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 |
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.
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.
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
Chapel Hill, North Carolina 27599
Principal Investigator: Edwin Kim, MD
Phone: 919-962-4409
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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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South 34th Street
Philadelphia, Pennsylvania 19104
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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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
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 Rady Children's Hospital-San Diego is the region’s pediatric medical...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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 At Children's Hospital Colorado, we see more, treat more and heal more...
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Bellevue, Nebraska 68123
Principal Investigator: Gregory Brooks, MD
Phone: 402-592-2055
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Boston, Massachusetts 02115
Principal Investigator: Rima Rachid, MD
Phone: 617-919-4602
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11700 North Meridian Street
Carmel, Indiana 46032
Carmel, Indiana 46032
Principal Investigator: Frederick Leickly, MD
Phone: 317-688-5700
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Centennial, Colorado 80112
Principal Investigator: Leon Greos, MD
Phone: 303-632-3646
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Charleston, South Carolina 29407
Principal Investigator: Ned Rupp, MD
Phone: 843-576-7485
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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El Paso, Texas 79903
Principal Investigator: Lyndon Mansfield, MD
Phone: 915-544-2557
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1 Children's Way
Little Rock, Arkansas 72202
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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Marietta, Georgia 30060
Principal Investigator: Stanley Fineman, MD
Phone: 770-592-4210
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51 North Dunlap Street
Memphis, Tennessee 38105
Memphis, Tennessee 38105
Principal Investigator: Jay Lieberman, MD
Phone: 901-287-6484
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Mission Viejo, California 92691
Principal Investigator: Warner Carr, MD
Phone: 949-347-8700
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Mountain View, California 94040
Principal Investigator: Sharon Chinthrajah, MD
Phone: 650-564-4568
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Plymouth, Minnesota 55441
Principal Investigator: Allan Stillerman, MD
Phone: 763-744-1140
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9495 Southwest Locust Street
Portland, Oregon 97223
Portland, Oregon 97223
Principal Investigator: James Baker, MD
Phone: 503-505-5916
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San Antonio, Texas 78229
Principal Investigator: Paul Ratner, MD
Phone: 210-614-6673
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San Diego, California 92123
Principal Investigator: Michael J. Welch, MD
Phone: 858-268-2368
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Sarasota, Florida 34239
Principal Investigator: Hugh Windom, MD
Phone: 941-927-4888
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Seattle, Washington 98101
Principal Investigator: David Jeong, MD
Phone: 206-342-6598
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9725 3rd Avenue Northeast
Seattle, Washington 98115
Seattle, Washington 98115
Principal Investigator: Stephen Tilles, MD
Phone: 206-525-5520
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Tampa, Florida 33613
Principal Investigator: Thomas Casale, MD
Phone: 813-631-4024
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111 Michigan Ave NW
Washington, District of Columbia
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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