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ARTEMIS Peanut Allergy In Children (ARTEMIS)

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ClinicalTrials.gov Identifier: NCT03201003
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Peanut Allergy Biological: AR101 Other: Placebo Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Biological/Vaccine: AR101
AR101 powder provided in capsules & sachets
Biological: AR101
AR101 powder
Placebo Comparator: Placebo
Placebo powder provided in capsules & sachets
Other: Placebo
Placebo powder


Outcome Measures

Primary Outcome Measures :
  1. Efficacy of AR101: Proportion of subjects who tolerate specified challenge doses with only AEs of mild severity at the Exit DBPCFC [ Time Frame: 9-14 months ]
    The proportion of subjects who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit DBPCFC


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 at or before 444 mg cumulative peanut protein at the Screening DBPCFC
  • 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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201003


Contacts
Contact: Kate McKeown 650-362-8705 clinicaltrials@aimmune.com

Locations
France
Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon Active, not recruiting
Bordeaux Cedex, France, 33076
Hopital Saint Vincent de Paul, Service d'Allergologie Recruiting
Lille Cedex, France, 59020
Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital Recruiting
Lille cedex, France, 59037
Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg Recruiting
Strasbourg Cedex, France, 67091
Germany
Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie Recruiting
Berlin, Germany, 13353
University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose Recruiting
Frankfurt am Main, Germany, 60590
Ireland
UCC Dept. of Paediatrics and Child, Cork University Hospital Recruiting
Cork, Ireland
National Children's Research Centre, Our Lady's Children's Hospital Crumlin Recruiting
Dublin, Ireland, D12 V004
Spain
Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46 Recruiting
Madrid, Spain, 28007
H. Infantil Universitario Niño Jesús, Servicio de Alergia Recruiting
Madrid, Spain, 28009
Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Sweden
Sachsska Children and Youth Hospital Recruiting
Stockholm, Sweden, 118 83
United Kingdom
James Paget University Hospital Recruiting
Gorleston-on-Sea, Norfolk, United Kingdom, NR31 6LA
Guy & St Thomas' Hospital, NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
St. Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
Royal Manchester Children's Hospital Recruiting
Manchester, United Kingdom, M13 9WL
University Hospitals Southampton Foundation NHS Trust Recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
Study Chair: Kate McKeown Aimmune Therapeutics
More Information

Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03201003     History of Changes
Other Study ID Numbers: ARC010
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Aimmune Therapeutics, Inc.:
AR101
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
Peanut-Allergic Children
Desensitization
ARTEMIS
Allergy

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate