RecruitingPhase 2NCT05866562

Dupilumab in the Treatment of Pediatric Alopecia Areata


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

76 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial tests dupilumab — a biologic drug already approved for eczema and asthma that blocks the immune signaling molecules IL-4 and IL-13 — for treating severe alopecia areata (AA) in children. AA is an autoimmune disease where the immune system attacks hair follicles, causing patchy or total hair loss. It can be devastating for children's psychological development and self-image, and current treatments are often inadequate or cause significant side effects. The trial builds on adult studies showing dupilumab can restore hair growth in patients who also have atopic (allergic) backgrounds. Children aged 6 to 17 with at least six months of moderate to severe alopecia areata (50% or more scalp hair loss) who have elevated IgE levels or a personal or family history of atopic conditions (eczema, asthma, allergies) are eligible. Children who are pregnant, breastfeeding, have indeterminate hair loss causes, have had no hair regrowth for 7 or more years, have severe uncontrolled asthma, active infections, immunodeficiency, or serious chronic disease are excluded. Participants receive dupilumab injections and are assessed for scalp hair regrowth over the study period. This research is meaningful because alopecia areata can cause profound psychological harm in children at a critical stage of identity development, and a safe and effective targeted treatment would fill a significant unmet need in pediatric dermatology.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDupilumab

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;

DRUGPlacebo

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

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NCT05866562


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