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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

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: