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
Study Description
The efficacy and safety of deuruxolitinib in adolescent 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 12 to <18 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, participants from the Treatment Period will receive deuruxolitinib for 52 weeks.
Brief 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.
Condition or Disease
Areata Alopecia
Study Design
| Study Type: | Interventional (Clinical Trial) |
| Estimated Enrollment: | 355 |
| Primary Outcome Measures |
1. Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) score ≤20
2. Safety and tolerability of deuruxolitinib will be assessed by evaluating adverse events, vital signs, electrocardiograms, and clinical laboratory results, as well as physical examinations
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| Actual Study Start Date: | August 2025 |
| Estimated Primary Completion Date: | May 2028 |
Eligibility Criteria
| Ages Eligible for Study: | 12-17 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Study Population
Alopecia Areata
Inclusion Criteria
- Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years
- At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50
Exclusion Criteria
- 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.