Dupilumab in the Treatment of Pediatric Alopecia Areata

This is a prospective, randomized, double-blind, placebo-controlled clinical trial. The study will take place at four sites. This trial will enroll a total of 76 children and adolescents with moderate to severe AA (affecting at least 30% of the scalp) at the time of screening with a targeted 61 participants completing through Week 48. All subjects must have evidence of hair regrowth within the last 7 years of their last episode of hair loss; and have screening IgE ≥200 and/or have personal and/or familial history of atopy. Study participation will be up to 124 weeks, consisting of: a screening period of up to 4 weeks; a 48-week placebo-controlled period; a 48-week open-label extension period; followed by a 24-week follow-up period.

NCT Number	NCT05866562
Lead Sponsor	Icahn School of Medicine at Mount Sinai
Conditions	Alopecia Areata
Enrollment	76 participants
Start Date	2024-07-11
Primary Completion	2028-08-17 (estimated)
Study Completion	2029-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-20