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Summary

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

Description

Summary

The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through characterized oral desensitization immunotherapy (CODIT) in peanut-allergic children and adults who have completed the ARC003 study.

Official Title

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) Follow-on Study

Details

This is an international, multicenter, open-label, 2-arm follow-on study of the safety, tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the ARC003 study. This study will explore alternative dosing regimens during extended maintenance with AR101.

Keywords

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

Eligibility

You can join if…

Open to people ages 4–55

  • Completion of the ARC003 study
  • Written informed consent and/or assent from subjects/guardians as appropriate
  • Use of effective birth control by sexually active female subjects of child-bearing potential

You CAN'T join if...

  • Early discontinuation from the ARC003 study
  • Meets any longitudinally applicable ARC003 study exclusion criteria
  • (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
  • 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 at Stanford University Packard-El Camino Hospital accepting new patients
    Mountain View, California, 94040, 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
NCT02993107
Phase
Phase 3
Lead Scientist
Morna Dorsey
Study Type
Interventional
Last Updated
September 7, 2017
I’m interested in this study!