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A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adult Patients with Severe Alopecia Areata with an Open-Label Extension Period (THRIVE-AAJP) (THRIVE-AAJP)

A Phase 3 Clinical Trial of Deuruxolitinib

Tamura Kazuya

Sun Pharma Japan Limited

KDX Hamamatsucho Place 1-7-6 Shibakoen, Minato-ku, Tokyo

JPS.clinicaltrial@sunpharma.com

Contact for Clinical Trial Information

Sun Pharma Japan Limited

KDX Hamamatsucho Place 1-7-6 Shibakoen, Minato-ku, Tokyo

+81-3-6432-0201

JPS.clinicaltrial@sunpharma.com

Recruiting

June. 19, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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.
- Clinically significant hematologic abnormalities, hepatic impairment, or renal impairment at Screening.

Both

Severe Alopecia Areata

This study consists of a 24-week double-blind, placebo-controlled period and a subsequent 28-week open-label treatment period.
During the double-blind period, subjects will be randomized in a 1:1 ratio to either the study drug group or the placebo group.
Subjects in the study drug group will receive deuruxolitinib 8 mg orally twice daily (every 12 hours).
Subjects in the placebo group will receive matching placebo orally under the same conditions.
During the open-label treatment period, all subjects will receive deuruxolitinib 8 mg orally twice daily (every 12 hours).
The treatment duration will be up to a maximum of 52 weeks from study initiation.

The percentage of subjects achieving an absolute SALT score of 20 or less at Week 24.

- Percentage of subjects achieving an absolute SALT score of 20 or less at each assessment time point up to Week 24.
- Percentage of responders ("much improved" or "very much improved") based on both investigator and subject global assessments at each assessment time point up to Week 24.
- Change from Baseline in eyebrow and eyelash assessment scores at each assessment time point up to Week 24.
- Percentage of responders (defined as "satisfied" or "very satisfied") on a patient-reported outcome for hair satisfaction at Week 24.
- Change from Baseline in anxiety and depression scale scores at Week 24.

No

none