A Phase 3 Clinical Trial of Deuruxolitinib

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031260062

Enrollment

Registered

2026-04-17

Start date

2026-06-19

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Alopecia Areata

Interventions

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 rati

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

—

Contacts

Public ContactContact for Clinical Trial Information

Sun Pharma Japan Limited

JPS.clinicaltrial@sunpharma.com+81-3-6432-0201

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026