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Dupilumab for Pediatric Alopecia Areata

This study is testing Dupilumab, a medication, to see if it can help children and adolescents with moderate to severe alopecia areata (AA), a condition causing hair loss. Participants will receive either Dupilumab or a placebo (an inactive substance) for a period. The study is looking to see how much hair regrowth occurs by measuring changes in the Severity of Alopecia Tool (SALT) score after 48 weeks. Children and adolescents aged 6 to 17 years with at least 30% scalp hair loss, some recent hair regrowth, and a history of allergies (IgE ≥200 and/or personal/family history of atopy) may be able to join. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either Dupilumab or a placebo, and neither you nor the study team will know which you are receiving. It plans to enroll 76 children and adolescents.
What's involved
Your participation would last up to 124 weeks, including a screening period, a 48-week period receiving Dupilumab or placebo, a 48-week open-label extension, and a 24-week follow-up. You would have visits every 8-16 weeks for assessments and monitoring.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 weeks after the open-label extension period, for a total study duration of up to 124 weeks.

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NCT05866562

Dupilumab in the Treatment of Pediatric Alopecia Areata

Recruiting
PHASE2Ages 6–17InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~76 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:DupilumabPlacebo

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the Severity of Alopecia Tool (SALT) score
Measured over Baseline and Week 48

Conditions

Alopecia Areata

Explore related trials

Alopecia

Where it's being run

5 sites across 3 states
California2
Illinois2
New York1

Study leadership

  • Emma Guttman-Yassky, MD, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Benjamin Ungar, MD
[email protected]
212-241-3288
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female participants who are at least 6 years old and under 18 years old, who can provide assent (if appropriate), and for whom signed informed consent can be provided by parent or legal guardian prior to participation in any study assessments or procedures
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product (IP), FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR
Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]);
Participant has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score.
Participant has a screening IgE ≥ 200 and/or personal and/or familial history of atopy (including asthma, atopic dermatitis, allergic rhinitis, food allergy, or eosinophilic esophagitis)
Participant is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.

Exclusion

Inability or unwillingness of a participant to give written informed consent or comply with study protocol
Participant is pregnant or breastfeeding.
Participant's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such traction, cicatricial, pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia (i.e. Ludwig Type III or Norwood-Hamilton Stage ≥ V).
Participant has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss.
Severe, uncontrolled asthma (having 2 or exacerbations in the last 12 months that require systemic steroids and/or hospitalization) or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic medications.
Participant has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics
Participant with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator.
Participant has a concurrent or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
Known active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology at the time of screening for subjects determined by the investigators to be at high-risk for this disease.
Participant has a suspected or active lymphoproliferative disorder or malignancy; OR a history of malignancy within 5 years before the Baseline assessment, except for completely treated in situ non-melanoma skin and cervical cancers without evidence of metastasis.
Participant has received a live attenuated vaccine ≤ 28 days prior to study randomization.
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
History of adverse systemic or allergic reactions to any component of the study drug.
Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, oral JAK inhibitor (tofacitinib, ruxolitinib, baricitinib, ritlecitinib, or investigational oral JAK Inhibitors) or ultraviolet (UV) phototherapy with/without Psoralen Ultraviolet A (PUVA) therapy, within 4 weeks prior to the Week 0/Baseline visit
Participant has been previously treated with dupilumab
Participant has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus within 1 week before the Baseline visit.

What this trial measures

  • Change in the Severity of Alopecia Tool (SALT) scoreBaseline and Week 48

    Change in the SALT score from baseline compared to Week 48 in Dupilumab treated vs placebo treated subjects. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss.