Summary

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

Conditions

  • Peanut Allergy

Recruitment Status

COMPLETED

Detailed Description

This study is enrolling participants by invitation only. This is an open-label, international, longer-term extension study for eligible subjects who have participated in one of the Aimmune AR101 clinical studies.

Eligibility Criteria

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

Phase

PHASE3

Gender

ALL

Min Age

1 Year

Max Age

55 Years

Download Date

2024-12-19

Principal Investigator

N/A

Intervention

Intervention Type

BIOLOGICAL

Intervention Name

AR101

Contact

For more information and to contact the study team:

Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008) NCT03292484