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 assess AR101's safety and tolerability over an extended dosing period.

Official Title

A Multicenter, Open-label, Long-term Safety Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study

Details

This study is enrolling participants by invitation only. This is an open-label, international, long-term safety extension study for eligible subjects who have participated in one of the Aimmune AR101 clinical studies.

Keywords

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

Eligibility

For people ages 4-55

Key Inclusion Criteria:

  • Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol
  • Written informed consent and/or assent from subjects/guardians as appropriate
  • Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

  • Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study
  • Early discontinuation from the parent study
  • In subjects treated with AR101 in the parent study requiring a food challenge, failure to successfully consume at least 300 mg single dose of peanut protein at parent study's exit food challenge

Locations

  • UCSF, Benioff Children's Hospital - Allergy and Immunology
    San Francisco California 95148 United States
  • Bay Area Allergy
    Walnut Creek California 94598 United States
  • Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital
    Mountain View California 94040 United States
  • Allergy & Asthma Associates of Santa Clara Valley Research Center
    San Jose California 95117 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Aimmune Therapeutics, Inc.
Links
Click to request more information about this study.
ID
NCT03292484
Phase
Phase 3
Study Type
Interventional
Last Updated
July 23, 2018