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

NCT07617597 | Recruiting Phase 3

• 2 other identifiers: CTP-543-25-01JPjRCT2031260062
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 18

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.

Conditions

Alopecia Areata

Keywords

alopecia areata; severe alopecia areata; hair loss; deuruxolitinib; JAK inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects achieving an absolute SALT score of 20 or less

  SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).

  Week 24

Secondary Outcomes (19)

• Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale

  Week 24

• Percentage of subjects achieving an absolute SALT score of 20 or less

  Weeks 12, 16, and 20

• Relative change in SALT scores from baseline

  Weeks 4, 8, 12, 16, 20, and 24

• Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I

  Weeks 12, 16, 20, and 24

• Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I

  Weeks 12, 16, 20, and 24

Study Arms (2)

Deuruxolitinib 8 mg

EXPERIMENTAL

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

Drug: Deuruxolitinib

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Deuruxolitinib DRUG

Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg

Deuruxolitinib 8 mg

Placebo DRUG

Deuruxolitinib matching placebo will be dosed orally as tablets for up to 24 weeks and then deuruxolitinib will be dosed for up to 52 weeks

Also known as: Deuruxolitinib

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharma Japan Limited: lead

Study Sites (18)

Study Site 102

Asahikawa, 078-8510, Japan

NOT YET RECRUITING

Study Site 117

Bunkyō City, 113-8431, Japan

NOT YET RECRUITING

Study Site 119

Ebina, 243-0432, Japan

NOT YET RECRUITING

Study Site 101

Hamamatsu, 431-3192, Japan

NOT YET RECRUITING

Study Site 116

Ishikawa, 920-0293, Japan

NOT YET RECRUITING

Study Site 112

Kitakyushu, 807-8556, Japan

NOT YET RECRUITING

Study Site 118

Kōtoku, 136-0075, Japan

NOT YET RECRUITING

Study Site 110

Kurashiki, 701-0192, Japan

NOT YET RECRUITING

Study Site 113

Kurume, 830-0011, Japan

NOT YET RECRUITING

Study Site 107

Kyoto, 606-8507, Japan

NOT YET RECRUITING

Study Site 106

Mitaka-shi, 181-8611, Japan

RECRUITING

Study Site 114

Miyagi-gun, 981-0112, Japan

NOT YET RECRUITING

Study Site 104

Niigata, 951-8520, Japan

RECRUITING

Study Site 109

Osaka, 542-0081, Japan

RECRUITING

Study Site 108

Osaka, 545-0051, Japan

RECRUITING

Study Site 103

Sapporo, 060-8648, Japan

RECRUITING

Study Site 105

Shinjuku-Ku, 160-0023, Japan

NOT YET RECRUITING

Study Site 111

Ube, 755-8505, Japan

NOT YET RECRUITING

MeSH Terms

Conditions

Alopecia Areata; Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 1, 2026
• Study Start: June 19, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

JP (18)