Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
- Interventional
- Recruiting
- NCT03292484
Contact Information
A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
Gender
All
Age Group
1 Year to 55 Years
Accepting Healthy Volunteers?
No
- 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
- Allergies
- Peanut Allergy