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    Clinical Trial Results:
    Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study.

    Summary
    EudraCT number
    		 2021-002533-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    04 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2022
    First version publication date
    19 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ARC002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02198664
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aimmune Therapeutics Inc.
    Sponsor organisation address
    8000 Marina Blvd, Suite 300, Brisbane, United States, 94005
    Public contact
    Director of Regulatory Affairs, Aimmune Therapeutics Inc., +1 650-409-5164, RegulatoryAffairs@aimmune.com
    Scientific contact
    Director of Regulatory Affairs, Aimmune Therapeutics Inc., +1 650-409-5164, RegulatoryAffairs@aimmune.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001734-PIP01-14
    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
    12 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001 (2021-002087-47).
    Protection of trial subjects
    Protocol and ICF were approved by IECs or IRBs and FDA in conformance with US code of Federal Regulations and ICH guidelines. Study was conducted per GCP and Declaration of Helsinki guidelines. Patients or parents /legal guardians of patients were educated on study and to notify sites of allergic symptoms occurring at home. Diary logs for completion at home by patients/families to measure IP compliance and alert sites of Adverse Events of Interest, including accidental exposure or Epi pen use.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Aug 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 23 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 47
    Worldwide total number of subjects
    47
    EEA total number of subjects
    0
    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)
    35
    Adolescents (12-17 years)
    11
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 47 subjects between the ages of 4 and 26 years with peanut allergy screened and enrolled. The population comprised of 26 subjects on the ARC001 placebo group and 21 subjects in the ARC001 AR101 group.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ARC001 Placebo Group
    Arm description
    		 A peanut-derived oral immunotherapy drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    AR101
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    Study product provided in peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

    Arm title
    		 ARC001 AR101 Group
    Arm description
    		 A peanut-derived oral immunotherapy drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    AR101
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    Study product provided in peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

    Number of subjects in period 1
    		ARC001 Placebo Group ARC001 AR101 Group
    Started
    26
    21
    Completed
    10
    13
    Not completed
    16
    8
         Consent withdrawn by subject
    11
    8
         unknown
    1
    -
         Adverse event, non-fatal
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ARC001 Placebo Group
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Reporting group title
    ARC001 AR101 Group
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Reporting group values
    		 ARC001 Placebo Group ARC001 AR101 Group Total
    Number of subjects
    		 26 21 47
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 20 15 35
        Adolescents (12-17 years)
    		 6 5 11
        Adults (18-64 years)
    		 0 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 8.5 (5 to 14) 8.0 (4 to 21) -
    Gender categorical
    Units: Subjects
        Female
    		 10 7 17
        Male
    		 16 14 30
    Subject analysis sets

    Subject analysis set title
    ARC001 Placebo Group safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population (subjects who received any amount of AR101)

    Subject analysis set title
    ARC001 AR101 Group safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population (subjects who received any amount of AR101)

    Subject analysis sets values
    		 ARC001 Placebo Group safety population ARC001 AR101 Group safety population
    Number of subjects
    26
    21
    Age categorical
    Units: Subjects
        Children (2-11 years)
    20
    15
        Adolescents (12-17 years)
    6
    5
        Adults (18-64 years)
    0
    1
    Age continuous
    Units: years
        median (full range (min-max))
    8.5 (5 to 14)
    8.0 (4 to 21)
    Gender categorical
    Units: Subjects
        Female
    10
    7
        Male
    16
    14

    End points

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    End points reporting groups
    Reporting group title
    ARC001 Placebo Group
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Reporting group title
    ARC001 AR101 Group
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Subject analysis set title
    ARC001 Placebo Group safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population (subjects who received any amount of AR101)

    Subject analysis set title
    ARC001 AR101 Group safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population (subjects who received any amount of AR101)

    Primary: Number of Participants With Treatment-Emergent Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months [1]
    End point description
    End point type
    Primary
    End point timeframe
    90 weeks
    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: No formal statistical analysis was performed for this end point, because no formal sample size calculation or hypothesis testing was done as this study was an open-label, follow-on study of ARC001. The number of subjects enrolled in ARC002 depended on the number of subjects completed ARC001.
    End point values
    		 ARC001 Placebo Group safety population ARC001 AR101 Group safety population
    Number of subjects analysed
    26
    21
    Units: participants
        Any TEAE
    26
    21
        Any Grade 3 or Higher TEAE
    1
    1
        Any TEAE Related to Study Treatment
    25
    15
        Any TEAE Leading to Treatment Permanent Withdrawn
    4
    0
        Any TEAE Leading to Treatment TemporarilyWithdrawn
    12
    15
        Any Treatment-Related Hypersensitivity AE
    5
    4
        Any serious TEAE
    0
    1
        Any Serious TEAE leading to Death
    0
    0
    No statistical analyses for this end point

    Secondary: The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC

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    End point title
    		 The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC
    End point description
    Only results for the "ARC001 AR101 Group" is reported as only subjects in this group underwent the Up-dosing Double Blind Placebo Controlled Food Challenge (DPPCFC) in the ARC002 study.
    End point type
    Secondary
    End point timeframe
    Up to 36 weeks.
    End point values
    		 ARC001 Placebo Group safety population
    Number of subjects analysed
    26
    Units: participants
        Up-dosing DBPCFC: Responder at 300 mg
    20
        Up-dosing DBPCFC: Responder at 600 mg
    19
    No statistical analyses for this end point

    Secondary: The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.

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    End point title
    		 The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.
    End point description
    Multiple food challenge dose levels were given at each DBPCFC, so results at 300 mg and 600 mg for Maintenance DBPCFC are not expected to match those for Up-dosing DBPCFC.
    End point type
    Secondary
    End point timeframe
    Up to 60 weeks.
    End point values
    		 ARC001 Placebo Group safety population ARC001 AR101 Group safety population
    Number of subjects analysed
    26 [2]
    21 [3]
    Units: participants
        Maintenance DBPCFC: Responder at 300 mg
    20
    20
        Maintenance DBPCC: Responder at 600 mg
    20
    18
        Maintenance DBPCC: Responder at 1000 mg
    17
    14
    Notes
    [2] - Subjects who received placebo in study ARC001
    [3] - Subjects who received AR101 and tolerated up to 300 mg peanut protein in DBPCFC the at end of ARC001
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein

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    End point title
    		 Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein
    End point description
    Only includes the food challenge completer population. Note: Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002. Consequently, values are reported as "0".
    End point type
    Secondary
    End point timeframe
    Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance).
    End point values
    		 ARC001 Placebo Group safety population ARC001 AR101 Group safety population
    Number of subjects analysed
    26
    21 [4]
    Units: milligram(s)
    geometric mean (standard deviation)
        AR101 baseline
    38.90 ( 4.37 )
    0 ( 0 )
        Up-dosing DBPCFC
    501.2 ( 1.55 )
    524.8 ( 1.32 )
        Maintenance DBPCFC
    776.2 ( 1.41 )
    758.6 ( 1.55 )
    Notes
    [4] - ARC001 AR101 group baseline values already summarized in ARC001 and were not resummarized for ARC002
    No statistical analyses for this end point

    Secondary: Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated

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    End point title
    		 Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated
    End point description
    The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs. Note: Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002. Consequently, values are reported as "0".
    End point type
    Secondary
    End point timeframe
    Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance).
    End point values
    		 ARC001 Placebo Group safety population ARC001 AR101 Group safety population
    Number of subjects analysed
    26
    21
    Units: participants
        Up-dosing DBPCFC: 100 mg
    1
    0
        Up-dosing DBPCFC: 300 mg
    3
    4
        Up-dosing DBPCFC: 600 mg
    17
    17
        Maintenance: 100 mg
    0
    0
        Maintenance: 300 mg
    1
    3
        Maintenance: 600 mg
    8
    4
        Maintenance: 1000 mg
    11
    13
    No statistical analyses for this end point

    Secondary: Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance

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    End point title
    		 Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance
    End point description
    Note: Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002. Consequently, values are reported as "0".
    End point type
    Secondary
    End point timeframe
    Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks).
    End point values
    		 ARC001 Placebo Group safety population ARC001 AR101 Group safety population
    Number of subjects analysed
    26
    21
    Units: kU/L
    geometric mean (standard deviation)
        Baseline
    56.826 ( 2.8864 )
    0 ( 0 )
        Up-dosing
    59.145 ( 2.9154 )
    29.964 ( 4.4817 )
        Extended maintenance
    14.880 ( 6.7531 )
    10.381 ( 4.0149 )
        Change from baseline
    0.387 ( 2.2479 )
    0 ( 0 )
        Change from up-dosing
    0.364 ( 2.8292 )
    0.228 ( 2.0544 )
    No statistical analyses for this end point

    Secondary: Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance

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    End point title
    		 Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance
    End point description
    Note: Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002. Consequently, values are reported as "0".
    End point type
    Secondary
    End point timeframe
    Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks).
    End point values
    		 ARC001 Placebo Group safety population ARC001 AR101 Group safety population
    Number of subjects analysed
    26
    21
    Units: μg/mL
    geometric mean (standard deviation)
        Baseline
    0.538 ( 2.4351 )
    0 ( 0 )
        Up-dosing
    3.004 ( 3.8962 )
    4.096 ( 3.9749 )
        Extended maintenance
    5.755 ( 3.6328 )
    12.429 ( 2.8292 )
        Change from baseline
    12.429 ( 2.2705 )
    0 ( 0 )
        Change from up-dosing
    1.682 ( 3.1268 )
    2.746 ( 3.4556 )
    No statistical analyses for this end point

    Secondary: Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance

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    End point title
    		 Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance
    End point description
    Note: Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002. Consequently, values are reported as "0".
    End point type
    Secondary
    End point timeframe
    Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
    End point values
    		 ARC001 Placebo Group safety population ARC001 AR101 Group safety population
    Number of subjects analysed
    26
    21
    Units: millimeter(s)
    arithmetic mean (standard deviation)
        Peanut wheal diameter; baseline
    11.8 ( 6.29 )
    0 ( 0 )
        Peanut wheal diameter; up-dosing
    8.6 ( 4.62 )
    6.6 ( 3.04 )
        Peanut wheal diameter; extended maintenance
    9.0 ( 5.77 )
    5.1 ( 3.40 )
        Change from baseline: Peanut wheal diameter
    -1.5 ( 6.52 )
    0 ( 0 )
        Change from up-dosing: Peanut wheal diameter
    -0.8 ( 4.72 )
    -0.7 ( 2.98 )
        Peanut erythema/flare; baseline
    37.6 ( 17.69 )
    0 ( 0 )
        Peanut erythema/flare; up-dosing
    26.8 ( 12.05 )
    21.8 ( 8.76 )
        Peanut erythema/flare; extended maintenance
    28.2 ( 19.73 )
    14.7 ( 11.62 )
        Change from baseline: peanut erythema/flare
    -8.7 ( 15.35 )
    0 ( 0 )
        Change from up-dosing: peanut erythema/flare
    -1.8 ( 11.55 )
    -5.4 ( 9.79 )
    No statistical analyses for this end point

    Secondary: Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance

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    End point title
    		 Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance
    End point description
    A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity. Note: Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002. Consequently, values are reported as "0".
    End point type
    Secondary
    End point timeframe
    Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks).
    End point values
    		 ARC001 Placebo Group safety population ARC001 AR101 Group safety population
    Number of subjects analysed
    26
    21
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    36.4 ( 24.31 )
    0 ( 0 )
        Up-dosing
    34.9 ( 21.42 )
    25.6 ( 17.78 )
        Extended maintenance
    27.5 ( 25.03 )
    20.1 ( 12.61 )
        Change from baseline
    -26.30 ( 34.50 )
    0 ( 0 )
        Change from up-dosing
    -20.00 ( 38.87 )
    -15.5 ( 20.56 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC

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    End point title
    		 Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC
    End point description
    Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC.
    End point type
    Secondary
    End point timeframe
    Up to 36 weeks for up-dosing.
    End point values
    		 ARC001 Placebo Group safety population ARC001 AR101 Group safety population
    Number of subjects analysed
    21
    21
    Units: participants
        No symptoms at 3 mg
    11
    18
        Mild symptoms at 3 mg
    0
    3
        Moderate symptoms at 3 mg
    0
    0
        Severe symptoms at 3 mg
    0
    0
        Missing symptom at 3 mg
    10
    0
        No symptoms at 10 mg
    10
    21
        Mild symptoms at 10 mg
    1
    0
        Moderate symptoms at 10 mg
    0
    0
        Severe symptoms at 10 mg
    0
    0
        Missing symptom at 10 mg
    10
    0
        No symptoms at 30 mg
    10
    20
        Mild symptoms at 30 mg
    2
    1
        Moderate symptoms at 30 mg
    0
    0
        Severe symptoms at 30 mg
    0
    0
        Missing symptoms at 30 mg
    9
    0
        No symptoms at 100 mg
    11
    18
        Mild symptoms at 100 mg
    1
    3
        Moderate symptoms at 100 mg
    0
    0
        Severe symptoms at 100 mg
    0
    0
        Missing symptoms at 100 mg
    9
    0
        No symptoms at 300 mg
    7
    20
        Mild symptoms at 300 mg
    4
    1
        Moderate symptoms at 300 mg
    0
    0
        Severe symptoms at 300 mg
    0
    0
        Missing symptoms at 300 mg
    10
    0
        No symptoms at 600 mg
    6
    12
        Mild symptoms at 600 mg
    6
    5
        Moderate symptoms at 600 mg
    0
    4
        Severe symptoms at 600 mg
    0
    0
        Missing symptoms at 600 mg
    9
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC

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    End point title
    		 Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC
    End point description
    Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC.
    End point type
    Secondary
    End point timeframe
    Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
    End point values
    		 ARC001 Placebo Group safety population ARC001 AR101 Group safety population
    Number of subjects analysed
    20
    20
    Units: participants
        No symptoms at 3 mg
    7
    9
        Mild symptoms at 3 mg
    0
    1
        Moderate symptoms at 3 mg
    0
    0
        Severe symptoms at 3 mg
    0
    0
        Missing symptoms at 3 mg
    13
    10
        No symptoms at 10 mg
    6
    9
        Mild symptoms at 10 mg
    0
    0
        Moderate symptoms at 10 mg
    0
    0
        Severe symptoms at 10 mg
    0
    0
        Missing symptoms at 10 mg
    14
    11
        No symptoms at 30 mg
    6
    9
        Mild symptoms at 30 mg
    0
    1
        Moderate symptoms at 30 mg
    0
    0
        Severe symptoms at 30 mg
    0
    0
        Missing symptoms at 30 mg
    14
    10
        No symptoms at 100 mg
    6
    9
        Mild symptoms at 100 mg
    1
    0
        Moderate symptoms at 100 mg
    0
    0
        Severe symptoms at 100 mg
    0
    0
        Missing symptoms at 100 mg
    13
    11
        No symptoms at 300 mg
    6
    8
        Mild symptoms at 300 mg
    0
    1
        Moderate symptoms at 300 mg
    0
    0
        Severe symptoms at 300 mg
    0
    0
        Missing symptoms at 300 mg
    14
    11
        No symptoms at 600 mg
    7
    7
        Mild symptoms at 600 mg
    2
    3
        Moderate symptoms at 600 mg
    0
    1
        Severe symptoms at 600 mg
    0
    0
        Missing symptoms at 600 mg
    11
    9
        No symptoms at 1000 mg
    5
    7
        Mild symptoms at 1000 mg
    7
    4
        Moderate symptoms at 1000 mg
    2
    2
        Severe symptoms at 1000 mg
    0
    1
        Missing symptoms at 1000 mg
    6
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    90 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    ARC001 Placebo Group
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Reporting group title
    ARC001 AR101 Group
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Serious adverse events
    		 ARC001 Placebo Group ARC001 AR101 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ARC001 Placebo Group ARC001 AR101 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 26 (100.00%)
    21 / 21 (100.00%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 21 (4.76%)
         occurrences all number
    3
    1
    Joint injury
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1
    Ligament sprain
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 21 (4.76%)
         occurrences all number
    3
    2
    Vascular disorders
    Flushing
         subjects affected / exposed
    3 / 26 (11.54%)
    0 / 21 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 26 (23.08%)
    8 / 21 (38.10%)
         occurrences all number
    8
    47
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    7 / 26 (26.92%)
    6 / 21 (28.57%)
         occurrences all number
    11
    14
    Chest discomfort
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 21 (9.52%)
         occurrences all number
    1
    4
    Malaise
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 21 (9.52%)
         occurrences all number
    2
    4
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    6 / 26 (23.08%)
    7 / 21 (33.33%)
         occurrences all number
    7
    20
    Anaphylactic reaction
         subjects affected / exposed
    4 / 26 (15.38%)
    2 / 21 (9.52%)
         occurrences all number
    5
    3
    Seasonal allergy
         subjects affected / exposed
    1 / 26 (3.85%)
    3 / 21 (14.29%)
         occurrences all number
    1
    8
    Food allergy
         subjects affected / exposed
    0 / 26 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    0
    4
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    3 / 26 (11.54%)
    0 / 21 (0.00%)
         occurrences all number
    3
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 21 (9.52%)
         occurrences all number
    3
    6
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    15 / 26 (57.69%)
    9 / 21 (42.86%)
         occurrences all number
    62
    33
    Vomiting
         subjects affected / exposed
    15 / 26 (57.69%)
    8 / 21 (38.10%)
         occurrences all number
    20
    27
    Abdominal pain upper
         subjects affected / exposed
    7 / 26 (26.92%)
    7 / 21 (33.33%)
         occurrences all number
    23
    24
    Nausea
         subjects affected / exposed
    7 / 26 (26.92%)
    6 / 21 (28.57%)
         occurrences all number
    12
    9
    Oral pruritus
         subjects affected / exposed
    6 / 26 (23.08%)
    2 / 21 (9.52%)
         occurrences all number
    33
    9
    Abdominal discomfort
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 21 (14.29%)
         occurrences all number
    14
    5
    Diarrhoea
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 21 (14.29%)
         occurrences all number
    3
    3
    Lip swelling
         subjects affected / exposed
    4 / 26 (15.38%)
    2 / 21 (9.52%)
         occurrences all number
    8
    12
    Dyspepsia
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 21 (4.76%)
         occurrences all number
    4
    2
    Constipation
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1
    Gastritis
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1
    Lip pruritus
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 21 (9.52%)
         occurrences all number
    1
    30
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 26 (42.31%)
    6 / 21 (28.57%)
         occurrences all number
    21
    20
    Nasal congestion
         subjects affected / exposed
    9 / 26 (34.62%)
    7 / 21 (33.33%)
         occurrences all number
    16
    10
    Oropharyngeal pain
         subjects affected / exposed
    7 / 26 (26.92%)
    4 / 21 (19.05%)
         occurrences all number
    12
    25
    Rhinorrhoea
         subjects affected / exposed
    6 / 26 (23.08%)
    5 / 21 (23.81%)
         occurrences all number
    8
    7
    Sneezing
         subjects affected / exposed
    8 / 26 (30.77%)
    3 / 21 (14.29%)
         occurrences all number
    14
    10
    Throat irritation
         subjects affected / exposed
    6 / 26 (23.08%)
    5 / 21 (23.81%)
         occurrences all number
    30
    16
    Rhinitis allergic
         subjects affected / exposed
    6 / 26 (23.08%)
    3 / 21 (14.29%)
         occurrences all number
    8
    4
    Wheezing
         subjects affected / exposed
    7 / 26 (26.92%)
    2 / 21 (9.52%)
         occurrences all number
    14
    15
    Nasal turbinate hypertrophy
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 21 (4.76%)
         occurrences all number
    3
    1
    Asthma
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 21 (4.76%)
         occurrences all number
    2
    3
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    7 / 26 (26.92%)
    5 / 21 (23.81%)
         occurrences all number
    36
    20
    Rash
         subjects affected / exposed
    5 / 26 (19.23%)
    5 / 21 (23.81%)
         occurrences all number
    7
    7
    Pruritus
         subjects affected / exposed
    5 / 26 (19.23%)
    4 / 21 (19.05%)
         occurrences all number
    19
    6
    Eczema
         subjects affected / exposed
    1 / 26 (3.85%)
    3 / 21 (14.29%)
         occurrences all number
    5
    3
    Erythema
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 21 (4.76%)
         occurrences all number
    3
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal discomfort
         subjects affected / exposed
    3 / 26 (11.54%)
    0 / 21 (0.00%)
         occurrences all number
    4
    0
    Infections and infestations
    Pharyngitis streptococcal
         subjects affected / exposed
    10 / 26 (38.46%)
    5 / 21 (23.81%)
         occurrences all number
    13
    8
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 26 (26.92%)
    8 / 21 (38.10%)
         occurrences all number
    13
    10
    Gastroenteritis viral
         subjects affected / exposed
    4 / 26 (15.38%)
    5 / 21 (23.81%)
         occurrences all number
    8
    5
    Viral infection
         subjects affected / exposed
    5 / 26 (19.23%)
    4 / 21 (19.05%)
         occurrences all number
    7
    6
    Gastroenteritis
         subjects affected / exposed
    3 / 26 (11.54%)
    5 / 21 (23.81%)
         occurrences all number
    6
    6
    Nasopharyngitis
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 21 (19.05%)
         occurrences all number
    8
    4
    Otitis media
         subjects affected / exposed
    3 / 26 (11.54%)
    2 / 21 (9.52%)
         occurrences all number
    4
    3
    Ear infection
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 21 (9.52%)
         occurrences all number
    2
    2
    Influenza
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 21 (9.52%)
         occurrences all number
    2
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Mar 2015
    Changes in study design, selection and withdrawal of subjects, study medication, study procedures and safety monitoring.
    23 Nov 2015
    Modified the formulation, packaging, and labeling. Changes in study procedures including treatment instructions, missed doses and anaphylaxis as well as pregnancy reporting requirements.
    15 Aug 2017
    Addition of optional OFC. To assess an exploratory objective or the maximum amount of desensitization based on an open-label food challenge up to a cumulative dose of 4043 mg of total peanut protein. To specify the procedures for termination of the study for all subjects remaining and provide continued treatment in a rollover trial ARC008

    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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