Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) Follow-on Study
Status: Completed
Location: See all (65) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 55
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Arkansas Children's Hospital
Little Rock
Arizona
Banner University of Arizona Medical Center
Tucson
California
Allergy & Asthma Associates of Southern California
Mission Viejo
Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
Mountain View
Peninsula Research Associates, Inc.
Rolling Hills Estates
Allergy & Asthma Medical Group and Research Center, APC
San Diego
Rady Children's Hospital, San Diego
San Diego
University of California, San Francisco
San Francisco
UCLA Medical Center, Santa Monica
Santa Monica
Colorado
Children's Hospital Colorado
Aurora
Colorado Allergy & Asthma Centers, P.C.
Centennial
National Jewish Health
Denver
Washington, D.c.
Children's National Medical Center
Washington
Florida
Sarasota Clinical Research
Sarasota
University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
Tampa
Georgia
Atlanta Allergy & Asthma Clinic, PA
Marietta
Idaho
Idaho Allergy and Research, dba Idaho Research
Eagle
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Comer Children's Hospital
Chicago
Sneeze, Wheeze, & Itch Associates, LLC
Normal
Indiana
IU North Riley Children's Specialist
Carmel
Massachusetts
Boston Children's Hospital, Div. of Allergy & Immunology
Boston
Massachusetts General Hospital
Boston
Maryland
Chesapeake Clinical Research, Inc.
Baltimore
Johns Hopkins Hospital
Baltimore
Michigan
Michigan Medicine, Michigan Clinical Research Unit
Ann Arbor
Minnesota
Clinical Research Institute, Inc.
Plymouth
Missouri
Children's Mercy on Broadway
Kansas City
North Carolina
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
Chapel Hill
Clinical Research of Charlotte
Charlotte
Nebraska
Nebraska Medical Research Institute Inc.
Bellevue
New Jersey
Atlantic Research Center, LLC
Ocean City
New York
Icahn School of Medicine at Mount Sinai, Clinical Research Unit
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Oregon
Baker Allergy, Asthma & Dermatology
Portland
Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Pittsburgh
South Carolina
National Allergy and Asthma Research, LLC
Charleston
Tennessee
Le Bonheur Children's Hospital - Outpatient Building
Memphis
Texas
'Specially for Children Allergy, Asthma and Immunology Clinic
Austin
Children's Health
Dallas
Western Sky Medical Research
El Paso
Texas Children's Hospital, Baylor College of Medicine
Houston
Central Texas Health Research
New Braunfels
Sylvana Research Associates
San Antonio
Washington
Asthma Inc Clinical Research Center
Seattle
Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center
Seattle
Other Locations
Canada
Triple A Lab
Hamilton
Cheema Research Inc.
Mississauga
Montreal Children's Hospital
Montréal
Ottawa Allergy Research Corp
Ottawa
Gordon Sussman Clinical Research, Inc.
Toronto
Germany
Charité Universitaetsmedizin Berlin
Berlin
University of Frankfurt
Frankfurt Am Main
Ireland
Cork University Hospital
Cork
Italy
Azienda Ospedaliera di Padova
Padova
Netherlands
Beatrix Children's Hospital, University Medical Center Groningen
Groningen
University Medical Center Groningen
Groningen
Spain
H. Infantil Universitario Niño Jesús
Madrid
Hospital Clinico San Carlos
Madrid
Hospital Gregorio Marañón
Madrid
Sweden
Sachsska Children and Youth Hospital
Stockholm
United Kingdom
Guy & St Thomas' NHS foundation Trust
London
Central Manchester University Hospitals, NHS Foundation Trust
Manchester
Central Manchester University Hospitals, NHS Foundation Trust
Manchester
Time Frame
Start Date: 2016-12-29
Completion Date: 2019-05-31
Participants
Target number of participants: 388
Treatments
Other: Group 1 (Placebo Crossovers)
Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC).
Other: Group 2 (Active Rollovers)
Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval.
Authors
Lyndon Mansfield, David Jeong, Ned Rupp, Jay Lieberman, Georgiana Sanders, Michael J. Welch, Frederick Leickly, Jonathan Spergel, Allan Stillerman, Stephen Tilles, Thomas Casale, Edwin Kim, Gregory Brooks, Todd Green, Stanley Fineman, Rima Rachid, Stacie Jones, Hugh Windom, Warner Carr, Leon Greos, William Yang
Sponsors
Leads: Aimmune Therapeutics, Inc.