Status:
COMPLETED
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
Lead Sponsor:
Aimmune Therapeutics, Inc.
Conditions:
Peanut Allergy
Eligibility:
All Genders
1-55 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
Detailed Description
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 clini...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
911 Patients enrolled
Trial Details
Trial ID
NCT03292484
Start Date
November 2 2017
End Date
April 27 2023
Last Update
December 19 2024
Active Locations (93)
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1
Alabama Allergy and Asthma Center
Birmingham, Alabama, United States, 35209
2
Medical Research of Arizona, Allergy, Asthma & Immunology Associates
Scottsdale, Arizona, United States, 85251
3
Banner Univ. of Arizona Medical Center
Tucson, Arizona, United States, 85724
4
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202