Using Dupilumab to treat children with Alopecia Areata

Dupilumab in the Treatment of Pediatric Alopecia Areata

This study is testing if Dupilumab can help children and teens with moderate to severe Alopecia Areata grow their hair back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Drugs / interventions: dupilumab, tofacitinib, ruxolitinib, baricitinib, ritlecitinib, methotrexate
• Locations: 5 sites (Irvine, California and 4 other locations)
• Trial ID: NCT05866562 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy of Dupilumab in treating pediatric patients with moderate to severe Alopecia Areata. A total of 76 children and adolescents, aged 6 to 17, will be enrolled across four sites, with participants monitored over a period of up to 124 weeks. The study includes a screening phase, a 48-week placebo-controlled phase, followed by an open-label extension and a follow-up period. Participants will undergo regular assessments to evaluate hair regrowth and monitor safety.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 6 to 17 with moderate to severe Alopecia Areata affecting at least 30% of their scalp.

Not a fit: Patients with no history of hair regrowth in the past 7 years or those with mild Alopecia Areata may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve hair regrowth in children suffering from Alopecia Areata.

How similar studies have performed: Previous studies have shown promise in using Dupilumab for other atopic conditions, suggesting potential success in this novel application for Alopecia Areata.

Eligibility criteria

Inclusion Criteria:

* 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

  \-- Participant is able to adhere to the study visit schedule and other protocol requirements.
* 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 Criteria:

* 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.

Where this trial is running

Irvine, California and 4 other locations

• University of California, Irvine — Irvine, California, United States (Recruiting)
• University of California San Diego — San Diego, California, United States (Recruiting)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (Recruiting)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Emma Guttman-Yassky, MD, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Benjamin Ungar, MD

Conditions Alopecia Areata