Status:
RECRUITING
Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Alopecia Areata
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
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.
Detailed 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 Pe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT07133308
Start Date
August 5 2025
End Date
May 1 2028
Last Update
August 21 2025
Active Locations (22)
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1
Total Skin And Beauty Dermatology Center
Birmingham, Alabama, United States, 35203
2
Dermatology Research Associates
Los Angeles, California, United States, 90045
3
Paradigm Clinical Research - San Diego
San Diego, California, United States, 92108
4
Pediatric Skin Research Llc
Coral Gables, Florida, United States, 33146