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
Baltimore, Maryland 21236
349
mi
from 43215
Baltimore, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
643
mi
from 43215
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...
97
mi
from 43215
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...
416
mi
from 43215
Philadelphia, PA
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164
mi
from 43215
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...
1153
mi
from 43215
Aurora, CO
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1065
mi
from 43215
Austin, TX
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344
mi
from 43215
Baltimore, MD
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Birmingham, Alabama 35209
495
mi
from 43215
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....
643
mi
from 43215
Boston, MA
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354
mi
from 43215
Chapel Hill, NC
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Charlotte, North Carolina 28277
348
mi
from 43215
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
274
mi
from 43215
Chicago, IL
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270
mi
from 43215
Chicago, IL
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Cincinnati, Ohio 45231
95
mi
from 43215
Cincinnati, OH
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8740 Southeast Sunnybrook Boulevard
Clackamas, Oregon 97015
2022
mi
from 43215
Clackamas, OR
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Colorado Springs, Colorado 80907
1162
mi
from 43215
Colorado Springs, CO
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1935 Medical District Drive
Dallas, Texas 75235
911
mi
from 43215
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,...
1160
mi
from 43215
Denver, CO
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1157
mi
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Denver, CO
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379 East Shore Drive
Eagle, Idaho 83616
1723
mi
from 43215
Eagle, ID
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El Paso, Texas 79903
1422
mi
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El Paso, TX
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Evansville, Indiana 47713
280
mi
from 43215
Evansville, IN
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145 Community Drive
Great Neck, New York 11021
493
mi
from 43215
Great Neck, NY
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?
mi
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Hamilton,
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995
mi
from 43215
Houston, TX
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Kansas City, Missouri 64111
618
mi
from 43215
Kansas City, MO
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11200 Seminole Boulevard
Largo, Florida 33778
835
mi
from 43215
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...
622
mi
from 43215
Little Rock, AR
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Los Angeles, California 90025
1972
mi
from 43215
Los Angeles, CA
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4650 Sunset Boulevard
Los Angeles, California 90027
1973
mi
from 43215
Los Angeles, CA
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188
mi
from 43215
Louisville, KY
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Marietta, Georgia 30060
423
mi
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Marietta, GA
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1953
mi
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Mission Viejo, CA
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2086
mi
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Mountain View, CA
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New Braunfels, Texas 78130
1108
mi
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New Braunfels, TX
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Normal, Illinois 61761
316
mi
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Normal, IL
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North Charleston, South Carolina 29420
511
mi
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North Charleston, SC
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North Palm Beach, Florida 33408
924
mi
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North Palm Beach, FL
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Ocean City, New Jersey 07712
451
mi
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Ocean City, NJ
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849
mi
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Oklahoma City, OK
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Plymouth, Minnesota 55441
635
mi
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Plymouth, MN
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9495 Southwest Locust Street
Portland, Oregon 97223
2031
mi
from 43215
Portland, OR
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355
mi
from 43215
Rochester, NY
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Rolling Hills Estates, California 66212
625
mi
from 43215
Rolling Hills Estates, CA
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1947
mi
from 43215
San Diego, CA
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?
mi
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San Diego, CA
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1975 4th Street
San Francisco, California 95148
2105
mi
from 43215
San Francisco, CA
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2088
mi
from 43215
San Jose, CA
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Santa Monica, California 90404
1985
mi
from 43215
Santa Monica, CA
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872
mi
from 43215
Sarasota, FL
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Scottsdale, Arizona 85251
1653
mi
from 43215
Scottsdale, AZ
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Seattle, Washington 98115
2006
mi
from 43215
Seattle, WA
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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...
2007
mi
from 43215
Seattle, WA
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Skillman, New Jersey 08558
440
mi
from 43215
Skillman, NJ
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821
mi
from 43215
Tampa, FL
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1639
mi
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Tucson, AZ
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Walnut Creek, California 94598
2086
mi
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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...
328
mi
from 43215
Washington,
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