Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata (THRIVE-AAJP)

Sun Pharma Japan Limited

Status and phase: Not yet enrolling; Phase 3

Conditions: Alopecia Areata

Treatments: Drug: Placebo; Drug: Deuruxolitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07617597

CTP-543-25-01JP

jRCT2031260062 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

Deuruxolitinib 8 mg

Experimental group

Description:

Participants in this arm will receive deuruxolitinib 8 mg administered orally twice daily (BID) during the 24-week double-blind treatment period and continue to receive deuruxolitinib 8 mg administered orally BID up to 52 weeks

Treatment:

Drug: Deuruxolitinib

Placebo

Placebo Comparator group

Description:

Participants in this arm will receive matching placebo administered orally BID during the 24-week double-blind treatment period and then receive deuruxolitinib 8 mg administered orally BID up to 52 weeks.

Treatment:

Drug: Placebo