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

Use our guide to learn which trials are right for you!

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
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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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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Philadelphia, PA
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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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Chapel Hill, NC
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Charlotte, North Carolina 28277
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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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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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