ARTEMIS Peanut Allergy In Children

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.

Detailed Description
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This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic children.

Official Title
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AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)

Conditions
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Peanut Allergy

Intervention / Treatment
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* Biological: AR101 powder provided in capsules & sachets
* Other: Placebo powder provided in capsules & sachets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AR101<br>AR101 powder provided in capsules & sachets | Biological: AR101 powder provided in capsules & sachets<br>* Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol<br>|
| Placebo Comparator: Placebo<br>Placebo powder provided in capsules & sachets | Other: Placebo powder provided in capsules & sachets<br>* Study product formulated to contain only inactive ingredients for use as defined in the protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge. | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. | Approximately 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. | Approximately 9 months | 
| Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge. | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. | Approximately 9 months | 
| Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge | The maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower) | Approximately 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Peanut-Allergic Children, Desensitization, ARTEMIS, Allergy