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Trial record 8 of 179 for:    DCLRE1C

ARTEMIS Peanut Allergy In Children (ARTEMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03201003
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : March 26, 2019
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 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
Actual Primary Completion Date : February 15, 2019
Actual Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03201003

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Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon
Bordeaux Cedex, France, 33076
Hopital Saint Vincent de Paul, Service d'Allergologie
Lille Cedex, France, 59020
Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital
Lille cedex, France, 59037
Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
Strasbourg Cedex, France, 67091
Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie
Berlin, Germany, 13353
University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose
Frankfurt am Main, Germany, 60590
UCC Dept. of Paediatrics and Child, Cork University Hospital
Cork, Ireland
National Children's Research Centre, Our Lady's Children's Hospital Crumlin
Dublin, Ireland, D12 V004
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46
Madrid, Spain, 28007
H. Infantil Universitario Niño Jesús, Servicio de Alergia
Madrid, Spain, 28009
Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos
Madrid, Spain, 28040
Sachsska Children and Youth Hospital
Stockholm, Sweden, 118 83
United Kingdom
James Paget University Hospital
Gorleston-on-Sea, Norfolk, United Kingdom, NR31 6LA
Guy & St Thomas' Hospital, NHS Foundation Trust
London, United Kingdom, SE1 7EH
St. Mary's Hospital
London, United Kingdom, W2 1NY
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
University Hospitals Southampton Foundation NHS Trust
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Aimmune Therapeutics, Inc.
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Study Chair: Kate McKeown Aimmune Therapeutics

Additional Information:
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Responsible Party: Aimmune Therapeutics, Inc. Identifier: NCT03201003     History of Changes
Other Study ID Numbers: ARC010
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.:
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
Peanut-Allergic Children

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