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for people ages 4–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



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.

Official Title

Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years


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.


Peanut Allergy AR101 Characterized Peanut Allergen CPNA (Characterized Peanut Allergen) OIT (oral immunotherapy) Peanut-Allergic Children Desensitization ARC007 Characterized Oral Desensitization Immunotherapy (CODIT™) Peanut Hypersensitivity


For people ages 4–17

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


  • University of California, San Francisco
    San Francisco, California, 94158, United States
  • Allergy and Asthma Clinical Research, Inc.
    Walnut Creek, California, 94598, United States
  • Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
    Mountain View, California, 94040, United States
  • Allergy & Asthma Associates of Santa Clara Valley Research Center
    San Jose, California, 95117, United States
  • Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
    Los Angeles, California, 90027, United States
  • Jonathan Corren, M.D., Inc.
    Los Angeles, California, 90025, United States
  • UCLA Medical Center, Santa Monica
    Santa Monica, California, 90404, United States
  • Peninsula Research Associates, Inc.
    Rolling Hills Estates, California, 90274, United States
  • Allergy & Asthma Associates of Southern California
    Mission Viejo, California, 92691, United States


in progress, not accepting new patients
Start Date
Completion Date
Aimmune Therapeutics, Inc.
Phase 3
Study Type
Last Updated
March 5, 2018