Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03292484

Enrollment

911

Registered

2017-09-25

Start date

2017-11-02

Completion date

2023-04-27

Last updated

2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peanut Allergy

Keywords

AR101, Characterized Peanut Allergen, OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization, CPNA (Characterized Peanut Allergen)

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.

Interventions

BIOLOGICALAR101

AR101

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 55 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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.
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 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.

Secondary

Measure	Time frame	Description
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.
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.

Countries

Canada, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, United States

Participant flow

Recruitment details

This Phase 3, open-label study was conducted in participants who participated in a prior AR101 study at 89 investigational sites in 10 countries (Canada, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, and the United States).

Pre-assignment details

A total of 911 participants were enrolled in this study. After enrolling in ARC008, all participants received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 milligrams (mg) per day.

Participants by arm

Arm	Count
AR101 Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).	911
Total	911

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Coronavirus Disease 2019	1
Overall Study	Investigator decision (unrelated to AE)	13
Overall Study	Lost to Follow-up	7
Overall Study	Other	20
Overall Study	Participants did not have Disposition - Study Exit forms	415
Overall Study	Protocol Violation	2
Overall Study	Sponsor decision	349
Overall Study	Withdrew consent (unrelated to adverse event [AE])	86

Baseline characteristics

Characteristic	AR101
Age, Continuous	9.8 years STANDARD_DEVIATION 4.75
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	842 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	31 Participants
Race/Ethnicity, Customized Asian	106 Participants
Race/Ethnicity, Customized Black or African American	18 Participants
Race/Ethnicity, Customized Multiple Races Reported	53 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	3 Participants
Race/Ethnicity, Customized Not Collected	2 Participants
Race/Ethnicity, Customized Other	65 Participants
Race/Ethnicity, Customized White	664 Participants
Sex: Female, Male Female	359 Participants
Sex: Female, Male Male	552 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 908
other Total, other adverse events	865 / 908
serious Total, serious adverse events	42 / 908

Outcome results

Primary

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.