ARTEMIS Peanut Allergy In Children

Phase 3

Completed

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

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

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge.	Approximately 9 months	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.

Secondary Outcome Measures

Name	Time	Method
Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge	Approximately 9 months	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)
Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge.	Approximately 9 months	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.
Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge	Approximately 9 months	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.

Locations (18): Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon
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Bordeaux Cedex, France
Hopital Saint Vincent de Paul, Service d'Allergologie
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Lille Cedex, France
Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital
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Lille cedex, France
Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
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Strasbourg Cedex, France
Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie
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Berlin, Germany
University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose
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Frankfurt am Main, Germany
UCC Dept. of Paediatrics and Child, Cork University Hospital
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Cork, Ireland
National Children's Research Centre, Our Lady's Children's Hospital Crumlin
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Dublin, Ireland
Azienda Ospedaliera di Padova
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Padova, Italy
Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46
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Madrid, Spain
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Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon
🇫🇷Bordeaux Cedex, France