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
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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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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Chapel Hill, North Carolina 27599
Principal Investigator: Edwin Kim, MD
Phone: 919-962-4409
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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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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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