Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

ID#: NCT03292484

Age: 1 year - 55 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Enrolling by invitation

Start Date: October 11, 2017

End Date: December 01, 2021

Summary: The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
Eligibility: Key

Inclusion Criteria:

- Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol

- Written informed consent and/or assent from subjects/guardians as appropriate

- Use of effective birth control by sexually active female subjects of childbearing potential Key

Exclusion Criteria:

- Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study

- Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless allowed in the parent study, and except during the follow-up observation period in this study

- Discontinued early from the parent study