Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)

Key Inclusion Criteria:

• Ages 4 to 17 years, inclusive
• History of physician-diagnosed peanut allergy that includes allergic signs andsymptoms within two hours of known oral exposure to peanut
• Mean peanut wheal diameter on SPT of at least 8mm and elevated psIgE of at least 14kUA/L at screening
• 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:

• Subjects in whom the clinical diagnosis of peanut allergy is uncertain
• Severe or uncontrolled asthma
• History of cardiovascular disease, including uncontrolled or inadequately controlledhypertension
• 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