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
PHASE3
Gender
ALL
Min Age
4 Years
Max Age
17 Years
Download Date
2021-11-02
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: