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.
Conditions
Peanut Allergy
Recruitment Status
Completed
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 study.
Eligibility Criteria
Key Inclusion Criteria:
Received AR101 in study ARC007
Completed the ARC007 study
Use of effective birth control by sexually active female subjects of childbearing potential
Key Exclusion Criteria:
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.
Intervention
Intervention Type
Intervention Name
Biological
AR101
Phase
Phase 3
Gender
All
Min Age
4 Years
Max Age
17 Years
Download Date
November 2, 2021
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: