AR101 Real-World Open-Label Extension Study



Status:Active, not recruiting
Conditions:Allergy, Allergy, Neurology
Therapuetic Areas:Neurology, Otolaryngology
Healthy:No
Age Range:4 - 18
Updated:12/22/2018
Start Date:October 19, 2017
End Date:April 2019

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Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)

This study is enrolling participants by invitation only. This is an open-label, safety
extension study for subjects who participated in the ARC007 study.

This is a Phase 3, multi-center, North American, open-label, long-term, safety extension
study for eligible subjects who received AR101 therapy in the ARC007 trial and completed the
study.

Key Inclusion Criteria:

- Received AR101 in study ARC007

- Completed the ARC007 study

- Use of effective birth control by sexually active female subjects of childbearing
potential

Key Exclusion Criteria:

- Developed a clinically significant change in health status during the ARC007 study
which in the opinion of the investigator would make the subject unsuitable for
participation in this study.

- Receiving a prohibited medication or anticipated use of a prohibited medication [e.g.,
angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium
channel blockers], any monoclonal antibody, any investigational peanut immunotherapy,
or any other immunomodulatory therapy.

- Currently in the build-up phase of immunotherapy for any nonfood allergen.

- Currently participating in any other interventional clinical study outside of the
ARC007 study that was just completed.
We found this trial at
59
sites
Charlotte, North Carolina 28277
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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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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Cincinnati, OH
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Ann Arbor, MI
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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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Austin, TX
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Baltimore, Maryland 21236
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Birmingham, Alabama 35209
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Chapel Hill, NC
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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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Cincinnati, Ohio 45231
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8740 Southeast Sunnybrook Boulevard
Clackamas, Oregon 97015
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Colorado Springs, Colorado 80907
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1935 Medical District Drive
Dallas, Texas 75235
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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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379 East Shore Drive
Eagle, Idaho 83616
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El Paso, Texas 79903
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Evansville, Indiana 47713
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145 Community Drive
Great Neck, New York 11021
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Hamilton,
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Kansas City, Missouri 64111
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11200 Seminole Boulevard
Largo, Florida 33778
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Los Angeles, California 90025
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4650 Sunset Boulevard
Los Angeles, California 90027
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Marietta, Georgia 30060
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New Braunfels, Texas 78130
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Normal, Illinois 61761
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North Charleston, South Carolina 29420
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North Palm Beach, Florida 33408
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Ocean City, New Jersey 07712
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Plymouth, Minnesota 55441
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9495 Southwest Locust Street
Portland, Oregon 97223
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Rolling Hills Estates, California 66212
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1975 4th Street
San Francisco, California 95148
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San Jose, CA
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Santa Monica, California 90404
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Scottsdale, Arizona 85251
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Seattle, Washington 98115
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Skillman, New Jersey 08558
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Walnut Creek, California 94598
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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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