ARTEMIS Peanut Allergy In Children

Key Inclusion Criteria: * Age 4 to 17 years, inclusive * Clinical history of allergy to peanuts * Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L * Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg * Written informed consent from the subject's parent/guardian * Written assent from the subject as appropriate (per local regulatory requirements) * Use of effective birth control by sexually active female subjects of childbearing potential Key Exclusion Criteria: * History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension * History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control * History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening * History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology * History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema * Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety