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Keep this study
Lead
Aimmune Therapeutics, Inc.
The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™ regimen for approximately 6 months in peanut-allergic children children aged 4 to 17 years, inclusive.
Age
4–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ages 4 to 17 years, inclusive
History of physician-diagnosed peanut allergy that includes allergic signs and symptoms 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 14 kUA/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 childbearing potential
You may not be if
Subjects in whom the clinical diagnosis of peanut allergy is uncertain
Severe or uncontrolled asthma
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
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
Clareo Health | Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
