Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
NCT ID: NCT03126227
Last Updated: 2021-11-02
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
506 participants
INTERVENTIONAL
2017-05-08
2018-09-23
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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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AR101 Powder Provided in Capsules
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
AR101
AR101 powder provided in capsules
Placebo powder
Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.
Placebo
Placebo powder provided in capsules
Interventions
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AR101
AR101 powder provided in capsules
Placebo
Placebo powder provided in capsules
Eligibility Criteria
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Inclusion Criteria
* History of physician-diagnosed peanut allergy that includes allergic signs and symptoms within two hours of known oral exposure to peanut
* Mean peanut wheal diameter on SPT of at least 8mm and elevated psIgE of at least 14 kUA/L at screening
* Written informed consent from the subject's parent/guardian
* Written assent from the subject as appropriate (per local regulatory requirements)
* Use of effective birth control by sexually active female subjects of childbearing potential
Exclusion Criteria
* Severe or uncontrolled asthma
* History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
* History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
* History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
* History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
* Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
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_CHAIR
Aimmune Therapeutics, Inc.
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
Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
Los Angeles, California, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, United States
Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
Mountain View, California, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, United States
Allergy & Asthma Medical Group and Research Center, A.P.C
San Diego, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
University of California, San Francisco
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
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Asthma & Allergy Associates, PC
Colorado Springs, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Colorado Allergy & Asthma Centers
Denver, Colorado, United States
Children's National Health System
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
Sarasota, Florida, United States
University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
Tampa, Florida, United States
Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia, United States
Idaho Allergy and Research
Eagle, Idaho, United States
Ann & Robert H. Lurie's 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
University of Iowa
Iowa City, Iowa, 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 Health System / Michigan Medicine
Ann Arbor, Michigan, United States
Clinical Research Institute, Inc.
Plymouth, Minnesota, United States
Children's Mercy on Broadway
Kansas City, Missouri, United States
Nebraska Medical Research Institute, Inc.
Bellevue, Nebraska, United States
Atlantic Research Center, LLC
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
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, United States
National Allergy and Asthma Research, LLC
Charleston, 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
Baker Allergy, Asthma and Dermatology Research Center
Portland, Oregon, United States
Children's Hospital of Philadelphia: Allergy/Immunology
Philadelphia, Pennsylvania, United States
Dell Children's Medical Group / Allergy, Asthma & 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
Central Texas Health Research
New Braunfels, Texas, United States
Biogenics Research Institute
San Antonio, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
ASTHMA Inc. Clinical Research Center
Seattle, Washington, United States
Triple A Lab (Hamilton Allergy)
Hamilton, Ontario, Canada
McMaster University Medical Center
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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ARC007
Identifier Type: -
Identifier Source: org_study_id