ARTEMIS Peanut Allergy In Children

Phase 3

Completed

• Conditions: Peanut Allergy
• Interventions: Biological: AR101 powder provided in capsules & sachets; Other: Placebo powder provided in capsules & sachets

• Registration Number: NCT03201003
• Lead Sponsor: Aimmune Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2017-06-12
• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Primary Completion: 2019-02-15
• Study Completion: 2019-02-15
• Disposition First Submitted: 2019-08-16
• Disposition First Submitted QC: 2019-08-16
• Disposition First Posted: 2019-08-20
• Status Verified: 2021-07
• Results First Submitted: 2021-07-13
• Results First Submitted QC: 2021-07-13
• Last Update Submitted: 2021-07-13
• Results First Posted: 2021-08-03
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AR101	AR101 powder provided in capsules & sachets	AR101 powder provided in capsules \& sachets
Placebo	Placebo powder provided in capsules & sachets	Placebo powder provided in capsules \& sachets

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.

Trial Locations

Locations (18)

Hopital Saint Vincent de Paul, Service d'Allergologie; 🇫🇷 Lille Cedex, France

Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon; 🇫🇷 Bordeaux Cedex, France

Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital; 🇫🇷 Lille cedex, France

Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg; 🇫🇷 Strasbourg Cedex, France

Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie; 🇩🇪 Berlin, Germany

University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose; 🇩🇪 Frankfurt am Main, Germany

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

National Children's Research Centre, Our Lady's Children's Hospital Crumlin; 🇮🇪 Dublin, Ireland

Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46; 🇪🇸 Madrid, Spain

H. Infantil Universitario Niño Jesús, Servicio de Alergia; 🇪🇸 Madrid, Spain

Sachsska Children and Youth Hospital; 🇸🇪 Stockholm, Sweden

James Paget University Hospital; 🇬🇧 Gorleston-on-Sea, Norfolk, United Kingdom

Guy & St Thomas' Hospital, NHS Foundation Trust; 🇬🇧 London, United Kingdom

Royal Manchester Children's Hospital; 🇬🇧 Manchester, United Kingdom

University Hospitals Southampton Foundation NHS Trust; 🇬🇧 Southampton, United Kingdom

St. Mary's Hospital; 🇬🇧 London, United Kingdom

UCC Dept. of Paediatrics and Child, Cork University Hospital; 🇮🇪 Cork, Ireland