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for people ages 4–55 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.


This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.


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


For people ages 4–55

Key Inclusion Criteria:

  • Age 4 through 55 years
  • Clinical history of allergy to peanuts or peanut-containing foods
  • Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific units per liter, determined by UniCAP™* within the past 12 months) and/or a skin prick test(SPT) to peanut ≥3 mm compared to control
  • Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL** guidelines
  • Not be residing at the same address as another subject in this or any peanut OIT study

UniCAP™*: a laboratory system for routine diagnostic testing of allergy and tool for basic studies on allergens and antibodies

PRACTALL**: PRACTical issues in ALLergology Joint United States/European Union Initiative

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 DBPCFC
  • History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen
  • 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, urticarial pigmentosa, and hereditary or idiopathic angioedema
  • Developing dose-limiting symptoms in reaction to the placebo part of the Screening DBPCFC
  • Having the same place of residence as another subject in the study


  • University of California, San Francisco
    San Francisco, California, 94158, United States
  • Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
    Mountain View, California, 94040, United States
  • UCLA Medical Center, Santa Monica
    Los Angeles, California, 90404, United States
  • Peninsula Research Associates, Inc.
    Rolling Hills Estates, California, 90274, United States
  • Long Beach Memorial Medical Center / Miller Children's and Women's Hospital
    Long Beach, California, 90806, United States
  • Allergy & Asthma Associates of Southern California dba Southern California Research
    Mission Viejo, California, 92691, United States


in progress, not accepting new patients
Start Date
Completion Date
Aimmune Therapeutics, Inc.
Phase 3
Lead Scientist
Morna Dorsey
Study Type
Last Updated
September 15, 2017