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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:

AR101 Real-World Open-Label Extension Study NCT03337542