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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

Enrolling by invitation

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

Intervention

Intervention Type

Intervention Name

Biological

AR101

Phase

Phase 3

Gender

All

Min Age

1 Year

Max Age

55 Years

Download Date

February 25, 2022

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: