ARTEMIS Peanut Allergy In Children

NCT03201003 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ARC010
• Study Type: interventional
• Target: 175
• Locations: 7 countries
• Sites: 18

Brief Summary

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

Conditions

Peanut Allergy

Keywords

AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Peanut-Allergic Children; Desensitization; ARTEMIS; Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge

  Approximately 9 months

Study Arms (2)

AR101

ACTIVE COMPARATOR

AR101 powder provided in capsules \& sachets

Biological: AR101 powder provided in capsules & sachets

Placebo

PLACEBO COMPARATOR

Placebo powder provided in capsules \& sachets

Other: Placebo powder provided in capsules & sachets

Interventions

AR101 powder provided in capsules & sachets BIOLOGICAL

Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol

AR101

Placebo powder provided in capsules & sachets OTHER

Study product formulated to contain only inactive ingredients for use as defined in the protocol

Placebo

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aimmune Therapeutics, Inc.: lead

Study Sites (18)

Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon

Bordeaux, 33076, France

Location

Hopital Saint Vincent de Paul, Service d'Allergologie

Lille, 59020, France

Location

Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital

Lille, 59037, France

Location

Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg

Strasbourg, 67091, France

Location

Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie

Berlin, 13353, Germany

Location

University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose

Frankfurt am Main, 60590, Germany

Location

UCC Dept. of Paediatrics and Child, Cork University Hospital

Cork, Ireland

Location

National Children's Research Centre, Our Lady's Children's Hospital Crumlin

Dublin, D12 V004, Ireland

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46

Madrid, 28007, Spain

Location

H. Infantil Universitario Niño Jesús, Servicio de Alergia

Madrid, 28009, Spain

Location

Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Sachsska Children and Youth Hospital

Stockholm, 118 83, Sweden

Location

James Paget University Hospital

Gorleston-on-Sea, Norfolk, NR31 6LA, United Kingdom

Location

Guy & St Thomas' Hospital, NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, M13 9WL, United Kingdom

Location

University Hospitals Southampton Foundation NHS Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (4)

• Blumchen K, Kleinheinz A, Klimek L, Beyer K, Anagnostou A, Vogelberg C, Butovas S, Ryan R, Norval D, Zeitler S, Du Toit G. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. Allergy Asthma Clin Immunol. 2023 Mar 13;19(1):21. doi: 10.1186/s13223-023-00757-8.

  PMID: 36915184 DERIVED

• 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.

  PMID: 34389504 DERIVED

• 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.

  PMID: 34320250 DERIVED

• 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.

  PMID: 32702315 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity; Severe combined immunodeficiency with sensitivity to ionizing radiation; Hypersensitivity

Interventions

Capsules

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Aimmune Therapeutics, Inc.

RegulatoryAffairs@aimmune.com

650-409-5164

Study Officials

• Director of Regulatory Affairs

  Aimmune Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 28, 2017
• Study Start: June 12, 2017
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: August 3, 2021
• Results First Posted: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2); IT (1); GB (5); DE (2); FR (4); ES (3); SE (1)