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

RecruitingPhase 3

Sponsor: Sun Pharma Japan Limited

Conditions: Alopecia Areata

Interventions: Deuruxolitinib, Placebo

Countries: Japan

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (18)

Asahikawa, Japan
Bunkyō City, Japan
Ebina, Japan
Hamamatsu, Japan
Ishikawa, Japan
Kitakyushu, Japan
Kōtoku, Japan
Kurashiki, Japan
Kurume, Japan
Kyoto, Japan
Mitaka-shi, Japan
Miyagi-gun, Japan
Niigata, Japan
Osaka, Japan
Osaka, Japan
Sapporo, Japan
Shinjuku-Ku, Japan
Ube, Japan