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AR101 Real-World Open-Label Extension Study | Clinical Trials | Clareo Health

COMPLETEDPHASE3

AR101 Real-World Open-Label Extension Study

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

NCT03337542•Aimmune Therapeutics, Inc.

View on ClinicalTrials.gov

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.

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 (NCT03126227) and completed the study.

Eligibility

Age

4 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

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 (60)

Clinical Research Center of Alabama

Birmingham, Alabama, United States

Medical Research of Arizona

Scottsdale, Arizona, United States

Banner University of Arizona Medical Center

Tucson, Arizona, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Jonathan Corren, M.D., Inc.

Los Angeles, California, United States

Allergy & Asthma Associates of Southern California

Mission Viejo, California, United States

Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital

Mountain View, California, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Allergy & Asthma Medical Group and Research Center

San Diego, California, United States

Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego

San Diego, California, United States

Key Dates

Start Date

October 18, 2017

Primary Completion Date

September 20, 2019

Completion Date

September 20, 2019

Last Updated

November 2, 2021

Enrollment

243

ACTUAL participants

Conditions

Peanut Allergy

Interventions

AR101

BIOLOGICAL

Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis

NCT03835767

Milk and/or Peanut Allergy

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ENROLLING_BY_INVITATIONPHASE2

Food Oral Immunotherapy for Peanut Allergy

NCT04222491

Peanut Allergy

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ACTIVE_NOT_RECRUITINGNA

Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT

NCT04511494

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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AR101 Real-World Open-Label Extension Study

Inclusion Criteria

Exclusion Criteria

Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis

Food Oral Immunotherapy for Peanut Allergy

Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants

Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children