Dupilumab in the Treatment of Pediatric Alopecia Areata

Part of paid clinical trials in Irvine, California.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05866562
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    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;
  • Placebo — DRUG
    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

Study Details

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 Dates

Start date
Jul 11, 2024
Status verified
Feb 2026
Primary completion
Aug 17, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    200 mg or 300 mg SC injections every 2 or 4 weeks (weight based)
  • Placebo Comparator: Placebo
    Injections without active ingredients

Primary Outcome Measure

Change in the Severity of Alopecia Tool (SALT) score [ Time Frame: Baseline and Week 48 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92697
Marcos Hurtado
[email protected]
949-824-7103
Jamy Paniagua
[email protected]
Natasha Mesinkovska (PRINCIPAL_INVESTIGATOR)
University of California San DiegoSan DiegoCalifornia92093
Luis F Martinez
[email protected]
619-507-1182
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Brian Cheng
[email protected]
312-503-5911
Amy Paller, MD
[email protected]
312-227-6060
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Brian Cheng
[email protected]
312-503-5911
Amy Paller, MD
[email protected]
312-227-6060
Amy Paller, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Giselle Singer
[email protected]
212-241-3288
Emma Guttman-Yassky, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By research site
University of California, Irvine· Irvine, CAUniversity of California San Diego· San Diego, CAAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILNorthwestern University Feinberg School of Medicine· Chicago, ILIcahn School of Medicine at Mount Sinai· New York, NY

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