Dupilumab in the Treatment of Pediatric Alopecia Areata

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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 adolescent subjects with moderate to severe AA (affecting more than 50% of the scalp) at the time of screening with a targeted 60 subjects 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 116 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 16-week follow-up period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Criteria

Inclusion Criteria:

• Male or female subjects 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

• Subject ≥ 30 kg.

• Subject 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]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

• Subject has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score.

• Subject 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 in the participant or a first degree relative).

• Subject 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

• Subject is pregnant or breastfeeding.

• Subject'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).

• Subject has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss.

• Severe, uncontrolled asthma or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic mediations.

• Subject has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics

• Subject with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator.

• Subject 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.

• Subject 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.

• Subject has received a live attenuated vaccine ≤ 30 days prior to study randomization.

• Subject has any uncertain or clinically significant laboratory abnormalities that may affect interpretation of study data or endpoints.

• 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, or ultraviolet (UV) phototherapy with/without Psoralen Ultraviolet A (PUVA) therapy within 4 weeks prior to randomization.

• Use of an oral JAK inhibitor (tofacitinib, ruxolitinib, baricitinib, or investigational oral JAK Inhibitors) within 12 weeks prior to the Baseline visit.

• Subject has been previously treated with dupilumab for more than 3 months

• Subject has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus within 1 week before the Baseline visit.

• Subject currently uses or plans to use anti-retroviral therapy at any time during the study.