Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
243 participants
INTERVENTIONAL
2017-10-18
2019-09-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment arm description
Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.
AR101
AR101
Interventions
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AR101
AR101
Eligibility Criteria
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Inclusion Criteria
* Completed the ARC007 study
* Use of effective birth control by sexually active female subjects of childbearing potential
Exclusion Criteria
* 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.
4 Years
17 Years
ALL
No
Sponsors
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Aimmune Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Director of Regulatory Affairs
Role: STUDY_DIRECTOR
Aimmune Therapeutics
Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Medical Research of Arizona
Scottsdale, Arizona, United States
Banner University of Arizona Medical Center
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Jonathan Corren, M.D., Inc.
Los Angeles, California, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, United States
Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital
Mountain View, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Allergy & Asthma Medical Group and Research Center
San Diego, California, United States
Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego
San Diego, California, United States
UCSF, Benioff Children's Hospital - Allergy and Immunology
San Francisco, California, United States
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
UCLA Medical Center, Santa Monica
Santa Monica, California, United States
Bay Area Allergy
Walnut Creek, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Asthma & Allergy Associates
Colorado Springs, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Colorado Allergy & Asthma Centers, P.C.
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Sher Allergy Specialists - Center for Cough
Largo, Florida, United States
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States
Sarasota Clinical Research Windom Allergy, Asthma and Sinus
Sarasota, Florida, United States
University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
Tampa, Florida, United States
Atlanta Allergy & Asthma Clinic
Marietta, Georgia, United States
Idaho Allergy and Research
Eagle, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
The University of Chicago Medicine, Comer Children's Hospital
Chicago, Illinois, United States
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, United States
Deaconess Clinic Downtown
Evansville, Indiana, United States
Family Allergy & Asthma Research Institute
Louisville, Kentucky, United States
Chesapeake Clinical Research, Inc.
Baltimore, Maryland, United States
Johns Hopkins Hospital, Pediatric Clinical Research Unit
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan Division of Allergy and Clinical Immunology
Ann Arbor, Michigan, United States
Clinical Research Institute, Inc.
Plymouth, Minnesota, United States
Children's Mercy on Broadway
Kansas City, Missouri, United States
Atlantic Research Center
Ocean City, New Jersey, United States
Princeton Center for Clinical Research
Skillman, New Jersey, United States
Northwell Health System
Great Neck, New York, United States
Univ. of Rochester Medical Center, Golisano Children's Hosp.
Rochester, New York, United States
University of North Carolina at Chapel Hill, Clinical & Translational Research Center
Chapel Hill, North Carolina, United States
Clinical Research of Charlotte
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
Oklahoma City, Oklahoma, United States
Columbia Asthma & Allergy Clinic
Clackamas, Oregon, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, United States
Specially for Children Allergy, Asthma and Immunology Clinic
Austin, Texas, United States
Children's Health
Dallas, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
ASTHMA Inc. Clinical Research Center
Seattle, Washington, United States
McMaster University Medical Center
Hamilton, Ontario, Canada
Triple A Lab / Hamilton Allergy
Hamilton, Ontario, Canada
Cheema Research Inc. (CRI)
Mississauga, Ontario, Canada
Ottawa Allergy Research Corp
Ottawa, Ontario, Canada
Gordon Sussman Clinical Research
Toronto, Ontario, Canada
Countries
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References
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Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARC011
Identifier Type: -
Identifier Source: org_study_id