Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
RAMSES
1 other identifier
interventional
506
2 countries
67
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODITâ„¢) regimen in peanut-allergic children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2017
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedStudy Start
First participant enrolled
May 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2018
CompletedResults Posted
Study results publicly available
November 2, 2021
CompletedNovember 2, 2021
October 1, 2021
1.3 years
April 20, 2017
August 9, 2021
October 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events
Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period. Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product.
Approximately 6 months
Secondary Outcomes (10)
Frequency of Premature Discontinuation of Dosing Due to Adverse Events
Approximately 6 months
Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events
Approximately 6 months
Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing
Approximately 6 months
Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment
Approximately 6 months
Frequency of Anaphylaxis as Defined in the Protocol
Approximately 6 months
- +5 more secondary outcomes
Study Arms (2)
AR101 Powder Provided in Capsules
ACTIVE COMPARATORStudy product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Placebo powder
PLACEBO COMPARATORPlacebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.
Interventions
Eligibility Criteria
You may qualify if:
- Ages 4 to 17 years, inclusive
- 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
You may not qualify if:
- Subjects in whom the clinical diagnosis of peanut allergy is uncertain
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
Medical Research of Arizona
Scottsdale, Arizona, 85251, United States
Banner University of Arizona Medical Center
Tucson, Arizona, 85724, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Jonathan Corren, M.D., Inc.
Los Angeles, California, 90025, United States
Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
Los Angeles, California, 90027, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691, United States
Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
Mountain View, California, 94040, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274, United States
Allergy & Asthma Medical Group and Research Center, A.P.C
San Diego, California, 92123, United States
Rady Children's Hospital San Diego
San Diego, California, 92123, United States
University of California, San Francisco
San Francisco, California, 94158, United States
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117, United States
UCLA Medical Center, Santa Monica
Santa Monica, California, 90404, United States
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Asthma & Allergy Associates, PC
Colorado Springs, Colorado, 80907, United States
National Jewish Health
Denver, Colorado, 80206-2761, United States
Colorado Allergy & Asthma Centers
Denver, Colorado, 80230, United States
Children's National Health System
Washington D.C., District of Columbia, 20010, United States
Sher Allergy Specialists - Center for Cough
Largo, Florida, 33778, United States
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, 33408, United States
Sarasota Clinical Research
Sarasota, Florida, 34239, United States
University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
Tampa, Florida, 33613, United States
Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia, 30060, United States
Idaho Allergy and Research
Eagle, Idaho, 83616, United States
Ann & Robert H. Lurie's Children's Hospital of Chicago
Chicago, Illinois, 60611-2605, United States
The University of Chicago Medicine, Comer Children's Hospital
Chicago, Illinois, 60637, United States
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, 61761, United States
Deaconess Clinic Downtown
Evansville, Indiana, 47713, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Family Allergy & Asthma Research Institute
Louisville, Kentucky, 40215, United States
Chesapeake Clinical Research, Inc.
Baltimore, Maryland, 21236, United States
Johns Hopkins Hospital, Pediatric Clinical Research Unit
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Health System / Michigan Medicine
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute, Inc.
Plymouth, Minnesota, 55441, United States
Children's Mercy on Broadway
Kansas City, Missouri, 64111, United States
Nebraska Medical Research Institute, Inc.
Bellevue, Nebraska, 68123, United States
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712, United States
Princeton Center for Clinical Research
Skillman, New Jersey, 08558, United States
Northwell Health System
Great Neck, New York, 11021, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, 27599, United States
National Allergy and Asthma Research, LLC
Charleston, North Carolina, 29420, United States
Clinical Research of Charlotte
Charlotte, North Carolina, 28277, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231, United States
Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
Oklahoma City, Oklahoma, 73131, United States
Columbia Asthma & Allergy Clinic
Clackamas, Oregon, 97015, United States
Baker Allergy, Asthma and Dermatology Research Center
Portland, Oregon, 97223, United States
Children's Hospital of Philadelphia: Allergy/Immunology
Philadelphia, Pennsylvania, 19104, United States
Dell Children's Medical Group / Allergy, Asthma & Immunology Clinic
Austin, Texas, 78723, United States
Children's Health
Dallas, Texas, 75235, United States
Western Sky Medical Research
El Paso, Texas, 79903, United States
Texas Children's Hospital / Baylor College of Medicine
Houston, Texas, 77030, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Biogenics Research Institute
San Antonio, Texas, 78229, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
ASTHMA Inc. Clinical Research Center
Seattle, Washington, 98115, United States
Triple A Lab (Hamilton Allergy)
Hamilton, Ontario, L8S 1G5, Canada
McMaster University Medical Center
Hamilton, Ontario, L8S 4K1, Canada
Cheema Research Inc. (CRI)
Mississauga, Ontario, L5A 3V4, Canada
Ottawa Allergy Research Corp.
Ottawa, Ontario, K1G 6C6, Canada
Gordon Sussman Clinical Research
Toronto, Ontario, M4V 1R2, Canada
Related Publications (1)
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.
PMID: 34389504DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Regulatory Affairs
- Organization
- Aimmune Therapeutics, Inc.
Study Officials
- STUDY CHAIR
Director of Regulatory Affairs
Aimmune Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2017
First Posted
April 24, 2017
Study Start
May 8, 2017
Primary Completion
August 31, 2018
Study Completion
September 23, 2018
Last Updated
November 2, 2021
Results First Posted
November 2, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share