Phase 3
Completed N=506
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
Peanut Allergy
Source: ClinicalTrials.gov NCT03126227 ↗
Enrolled (actual)
506
Serious AEs
0.8%
Results posted
Nov 2021
Primary outcomePrimary: Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events — 334; 159; 171; 110 Participants
◆ Published Evidence
Established
23citations · ~5 / year
Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy.
Summary
This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.
Linked Publications
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Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events |
334; 159; 171; 110; 151; 47 | — |
| SECONDARY Frequency of Premature Discontinuation of Dosing Due to Adverse Events |
41; 5 | — |
| SECONDARY Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events |
20; 0 | — |
| SECONDARY Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing |
17; 0; 2; 0; 0; 0 | — |
| SECONDARY Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment |
1434; 51; 1184; 83; 911; 65 | — |
| SECONDARY Frequency of Anaphylaxis as Defined in the Protocol |
36; 9 | — |
| SECONDARY Frequency of Epinephrine Use as Rescue Medication |
37; 9 | — |
| SECONDARY Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods |
26; 31 | — |
| SECONDARY Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 |
23.9; 23.7; 24.2; 23.7; 24.2; 23.8 | — |
| SECONDARY Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 |
22.8; 22.9; 23.0; 23.1; 23.7; 23.2 | — |
| SECONDARY Frequency of Adverse Events That Led to Early Withdrawal |
36; 5 | — |
Eligibility Criteria
Key Inclusion Criteria
- 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
Key Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03126227) 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.