Status:
COMPLETED
AR101 Real-World Open-Label Extension Study
Lead Sponsor:
Aimmune Therapeutics, Inc.
Conditions:
Peanut Allergy
Eligibility:
All Genders
4-17 years
Phase:
PHASE3
Brief Summary
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
Detailed Description
This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and completed the stud...
Eligibility Criteria
Inclusion
- Key
- Received AR101 in study ARC007
- Completed the ARC007 study
- Use of effective birth control by sexually active female subjects of childbearing potential
- Key
Exclusion
- Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
- Receiving a prohibited medication or anticipated use of a prohibited medication \[e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers\], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
- Currently in the build-up phase of immunotherapy for any nonfood allergen.
- Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.
Key Trial Info
Start Date :
October 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2019
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT03337542
Start Date
October 18 2017
End Date
September 20 2019
Last Update
November 2 2021
Active Locations (60)
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1
Clinical Research Center of Alabama
Birmingham, Alabama, United States, 35209
2
Medical Research of Arizona
Scottsdale, Arizona, United States, 85251
3
Banner University of Arizona Medical Center
Tucson, Arizona, United States, 85724
4
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202