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Trial record 1 of 1 for:    arc011
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AR101 Real-World Open-Label Extension Study

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. Identifier: NCT03337542
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : December 24, 2019
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

Brief Summary:
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

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

Detailed Description:
This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial and completed the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
Actual Study Start Date : October 19, 2017
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : September 20, 2019

Arm Intervention/treatment
Treatment arm description
Subjects will receive maintenance dosing with AR101.
Biological: AR101

Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 6 months ]
    Incidence and frequency of treatment-emergent adverse events including serious adverse events during the overall study period (Safety and Tolerability)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Received AR101 in study ARC007
  • Completed the ARC007 study
  • Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

  • Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
  • Receiving a prohibited medication or anticipated use of a prohibited medication [e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
  • Currently in the build-up phase of immunotherapy for any nonfood allergen.
  • Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.

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 identifier (NCT number): NCT03337542

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Sponsors and Collaborators
Aimmune Therapeutics, Inc.
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Study Chair: Freddy Byrth Director, Clinical Operations
Additional Information:
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Responsible Party: Aimmune Therapeutics, Inc. Identifier: NCT03337542    
Other Study ID Numbers: ARC011
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
Peanut-Allergic Children
Food Allergy
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate