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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.
 
ClinicalTrials.gov Identifier: NCT03201003
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

Study Description
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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
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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

Arms and Interventions
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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
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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
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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
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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


Locations
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Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
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Study Chair: Kate McKeown Aimmune Therapeutics
More Information
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Additional Information:

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Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03201003    
Other Study ID Numbers: ARC010
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: August 20, 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.:
AR101
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
 Peanut-Allergic Children
Desensitization
ARTEMIS
Allergy
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
 Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate