ARTEMIS Peanut Allergy In Children

AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)

The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.

This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic 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