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
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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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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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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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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Bellevue, NE
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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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Centennial, CO
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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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El Paso, TX
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Triple A Lab
Hamilton, Ontario
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Hamilton,
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Texas Childrens Hospital. Baylor College of Medicine
Houston, Texas 77030
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Houston, TX
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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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Mountain View, CA
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Central Texas Health Research
New Braunfels, Texas 78130
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New Braunfels, TX
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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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Plymouth, MN
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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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University of California at San Francisco
San Francisco, California 94143
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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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