Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

Last updated: November 29, 2024
Sponsor: Aimmune Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Allergy

Allergies & Asthma

Allergy (Peanut)

Treatment

AR101

Clinical Study ID

NCT03292484
ARC008
  • Ages 1-55
  • All Genders

Study Summary

The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Prior participation in an Aimmune AR101 clinical study or any future clinical studythat identifies ARC008 as a follow-on study option in the protocol

  • Written informed consent and/or assent from subjects/guardians as appropriate

  • Use of effective birth control by sexually active female subjects of childbearingpotential

Exclusion

Key Exclusion Criteria:

  • Did not complete a minimum of 3 months of AR101 maintenance therapy if the subjectwas assigned to AR101 in the parent study

  • Currently receiving or received within 5 years prior to Screening any type of peanutor other food allergen immunotherapy, except AR101 or unless allowed in the parentstudy, and except during the follow-up observation period in this study

  • Discontinued early from the parent study

Study Design

Total Participants: 911
Treatment Group(s): 1
Primary Treatment: AR101
Phase: 3
Study Start date:
November 02, 2017
Estimated Completion Date:
April 27, 2023

Study Description

This study is enrolling participants by invitation only. This is an open-label, international, longer-term extension study for eligible subjects who have participated in one of the Aimmune AR101 clinical studies.

Connect with a study center

  • McMaster University Medical Center

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Triple A Lab

    Hamilton, Ontario L8S 1G5
    Canada

    Site Not Available

  • Cheema Research Inc.

    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

  • Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants

    Bordeaux, Cedex 33076
    France

    Site Not Available

  • Hopital Saint Vincent de Paul- Service d'Allergologie

    Lille, Cedex 59020
    France

    Site Not Available

  • Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center

    Lille, Cedex 59037
    France

    Site Not Available

  • Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg

    Strasbourg, Cedex 67091
    France

    Site Not Available

  • Charité Universitaetsmedizin Berlin

    Berlin, 13353
    Germany

    Site Not Available

  • University of Frankfurt

    Frankfurt, 60590
    Germany

    Site Not Available

  • Cork University Hospital, UCC Department of Paediatrics and Child Health

    Cork, T12 DC4A
    Ireland

    Site Not Available

  • National Children's Research Centre, Our Lady's Children's Hospital Crumlin

    Dublin, D12 V004
    Ireland

    Site Not Available

  • Azienda Ospedaliera di Padova

    Padova, Province Of Padua 35128
    Italy

    Site Not Available

  • Beatrix Children's Hospital, University Medical Center Groningen

    Groningen, 9700 RB
    Netherlands

    Site Not Available

  • University Medical Center Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • H. Infantil Universitario Niño Jesús, Servicio de Alergia

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Madrid Hospital Clinico San Carlos, Servicio de Alergia

    Madrid, 28040
    Spain

    Site Not Available

  • Sachsska Children and Youth Hospital

    Stockholm, 118 83
    Sweden

    Site Not Available

  • Leicester Royal infirmary

    Leicester, Leicestershire LE1 5WW
    United Kingdom

    Site Not Available

  • James Paget University Hospital

    Gorleston-on-Sea, Norfolk NR31 6LA
    United Kingdom

    Site Not Available

  • Guy & St Thomas' NHS Foundation Trust, Children Allergies Department

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • St Mary's Hospital - Paediatric Research Unit

    London, W2 1NY
    United Kingdom

    Site Not Available

  • Children's Clinical Research Facility, Royal Manchester Children's Hospital

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital

    Sheffield, S10 2TH
    United Kingdom

    Site Not Available

  • University Hospitals Southampton Foundation NHS Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Central Manchester University Hospitals

    Wythenshawe, M23 9LT
    United Kingdom

    Site Not Available

  • Alabama Allergy and Asthma Center

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Medical Research of Arizona, Allergy, Asthma & Immunology Associates

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Banner Univ. 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

  • Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy

    Los Angeles, California 90027
    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 and Asthma Research LPCH El Camino Hospital

    Mountain View, California 94040
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94305
    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. of Allergy & Immunology

    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 Health System

    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

    Sarasota, Florida 34239
    United States

    Site Not Available

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

    Tampa, Florida 33613
    United States

    Site Not Available

  • Children's Healthcare of Atlanta

    Atlanta, Georgia 30329
    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

    Normal, Illinois 61761
    United States

    Site Not Available

  • Riley Children's Specialists

    Carmel, Indiana 46032
    United States

    Site Not Available

  • Deaconess Clinic, Inc.

    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

  • Univ. of Michigan Health System, Div. 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

  • Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    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, LLC

    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

    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

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • National Allergy and Asthma Research, LLC

    North Charleston, South Carolina 29420
    United States

    Site Not Available

  • Le Bonheur Children's Hospital, Outpatient Bldg.

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • 'Specially for Children Allergy, Asthma and Immunology Clinic

    Austin, Texas 78723
    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

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.