Summary

for people ages 4-55 (full criteria)
at UCLA UCSF
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
  • Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless specified in the parent study

Locations

  • UCSF, Benioff Children's Hospital - Allergy and Immunology
    San Francisco California 95148 United States
  • UCLA Medical Center, Santa Monica
    Santa Monica California 90404 United States
  • Jonathan Corren, M.D., Inc.
    Los Angeles California 90025 United States
  • Allergy & Asthma Medical Group and Research Center
    San Diego California 92123 United States
  • Rady Children's Hospital, Div. of Allergy & Immunology
    San Diego California 92123 United States
  • Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
    Los Angeles California 90027 United States
  • Allergy & Asthma Associates of Southern California
    Mission Viejo California 92691 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