PALISADE Follow-on Study (ARC004)



Status:Active, not recruiting
Conditions:Allergy, Allergy, Neurology
Therapuetic Areas:Neurology, Otolaryngology
Healthy:No
Age Range:4 - 55
Updated:3/28/2019
Start Date:December 2016
End Date:June 2019

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Trial Summary
Trial Overview
Inclusion Criteria

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) Follow-on Study

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.

This is an international, multicenter, open-label, 2-arm follow-on study of the safety,
tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the
ARC003 study. This study will explore alternative dosing regimens during extended maintenance
with AR101.

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
We found this trial at
48
sites
University of California at San Francisco
San Francisco, California 94143
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Cincinnati Children's Hospital Medical Center
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Jonathan Spergel, MD
Phone: 267-425-0010
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Children's Hospital of Pittsburgh of UPMC
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Rady Children's Hospital - San Diego
3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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University of Michigan Health System
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Georgiana Sanders, MD
Phone: 734-615-1590
University of Michigan Health System The University of Michigan is home to one of the...
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Children's Hospital Colorado
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Specially for Children Allergy, Asthma and Immunology Clinic
Austin, Texas 78723
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Austin, TX
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Johns Hopkins Hospital
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Chesapeake Clinical Research, Inc
Baltimore, Maryland 21236
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The Asthma & Allergy Center, PC
Bellevue, Nebraska 68123
Principal Investigator: Gregory Brooks, MD
Phone: 402-592-2055
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Boston Children's Hospital, Div. of Allergy & Immunology
Boston, Massachusetts 02115
Principal Investigator: Rima Rachid, MD
Phone: 617-919-4602
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Riley Hospital for Children, IU Health North Hospital
11700 North Meridian Street
Carmel, Indiana 46032
Principal Investigator: Frederick Leickly, MD
Phone: 317-688-5700
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Colorado Allergy & Asthma Centers, PC
Centennial, Colorado 80112
Principal Investigator: Leon Greos, MD
Phone: 303-632-3646
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University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina 27599
Principal Investigator: Edwin Kim, MD
Phone: 919-962-4409
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National Allergy and Asthma Research, LLC
Charleston, South Carolina 29407
Principal Investigator: Ned Rupp, MD
Phone: 843-576-7485
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Clinical Research of Charlotte
Charlotte, North Carolina 28277
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Charlotte, NC
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Ann & Robert H. Lurie Children's Hospital of Chicago
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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University of Chicago Medicine Comer Children's Hospital
Chicago, Illinois 60637
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Children's Health
1935 Medical District Drive
Dallas, Texas 75235
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National Jewish Health
1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Idaho Allergy and Research, dba Idaho Research
379 East Shore Drive
Eagle, Idaho 83616
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Eagle, ID
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Western Sky Medical Research
El Paso, Texas 79903
Principal Investigator: Lyndon Mansfield, MD
Phone: 915-544-2557
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Triple A Lab
Hamilton, Ontario
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Texas Childrens Hospital. Baylor College of Medicine
Houston, Texas 77030
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Children's Mercy on Broadway
Kansas City, Missouri 64111
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Arkansas Children's Hospital
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: Stacie Jones, MD
Phone: 501-364-1998
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia 30060
Principal Investigator: Stanley Fineman, MD
Phone: 770-592-4210
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Le Bonheur Children's Hospital - Outpatient Building
51 North Dunlap Street
Memphis, Tennessee 38105
Principal Investigator: Jay Lieberman, MD
Phone: 901-287-6484
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Allergy and Asthma Associates of Southern California
Mission Viejo, California 92691
Principal Investigator: Warner Carr, MD
Phone: 949-347-8700
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Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
Mountain View, California 94040
Principal Investigator: Sharon Chinthrajah, MD
Phone: 650-564-4568
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Central Texas Health Research
New Braunfels, Texas 78130
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Icahn School of Medicine at Mount Sinai, Clinical Research Unit
New York, New York 10029
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New York, NY
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Sneeze, Wheeze & Itch Associates LLC
Normal, Illinois 61761
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Normal, IL
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Atlantic Research Center, LLC
Ocean City, New Jersey 07712
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Clinical Research Institute Inc
Plymouth, Minnesota 55441
Principal Investigator: Allan Stillerman, MD
Phone: 763-744-1140
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Baker Allergy, Asthma & Dermatology
9495 Southwest Locust Street
Portland, Oregon 97223
Principal Investigator: James Baker, MD
Phone: 503-505-5916
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Portland, OR
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Peninsula Research Associates, Inc.
Rolling Hills Estates, California 66212
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Sylvana Research Associates
San Antonio, Texas 78229
Principal Investigator: Paul Ratner, MD
Phone: 210-614-6673
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Allergy & Asthma Medical Group & Research Center A.P.C.
San Diego, California 92123
Principal Investigator: Michael J. Welch, MD
Phone: 858-268-2368
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UCLA Medical Center Santa Monica
Santa Monica, California 90404
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Windom Allergy, Asthma and Sinus
Sarasota, Florida 34239
Principal Investigator: Hugh Windom, MD
Phone: 941-927-4888
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Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center
Seattle, Washington 98101
Principal Investigator: David Jeong, MD
Phone: 206-342-6598
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Northwest Allergy & Asthma Center
9725 3rd Avenue Northeast
Seattle, Washington 98115
Principal Investigator: Stephen Tilles, MD
Phone: 206-525-5520
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University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida 33613
Principal Investigator: Thomas Casale, MD
Phone: 813-631-4024
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Banner University of Arizona Medical Center
Tucson, Arizona 85724
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Childrens National Medical Center
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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