Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

Key Inclusion Criteria:

• Age 4 through 55 years
• Clinical history of allergy to peanuts or peanut-containing foods
• Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific unitsper liter, determined by UniCAP™* within the past 12 months) and/or a skin prick test (SPT) to peanut ≥3 mm compared to control
• Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanutprotein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted inaccordance with PRACTALL** guidelines
• Not be residing at the same address as another subject in this or any peanut OIT study UniCAP™*: a laboratory system for routine diagnostic testing of allergy and tool for basicstudies on allergens and antibodies PRACTALL**: PRACTical issues in ALLergology Joint United States/European Union Initiative

Key Exclusion Criteria:

• 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 DBPCFC
• History of chronic disease (other than asthma, atopic dermatitis, or allergicrhinitis) that is, or is at significant risk of becoming, unstable or requiring achange in chronic therapeutic regimen
• 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 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 steroid medication use
• History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, andhereditary or idiopathic angioedema
• Developing dose-limiting symptoms in reaction to the placebo part of the ScreeningDBPCFC
• Having the same place of residence as another subject in the study