Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
- Conditions
- Peanut Allergy
- Interventions
- Biological: AR101
- Registration Number
- NCT03292484
- Lead Sponsor
- Aimmune Therapeutics, Inc.
- Brief Summary
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
- Detailed Description
This study is enrolling participants by invitation only. This is an open-label, international, longer-term extension study for eligible subjects who have participated in one of the Aimmune AR101 clinical studies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 911
- Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol
- Written informed consent and/or assent from subjects/guardians as appropriate
- Use of effective birth control by sexually active female subjects of childbearing potential
Key
- Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AR101 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).
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) From first dose of study drug through 30 days after last dose of study drug, up to 59 months An AE was any untoward medical occurrence in humans, whether or not considered related to the investigational product (IP), that occurred during the conduct of a clinical study. A SAE was any event that resulted in any of the following: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital abnormality or birth defect, or important medical event that did not result in one of the above outcomes, but jeopardized the health of the study participant or required medical or surgical intervention to prevent one of the outcomes listed above. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.
Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs From first dose of study drug through 30 days after last dose of study drug, up to 59 months An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.
Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs From first dose of study drug through 30 days after last dose of study drug, up to 59 months An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug. Gastrointestinal (GI) AEs, typically chronic/recurrent GI AEs, that resulted in prolonged interruption of dosing are reported.
Number of Participants With TEAEs That Led to a Change in Treatment Regimen From first dose of study drug through 30 days after last dose of study drug, up to 59 months An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug. Number of participants with TEAEs requiring dose interruption and dose reduction of study treatment are reported.
Number of Participants With TEAEs That Led to Early Withdrawal From first dose of study drug through 30 days after last dose of study drug, up to 59 months An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.
Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction From first dose of study drug through 30 days after last dose of study drug, up to 59 months Anaphylaxis was defined by a number of signs and symptoms that occurred alone or in combination within minutes up to a few hours after exposure to a provoking agent. Treatment-emergent anaphylactic reactions included anaphylactic reactions that occurred after first dose of AR101 in ARC008 through 30 days after last dose of study product but excluding anaphylactic reactions that occurred during or related to a food challenge.
Number of Participants With Use of Epinephrine as a Rescue Medication From first dose of study drug through 30 days after last dose of study drug, up to 59 months Rescue medications were any medication used to treat individual acute allergic reactions during ARC008 and were according to recognized standards of care for allergy practice.
Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes From first dose of study drug through 30 days after last dose of study drug, up to 59 months An accidental food allergen exposure was any known or suspected exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. A non-accidental food allergen exposure was an intentional exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. Treatment-emergent food allergy episodes included food allergy episodes that occurred after first dose of AR101 in ARC008 through 30 days after last dose of study product but excluding food allergy episodes that occurred during or related to a food challenge.
Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods From first dose of study drug through 30 days after last dose of study drug, up to 59 months An accidental food allergen exposure was any known or suspected exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. A non-accidental food allergen exposure was an intentional exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. Treatment-emergent food allergy episodes included food allergy episodes that occurred after first dose of AR101 in ARC008 through 30 days after last dose of study product but excluding food allergy episodes that occurred during or related to a food challenge.
Number of Participants With Eosinophilic Esophagitis (EoE) From first dose of study drug through 30 days after last dose of study drug, up to 59 months EoE was diagnosed by biopsy/endoscopy.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC) OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58) During the OLFC, single doses (300, 600, 1000, and 2000 mg) of peanut protein were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals. During the DBPCFC, single doses (3, 10, 30, 100, 300, 600, 1000, and 2000 mg) of peanut protein and placebo were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals up to a single highest challenge dose of 2000 mg.
Maximum Tolerated Challenge Dose at Each Food Challenge OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58) The maximum tolerated challenge dose for a food challenge was defined as the maximum single dose of peanut protein resulting in no more than mild symptoms and assessed by the investigator to have been tolerated (i.e., the participant did not experience any dose-limiting symptoms). During the OLFC, single doses (300, 600, 1000, and 2000 mg) of peanut protein were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals. During the DBPCFC, single doses (3, 10, 30, 100, 300, 600, 1000, and 2000 mg) of peanut protein and placebo were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals up to a single highest challenge dose of 2000 mg.
Number of Participants With Use of Epinephrine as a Rescue Medication During the Food Challenges OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58) Rescue medications were any medication used to treat individual acute allergic reactions during ARC008 and were according to recognized standards of care for allergy practice. During the OLFC, single doses (300, 600, 1000, and 2000 mg) of peanut protein were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals. During the DBPCFC, single doses (3, 10, 30, 100, 300, 600, 1000, and 2000 mg) of peanut protein and placebo were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals up to a single highest challenge dose of 2000 mg.
Trial Locations
- Locations (93)
Jonathan Corren, M.D., Inc.
🇺🇸Los Angeles, California, United States
Chesapeake Clinical Research, Inc.
🇺🇸Baltimore, Maryland, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Johns Hopkins Hospital, Pediatric Clinical Research Unit
🇺🇸Baltimore, Maryland, United States
Gordon Sussman Clinical Research
🇨🇦Toronto, Ontario, Canada
UCLA Medical Center, Santa Monica
🇺🇸Santa Monica, California, United States
Columbia Asthma & Allergy Clinic
🇺🇸Clackamas, Oregon, United States
National Allergy and Asthma Research, LLC
🇺🇸North Charleston, South Carolina, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Clinical Research Facility, Royal Manchester Children's Hospital
🇬🇧Manchester, United Kingdom
James Paget University Hospital
🇬🇧Gorleston-on-Sea, Norfolk, United Kingdom
ASTHMA, Inc. Clinical Research Center
🇺🇸Seattle, Washington, United States
UCSF, Benioff Children's Hospital - Allergy and Immunology
🇺🇸San Francisco, California, United States
Alabama Allergy and Asthma Center
🇺🇸Birmingham, Alabama, United States
Rady Children's Hospital, Div. of Allergy & Immunology
🇺🇸San Diego, California, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Oklahoma Institute of Allergy and Asthma Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Baker Allergy, Asthma and Dermatology
🇺🇸Portland, Oregon, United States
Allergy & Asthma Medical Group and Research Center
🇺🇸San Diego, California, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Bernstein Clinical Research Center, LLC
🇺🇸Cincinnati, Ohio, United States
Texas Children's Hospital, Baylor College of Medicine
🇺🇸Houston, Texas, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Colorado Allergy & Asthma Centers, P.C.
🇺🇸Denver, Colorado, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, 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
Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
🇺🇸Los Angeles, California, United States
Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital
🇺🇸Mountain View, California, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Allergy & Asthma Associates of Santa Clara Valley Research Center
🇺🇸San Jose, 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
Sher Allergy Specialists - Center for Cough
🇺🇸Largo, Florida, United States
Children's National Health System
🇺🇸Washington, District of Columbia, United States
Allergy Associates of the Palm Beaches
🇺🇸North Palm Beach, Florida, United States
Atlanta Allergy & Asthma Clinic
🇺🇸Marietta, Georgia, United States
Sarasota Clinical Research
🇺🇸Sarasota, Florida, United States
University of South Florida, Asthma Allergy & Immunology Clinical Research Unit
🇺🇸Tampa, Florida, United States
Idaho Allergy and Research
🇺🇸Eagle, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Deaconess Clinic, Inc.
🇺🇸Evansville, Indiana, United States
Riley Children's Specialists
🇺🇸Carmel, Indiana, United States
The University of Chicago Medicine, Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
Sneeze, Wheeze, & Itch Associates
🇺🇸Normal, Illinois, United States
Family Allergy & Asthma Research Institute
🇺🇸Louisville, Kentucky, 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
Princeton Center for Clinical Research
🇺🇸Skillman, New Jersey, United States
Atlantic Research Center
🇺🇸Ocean City, New Jersey, United States
Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Clinical Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
Northwell Health System
🇺🇸Great Neck, 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
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, 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
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Central Texas Health Research
🇺🇸New Braunfels, Texas, United States
McMaster University Medical Center
🇨🇦Hamilton, Ontario, Canada
Triple A Lab
🇨🇦Hamilton, Ontario, Canada
Ottawa Allergy Research Corp
🇨🇦Ottawa, Ontario, Canada
Cheema Research Inc.
🇨🇦Mississauga, Ontario, Canada
Hopital Saint Vincent de Paul- Service d'Allergologie
🇫🇷Lille, Cedex, France
Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center
🇫🇷Lille, Cedex, France
Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants
🇫🇷Bordeaux, Cedex, France
Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
🇫🇷Strasbourg, Cedex, France
Charité Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Cork University Hospital, UCC Department of Paediatrics and Child Health
🇮🇪Cork, Ireland
University of Frankfurt
🇩🇪Frankfurt, Germany
National Children's Research Centre, Our Lady's Children's Hospital Crumlin
🇮🇪Dublin, Ireland
Azienda Ospedaliera di Padova
🇮🇹Padova, Province Of Padua, Italy
Beatrix Children's Hospital, University Medical Center Groningen
🇳🇱Groningen, Netherlands
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Sachsska Children and Youth Hospital
🇸🇪Stockholm, Sweden
H. Infantil Universitario Niño Jesús, Servicio de Alergia
🇪🇸Madrid, Spain
Leicester Royal infirmary
🇬🇧Leicester, Leicestershire, United Kingdom
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom
Guy & St Thomas' NHS Foundation Trust, Children Allergies Department
🇬🇧London, United Kingdom
St Mary's Hospital - Paediatric Research Unit
🇬🇧London, United Kingdom
Central Manchester University Hospitals
🇬🇧Wythenshawe, United Kingdom
University Hospitals Southampton Foundation NHS Trust
🇬🇧Southampton, United Kingdom
Madrid Hospital Clinico San Carlos, Servicio de Alergia
🇪🇸Madrid, Spain
Allergy & Asthma Associates of Southern California
🇺🇸Mission Viejo, California, United States