Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
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ClinicalTrials.gov Identifier: NCT03292484 |
Recruitment Status :
Enrolling by invitation
First Posted : September 25, 2017
Last Update Posted : February 25, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peanut Allergy | Biological: AR101 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 950 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study |
Actual Study Start Date : | October 11, 2017 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | December 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment Pathway 1, 2, 3, 4, 5
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).
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Biological: AR101
AR101 |
- Incidence of adverse events including serious adverse events (Safety and Tolerability) [ Time Frame: Approximately 10 years ]To describe safety and tolerability during longer-term administration of AR101 and follow-up observation after the last dose of AR101
- Peanut allergy desensitization through extended maintenance dosing of AR101 [ Time Frame: Following 3-5 years of AR101 treatment ]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

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Ages Eligible for Study: | 1 Year to 55 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292484

Study Chair: | Sharon Vadher | Director, Clinical Operations |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Aimmune Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03292484 |
Other Study ID Numbers: |
ARC008 |
First Posted: | September 25, 2017 Key Record Dates |
Last Update Posted: | February 25, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
AR101 Characterized Peanut Allergen OIT (oral immunotherapy) Peanut Allergy Allergy |
Peanut-Allergic Children Peanut-Allergic Adults Desensitization CPNA (Characterized Peanut Allergen) |
Hypersensitivity Peanut Hypersensitivity Immune System Diseases |
Nut and Peanut Hypersensitivity Food Hypersensitivity Hypersensitivity, Immediate |