assigned to deuruxolitinib or placebo for 24 weeks, followed by a 52-week open-label extension where all receive deuruxolitinib. Key safety and efficacy outcomes, including hair regrowth and adverse events, will be monitored, with SALT scores used to measure scalp hair loss. Eligibility excludes recent systemic immunosuppressants or biologics and certain infections or organ impairments.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.