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

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, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology
• •History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
• •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