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Summary

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

Description

Summary

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.

Details

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.

Keywords

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

Eligibility

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

Locations

  • 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 Viego, California, 92691, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aimmune Therapeutics, Inc.
ID
NCT02635776
Phase
Phase 3
Lead Scientist
Morna Dorsey
Study Type
Interventional
Last Updated
March 1, 2017