NCT07133308

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 355 (estimated)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	Deuruxolitinib	Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
DRUG	Placebo	Deuruxolitinib matching placebo will be dosed orally as tablets

Timeline

• Start date: 2025-08-05
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-08-21
• Last updated: 2026-01-28

Locations

64 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study