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

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

Detailed Description
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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.

Official Title
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A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study

Conditions
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Peanut Allergy

Intervention / Treatment
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* Biological: AR101


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Pathway 1, 2, 3, 4, 5<br>Subjects will be assigned to one of five treatment pathways when first enrolled into ARC008, which is dependent on the treatment received (AR101 or placebo) during the parent study and their tolerance of this treatment regimen (e.g., daily or non-daily schedule). | Biological: AR101<br>* AR101<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events including serious adverse events (Safety and Tolerability) | To describe safety and tolerability during longer-term administration of AR101 and follow-up observation after the last dose of AR101 | Approximately 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peanut allergy desensitization through extended maintenance dosing of AR101 | Proportion of subjects who have completed 3-5 years of AR101 (depending on age group) who tolerate each food challenge dose double-blind, placebo-controlled food challenge (DBPCFC) to a maximum 2000mg peanut protein | Following 3-5 years of AR101 treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AR101, Characterized Peanut Allergen, OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization, CPNA (Characterized Peanut Allergen)