Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Sponsored by Aimmune Therapeutics, Inc.
About this trial
Last updated 4 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 8 years ago
What is this trial about?
What are the Participation Requirements?
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 units per 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 peanut protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in accordance 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 basic studies 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 controlled hypertension * History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of Screening DBPCFC * History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen * 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 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, and hereditary or idiopathic angioedema * Developing dose-limiting symptoms in reaction to the placebo part of the Screening DBPCFC * Having the same place of residence as another subject in the study
