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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Trial Summary
Trial Overview
Inclusion Criteria

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
University of North Carolina at Chapel Hill, Clinical & Translational Research Center
Chapel Hill, North Carolina 27599
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Cincinnati Children's Hospital Medical Center
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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Children's Hospital of Philadelphia
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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Children's Hospital of Pittsburgh of UPMC
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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Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology
Ann Arbor, Michigan 48106
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Ann Arbor, MI
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Children's Hospital Colorado
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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Specially for Children Allergy, Asthma and Immunology Clinic
Austin, Texas 78723
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Austin, TX
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Chesapeake Clinical Research, Inc
Baltimore, Maryland 21236
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Baltimore, MD
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Johns Hopkins Hospital Pediatric Clinical Research Unit
Baltimore, Maryland 21231
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Alabama Allergy and Asthma Center
504 Brookwood Boulevard
Birmingham, Alabama 35209
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Birmingham, AL
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Boston Children's Hospital
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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Riley Children's Specialists
Carmel, Indiana 46032
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Carmel, IN
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Clinical Research of Charlotte
Charlotte, North Carolina 28277
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Charlotte, NC
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Ann & Robert H. Lurie Children's Hospital of Chicago
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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University of Chicago Medicine Comer Children's Hospital
Chicago, Illinois 60637
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Bernstein Clinical Research Center
Cincinnati, Ohio 45231
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Columbia Asthma & Allergy Clinic
8740 Southeast Sunnybrook Boulevard
Clackamas, Oregon 97015
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Clackamas, OR
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Asthma And Allergy Associates, P.C.
Colorado Springs, Colorado 80907
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Children's Health
1935 Medical District Drive
Dallas, Texas 75235
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Dallas, TX
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National Jewish Health
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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Colorado Allergy and Asthma Centers, PC
Denver, Colorado 80230
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Idaho Allergy and Research
379 East Shore Drive
Eagle, Idaho 83616
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Eagle, ID
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Western Sky Medical Research
El Paso, Texas 79903
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El Paso, TX
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Deaconess Clinic, Inc.
Evansville, Indiana 47713
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Evansville, IN
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Northwell Health System
145 Community Drive
Great Neck, New York 11021
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Great Neck, NY
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McMaster University Medical Center
Hamilton, Ontario
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Hamilton,
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Texas Childrens Hospital. Baylor College of Medicine
Houston, Texas 77030
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Houston, TX
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Children's Mercy on Broadway
Kansas City, Missouri 64111
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Sher Allergy Specialists - Center for Cough
11200 Seminole Boulevard
Largo, Florida 33778
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Largo, FL
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Arkansas Children's Hospital
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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Jonathan Corren MD, Inc.
Los Angeles, California 90025
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Los Angeles, CA
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Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
4650 Sunset Boulevard
Los Angeles, California 90027
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Los Angeles, CA
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Family Allergy and Asthma Research Institute
Louisville, Kentucky 40215
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Louisville, KY
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Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia 30060
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Marietta, GA
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Le Bonheur Children's Hospital, Outpatient Bldg.
51 North Dunlap Street
Memphis, Tennessee 38105
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Memphis, TN
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Allergy and Asthma Associates of Southern California
Mission Viejo, California 92691
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Mission Viejo, CA
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Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital
Mountain View, California 94040
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Mountain View, CA
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Central Texas Health Research
New Braunfels, Texas 78130
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Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai
New York, New York 10029
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New York, NY
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Sneeze, Wheeze & Itch Associates LLC
Normal, Illinois 61761
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Normal, IL
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National Allergy and Asthma Research, LLC
North Charleston, South Carolina 29420
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North Charleston, SC
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Allergy Associates of the Palm Beaches, PA
North Palm Beach, Florida 33408
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Atlantic Research Center, LLC
Ocean City, New Jersey 07712
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Ocean City, NJ
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Oklahoma Institute of Allergy & Asthma Clinical Research
Oklahoma City, Oklahoma 73131
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Oklahoma City, OK
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Clinical Research Institute Inc
Plymouth, Minnesota 55441
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Plymouth, MN
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Baker Allergy, Asthma & Dermatology
9495 Southwest Locust Street
Portland, Oregon 97223
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Portland, OR
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University of Rochester Medical Center/ Golisano Children's Hospital
Rochester, New York 14642
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Rochester, NY
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Peninsula Research Associates, Inc.
Rolling Hills Estates, California 66212
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Rolling Hills Estates, CA
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Allergy and Asthma Medical Group and Research Center
San Diego, California 92123
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San Diego, CA
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Rady Children's Hospital, Div. of Allergy & Immunology
San Diego, California 92123
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UCSF, Benioff Children's Hospital - Allergy and Immunology
1975 4th Street
San Francisco, California 95148
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Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California 95117
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San Jose, CA
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UCLA Medical Center Santa Monica
Santa Monica, California 90404
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Santa Monica, CA
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Sarasota Clinical Research
Sarasota, Florida 34233
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Sarasota, FL
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Medical Research of Arizona, Allergy, Asthma & Immunology Associates
Scottsdale, Arizona 85251
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Scottsdale, AZ
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Virginia Mason Medical Center
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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ASTHMA Inc. Clinical Research Center
Seattle, Washington 98115
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Seattle, WA
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Princeton Center for Clinical Research
Skillman, New Jersey 08558
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Skillman, NJ
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University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida 33613
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Tampa, FL
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Banner University of Arizona Medical Center
Tucson, Arizona 85724
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Bay Area Allergy
Walnut Creek, California 94598
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Children's National Health System
Washington, District of Columbia 20010
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