Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALI… (NCT02635776) | Clinical Trial Compass
CompletedPhase 3
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
United States555 participantsStarted 2015-12-22
Plain-language summary
The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
Who can participate
Age range4 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 gastrointes…
What they're measuring
1
Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)