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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03292484
Recruitment Status : Enrolling by invitation
First Posted : September 25, 2017
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Peanut Allergy Biological: AR101 Phase 3

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.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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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).
 Biological: AR101
AR101


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
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Study Chair: Sharon Vadher Director, Clinical Operations
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aimmune Therapeutics, Inc.:
AR101
Characterized Peanut Allergen
OIT (oral immunotherapy)
Peanut Allergy
Allergy
 Peanut-Allergic Children
Peanut-Allergic Adults
Desensitization
CPNA (Characterized Peanut Allergen)
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
 Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate