Actively Recruiting
Dupilumab in the Treatment of Pediatric Alopecia Areata
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-02-20
76
Participants Needed
5
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dupilumab in the Treatment of Pediatric Alopecia Areata
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 6 to under 18 years who can provide assent and whose parent or guardian can provide signed informed consent
- Ability to follow study visit schedule and protocol requirements
- Females of childbearing potential must have a negative pregnancy test at screening and baseline and use approved contraceptive methods during and for 28 days after treatment
- History of at least 6 months of moderate to severe alopecia areata with 50% or more scalp involvement as measured by SALT score
- Screening IgE level of 200 or higher and/or personal or family history of atopy (including asthma, atopic dermatitis, allergic rhinitis, food allergy, or eosinophilic esophagitis)
- Overall good health based on medical history, physical exam, and lab tests
You will not qualify if you...
- Inability or unwillingness to provide informed consent or comply with study protocol
- Pregnancy or breastfeeding
- Unknown cause of hair loss or other types of alopecia such as traction, cicatricial, pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia
- No hair regrowth evidence for 7 or more years since last hair loss episode
- Severe uncontrolled asthma or history of life-threatening asthma exacerbations
- Active bacterial, viral, or parasitic infections or history of severe recurrent infections
- Known or suspected immunodeficiency or immune-compromised state
- Severe, progressive, or uncontrolled major organ system diseases
- Known active hepatitis B, hepatitis C, HIV, or high-risk HIV serology
- Suspected or active lymphoproliferative disorder or recent malignancy within 5 years except certain treated skin or cervical cancers
- Receipt of live attenuated vaccine within 28 days before randomization
- Any medical problems or findings that may pose additional risk or interfere with participation
- History of allergic reactions to study drug components
- Use of systemic immunosuppressive medications or phototherapy within 4 weeks before baseline
- Previous treatment with dupilumab
- Use of topical corticosteroids, tacrolimus, or pimecrolimus within 1 week before baseline
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of California, Irvine
Irvine, California, United States, 92697
Actively Recruiting
2
University of California San Diego
San Diego, California, United States, 92093
Actively Recruiting
3
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
B
Benjamin Ungar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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