Phase 3
Completed N=555
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Peanut Allergy
Source: ClinicalTrials.gov NCT02635776 ↗
Enrolled (actual)
555
Serious AEs
2.2%
Results posted
Mar 2022
Primary outcomePrimary: 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) — 250; 5 Participants — p=<0.0001
◆ Published Evidence
Highly cited
750citations · ~94 / year
AR101 Oral Immunotherapy for Peanut Allergy.
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.
Linked Publications (5)
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AR101 Oral Immunotherapy for Peanut Allergy.
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Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy.
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Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy.
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Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials.
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Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
250; 5 | <0.0001 sig |
| SECONDARY Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) |
187; 3 | <0.0001 sig |
| SECONDARY Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) |
285; 10 | <0.0001 sig |
| SECONDARY Percentage of Subjects Ages 4-17 by Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein During the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) |
140; 3; 119; 35; 94; 73 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02635776) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.