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 childbearingpotential

Key Exclusion Criteria:

• History of cardiovascular disease, including uncontrolled or inadequately controlledhypertension
• 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 shockwithin 60 days of screening
• History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinaldisease, 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, chronicidiopathic or chronic physical urticaria beyond simple dermatographism (e.g., coldurticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
• Any other condition that, in the opinion of the Investigator, precludes participationfor reasons of safety