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Summary

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

Description

Summary

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

Details

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.

Keywords

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

Eligibility

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

Locations

  • University of California, San Francisco accepting new patients
    San Francisco, California, 94158, United States
  • Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital in progress, not accepting new patients
    Mountain View, California, 94040, United States
  • Allergy & Asthma Associates of Santa Clara Valley Research Center accepting new patients
    San Jose, California, 95117, United States
  • Jonathan Corren, M.D., Inc. accepting new patients
    Los Angeles, California, 90025, United States
  • UCLA Medical Center, Santa Monica accepting new patients
    Santa Monica, California, 90404, United States
  • Peninsula Research Associates, Inc. accepting new patients
    Rolling Hills Estates, California, 90274, United States
  • Allergy & Asthma Associates of Southern California accepting new patients
    Mission Viejo, California, 92691, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aimmune Therapeutics, Inc.
ID
NCT03126227
Phase
Phase 3
Lead Scientist
Study Type
Interventional
Last Updated
October 6, 2017
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