Summary

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

Description

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.

Official Title

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

Details

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.

Keywords

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

Eligibility

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.

Locations

  • 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

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Aimmune Therapeutics, Inc.
Links
Click to request more information about this study.
ID
NCT03337542
Phase
Phase 3
Study Type
Interventional
Last Updated