ARTEMIS Peanut Allergy In Children

Peanut Allergy Clinical Trial

— ARTEMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201003
• Other study ID #: ARC010
• Status: Completed
• Phase: Phase 3
• Start date: June 12, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: July 2021
• Source: Aimmune Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• AR101 powder provided in capsules & sachets
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol

Other:
• Placebo powder provided in capsules & sachets
Study product formulated to contain only inactive ingredients for use as defined in the protocol

Locations

Country	Name	City	State
France	Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon	Bordeaux Cedex
France	Hopital Saint Vincent de Paul, Service d'Allergologie	Lille 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
Germany	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
Ireland	UCC Dept. of Paediatrics and Child, Cork University Hospital	Cork
Ireland	National Children's Research Centre, Our Lady's Children's Hospital Crumlin	Dublin
Italy	Azienda Ospedaliera di Padova	Padova
Spain	H. Infantil Universitario Niño Jesús, Servicio de Alergia	Madrid
Spain	Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46	Madrid
Sweden	Sachsska Children and Youth Hospital	Stockholm
United Kingdom	James Paget University Hospital	Gorleston-on-Sea	Norfolk
United Kingdom	Guy & St Thomas' Hospital, NHS Foundation Trust	London
United Kingdom	St. Mary's Hospital	London
United Kingdom	Royal Manchester Children's Hospital	Manchester
United Kingdom	University Hospitals Southampton Foundation NHS Trust	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Aimmune Therapeutics, Inc.

Countries where clinical trial is conducted

France,  Germany,  Ireland,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	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
Secondary	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
Secondary	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