Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
388 participants
INTERVENTIONAL
2016-12-29
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 (Placebo Crossovers)
Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC).
AR101
AR101 powder provided in capsules \& sachets
Group 2 (Active Rollovers)
Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval.
AR101
AR101 powder provided in capsules \& sachets
Interventions
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AR101
AR101 powder provided in capsules \& sachets
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 child-bearing potential
Exclusion Criteria
* (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
* Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
4 Years
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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Director of Regulatory Affairs
Role: STUDY_DIRECTOR
Aimmune Regulatory Affairs
Locations
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Banner University of Arizona Medical Center
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 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, Inc.
Rolling Hills Estates, California, United States
Allergy & Asthma Medical Group and Research Center, APC
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
UCLA Medical Center, Santa Monica
Santa Monica, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Colorado Allergy & Asthma Centers, P.C.
Centennial, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, 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, dba Idaho Research
Eagle, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Comer Children's Hospital
Chicago, Illinois, United States
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, United States
IU North Riley Children's Specialist
Carmel, Indiana, United States
Chesapeake Clinical Research, Inc.
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital, Div. of Allergy & Immunology
Boston, Massachusetts, United States
Michigan Medicine, Michigan Clinical Research Unit
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
Icahn School of Medicine at Mount Sinai, Clinical Research Unit
New York, New York, United States
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
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
Baker Allergy, Asthma & 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
Charleston, South Carolina, United States
Le Bonheur Children's Hospital - Outpatient Building
Memphis, Tennessee, 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
Sylvana Research Associates
San Antonio, Texas, United States
Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center
Seattle, Washington, United States
Asthma Inc Clinical Research Center
Seattle, Washington, United States
Triple A Lab
Hamilton, Ontario, Canada
Cheema Research Inc.
Mississauga, Ontario, Canada
Ottawa Allergy Research Corp
Ottawa, Ontario, Canada
Gordon Sussman Clinical Research, Inc.
Toronto, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Charité Universitaetsmedizin Berlin
Berlin, , Germany
University of Frankfurt
Frankfurt am Main, , Germany
Cork University Hospital
Cork, , Ireland
Azienda Ospedaliera di Padova
Padua, , Italy
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Hospital Gregorio Marañón
Madrid, , Spain
H. Infantil Universitario Niño Jesús
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Sachsska Children and Youth Hospital
Stockholm, , Sweden
Guy & St Thomas' NHS foundation Trust
London, , United Kingdom
Central Manchester University Hospitals, NHS Foundation Trust
Manchester, , United Kingdom
Central Manchester University Hospitals, NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Blumchen K, Kleinheinz A, Klimek L, Beyer K, Anagnostou A, Vogelberg C, Butovas S, Ryan R, Norval D, Zeitler S, Du Toit G. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. Allergy Asthma Clin Immunol. 2023 Mar 13;19(1):21. doi: 10.1186/s13223-023-00757-8.
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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ARC004
Identifier Type: -
Identifier Source: org_study_id
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