Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy

Inclusion Criteria: * Age 4 to 50 years (inclusive) * Clinical history of allergy to cow's milk or milk-containing foods * Serum IgE to milk of \>4 kUA/L within the last 12 months and/or a SPT to milk ≥6 mm compared to a negative control * Experience clinical reaction at or before 444 mg cumulative protein dose of cow's milk protein on Screening DBPCFC * No clinical reaction observed during the placebo (oat) Screening DBPCFC * Subjects with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study * Use of effective birth control by female participants of childbearing potential Exclusion Criteria: * Any previous exposure to dupilumab * Known hypersensitivity to dupilumab or any of its excipients * Known hypersensitivity to epinephrine or any of its excipients * Allergy to oat (placebo in DBPCFC) * History of severe anaphylaxis to cow's milk, defined as neurological compromise or requiring intubation * Recent history of frequent severe, life-threatening episodes of anaphylaxis or anaphylactic shock as defined as 3 or more episodes of anaphylaxis within the past year * Inability to tolerate biological (antibody) therapies * Body weight \<5 kg at the time of screening * History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, foo…