Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
NCT ID: NCT03292484
Last Updated: 2024-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
911 participants
INTERVENTIONAL
2017-11-02
2023-04-27
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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AR101
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 milligrams (mg) per day until discontinuation criteria was met (maximum exposure: 4.8 years).
AR101
AR101
Interventions
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AR101
AR101
Eligibility Criteria
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Inclusion Criteria
* Written informed consent and/or assent from subjects/guardians as appropriate
* Use of effective birth control by sexually active female subjects of childbearing potential
Exclusion Criteria
* Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless allowed in the parent study, and except during the follow-up observation period in this study
* Discontinued early from the parent study
1 Year
55 Years
ALL
No
Sponsors
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Aimmune Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jen Garcia
Role: STUDY_CHAIR
Director, Clinical Operations
Locations
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Alabama Allergy and Asthma Center
Birmingham, Alabama, United States
Medical Research of Arizona, Allergy, Asthma & Immunology Associates
Scottsdale, Arizona, United States
Banner Univ. 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 and Asthma Research LPCH El Camino Hospital
Mountain View, California, United States
Stanford University
Palo Alto, 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. of Allergy & Immunology
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 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 & Immunology Clinical Research Unit
Tampa, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 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
Normal, Illinois, United States
Riley Children's Specialists
Carmel, Indiana, United States
Deaconess Clinic, Inc.
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
Univ. of Michigan Health System, Div. 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
Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai
New York, 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, LLC
Cincinnati, Ohio, United States
Oklahoma Institute of Allergy and Asthma Clinical Research
Oklahoma City, Oklahoma, United States
Columbia Asthma & Allergy Clinic
Clackamas, Oregon, United States
Baker Allergy, Asthma and Dermatology
Portland, Oregon, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, United States
Le Bonheur Children's Hospital, Outpatient Bldg.
Memphis, Tennessee, United States
'Specially for Children Allergy, Asthma and Immunology Clinic
Austin, Texas, 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
Central Texas Health Research
New Braunfels, 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, Ontario, Canada
Cheema Research Inc.
Mississauga, Ontario, Canada
Ottawa Allergy Research Corp
Ottawa, Ontario, Canada
Gordon Sussman Clinical Research
Toronto, Ontario, Canada
Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants
Bordeaux, Cedex, France
Hopital Saint Vincent de Paul- Service d'Allergologie
Lille, Cedex, France
Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center
Lille, Cedex, France
Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
Strasbourg, Cedex, France
Charité Universitaetsmedizin Berlin
Berlin, , Germany
University of Frankfurt
Frankfurt, , Germany
Cork University Hospital, UCC Department of Paediatrics and Child Health
Cork, , Ireland
National Children's Research Centre, Our Lady's Children's Hospital Crumlin
Dublin, , Ireland
Azienda Ospedaliera di Padova
Padua, Province Of Padua, Italy
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
H. Infantil Universitario Niño Jesús, Servicio de Alergia
Madrid, , Spain
Madrid Hospital Clinico San Carlos, Servicio de Alergia
Madrid, , Spain
Sachsska Children and Youth Hospital
Stockholm, , Sweden
Leicester Royal infirmary
Leicester, Leicestershire, United Kingdom
James Paget University Hospital
Gorleston-on-Sea, Norfolk, United Kingdom
Guy & St Thomas' NHS Foundation Trust, Children Allergies Department
London, , United Kingdom
St Mary's Hospital - Paediatric Research Unit
London, , United Kingdom
Children's Clinical Research Facility, Royal Manchester Children's Hospital
Manchester, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
University Hospitals Southampton Foundation NHS Trust
Southampton, , United Kingdom
Central Manchester University Hospitals
Wythenshawe, , United Kingdom
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.
Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARC008
Identifier Type: -
Identifier Source: org_study_id