Clinical trial NCT03201003: ARTEMIS Peanut Allergy In Children
Official title: AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peanut Allergy
Keywords: AR101
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
Peanut-Allergic Children
Desensitization
ARTEMIS
Allergy
Lead sponsor: Aimmune Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-28
Enrollment: 175
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge.
timeFrame: Approximately 9 months
Secondary outcomes:
measure: Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge
timeFrame: Approximately 9 months
measure: Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge.
timeFrame: Approximately 9 months
measure: Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge
timeFrame: Approximately 9 months
Other outcomes:
Locations:
city: Bordeaux Cedex
country: France
facility: Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon
city: Lille Cedex
country: France
facility: Hopital Saint Vincent de Paul, Service d'Allergologie
city: Lille cedex
country: France
facility: Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital
city: Strasbourg Cedex
country: France
facility: Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie
city: Frankfurt am Main
country: Germany
facility: University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose
city: Cork
country: Ireland
facility: UCC Dept. of Paediatrics and Child, Cork University Hospital
city: Dublin
country: Ireland
facility: National Children's Research Centre, Our Lady's Children's Hospital Crumlin
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46
city: Madrid
country: Spain
facility: H. Infantil Universitario Niño Jesús, Servicio de Alergia
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos
city: Stockholm
country: Sweden
facility: Sachsska Children and Youth Hospital
city: Gorleston-on-Sea
country: United Kingdom
facility: James Paget University Hospital
state: Norfolk
city: London
country: United Kingdom
facility: Guy & St Thomas' Hospital, NHS Foundation Trust
city: London
country: United Kingdom
facility: St. Mary's Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Southampton
country: United Kingdom
facility: University Hospitals Southampton Foundation NHS Trust
Study officials:
affiliation: Aimmune Therapeutics
name: Director of Regulatory Affairs
role: STUDY_DIRECTOR
References:
citation: Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.
citation: Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.
citation: O'B Hourihane J, Beyer K, Abbas A, Fernandez-Rivas M, Turner PJ, Blumchen K, Nilsson C, Ibanez MD, Deschildre A, Muraro A, Sharma V, Erlewyn-Lajeunesse M, Zubeldia JM, De Blay F, Sauvage CD, Byrne A, Chapman J, Boralevi F, DunnGalvin A, O'Neill C, Norval D, Vereda A, Skeel B, Adelman DC, du Toit G. Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial. Lancet Child Adolesc Health. 2020 Oct;4(10):728-739. doi: 10.1016/S2352-4642(20)30234-0. Epub 2020 Jul 20.