Long-term Safety Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)



Status:Enrolling by invitation
Conditions:Allergy, Allergy, Neurology
Therapuetic Areas:Neurology, Otolaryngology
Healthy:No
Age Range:4 - 55
Updated:3/13/2019
Start Date:October 11, 2017
End Date:December 2021

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A Multicenter, Open-label, Long-term Safety Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study

The purpose of this study is to assess AR101's safety and tolerability over an extended
dosing period.

This study is enrolling participants by invitation only. This is an open-label,
international, long-term safety extension study for eligible subjects who have participated
in one of the Aimmune AR101 clinical studies.

Key Inclusion Criteria:

- Prior participation in an Aimmune AR101 clinical study or any future clinical study
that identifies ARC008 as a follow-on study option in the protocol

- Written informed consent and/or assent from subjects/guardians as appropriate

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

Key Exclusion Criteria:

- Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was
assigned to AR101 in the parent study

- Early discontinuation from the parent study

- Currently receiving or received within 5 years prior to Screening any type of peanut
or other food allergen immunotherapy, except AR101 or unless specified in the parent
study
We found this trial at
63
sites
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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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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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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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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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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504 Brookwood Boulevard
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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Carmel, Indiana 46032
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Chapel Hill, NC
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Charlotte, North Carolina 28277
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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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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...
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Los Angeles, California 90025
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4650 Sunset Boulevard
Los Angeles, California 90027
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Louisville, KY
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Marietta, Georgia 30060
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51 North Dunlap Street
Memphis, Tennessee 38105
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Mission Viejo, CA
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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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Sarasota, Florida 34233
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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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Seattle, Washington 98115
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Skillman, New Jersey 08558
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Walnut Creek, California 94598
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Washington, District of Columbia 20010
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