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RECRUITING
NCT05866562
PHASE2

Dupilumab in the Treatment of Pediatric Alopecia Areata

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2024-07-11

Completion Date

2029-04-30

Last Updated

2026-02-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Dupilumab

Participants weighing 15 kg \< 30 kg = 300 mg Every 4 Weeks; Participants weighing 30 kg \< 60 kg = 200 mg Every 2 Weeks; Participants weighing ≥ 60 kg = 300 mg Every 2 Weeks;

DRUG

Placebo

Participants weighing 15 kg \< 30 kg Every 4 Weeks; Participants weighing 30 kg \< 60 kg Every 2 Weeks; Participants weighing ≥ 60 kg Every 2 Weeks

Locations (5)

University of California, Irvine

Irvine, California, United States

University of California San Diego

San Diego, California, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States