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 mmcompared to a negative control

• Experience clinical reaction at or before 444 mg cumulative protein dose of cow'smilk 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 fooditems from their diet so as not to confound the safety and efficacy data from thestudy

• 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 orrequiring intubation

• Recent history of frequent severe, life-threatening episodes of anaphylaxis oranaphylactic shock as defined as 3 or more episodes of anaphylaxis within the pastyear

• Inability to tolerate biological (antibody) therapies

• Body weight <5 kg at the time of screening

• History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinaldisease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD),symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), orrecurrent gastrointestinal symptoms of undiagnosed etiology

• History of cardiovascular disease, including uncontrolled or inadequately controlledhypertension

• History of a mast cell disorder

• Established diagnosis of a primary immunodeficiency disorder

• Severe asthma or mild or moderate asthma if uncontrolled or difficult to control

• Current participation or within the last 4 months in any other interventional study

• Use of medication such as beta-blockers (oral), angiotensin-converting enzyme (ACE)inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers

• Pregnant or breastfeeding women