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
Intervention
Intervention Type
Intervention Name
Biological
AR101
Phase
Phase 3
Gender
All
Min Age
1 Year
Max Age
55 Years
Download Date
December 14, 2023
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: