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
Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
1410
mi
from
Seattle, WA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
1443
mi
from
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...
726
mi
from
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...
1225
mi
from
Philadelphia, PA
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806
mi
from
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...
400
mi
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Aurora, CO
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517
mi
from
Austin, TX
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Baltimore, Maryland 21236
1155
mi
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Baltimore, MD
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1148
mi
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Baltimore, MD
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Birmingham, Alabama 35209
685
mi
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Birmingham, AL
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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....
1444
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Boston, MA
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1044
mi
from
Chapel Hill, NC
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Charlotte, North Carolina 28277
957
mi
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Charlotte, 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
610
mi
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Chicago, IL
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609
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Chicago, IL
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Cincinnati, Ohio 45231
724
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Cincinnati, OH
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8740 Southeast Sunnybrook Boulevard
Clackamas, Oregon 97015
1377
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Clackamas, OR
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Colorado Springs, Colorado 80907
387
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Colorado Springs, CO
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1935 Medical District Drive
Dallas, Texas 75235
345
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Dallas, TX
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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,...
407
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Denver, CO
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404
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Denver, CO
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379 East Shore Drive
Eagle, Idaho 83616
1050
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Eagle, ID
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El Paso, Texas 79903
639
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El Paso, TX
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Evansville, Indiana 47713
559
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Evansville, IN
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145 Community Drive
Great Neck, New York 11021
1302
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Great Neck, NY
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Hamilton,
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572
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Houston, TX
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Kansas City, Missouri 64111
198
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Kansas City, MO
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11200 Seminole Boulevard
Largo, Florida 33778
1105
mi
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Largo, FL
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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...
372
mi
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Little Rock, AR
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Los Angeles, California 90025
1168
mi
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Los Angeles, CA
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4650 Sunset Boulevard
Los Angeles, California 90027
1170
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Los Angeles, CA
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656
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Louisville, KY
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Marietta, Georgia 30060
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Marietta, GA
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1147
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Mission Viejo, CA
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1321
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Mountain View, CA
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New Braunfels, Texas 78130
556
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New Braunfels, TX
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Normal, Illinois 61761
510
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Normal, IL
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North Charleston, South Carolina 29420
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North Charleston, SC
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North Palm Beach, Florida 33408
1279
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Ocean City, New Jersey 07712
1257
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Ocean City, NJ
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158
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Oklahoma City, OK
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Plymouth, Minnesota 55441
550
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Plymouth, MN
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9495 Southwest Locust Street
Portland, Oregon 97223
1387
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Portland, OR
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1122
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Rochester, NY
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Rolling Hills Estates, California 66212
189
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Rolling Hills Estates, CA
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1139
mi
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San Diego, CA
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1975 4th Street
San Francisco, California 95148
1338
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1314
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San Jose, CA
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Santa Monica, California 90404
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Santa Monica, CA
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Sarasota, FL
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Scottsdale, Arizona 85251
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Scottsdale, AZ
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Seattle, Washington 98115
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Skillman, New Jersey 08558
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Skillman, NJ
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1110
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Tampa, FL
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833
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Tucson, AZ
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Walnut Creek, California 94598
1319
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Walnut Creek, CA
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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...
1127
mi
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Washington,
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