Phase 3
N=175
ARTEMIS Peanut Allergy In Children
Peanut Allergy
Bottom Line
View on ClinicalTrials.gov: NCT03201003 ↗Enrolled (actual)
175
Serious AEs
1.7%
Results posted
Aug 2021
Primary outcome: Primary: The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge. — 77; 1 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AR101 powder provided in capsules & sachets (Biological); Placebo powder provided in capsules & sachets (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Aimmune Therapeutics, Inc.
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge. |
77; 1 | <0.0001 sig |
| SECONDARY Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge |
90; 4 | <0.0001 sig |
| SECONDARY Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge. |
97; 7 | <0.0001 sig |
| SECONDARY Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge |
47; 0; 55; 16; 24; 20 | <0.0001 sig |
Summary
The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.
Eligibility Criteria
Key Inclusion Criteria
- Age 4 to 17 years, inclusive
- Clinical history of allergy to peanuts
- Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L
- Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg
- 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
- History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- 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 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 (NCT03201003). 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.