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

ClinicalTrials.gov ID

NCT07617597

Lead Sponsor

Sun Pharma Japan LimitedINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

78Estimated

Last Update Posted

Aug 18, 2026Actual

Start Date

Jun 19, 2026Actual

Primary Completion Date

Feb 2028Estimated

Completion Date

Sep 2028Estimated

Official Title

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

Brief 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.

Detailed Description

The efficacy and safety of deuruxolitinib in adult subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects between 18 and 65 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, all participants from the Treatment Period will receive deuruxolitinib for 52 weeks.

• Alopecia Areata

• Deuruxolitinib
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Sun Pharma Japan LimitedINDUSTRY

JPS.clinicaltrial@sunpharma.com+81-93-691-7503

JPS.clinicaltrial@sunpharma.com+81-25-227-2436

JPS.clinicaltrial@sunpharma.com+81-6-6484-5755

JPS.clinicaltrial@sunpharma.com+81-06-6645-2121

JPS.clinicaltrial@sunpharma.com+81-11-706-7061

JPS.clinicaltrial@sunpharma.com+81-836-85-3030

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