AR101 Real-World Open-Label Extension Study
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
1 other identifier
interventional
243
2 countries
60
Brief Summary
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
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 Oct 2017
60 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
Study Start
First participant enrolled
October 18, 2017
CompletedFirst Submitted
Initial submission to the registry
November 6, 2017
CompletedFirst Posted
Study publicly available on registry
November 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2019
CompletedResults Posted
Study results publicly available
November 2, 2021
CompletedNovember 2, 2021
October 1, 2021
1.9 years
November 6, 2017
August 6, 2021
October 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)
Approximately 6 months
Secondary Outcomes (10)
Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events
Approximately 6 months
Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events
Approximately 6 months
Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing
Approximately 6 months
Number of Participants With Allergic Hypersensitivity Adverse Events
Approximately 6 months
Number of Participants With of Anaphylaxis as Defined in the Protocol
Approximately 6 months
- +5 more secondary outcomes
Study Arms (1)
Treatment arm description
OTHERSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- Received AR101 in study ARC007
- Completed the ARC007 study
- Use of effective birth control by sexually active female subjects of childbearing potential
You may not qualify if:
- Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
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
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691, United States
Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital
Mountain View, California, 94040, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123, United States
Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego
San Diego, California, 92123, United States
UCSF, Benioff Children's Hospital - Allergy and Immunology
San Francisco, California, 95148, 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
Bay Area Allergy
Walnut Creek, California, 94598, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Asthma & Allergy Associates
Colorado Springs, Colorado, 80907, United States
National Jewish Health
Denver, Colorado, 80206, United States
Colorado Allergy & Asthma Centers, P.C.
Denver, Colorado, 80230, United States
Children's National Medical Center
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 Windom Allergy, Asthma and Sinus
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
Marietta, Georgia, 30060, United States
Idaho Allergy and Research
Eagle, Idaho, 83616, United States
Ann & Robert H. Lurie 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
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 Division of Allergy and Clinical Immunology
Ann Arbor, Michigan, 48106, United States
Clinical Research Institute, Inc.
Plymouth, Minnesota, 55441, United States
Children's Mercy on Broadway
Kansas City, Missouri, 64111, United States
Atlantic Research Center
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
Univ. of Rochester Medical Center, Golisano Children's Hosp.
Rochester, New York, 14642, United States
University of North Carolina at Chapel Hill, Clinical & Translational Research Center
Chapel Hill, North Carolina, 27599, 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
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, 29420, United States
Specially for Children Allergy, Asthma and 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
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
ASTHMA Inc. Clinical Research Center
Seattle, Washington, 98115-2024, United States
McMaster University Medical Center
Hamilton, Ontario, L8N 3Z5, Canada
Triple A Lab / Hamilton Allergy
Hamilton, Ontario, L8S 1G5, 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 DIRECTOR
Director of Regulatory Affairs
Aimmune Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2017
First Posted
November 9, 2017
Study Start
October 18, 2017
Primary Completion
September 20, 2019
Study Completion
September 20, 2019
Last Updated
November 2, 2021
Results First Posted
November 2, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share