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

Sponsor
Sun Pharma Japan Limited
Study ID
NCT07617597
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Deuruxolitinib — DRUG
    Deuruxolitinib will be dosed orally as tablets at a dose of 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

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Jun 19, 2026
Status verified
Aug 2026
Primary completion
Feb 29, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Deuruxolitinib 8 mg
    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
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Percentage of subjects achieving an absolute SALT score of 20 or less [ Time Frame: Week 24 ]

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