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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 : Active, not recruiting
First Posted : June 28, 2017
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

June 22, 2017
June 28, 2017
July 16, 2018
June 12, 2017
December 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03201003 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
ARTEMIS Peanut Allergy In Children
AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)
The purpose of this study is to demonstrate the efficacy and safety of AR101 through characterized oral desensitization immunotherapy (CODIT) in peanut-allergic children.
This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic children.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peanut Allergy
  • Biological: AR101
    AR101 powder
  • Other: Placebo
    Placebo powder
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
175
160
February 2019
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
4 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Ireland,   Italy,   Spain,   Sweden,   United Kingdom
 
 
NCT03201003
ARC010
Yes
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
Plan to Share IPD: Undecided
Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc.
Not Provided
Study Chair: Kate McKeown Aimmune Therapeutics
Aimmune Therapeutics, Inc.
July 2018

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