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
New Braunfels, Texas 78130
1733
mi
from 02139
New Braunfels, TX
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
1
mi
from 02139
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...
734
mi
from 02139
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...
268
mi
from 02139
Philadelphia, PA
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645
mi
from 02139
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...
1754
mi
from 02139
Aurora, CO
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1691
mi
from 02139
Austin, TX
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Baltimore, Maryland 21236
348
mi
from 02139
Baltimore, MD
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357
mi
from 02139
Baltimore, MD
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Birmingham, Alabama 35209
1051
mi
from 02139
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....
2
mi
from 02139
Boston, MA
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616
mi
from 02139
Chapel Hill, NC
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Charlotte, North Carolina 28277
719
mi
from 02139
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
846
mi
from 02139
Chicago, IL
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845
mi
from 02139
Chicago, IL
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Cincinnati, Ohio 45231
734
mi
from 02139
Cincinnati, OH
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8740 Southeast Sunnybrook Boulevard
Clackamas, Oregon 97015
2527
mi
from 02139
Clackamas, OR
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Colorado Springs, Colorado 80907
1772
mi
from 02139
Colorado Springs, CO
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1935 Medical District Drive
Dallas, Texas 75235
1547
mi
from 02139
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,...
1761
mi
from 02139
Denver, CO
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1758
mi
from 02139
Denver, CO
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379 East Shore Drive
Eagle, Idaho 83616
2258
mi
from 02139
Eagle, ID
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El Paso, Texas 79903
2062
mi
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El Paso, TX
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Evansville, Indiana 47713
918
mi
from 02139
Evansville, IN
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145 Community Drive
Great Neck, New York 11021
173
mi
from 02139
Great Neck, NY
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?
mi
from 02139
Hamilton,
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1606
mi
from 02139
Houston, TX
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Kansas City, Missouri 64111
1245
mi
from 02139
Kansas City, MO
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11200 Seminole Boulevard
Largo, Florida 33778
1196
mi
from 02139
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...
1255
mi
from 02139
Little Rock, AR
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Los Angeles, California 90025
2588
mi
from 02139
Los Angeles, CA
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4650 Sunset Boulevard
Los Angeles, California 90027
2589
mi
from 02139
Los Angeles, CA
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821
mi
from 02139
Louisville, KY
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Marietta, Georgia 30060
931
mi
from 02139
Marietta, GA
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2573
mi
from 02139
Mission Viejo, CA
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2668
mi
from 02139
Mountain View, CA
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Normal, Illinois 61761
933
mi
from 02139
Normal, IL
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North Charleston, South Carolina 29420
815
mi
from 02139
North Charleston, SC
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North Palm Beach, Florida 33408
1187
mi
from 02139
North Palm Beach, FL
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Ocean City, New Jersey 07712
280
mi
from 02139
Ocean City, NJ
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1490
mi
from 02139
Oklahoma City, OK
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Plymouth, Minnesota 55441
1128
mi
from 02139
Plymouth, MN
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9495 Southwest Locust Street
Portland, Oregon 97223
2536
mi
from 02139
Portland, OR
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334
mi
from 02139
Rochester, NY
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Rolling Hills Estates, California 66212
1253
mi
from 02139
Rolling Hills Estates, CA
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2572
mi
from 02139
San Diego, CA
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?
mi
from 02139
San Diego, CA
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1975 4th Street
San Francisco, California 95148
2689
mi
from 02139
San Francisco, CA
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2675
mi
from 02139
San Jose, CA
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Santa Monica, California 90404
2601
mi
from 02139
Santa Monica, CA
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1221
mi
from 02139
Sarasota, FL
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Scottsdale, Arizona 85251
2283
mi
from 02139
Scottsdale, AZ
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Seattle, Washington 98115
2483
mi
from 02139
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...
2483
mi
from 02139
Seattle, WA
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Skillman, New Jersey 08558
229
mi
from 02139
Skillman, NJ
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1174
mi
from 02139
Tampa, FL
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2274
mi
from 02139
Tucson, AZ
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Walnut Creek, California 94598
2668
mi
from 02139
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...
392
mi
from 02139
Washington,
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