This study is accepting new patients by invitation only

Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

a study on Peanut Allergy Immunotherapy

Summary

Eligibility
for people ages 1-55 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.

Official Title

A Multicenter, Open-Label, Longer-Term 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, longer-term 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

You can join if…

Open to people ages 1-55

  • 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

You CAN'T join if...

  • Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in 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 allowed in the parent study, and except during the follow-up observation period in this study
  • Discontinued early from the parent study

Locations

  • UCSF, Benioff Children's Hospital - Allergy and Immunology
    San Francisco California 95148 United States
  • Bay Area Allergy
    Walnut Creek California 94598 United States
  • Stanford University
    Palo Alto California 94305 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Aimmune Therapeutics, Inc.
ID
NCT03292484
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 950 study participants
Last Updated