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Dupilumab in the Treatment of Pediatric Alopecia Areata (PEDAL)

Study type: Clinical Trials Posting date: 05/21/2024 Last updated: 05/21/2024 Status: Recruiting Phase: Phase 2 Country: United States Eligibility:

Ages 6 to under 18 years old; history of at least 6 months with moderate to severe AA (≥ 30% scalp hair loss) screening IgE ≥ 200 and/or personal and/or familial history of atopy (including asthma, atopic dermatitis, allergic rhinitis, food allergy, or eosinophilic esophagitis)

Drug: Dupilumab Administration: subcutaneous injection Sponsor: Icahn School of Medicine at Mount Sinai ClinicalTrials.gov link: Click here Location: Multiple locations


Description:

For more information, contact Giselle Singer, Clinical Research Program Director, at giselle.singer@mssm.edu or 212-241-3288

This is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will take place at 4 sites. This trial will enroll a total of 68 patients with moderate to severe AA (affecting more than 30% of the scalp) at the time of screening with a targeted 54 subjects completers through Week 48. AA 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.

Subjects will be randomized (2:1) to either receive weekly dupilumab or placebo for 48 weeks, with all subjects completing participation through Week 48 receiving an additional 48 weeks of dupilumab (through Week 96).

Eligibilty criteria:*

  • Age 6 to under 18
  • Diagnosed with alopecia areata
  • Have 30% or greater scalp hair loss
  • Screening IgE ≥ 200 and/or have personal and/or familial history of atopy (including asthma, atopic dermatitis, allergic rhinitis, food allergy, or eosinophilic esophagitis)

* There are additional requirements as determined by a screening process.

This study will take place at sites in New York, NY; Irvine, CA; New Haven, CT; and Chicago, IL.

For more information, contact Giselle Singer, Clinical Research Program Director, at giselle.singer@mssm.edu or 212-241-3288.