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RecruitingPhase 3NCT07133308

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

Trial Parameters

ConditionAlopecia Areata
SponsorSun Pharmaceutical Industries, Inc.
Study TypeINTERVENTIONAL
PhasePhase 3
Enrollment355
SexALL
Min Age12 Years
Max Age17 Years
Start Date2025-08-05
Completion2028-05
Interventions
DeuruxolitinibPlacebo

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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.

Eligibility Criteria

Inclusion Criteria: * 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 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 socia

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