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Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children

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ClinicalTrials.gov Identifier: NCT03126227
Recruitment Status : Active, not recruiting
First Posted : April 24, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT ™) regimen in peanut-allergic children.

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

Detailed Description:
The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™ regimen for approximately 6 months in peanut-allergic children.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2:1 randomization
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Peanut allergen formulation
Subjects will be randomized to active arm of ARC007 and will be administered IP (AR101) in escalating doses for approximately 6 months.
Biological: AR101
AR101 powder provided in capsules

Placebo Comparator: Placebo powder
Subjects will be randomized to placebo arm of ARC007 and will be administered escalating doses of IP (placebo) for approximately 6 months.
Biological: Placebo
Placebo powder provided in capsules




Primary Outcome Measures :
  1. Safety and Tolerability of AR101: Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events [ Time Frame: approximately 6 months, after which the subjects may rollover into an open-label study ]
    Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period



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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
  • History of physician-diagnosed peanut allergy
  • Positive SPT for peanut and elevated psIgE
  • 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:

  • Subjects in whom the clinical diagnosis of peanut allergy is uncertain
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03126227


  Show 64 Study Locations
Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
Study Chair: Freddy Byrth Director, Clinical Operations

Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03126227     History of Changes
Other Study ID Numbers: ARC007
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 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

Keywords provided by Aimmune Therapeutics, Inc.:
AR101
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
Peanut-Allergic Children
Desensitization
ARC007
Characterized Oral Desensitization Immunotherapy (CODIT™)

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