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Trial record 8 of 181 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.
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.

Tracking Information
First Submitted Date  ICMJE June 22, 2017
First Posted Date  ICMJE June 28, 2017
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE June 12, 2017
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03201003 on ClinicalTrials.gov Archive Site
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 ARTEMIS Peanut Allergy In Children
Official Title  ICMJE AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peanut Allergy
Intervention  ICMJE
  • Biological: AR101
    AR101 powder
  • Other: Placebo
    Placebo powder
Study Arms  ICMJE
  • Active Comparator: Biological/Vaccine: AR101
    AR101 powder provided in capsules & sachets
    Intervention: Biological: AR101
  • Placebo Comparator: Placebo
    Placebo powder provided in capsules & sachets
    Intervention: Other: 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: March 6, 2018)
175
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2017)
160
Actual Study Completion Date  ICMJE February 15, 2019
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 France,   Germany,   Ireland,   Italy,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03201003
Other Study ID Numbers  ICMJE ARC010
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
Product Manufactured in and Exported from the U.S.: Yes
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: Kate McKeown Aimmune Therapeutics
PRS Account Aimmune Therapeutics, Inc.
Verification Date March 2019

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