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

    Summary
    EudraCT number
    		 2017-001334-26
    Trial protocol
    		 GB   IE   SE   ES   DE   FR   NL   IT  
    Global end of trial date
    27 Apr 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    13 Feb 2025
    First version publication date
    26 Oct 2024
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Updated subject disposition (pre-assignment details, milestones) and clarified reporting group descriptions.

    Trial information

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    Trial identification
    Sponsor protocol code
    ARC008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03292484
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aimmune Therapeutics, a Nestlé Health Science Company
    Sponsor organisation address
    1007 US Hwy 202/206, Bldg JR2, Suite E102 Bridgewater, New Jersey, United States, 08807
    Public contact
    Jay Patel , Aimmune Therapeutics, a Nestlé Health Science Company, jay.patel@uk.nestle.com
    Scientific contact
    Jay Patel , Aimmune Therapeutics, a Nestlé Health Science Company, jay.patel@uk.nestle.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Apr 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To describe safety and tolerability during longer-term administration of AR101 and follow-up observation after the last dose of AR101.
    Protection of trial subjects
    The study was conducted in conformance with the principles of the Declaration of Helsinki (2013) or with the laws and regulations of the country in which the research was conducted, whichever provided greater protection of the individual. In addition, the study was conducted in accordance with Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use guidelines, EU (European Union) Directive 2001/20/EC, EU Directive 2005/28/EC, EU Clinical Trials Regulation (CTR) 536/2014, local applicable legislation including but not limited to the United Kingdom (UK) SI 2004/1031 Medicines for Human Use (Clinical Trials) Regulations 2004 as amended, Council for International Organizations of Medical Sciences International Ethical Guidelines, and national and local regulations and directives as appropriate including the archiving of essential records. The study was conducted under a protocol reviewed and approved by an ethics committee and conducted by scientifically and medically qualified persons.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 96
    Country: Number of subjects enrolled
    United States: 592
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Germany: 48
    Country: Number of subjects enrolled
    Ireland: 36
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Spain: 31
    Country: Number of subjects enrolled
    Sweden: 10
    Country: Number of subjects enrolled
    Canada: 67
    Worldwide total number of subjects
    911
    EEA total number of subjects
    156
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    607
    Adolescents (12-17 years)
    274
    Adults (18-64 years)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    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
    Screening 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. OLFC= Open-label food challenge and DBPCFC= Double-blind, placebo-controlled food challenge.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 AR101
    Arm description
    		 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).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AR101
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Modified-release granules
    Routes of administration
    Oral use
    Dosage and administration details
    AR101 was administered as pull-apart capsules formulated to contain 0.5, 1, 10, 20, or 100 mg of peanut protein or as foil-laminate sachets containing 300 mg of peanut protein.

    Number of subjects in period 1
    		AR101
    Started
    911
    Safety Population
    908
    Participants Who Had an OLFC
    517
    Participants Who Had a DBPCFC
    211
    Completed
    18
    Not completed
    893
         Investigator decision (unrelated to AE)
    13
         Protocol Violation
    2
         Coronavirus Disease 2019
    1
         Unspecified
    20
         Withdrew consent (unrelated to adverse event [AE])
    86
         Sponsor decision
    349
         Lost to follow-up
    7
         Participants did not have Study Exit Forms
    415

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 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).

    Reporting group values
    		 AR101 Total
    Number of subjects
    		 911 911
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.8 ( 4.75 ) -
    Gender categorical
    Units: Subjects
        Female
    		 359 359
        Male
    		 552 552
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 38 38
        Not Hispanic or Latino
    		 842 842
        Not collected
    		 31 31
    Race
    Units: Subjects
        Asian
    		 106 106
        Black or African American
    		 18 18
        Native Hawaiian or Other Pacific Islander
    		 3 3
        White
    		 664 664
        Other
    		 65 65
        Multiple Races Reported
    		 53 53
        Not Collected
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 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).

    Subject analysis set title
    AR101
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    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).

    Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [1]
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through 30 days after last dose of study drug, up to 59 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 AR101
    Number of subjects analysed
    908
    Units: participants
        TEAEs
    866
        TESAEs
    42
    No statistical analyses for this end point

    Primary: Number of Participants With Premature Discontinuation of AR101 Dosing due to TEAEs

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    End point title
    		 Number of Participants With Premature Discontinuation of AR101 Dosing due to TEAEs [2]
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through 30 days after last dose of study drug, up to 59 months
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 AR101
    Number of subjects analysed
    908
    Units: participants
    53
    No statistical analyses for this end point

    Primary: Number of Participants With Premature Discontinuation of AR101 Dosing due to Chronic/Recurrent Gastrointestinal TEAEs

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    End point title
    		 Number of Participants With Premature Discontinuation of AR101 Dosing due to Chronic/Recurrent Gastrointestinal TEAEs [3]
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through 30 days after last dose of study drug, up to 59 months
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 AR101
    Number of subjects analysed
    908
    Units: participants
    25
    No statistical analyses for this end point

    Primary: Number of Participants With TEAEs That led to a Change in Treatment Regimen

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    End point title
    		 Number of Participants With TEAEs That led to a Change in Treatment Regimen [4]
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through 30 days after last dose of study drug, up to 59 months
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 AR101
    Number of subjects analysed
    908
    Units: participants
        TEAEs requiring dose interruption of treatment
    669
        TEAEs requiring dose reduction of treatment
    167
    No statistical analyses for this end point

    Primary: Number of Participants With TEAEs That led to Early Withdrawal

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    End point title
    		 Number of Participants With TEAEs That led to Early Withdrawal [5]
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through 30 days after last dose of study drug, up to 59 months
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 AR101
    Number of subjects analysed
    908
    Units: participants
    27
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction

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    End point title
    		 Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction [6]
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through 30 days after last dose of study drug, up to 59 months
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 AR101
    Number of subjects analysed
    908
    Units: participants
    192
    No statistical analyses for this end point

    Primary: Number of Participants With use of Epinephrine as a Rescue Medication

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    End point title
    		 Number of Participants With use of Epinephrine as a Rescue Medication [7]
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through 30 days after last dose of study drug, up to 59 months
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 AR101
    Number of subjects analysed
    908
    Units: participants
    234
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes

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    End point title
    		 Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes [8]
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through 30 days after last dose of study drug, up to 59 months
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 AR101
    Number of subjects analysed
    908
    Units: participants
        Accidental Food Allergy Episodes
    208
        Non-accidental Food Allergy Episodes
    35
    No statistical analyses for this end point

    Primary: Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods

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    End point title
    		 Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods [9]
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through 30 days after last dose of study drug, up to 59 months
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 AR101
    Number of subjects analysed
    908
    Units: participants
    227
    No statistical analyses for this end point

    Primary: Number of Participants With Eosinophilic Esophagitis (EoE)

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    End point title
    		 Number of Participants With Eosinophilic Esophagitis (EoE) [10]
    End point description
    EoE was diagnosed by biopsy/endoscopy. The safety population consisted of all participants who received AR101 during ARC008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through 30 days after last dose of study drug, up to 59 months
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 AR101
    Number of subjects analysed
    908
    Units: participants
    7
    No statistical analyses for this end point

    Secondary: Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)

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    End point title
    		 Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008. Only those participants who had an OLFC or a DBPCFC are reported. Here, n=number of participants with data collected for each specified category
    End point type
    Secondary
    End point timeframe
    OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
    End point values
    		 AR101
    Number of subjects analysed
    517
    Units: percentage of participants
    number (confidence interval 95%)
        OLFC: Tolerated at least 300 mg (n=517)
    98.6 (97.2 to 99.5)
        OLFC: Tolerated at least 600 mg (n=517)
    94.2 (91.8 to 96.1)
        OLFC: Tolerated at least 1000 mg (n=517)
    78.7 (74.9 to 82.2)
        OLFC: Tolerated at least 2000 mg (n=517)
    55.9 (51.5 to 60.2)
        DBPCFC: Tolerated at least 3 mg (n=211)
    100.0 (98.3 to 100.0)
        DBPCFC: Tolerated at least 10 mg (n=211)
    100.0 (98.3 to 100.0)
        DBPCFC: Tolerated at least 30 mg (n=211)
    99.5 (97.4 to 100.0)
        DBPCFC: Tolerated at least 100 mg (n=211)
    99.1 (96.6 to 99.9)
        DBPCFC: Tolerated at least 300 mg (n=211)
    94.8 (90.9 to 97.4)
        DBPCFC: Tolerated at least 600 mg (n=211)
    88.2 (83.0 to 92.2)
        DBPCFC: Tolerated at least 1000 mg (n=211)
    75.8 (69.5 to 81.4)
        DBPCFC: Tolerated at least 2000 mg (n=211)
    60.2 (53.2 to 66.8)
    No statistical analyses for this end point

    Secondary: Maximum Tolerated Challenge Dose at Each Food Challenge

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    End point title
    		 Maximum Tolerated Challenge Dose at Each Food Challenge
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008. Only those participants who had an OLFC or a DBPCFC are reported. Here, n=number of participants with data collected for each specified category.
    End point type
    Secondary
    End point timeframe
    OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
    End point values
    		 AR101
    Number of subjects analysed
    517
    Units: mg
    number (not applicable)
        OLFC (n=517)
    2000
        DBPCFC (n=211)
    2000
    No statistical analyses for this end point

    Secondary: Number of Participants With use of Epinephrine as a Rescue Medication During the Food Challenges

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    End point title
    		 Number of Participants With use of Epinephrine as a Rescue Medication During the Food Challenges
    End point description
    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. The safety population consisted of all participants who received AR101 during ARC008. Only those participants who had an OLFC or a DBPCFC are reported. Here, n=number of participants with data collected for each specified category.
    End point type
    Secondary
    End point timeframe
    OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
    End point values
    		 AR101
    Number of subjects analysed
    517
    Units: participants
        OLFC (n=517)
    110
        DBPCFC (n=211)
    35
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug through 30 days after last dose of study drug, up to 59 months
    Adverse event reporting additional description
    The safety population consisted of all participants who received AR101 during ARC008.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 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).

    Serious adverse events
    		 AR101
    Total subjects affected by serious adverse events
         subjects affected / exposed
    42 / 908 (4.63%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    2 / 908 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    8 / 908 (0.88%)
         occurrences causally related to treatment / all
    4 / 8
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vestibular disorder
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 908 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Coeliac disease
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral disorder
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    4 / 908 (0.44%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wheezing
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    8 / 908 (0.88%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Croup infectious
         subjects affected / exposed
    2 / 908 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis viral
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Salmonella bacteraemia
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 908 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AR101
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    865 / 908 (95.26%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    240 / 908 (26.43%)
         occurrences all number
    816
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    293 / 908 (32.27%)
         occurrences all number
    597
    Illness
         subjects affected / exposed
    61 / 908 (6.72%)
         occurrences all number
    118
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    187 / 908 (20.59%)
         occurrences all number
    334
    Seasonal allergy
         subjects affected / exposed
    50 / 908 (5.51%)
         occurrences all number
    87
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    47 / 908 (5.18%)
         occurrences all number
    65
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    83 / 908 (9.14%)
         occurrences all number
    163
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    293 / 908 (32.27%)
         occurrences all number
    769
    Abdominal pain
         subjects affected / exposed
    271 / 908 (29.85%)
         occurrences all number
    2212
    Nausea
         subjects affected / exposed
    183 / 908 (20.15%)
         occurrences all number
    1122
    Abdominal pain upper
         subjects affected / exposed
    173 / 908 (19.05%)
         occurrences all number
    684
    Abdominal discomfort
         subjects affected / exposed
    166 / 908 (18.28%)
         occurrences all number
    1028
    Diarrhoea
         subjects affected / exposed
    127 / 908 (13.99%)
         occurrences all number
    272
    Oral pruritus
         subjects affected / exposed
    88 / 908 (9.69%)
         occurrences all number
    739
    Lip swelling
         subjects affected / exposed
    68 / 908 (7.49%)
         occurrences all number
    158
    Paraesthesia oral
         subjects affected / exposed
    59 / 908 (6.50%)
         occurrences all number
    1215
    Lip pruritus
         subjects affected / exposed
    53 / 908 (5.84%)
         occurrences all number
    253
    Dyspepsia
         subjects affected / exposed
    51 / 908 (5.62%)
         occurrences all number
    173
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    302 / 908 (33.26%)
         occurrences all number
    949
    Throat irritation
         subjects affected / exposed
    169 / 908 (18.61%)
         occurrences all number
    2368
    Oropharyngeal pain
         subjects affected / exposed
    165 / 908 (18.17%)
         occurrences all number
    363
    Nasal congestion
         subjects affected / exposed
    145 / 908 (15.97%)
         occurrences all number
    317
    Sneezing
         subjects affected / exposed
    118 / 908 (13.00%)
         occurrences all number
    413
    Rhinorrhoea
         subjects affected / exposed
    114 / 908 (12.56%)
         occurrences all number
    272
    Wheezing
         subjects affected / exposed
    107 / 908 (11.78%)
         occurrences all number
    287
    Asthma
         subjects affected / exposed
    85 / 908 (9.36%)
         occurrences all number
    160
    Oropharyngeal discomfort
         subjects affected / exposed
    85 / 908 (9.36%)
         occurrences all number
    466
    Rhinitis allergic
         subjects affected / exposed
    60 / 908 (6.61%)
         occurrences all number
    105
    Dyspnoea
         subjects affected / exposed
    59 / 908 (6.50%)
         occurrences all number
    131
    Throat tightness
         subjects affected / exposed
    50 / 908 (5.51%)
         occurrences all number
    71
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    251 / 908 (27.64%)
         occurrences all number
    862
    Pruritus
         subjects affected / exposed
    191 / 908 (21.04%)
         occurrences all number
    827
    Rash
         subjects affected / exposed
    121 / 908 (13.33%)
         occurrences all number
    182
    Eczema
         subjects affected / exposed
    74 / 908 (8.15%)
         occurrences all number
    143
    Erythema
         subjects affected / exposed
    65 / 908 (7.16%)
         occurrences all number
    125
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    221 / 908 (24.34%)
         occurrences all number
    474
    Upper respiratory tract infection
         subjects affected / exposed
    213 / 908 (23.46%)
         occurrences all number
    421
    Viral infection
         subjects affected / exposed
    143 / 908 (15.75%)
         occurrences all number
    250
    Influenza
         subjects affected / exposed
    108 / 908 (11.89%)
         occurrences all number
    134
    COVID-19
         subjects affected / exposed
    102 / 908 (11.23%)
         occurrences all number
    114
    Gastroenteritis viral
         subjects affected / exposed
    90 / 908 (9.91%)
         occurrences all number
    117
    Gastroenteritis
         subjects affected / exposed
    88 / 908 (9.69%)
         occurrences all number
    118
    Rhinitis
         subjects affected / exposed
    76 / 908 (8.37%)
         occurrences all number
    171
    Conjunctivitis
         subjects affected / exposed
    54 / 908 (5.95%)
         occurrences all number
    79
    Pharyngitis streptococcal
         subjects affected / exposed
    54 / 908 (5.95%)
         occurrences all number
    69
    Ear infection
         subjects affected / exposed
    50 / 908 (5.51%)
         occurrences all number
    56
    Sinusitis
         subjects affected / exposed
    47 / 908 (5.18%)
         occurrences all number
    60

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Dec 2017
    The primary purpose of this amendment was to modify the eligibility criteria to ensure that appropriate participants were enrolled in this follow-on study, remove changes in basophil activation as an objective and endpoint of the study, clarify contraceptive methods, clarify the study duration, and remove the requirement for medical monitor confirmation of participant eligibility.
    11 May 2018
    The primary purpose of this amendment was to modify exclusion criterion 2 to allow AR101 treated participants who did not successfully consume at least the 300 mg single dose of peanut protein at the exit DBPCFC of an originating study that required a food challenge to enroll in study ARC008, if specified in the originating study. This amendment also clarified additional participants from originating study ARC004 who might be eligible to receive daily dosing with AR101 in treatment pathway 2 of ARC008.
    24 Jul 2018
    The primary purpose of this amendment was to accommodate participants who did not complete their AR101 dosing regimen in an eligible originating study. Allowed one additional dosing kit to be dispensed in exceptional circumstances to provide flexibility for participants with scheduling issues who required continued dosing. Removed the requirement for repeat up-dosing to be completed within 26 weeks in treatment pathway 2 to provide flexibility and allowed more time for tolerability so participants could continue treatment. Allowed safety follow-up to continue for participants who discontinued early due to AEs from an eligible originating study.
    01 Nov 2019
    The primary purpose of this amendment was to add 2 new treatment pathways (Treatment Pathways 4 and 5) for eligible participants from prior study ARC005 to begin or continue treatment with AR101. This amendment also removed the optional real world peanut challenge, which was introduced to inform participants of their potential risk of allergic reaction from unintended ingestion of peanut-containing foods. Extended the study duration to allow assessment of long-term safety of AR101. Removed the daily diary from treatment pathways 1, 2, and 3 and from safety follow-up after early discontinuation to reduce burden for these participants who already have at least 9 months experience taking AR101. Consolidated the procedures for the end of the study. Added or removed telephone calls or expands the window for telephone calls after study site visits for safety follow-up, feasibility, or participant convenience, as appropriate. Added guidance for safety follow-up for participants diagnosed with EoE. Added an exclusion criterion for participants currently committed to an institution by virtue of an order issued by judicial or administrative authorities per some local requirements. Added total immunoglobulin G4 (IgG4) and IgE to immunology assessments. Added an exploratory objective and endpoint to evaluate changes in asthma or atopic dermatitis in participants from prior study ARC005.
    28 May 2020
    The primary purpose of this amendment was to provide guidance on changes to study conduct during a pandemic, epidemic, or other emergency not related to the study, when restrictions issued at the country, state, regional, and/or local level prevent the conduct of study site visits and access to study product for an extended period.
    22 Dec 2020
    The primary purpose of this amendment was to modify the study design to demonstrate a sustained clinical effect after 5 years total of AR101 treatment including all prior studies, and a 1-year observation period after stopping AR101 treatment per regulatory authority request. The study objectives, endpoints, duration, procedures, and schedules of events were updated in accordance with the study design changes. Removed the optional OLFC at the end of treatment as a DBPCFC was required per study design changes. Added guidance to assess the benefit-risk of continued AR101 treatment when a participant had several AR101-related systemic allergic reactions during maintenance treatment for safety reasons. Reduced time points for Asthma Control Test/Childhood Asthma Control Test, Total Nasal Symptom Score, and Test for Respiratory and Asthma Control in Kids during extended maintenance in all treatment pathways to reduce the burden for participants. Removed the Food Allergy Quality of Life – Parental Burden questionnaire from treatment pathways 1 and 2, as it was not administered in prior AR101 studies and changes from baseline cannot be assessed. Added a window for telephone calls after initial dose-escalation day 2, up-dosing visits, and initial maintenance visits in treatment pathway 5 for feasibility. Expanded the window for telephone call after the OLFC from the next day to within 2 days for feasibility.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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