Dupilumab in the Treatment of Pediatric Alopecia Areata

Inclusion Criteria:

• Male or female participants who are at least 6 years old and under 18 years old, whocan provide assent (if appropriate), and for whom signed informed consent can beprovided by parent or legal guardian prior to participation in any study assessmentsor procedures

-- Participant is able to adhere to the study visit schedule and other protocolrequirements.

• Females of childbearing potential (FCBP) must have a negative pregnancy test atScreening and Baseline. While on investigational product and for at least 28 daysafter taking the last dose of investigational product (IP), FCBP who engage inactivity in which conception is possible must use one of the approved contraceptiveoptions described below:

• Option 1: Any one of the following highly effective methods: hormonalcontraception (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 outof natural [animal] membrane [for example, polyurethane]);

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

• Participant has a screening IgE ≥ 200 and/or personal and/or familial history ofatopy (including asthma, atopic dermatitis, allergic rhinitis, food allergy, oreosinophilic esophagitis)

• Participant is judged to be in otherwise good overall health following a detailedmedical and medication history, physical examination, and laboratory testing.

Exclusion Criteria:

• Inability or unwillingness of a participant to give written informed consent orcomply with study protocol

• Participant is pregnant or breastfeeding.

• Participant's cause of hair loss is indeterminable and/or they have concomitantcauses of alopecia, such traction, cicatricial, pregnancy-related, drug-induced,telogen effluvium, or advanced androgenetic alopecia (i.e. Ludwig Type III orNorwood-Hamilton Stage ≥ V).

• Participant has a history of AA with no evidence of hair regrowth for ≥ 7 yearssince their last episode of hair loss.

• Severe, uncontrolled asthma (having 2 or exacerbations in the last 12 months thatrequire systemic steroids and/or hospitalization) or a history of life-threateningasthma exacerbations while on appropriate anti-asthmatic medications.

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

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

• Participant has a concurrent or recent history of severe, progressive, oruncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine,pulmonary, cardiovascular, or neurological disease.

• Known active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), orpositive HIV serology at the time of screening for subjects determined by theinvestigators to be at high-risk for this disease.

• Participant has a suspected or active lymphoproliferative disorder or malignancy; ORa history of malignancy within 5 years before the Baseline assessment, except forcompletely treated in situ non-melanoma skin and cervical cancers without evidenceof metastasis.

• Participant has received a live attenuated vaccine ≤ 28 days prior to studyrandomization.

• Past or current medical problems or findings from physical examination or laboratorytesting that are not listed above, which, in the opinion of the investigator, maypose additional risks from participation in the study, may interfere with theparticipant's ability to comply with study requirements or that may impact thequality or interpretation of the data obtained from the study.

• History of adverse systemic or allergic reactions to any component of the studydrug.

• 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) orultraviolet (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 pimecrolimuswithin 1 week before the Baseline visit.