AR101 Real-World Open-Label Extension Study

Aimmune Therapeutics

Status and phase: Completed; Phase 3

Conditions: Peanut Allergy

Treatments: Biological: AR101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03337542

ARC011

Details and patient eligibility

About

This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

Full 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.

Enrollment: 243 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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243 participants in 1 patient group

Treatment arm description

Other group

Description:

Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.

Treatment:

Biological: AR101