We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03126227
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : December 19, 2017
Information provided by (Responsible Party):

Study Description
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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.

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
  • 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
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): NCT03126227

Contact: Freddy Byrth 650-362-8705 clinicaltrials@aimmune.com

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

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: December 19, 2017
Last Verified: December 2017
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.:
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
Peanut-Allergic Children
Characterized Oral Desensitization Immunotherapy (CODIT™)

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