The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
911
AR101
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
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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
...and 83 more locations
Number of Participants With TEAEs That Led to a Change in Treatment Regimen
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With TEAEs That Led to Early Withdrawal
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Use of Epinephrine as a Rescue Medication
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Eosinophilic Esophagitis (EoE)
EoE was diagnosed by biopsy/endoscopy.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
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.
Time frame: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
Maximum Tolerated Challenge Dose at Each Food Challenge
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.
Time frame: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
Number of Participants With Use of Epinephrine as a Rescue Medication During the Food Challenges
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.
Time frame: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)