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AR101 Real-World Open-Label Extension Study

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ClinicalTrials.gov Identifier: NCT03337542
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 13, 2017
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

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

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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 another 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 ClinicalTrials.gov identifier (NCT number): NCT03337542

Contact: Jerome G. Pinkett, MBA 650-362-8705 clinicaltrials@aimmune.com

United States, Georgia
Atlanta Allergy & Asthma Clinic Recruiting
Marietta, Georgia, United States, 30060-0950
Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Study Chair: Jerome G. Pinkett, MBA Sr. Director, Clinical Operations

Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03337542     History of Changes
Other Study ID Numbers: ARC011
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
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

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:
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate