for people ages 4-18 (full criteria)
at San Diego, California and other locations
study started
estimated completion:



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

Official Title

Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)


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.


Peanut Allergy AR101 Characterized Peanut Allergen CPNA (Characterized Peanut Allergen) OIT (oral immunotherapy) Peanut-Allergic Children Desensitization Food Allergy Hypersensitivity Peanut Hypersensitivity


For people ages 4-18

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.


  • Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego
    San Diego California 92123 United States
  • Allergy & Asthma Medical Group and Research Center
    San Diego California 92123 United States
  • Allergy & Asthma Associates of Southern California
    Mission Viejo California 92691 United States


accepting new patients by invitation only
Start Date
Completion Date
Aimmune Therapeutics, Inc.
Click to request more information about this study.
Phase 3
Study Type
Last Updated
July 9, 2018