Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata
A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescent Patients With Severe Alopecia Areata With an Open-label Extension Period
Sun Pharmaceutical Industries, Inc.
355 participants
Aug 5, 2025
INTERVENTIONAL
Conditions
Summary
This study evaluates the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.
Eligibility
Inclusion Criteria4
- Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years.
- Between 12 to <18 years of age
- At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50.
- Willing to comply with the study visits and requirements of the study protocol
Exclusion Criteria4
- Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis at Screening and/or Baseline
- Treatment with other medications or agents within 28 days of Baseline or during the study that may affect hair regrowth or immune response.
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
- Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
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Interventions
Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
Deuruxolitinib matching placebo will be dosed orally as tablets
Locations(64)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07133308