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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03126227
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE April 20, 2017
First Posted Date  ICMJE April 24, 2017
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE May 8, 2017
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children
Official Title  ICMJE Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2:1 randomization
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peanut Allergy
Intervention  ICMJE
  • Biological: AR101
    AR101 powder provided in capsules
  • Biological: Placebo
    Placebo powder provided in capsules
Study Arms  ICMJE
  • 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.
    Intervention: Biological: AR101
  • 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.
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2018)
506
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2017)
440
Actual Study Completion Date  ICMJE September 23, 2018
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03126227
Other Study ID Numbers  ICMJE ARC007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Aimmune Therapeutics, Inc.
Study Sponsor  ICMJE Aimmune Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Freddy Byrth Director, Clinical Operations
PRS Account Aimmune Therapeutics, Inc.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP