AR101 Real-World Open-Label Extension Study

Last updated: October 5, 2021
Sponsor: Aimmune Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Allergies & Asthma

Allergy

Allergy (Peanut)

Treatment

N/A

Clinical Study ID

NCT03337542
ARC011
  • Ages 4-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

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

Exclusion

Key Exclusion Criteria:

  • Developed a clinically significant change in health status during the ARC007 studywhich in the opinion of the investigator would make the subject unsuitable forparticipation in this study.
  • Receiving a prohibited medication or anticipated use of a prohibited medication [e.g.,angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calciumchannel 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 theARC007 study that was just completed.

Study Design

Total Participants: 243
Study Start date:
October 18, 2017
Estimated Completion Date:
September 20, 2019

Study 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.

Connect with a study center

  • McMaster University Medical Center

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Triple A Lab / Hamilton Allergy

    Hamilton, Ontario L8S 1G5
    Canada

    Site Not Available

  • Cheema Research Inc. (CRI)

    Mississauga, Ontario L5A 3V4
    Canada

    Site Not Available

  • Ottawa Allergy Research Corp

    Ottawa, Ontario K1G 6C6
    Canada

    Site Not Available

  • Gordon Sussman Clinical Research

    Toronto, Ontario M4V 1R2
    Canada

    Site Not Available

  • Clinical Research Center of Alabama

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Medical Research of Arizona

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Banner University of Arizona Medical Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Jonathan Corren, M.D., Inc.

    Los Angeles, California 90025
    United States

    Site Not Available

  • Allergy & Asthma Associates of Southern California

    Mission Viejo, California 92691
    United States

    Site Not Available

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

    Mountain View, California 94040
    United States

    Site Not Available

  • Peninsula Research Associates

    Rolling Hills Estates, California 90274
    United States

    Site Not Available

  • Allergy & Asthma Medical Group and Research Center

    San Diego, California 92123
    United States

    Site Not Available

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

    San Diego, California 92123
    United States

    Site Not Available

  • UCSF, Benioff Children's Hospital - Allergy and Immunology

    San Francisco, California 95148
    United States

    Site Not Available

  • Allergy & Asthma Associates of Santa Clara Valley Research Center

    San Jose, California 95117
    United States

    Site Not Available

  • UCLA Medical Center, Santa Monica

    Santa Monica, California 90404
    United States

    Site Not Available

  • Bay Area Allergy

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Asthma & Allergy Associates

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Colorado Allergy & Asthma Centers, P.C.

    Denver, Colorado 80230
    United States

    Site Not Available

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Sher Allergy Specialists - Center for Cough

    Largo, Florida 33778
    United States

    Site Not Available

  • Allergy Associates of the Palm Beaches

    North Palm Beach, Florida 33408
    United States

    Site Not Available

  • Sarasota Clinical Research Windom Allergy, Asthma and Sinus

    Sarasota, Florida 34239
    United States

    Site Not Available

  • University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit

    Tampa, Florida 33613
    United States

    Site Not Available

  • Atlanta Allergy & Asthma Clinic

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Idaho Allergy and Research

    Eagle, Idaho 83616
    United States

    Site Not Available

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611-2605
    United States

    Site Not Available

  • The University of Chicago Medicine, Comer Children's Hospital

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Sneeze, Wheeze, & Itch Associates, LLC

    Normal, Illinois 61761
    United States

    Site Not Available

  • Deaconess Clinic Downtown

    Evansville, Indiana 47713
    United States

    Site Not Available

  • Family Allergy & Asthma Research Institute

    Louisville, Kentucky 40215
    United States

    Site Not Available

  • Chesapeake Clinical Research, Inc.

    Baltimore, Maryland 21236
    United States

    Site Not Available

  • Johns Hopkins Hospital, Pediatric Clinical Research Unit

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan Division of Allergy and Clinical Immunology

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Clinical Research Institute, Inc.

    Plymouth, Minnesota 55441
    United States

    Site Not Available

  • Children's Mercy on Broadway

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Atlantic Research Center

    Ocean City, New Jersey 07712
    United States

    Site Not Available

  • Princeton Center for Clinical Research

    Skillman, New Jersey 08558
    United States

    Site Not Available

  • Northwell Health System

    Great Neck, New York 11021
    United States

    Site Not Available

  • Univ. of Rochester Medical Center, Golisano Children's Hosp.

    Rochester, New York 14642
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill, Clinical & Translational Research Center

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Clinical Research of Charlotte

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Bernstein Clinical Research Center

    Cincinnati, Ohio 45231
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Oklahoma Institute of Allergy and Asthma Clinical Research, LLC

    Oklahoma City, Oklahoma 73131
    United States

    Site Not Available

  • Columbia Asthma & Allergy Clinic

    Clackamas, Oregon 97015
    United States

    Site Not Available

  • Baker Allergy, Asthma and Dermatology

    Portland, Oregon 97223
    United States

    Site Not Available

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • National Allergy and Asthma Research, LLC

    North Charleston, South Carolina 29420
    United States

    Site Not Available

  • Specially for Children Allergy, Asthma and Immunology Clinic

    Austin, Texas 78723
    United States

    Site Not Available

  • Children's Health

    Dallas, Texas 75235
    United States

    Site Not Available

  • Western Sky Medical Research

    El Paso, Texas 79903
    United States

    Site Not Available

  • Texas Children's Hospital, Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Central Texas Health Research

    New Braunfels, Texas 78130
    United States

    Site Not Available

  • ASTHMA Inc. Clinical Research Center

    Seattle, Washington 98115-2024
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

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