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Keep this study
Lead
Aimmune Therapeutics, Inc.
This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.
Age
4–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
