PALISADE Follow-on Study (ARC004)

Description

The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through characterized oral desensitization immunotherapy (CODIT) in peanut-allergic children and adults who have completed the ARC003 study.

Study Start Date

December, 01 2016

Estimated Completion Date

December 2020

Interventions

  • Biological: AR101

Study ID

Aimmune Therapeutics, Inc. -- ARC004

Status

Recruiting

Trial ID

NCT02993107

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

500

Sponsor

Aimmune Therapeutics, Inc.

Inclusion Criteria

  • Completion of the ARC003 study
  • Written informed consent and/or assent from subjects/guardians as appropriate
  • Use of effective birth control by sexually active female subjects of child-bearing potential

Exclusion Criteria

  • Early discontinuation from the ARC003 study
  • Meets any longitudinally applicable ARC003 study exclusion criteria
  • (Group 2 only) Failure to tolerate ? 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
  • Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety

Gender

All

Ages

4 Years to 55 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (198)

Study Location Distance Name Phone Email
Boston Childrens Hospital Div of Allergy Immunology - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital Div of Allergy Immunology - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital Div of Allergy Immunology - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital Div of Allergy Immunology - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital Div of Allergy Immunology - Boston, Massachusetts 2.6 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Icahn School of Medicine at Mount Sinai Clinical Research Unit - New York, New York 183.2 miles None None None
Icahn School of Medicine at Mount Sinai Clinical Research Unit - New York, New York 183.2 miles None None None
Icahn School of Medicine at Mount Sinai Clinical Research Unit - New York, New York 183.2 miles None None None
Icahn School of Medicine at Mount Sinai Clinical Research Unit - New York, New York 183.2 miles None None None
Icahn School of Medicine at Mount Sinai Clinical Research Unit - New York, New York 183.2 miles None None None
Atlantic Research Center LLC - Ocean City, New Jersey 212.1 miles None None None
Atlantic Research Center LLC - Ocean City, New Jersey 212.1 miles None None None
Atlantic Research Center LLC - Ocean City, New Jersey 212.1 miles None None None
Atlantic Research Center LLC - Ocean City, New Jersey 212.1 miles None None None
Atlantic Research Center LLC - Ocean City, New Jersey 212.1 miles None None None
The Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles None None None
The Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles None None None
The Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles None None None
The Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles None None None
The Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles None None None
Chesapeake Clinical Research Inc - Baltimore, Maryland 349.6 miles None None None
Chesapeake Clinical Research Inc - Baltimore, Maryland 349.6 miles None None None
Chesapeake Clinical Research Inc - Baltimore, Maryland 349.6 miles None None None
Chesapeake Clinical Research Inc - Baltimore, Maryland 349.6 miles None None None
Chesapeake Clinical Research Inc - Baltimore, Maryland 349.6 miles None None None
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles None None None
Childrens National Medical Center - Washington, District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, District of Columbia 391.7 miles None None None
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles None None None
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles None None None
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles None None None
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles None None None
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles None None None
University of North Carolina at Chapel Hill Clinical Translational Research Center CTRC - Chapel Hill, North Carolina 616.4 miles None None None
University of North Carolina at Chapel Hill Clinical Translational Research Center CTRC - Chapel Hill, North Carolina 616.4 miles None None None
University of North Carolina at Chapel Hill Clinical Translational Research Center CTRC - Chapel Hill, North Carolina 616.4 miles None None None
University of North Carolina at Chapel Hill Clinical Translational Research Center CTRC - Chapel Hill, North Carolina 616.4 miles None None None
University of North Carolina at Chapel Hill Clinical Translational Research Center CTRC - Chapel Hill, North Carolina 616.4 miles None None None
University of Michigan Health System - Ann Arbor, Michigan 646.7 miles None None None
Clinical Research of Charlotte - Charlotte, North Carolina 727.5 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles None None None
Riley Hospital for Children IU Health North Hospital - Carmel, Indiana 801.4 miles None None None
Riley Hospital for Children IU Health North Hospital - Carmel, Indiana 801.4 miles None None None
Riley Hospital for Children IU Health North Hospital - Carmel, Indiana 801.4 miles None None None
Riley Hospital for Children IU Health North Hospital - Carmel, Indiana 801.4 miles None None None
Riley Hospital for Children IU Health North Hospital - Carmel, Indiana 801.4 miles None None None
National Allergy and Asthma Research LLC - Charleston, South Carolina 822.5 miles None None None
National Allergy and Asthma Research LLC - Charleston, South Carolina 822.5 miles None None None
National Allergy and Asthma Research LLC - Charleston, South Carolina 822.5 miles None None None
National Allergy and Asthma Research LLC - Charleston, South Carolina 822.5 miles None None None
National Allergy and Asthma Research LLC - Charleston, South Carolina 822.5 miles None None None
Ann Robert H Lurie Childrens Hospital of Chicago - Chicago, Illinois 847.9 miles None None None
Ann Robert H Lurie Childrens Hospital of Chicago - Chicago, Illinois 847.9 miles None None None
Ann Robert H Lurie Childrens Hospital of Chicago - Chicago, Illinois 847.9 miles None None None
Ann Robert H Lurie Childrens Hospital of Chicago - Chicago, Illinois 847.9 miles None None None
Ann Robert H Lurie Childrens Hospital of Chicago - Chicago, Illinois 847.9 miles None None None
The University of Chicago Medicine Comer Childrens Hospital - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medicine Comer Childrens Hospital - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medicine Comer Childrens Hospital - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medicine Comer Childrens Hospital - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medicine Comer Childrens Hospital - Chicago, Illinois 848.0 miles None None None
Atlanta Allergy Asthma Clinic PA - Marietta, Georgia 933.9 miles None None None
Atlanta Allergy Asthma Clinic PA - Marietta, Georgia 933.9 miles None None None
Atlanta Allergy Asthma Clinic PA - Marietta, Georgia 933.9 miles None None None
Atlanta Allergy Asthma Clinic PA - Marietta, Georgia 933.9 miles None None None
Atlanta Allergy Asthma Clinic PA - Marietta, Georgia 933.9 miles None None None
Sneeze Wheeze Itch Associates LLC - Normal, Illinois 935.8 miles None None None
Sneeze Wheeze Itch Associates LLC - Normal, Illinois 935.8 miles None None None
Sneeze Wheeze Itch Associates LLC - Normal, Illinois 935.8 miles None None None
Sneeze Wheeze Itch Associates LLC - Normal, Illinois 935.8 miles None None None
Sneeze Wheeze Itch Associates LLC - Normal, Illinois 935.8 miles None None None
Clinical Research Institute Inc - Plymouth, Minnesota 1,129.6 miles None None None
Clinical Research Institute Inc - Plymouth, Minnesota 1,129.6 miles None None None
Clinical Research Institute Inc - Plymouth, Minnesota 1,129.6 miles None None None
Clinical Research Institute Inc - Plymouth, Minnesota 1,129.6 miles None None None
Clinical Research Institute Inc - Plymouth, Minnesota 1,129.6 miles None None None
Le Bonheur Childrens Hospital Outpatient Building - Memphis, Tennessee 1,134.7 miles None None None
Le Bonheur Childrens Hospital Outpatient Building - Memphis, Tennessee 1,134.7 miles None None None
Le Bonheur Childrens Hospital Outpatient Building - Memphis, Tennessee 1,134.7 miles None None None
Le Bonheur Childrens Hospital Outpatient Building - Memphis, Tennessee 1,134.7 miles None None None
Le Bonheur Childrens Hospital Outpatient Building - Memphis, Tennessee 1,134.7 miles None None None
University of South Florida Asthma Allergy and Immunology Clinical Research Unit - Tampa, Florida 1,177.4 miles None None None
University of South Florida Asthma Allergy and Immunology Clinical Research Unit - Tampa, Florida 1,177.4 miles None None None
University of South Florida Asthma Allergy and Immunology Clinical Research Unit - Tampa, Florida 1,177.4 miles None None None
University of South Florida Asthma Allergy and Immunology Clinical Research Unit - Tampa, Florida 1,177.4 miles None None None
University of South Florida Asthma Allergy and Immunology Clinical Research Unit - Tampa, Florida 1,177.4 miles None None None
Windom Allergy Asthma and Sinus - Sarasota, Florida 1,225.8 miles None None None
Windom Allergy Asthma and Sinus - Sarasota, Florida 1,225.8 miles None None None
Windom Allergy Asthma and Sinus - Sarasota, Florida 1,225.8 miles None None None
Windom Allergy Asthma and Sinus - Sarasota, Florida 1,225.8 miles None None None
Windom Allergy Asthma and Sinus - Sarasota, Florida 1,225.8 miles None None None
Childrens Mercy on Broadway - Kansas City, Missouri 1,250.3 miles None None None
Childrens Mercy on Broadway - Kansas City, Missouri 1,250.3 miles None None None
Childrens Mercy on Broadway - Kansas City, Missouri 1,250.3 miles None None None
Childrens Mercy on Broadway - Kansas City, Missouri 1,250.3 miles None None None
Childrens Mercy on Broadway - Kansas City, Missouri 1,250.3 miles None None None
Arkansas Childrens Hospital - Little Rock, Arkansas 1,258.0 miles None None None
Arkansas Childrens Hospital - Little Rock, Arkansas 1,258.0 miles None None None
Arkansas Childrens Hospital - Little Rock, Arkansas 1,258.0 miles None None None
Arkansas Childrens Hospital - Little Rock, Arkansas 1,258.0 miles None None None
Arkansas Childrens Hospital - Little Rock, Arkansas 1,258.0 miles None None None
The Asthma Allergy Center - Bellevue, Nebraska 1,283.0 miles None None None
The Asthma Allergy Center - Bellevue, Nebraska 1,283.0 miles None None None
The Asthma Allergy Center - Bellevue, Nebraska 1,283.0 miles None None None
The Asthma Allergy Center - Bellevue, Nebraska 1,283.0 miles None None None
The Asthma Allergy Center - Bellevue, Nebraska 1,283.0 miles None None None
Childrens Health - Dallas, Texas 1,551.5 miles None None None
Childrens Health - Dallas, Texas 1,551.5 miles None None None
Childrens Health - Dallas, Texas 1,551.5 miles None None None
Childrens Health - Dallas, Texas 1,551.5 miles None None None
Childrens Health - Dallas, Texas 1,551.5 miles None None None
Texas Childrens Hospital Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
Texas Childrens Hospital Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
Texas Childrens Hospital Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
Texas Childrens Hospital Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
Texas Childrens Hospital Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
Specially for Children Allergy Asthma and Immunology Clinic - Austin, Texas 1,691.8 miles None None None
Specially for Children Allergy Asthma and Immunology Clinic - Austin, Texas 1,691.8 miles None None None
Specially for Children Allergy Asthma and Immunology Clinic - Austin, Texas 1,691.8 miles None None None
Specially for Children Allergy Asthma and Immunology Clinic - Austin, Texas 1,691.8 miles None None None
Specially for Children Allergy Asthma and Immunology Clinic - Austin, Texas 1,691.8 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles None None None
National Jewish Health - Denver, Colorado 1,766.1 miles None None None
Sylvana Research Associates - San Antonio, Texas 1,768.2 miles None None None
Colorado Allergy Asthma Centers PC - Centennial, Colorado 1,769.2 miles None None None
Colorado Allergy Asthma Centers PC - Centennial, Colorado 1,769.2 miles None None None
Colorado Allergy Asthma Centers PC - Centennial, Colorado 1,769.2 miles None None None
Colorado Allergy Asthma Centers PC - Centennial, Colorado 1,769.2 miles None None None
Colorado Allergy Asthma Centers PC - Centennial, Colorado 1,769.2 miles None None None
Western Sky Medical Research - El Paso, Texas 2,068.3 miles None None None
Idaho Allergy and Research dba Idaho Research - Eagle, Idaho 2,265.4 miles None None None
Idaho Allergy and Research dba Idaho Research - Eagle, Idaho 2,265.4 miles None None None
Idaho Allergy and Research dba Idaho Research - Eagle, Idaho 2,265.4 miles None None None
Idaho Allergy and Research dba Idaho Research - Eagle, Idaho 2,265.4 miles None None None
Idaho Allergy and Research dba Idaho Research - Eagle, Idaho 2,265.4 miles None None None
Banner University of Arizona Medical Center - Tucson, Arizona 2,281.0 miles None None None
Northwest Allergy Asthma Center - Seattle, Washington 2,486.9 miles None None None
Northwest Allergy Asthma Center - Seattle, Washington 2,486.9 miles None None None
Northwest Allergy Asthma Center - Seattle, Washington 2,486.9 miles None None None
Northwest Allergy Asthma Center - Seattle, Washington 2,486.9 miles None None None
Northwest Allergy Asthma Center - Seattle, Washington 2,486.9 miles None None None
Benaroya Research Inst at Virginia Mason Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles None None None
Benaroya Research Inst at Virginia Mason Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles None None None
Benaroya Research Inst at Virginia Mason Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles None None None
Benaroya Research Inst at Virginia Mason Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles None None None
Benaroya Research Inst at Virginia Mason Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles None None None
Baker Allergy Asthma Dermatology - Portland, Oregon 2,543.2 miles None None None
Baker Allergy Asthma Dermatology - Portland, Oregon 2,543.2 miles None None None
Baker Allergy Asthma Dermatology - Portland, Oregon 2,543.2 miles None None None
Baker Allergy Asthma Dermatology - Portland, Oregon 2,543.2 miles None None None
Baker Allergy Asthma Dermatology - Portland, Oregon 2,543.2 miles None None None
Rady Childrens Hospital San Diego - San Diego, California 2,579.1 miles None None None
Allergy Asthma Medical Group and Research Center APC - San Diego, California 2,579.1 miles None None None
Rady Childrens Hospital San Diego - San Diego, California 2,579.1 miles None None None
Rady Childrens Hospital San Diego - San Diego, California 2,579.1 miles None None None
Allergy Asthma Medical Group and Research Center APC - San Diego, California 2,579.1 miles None None None
Rady Childrens Hospital San Diego - San Diego, California 2,579.1 miles None None None
Allergy Asthma Medical Group and Research Center APC - San Diego, California 2,579.1 miles None None None
Allergy Asthma Medical Group and Research Center APC - San Diego, California 2,579.1 miles None None None
Rady Childrens Hospital San Diego - San Diego, California 2,579.1 miles None None None
Allergy Asthma Medical Group and Research Center APC - San Diego, California 2,579.1 miles None None None
Allergy Asthma Associates of Southern California - Mission Viejo, California 2,579.6 miles None None None
Allergy Asthma Associates of Southern California - Mission Viejo, California 2,579.6 miles None None None
Allergy Asthma Associates of Southern California - Mission Viejo, California 2,579.6 miles None None None
Allergy Asthma Associates of Southern California - Mission Viejo, California 2,579.6 miles None None None
Allergy Asthma Associates of Southern California - Mission Viejo, California 2,579.6 miles None None None
UCLA Medical Center Santa Monica - Santa Monica, California 2,607.9 miles None None None
UCLA Medical Center Santa Monica - Santa Monica, California 2,607.9 miles None None None
UCLA Medical Center Santa Monica - Santa Monica, California 2,607.9 miles None None None
UCLA Medical Center Santa Monica - Santa Monica, California 2,607.9 miles None None None
UCLA Medical Center Santa Monica - Santa Monica, California 2,607.9 miles None None None
Peninsula Research Associates Inc - Rolling Hills Estates, California 2,610.8 miles None None None
Peninsula Research Associates Inc - Rolling Hills Estates, California 2,610.8 miles None None None
Peninsula Research Associates Inc - Rolling Hills Estates, California 2,610.8 miles None None None
Peninsula Research Associates Inc - Rolling Hills Estates, California 2,610.8 miles None None None
Peninsula Research Associates Inc - Rolling Hills Estates, California 2,610.8 miles None None None
Sean N Parker Center for Allergy Research at Stanford University PackardEl Camino Hospital - Mountain View, California 2,691.6 miles None None None
Sean N Parker Center for Allergy Research at Stanford University PackardEl Camino Hospital - Mountain View, California 2,691.6 miles None None None
Sean N Parker Center for Allergy Research at Stanford University PackardEl Camino Hospital - Mountain View, California 2,691.6 miles None None None
Sean N Parker Center for Allergy Research at Stanford University PackardEl Camino Hospital - Mountain View, California 2,691.6 miles None None None
Sean N Parker Center for Allergy Research at Stanford University PackardEl Camino Hospital - Mountain View, California 2,691.6 miles None None None
University of California San Francisco - San Francisco, California 2,696.4 miles None None None
University of California San Francisco - San Francisco, California 2,696.4 miles None None None
University of California San Francisco - San Francisco, California 2,696.4 miles None None None
University of California San Francisco - San Francisco, California 2,696.4 miles None None None
University of California San Francisco - San Francisco, California 2,696.4 miles None None None

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