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    Clinical Trial Results:
    AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)

    Summary
    EudraCT number
    		 2016-005004-26
    Trial protocol
    		 GB   FR   DE   ES   SE   IE   IT  
    Global end of trial date
    15 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Aug 2020
    First version publication date
    15 Aug 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ARC010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03201003
    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
    Clinical Operations, Aimmune Therapeutics Inc., +1 6503963822, amarcantonio@aimmune.com
    Scientific contact
    Clinical Operations, Aimmune Therapeutics Inc., +1 6503963822, amarcantonio@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
    17 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate the efficacy of AR101, a pharmaceutical-grade peanut allergen formulation, through reduction in clinical reactivity to limited amounts of peanut allergen in peanut-allergic children and adolescents (ages 4 to 17 years, inclusive).
    Protection of trial subjects
    • Education of patients to notify sites of allergic symptoms occurring at home. • Patient emergency card, dos and don’t card, home dosing card. • Patients/caregivers asked to carry epi-pen with them at all times during study. • Patient advised to go to local emergency unit outside of normal clinical working hours. • Patient advised to report rare or unforeseen AEs immediately. • Advised to practice usual peanut avoidance • Specific reporting/monitoring of AEIs, Gastrointestinal AEs (monitoring and follow-up for EOE), capture of AEs in patient diaries, EDC, SAE reporting, study and individual stopping rules & in clinic, supervised up-dosing, including observation timelines prior to Clinic departure.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jun 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Regulatory reason, Scientific research
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    Sweden: 11
    Country: Number of subjects enrolled
    United Kingdom: 59
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 28
    Country: Number of subjects enrolled
    Ireland: 26
    Country: Number of subjects enrolled
    Italy: 8
    Worldwide total number of subjects
    175
    EEA total number of subjects
    175
    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)
    127
    Adolescents (12-17 years)
    48
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 227 subjects between the ages of 4 and 17 years with suspected peanut allergy were screened for inclusion of which 175 were randomised and enrolled in the study.

    Pre-assignment
    Screening details
    		 Selection criteria included the following prior to randomisation: • a clinical history of peanut allergy • a mean peanut skin prick test wheal diameter ≥3 mm larger than the control and/or a serum peanut-specific IgE ≥0.35 kUA/L • experiencing dose-limiting symptoms at or before the 300 mg dose of peanut protein during the screening DBPCFC

    Period 1
    Period 1 title
    Post- randomisation (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AR101
    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
    AR101 drug product was supplied in 2 presentations. These were capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. These 3, post-randomisation, phases are described below. Initial escalation: Comprised of dose-escalation (from 0.5mg to a maximum of 6 mg at 20 to 30-minute intervals) on Day 1 and confirmation of the tolerability of a single 3 mg dose on Day 2. Up-dosing: Following initial escalation, subjects received daily doses of AR101 and are up-dosed every 2 weeks for approximately 20 weeks. Dosing commenced at 3mg and progressed to 300mg via 10 incremental dosing steps at 2 weekly intervals. Maintenance: All subjects who reach and tolerate 300 mg/d will continue to take a daily maintenance dose of 300mg/d for 12 to 16 weeks. Maintenance visits occur every 4 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Matching Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. These 3, post-randomisation, phases are described above but utilising the placebo presentations.

    Number of subjects in period 1
    		AR101 Placebo
    Started
    132
    43
    Completed
    106
    40
    Not completed
    26
    3
         Consent withdrawn by subject
    4
    1
         Adverse event, non-fatal
    14
    1
         Other
    5
    1
         Lost to follow-up
    2
    -
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo

    Reporting group values
    		 AR101 Placebo Total
    Number of subjects
    		 132 43 175
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 97 30 127
        Adolescents (12-17 years)
    		 35 13 48
    Gender categorical
    Units: Subjects
        Female
    		 64 16 80
        Male
    		 68 27 95

    End points

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    End points reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo

    Subject analysis set title
    AR101 ITT/ Safety Population Ages 4-17
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The pre-specified primary efficacy population includes subjects Ages 4-17 in the ITT Population

    Subject analysis set title
    Placebo ITT / Safety Population Ages 4-17
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The pre-specified primary efficacy population includes subjects Ages 4-17 in the ITT Population

    Primary: Primary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 1000 mg in the Exit Oral Food Challenge

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    End point title
    		 Primary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 1000 mg in the Exit Oral Food Challenge
    End point description
    The pre-specified primary efficacy population includes subjects Ages 4-17 in the ITT Population
    End point type
    Primary
    End point timeframe
    Exit oral food challenge (after approximately 9 months of blinded therapy)
    End point values
    		 AR101 ITT/ Safety Population Ages 4-17 Placebo ITT / Safety Population Ages 4-17
    Number of subjects analysed
    132
    43
    Units: Percentage of Patients
    number (confidence interval 95%)
        Responder %
    58.3 (49.4 to 66.8)
    2.3 (0.1 to 12.3)
    Statistical analysis title
    		 Treatment difference at 1000 mg
    Statistical analysis description
    The 95% CIs for difference in binomial proportions were based on exact unconditional confidence limits using the score statistic. p-values were based on Fisher's exact test.
    Comparison groups
    AR101 ITT/ Safety Population Ages 4-17 v Placebo ITT / Safety Population Ages 4-17
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 44.1
         upper limit
    		 65.2

    Secondary: Secondary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 600 mg in the Exit Oral Food Challenge

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    End point title
    		 Secondary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 600 mg in the Exit Oral Food Challenge
    End point description
    The pre-specified efficacy population includes subjects Ages 4-17 in the ITT Population
    End point type
    Secondary
    End point timeframe
    Exit oral food challenge (after approximately 9 months of blinded therapy)
    End point values
    		 AR101 ITT/ Safety Population Ages 4-17 Placebo ITT / Safety Population Ages 4-17
    Number of subjects analysed
    132
    43
    Units: Percentage of Patients
    number (confidence interval 95%)
        Responder %
    68.2 (59.5 to 76.0)
    9.3 (2.6 to 22.1)
    Statistical analysis title
    		 Treatment difference at 600 mg
    Statistical analysis description
    The 95% CIs for difference in binomial proportions were based on exact unconditional confidence limits using the score statistic. p-values were based on Fisher's exact test.
    Comparison groups
    AR101 ITT/ Safety Population Ages 4-17 v Placebo ITT / Safety Population Ages 4-17
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    58.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 44.2
         upper limit
    		 69.3

    Secondary: Secondary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 300 mg in the Exit Oral Food Challenge

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    End point title
    		 Secondary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 300 mg in the Exit Oral Food Challenge
    End point description
    The pre-specified secondary efficacy population includes subjects Ages 4-17 in the ITT Population
    End point type
    Secondary
    End point timeframe
    Exit oral food challenge (after approximately 9 months of blinded therapy)
    End point values
    		 AR101 ITT/ Safety Population Ages 4-17 Placebo ITT / Safety Population Ages 4-17
    Number of subjects analysed
    132
    43
    Units: Percentage of Patients
    number (confidence interval 95%)
        Responder %
    73.5 (65.1 to 80.8)
    16.3 (6.8 to 30.7)
    Statistical analysis title
    		 Treatment difference at 300 mg
    Statistical analysis description
    The 95% CIs for difference in binomial proportions were based on exact unconditional confidence limits using the score statistic. p-values were based on Fisher's exact test.
    Comparison groups
    AR101 ITT/ Safety Population Ages 4-17 v Placebo ITT / Safety Population Ages 4-17
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    57.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 41.2
         upper limit
    		 69.1

    Secondary: Secondary Efficacy Endpoint: Maximum severity of symptoms at any challenge dose during the peanut exit DBPCFC

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    End point title
    		 Secondary Efficacy Endpoint: Maximum severity of symptoms at any challenge dose during the peanut exit DBPCFC
    End point description
    End point type
    Secondary
    End point timeframe
    Exit oral food challenge (after approximately 9 months of blinded therapy)
    End point values
    		 AR101 ITT/ Safety Population Ages 4-17 Placebo ITT / Safety Population Ages 4-17
    Number of subjects analysed
    132
    43
    Units: Percentage of Subjects
    number (not applicable)
        None
    35.6
    0
        Mild
    41.7
    37.2
        Moderate
    18.2
    46.5
        Severe or Higher
    4.5
    16.3
    Statistical analysis title
    		 Treatment difference in Maximum Severity
    Statistical analysis description
    Tested using the Cochran-Mantel-Haenszel statistic (with equally spaced scores) stratified by country.
    Comparison groups
    AR101 ITT/ Safety Population Ages 4-17 v Placebo ITT / Safety Population Ages 4-17
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Through study completion (approximately 9 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo

    Serious adverse events
    		 AR101 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 132 (0.76%)
    2 / 43 (4.65%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Intentional overdose
    Additional description: Paracetamol and a combination hormone birth control medication.
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis bacterial
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 43 (2.33%)
         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
    		 AR101 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    130 / 132 (98.48%)
    42 / 43 (97.67%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    15 / 132 (11.36%)
    1 / 43 (2.33%)
         occurrences all number
    42
    3
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    29 / 132 (21.97%)
    14 / 43 (32.56%)
         occurrences all number
    41
    19
    Fatigue
         subjects affected / exposed
    13 / 132 (9.85%)
    5 / 43 (11.63%)
         occurrences all number
    36
    5
    Malaise
         subjects affected / exposed
    8 / 132 (6.06%)
    3 / 43 (6.98%)
         occurrences all number
    12
    3
    Chest discomfort
         subjects affected / exposed
    7 / 132 (5.30%)
    1 / 43 (2.33%)
         occurrences all number
    15
    1
    Immune system disorders
    Systemic allergic reaction
         subjects affected / exposed
    16 / 132 (12.12%)
    1 / 43 (2.33%)
         occurrences all number
    2
    22
    Seasonal allergy
         subjects affected / exposed
    10 / 132 (7.58%)
    2 / 43 (4.65%)
         occurrences all number
    20
    2
    Respiratory, thoracic and mediastinal disorders
    Throat irritation
         subjects affected / exposed
    57 / 132 (43.18%)
    8 / 43 (18.60%)
         occurrences all number
    659
    25
    Sneezing
         subjects affected / exposed
    43 / 132 (32.58%)
    7 / 43 (16.28%)
         occurrences all number
    157
    24
    Cough
         subjects affected / exposed
    66 / 132 (50.00%)
    24 / 43 (55.81%)
         occurrences all number
    166
    53
    Rhinorrhoea
         subjects affected / exposed
    34 / 132 (25.76%)
    10 / 43 (23.26%)
         occurrences all number
    89
    22
    Nasal congestion
         subjects affected / exposed
    23 / 132 (17.42%)
    8 / 43 (18.60%)
         occurrences all number
    63
    12
    Dyspnoea
         subjects affected / exposed
    15 / 132 (11.36%)
    3 / 43 (6.98%)
         occurrences all number
    40
    11
    Wheezing
         subjects affected / exposed
    22 / 132 (16.67%)
    3 / 43 (6.98%)
         occurrences all number
    45
    8
    Throat tightness
         subjects affected / exposed
    10 / 132 (7.58%)
    1 / 43 (2.33%)
         occurrences all number
    31
    8
    Nasal pruritus
         subjects affected / exposed
    11 / 132 (8.33%)
    3 / 43 (6.98%)
         occurrences all number
    19
    3
    Oropharyngeal pain
         subjects affected / exposed
    37 / 132 (28.03%)
    12 / 43 (27.91%)
         occurrences all number
    99
    18
    Pharyngeal paraesthesia
         subjects affected / exposed
    7 / 132 (5.30%)
    2 / 43 (4.65%)
         occurrences all number
    37
    3
    Asthma
         subjects affected / exposed
    7 / 132 (5.30%)
    3 / 43 (6.98%)
         occurrences all number
    12
    7
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    6 / 132 (4.55%)
    5 / 43 (11.63%)
         occurrences all number
    7
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    46 / 132 (34.85%)
    19 / 43 (44.19%)
         occurrences all number
    128
    65
    Dizziness
         subjects affected / exposed
    4 / 132 (3.03%)
    3 / 43 (6.98%)
         occurrences all number
    4
    3
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    8 / 132 (6.06%)
    1 / 43 (2.33%)
         occurrences all number
    10
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    14 / 132 (10.61%)
    0 / 43 (0.00%)
         occurrences all number
    21
    0
    Motion sickness
         subjects affected / exposed
    4 / 132 (3.03%)
    3 / 43 (6.98%)
         occurrences all number
    5
    4
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    24 / 132 (18.18%)
    8 / 43 (18.60%)
         occurrences all number
    37
    12
    Eye swelling
         subjects affected / exposed
    11 / 132 (8.33%)
    3 / 43 (6.98%)
         occurrences all number
    18
    7
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    88 / 132 (66.67%)
    19 / 43 (44.19%)
         occurrences all number
    835
    126
    Nausea
         subjects affected / exposed
    58 / 132 (43.94%)
    11 / 43 (25.58%)
         occurrences all number
    437
    31
    Paraesthesia oral
         subjects affected / exposed
    52 / 132 (39.39%)
    9 / 43 (20.93%)
         occurrences all number
    961
    49
    Vomiting
         subjects affected / exposed
    53 / 132 (40.15%)
    10 / 43 (23.26%)
         occurrences all number
    120
    17
    0ral pruritus
         subjects affected / exposed
    28 / 132 (21.21%)
    1 / 43 (2.33%)
         occurrences all number
    236
    1
    Lip swelling
         subjects affected / exposed
    20 / 132 (15.15%)
    4 / 43 (9.30%)
         occurrences all number
    112
    6
    Lip pruritus
         subjects affected / exposed
    16 / 132 (12.12%)
    2 / 43 (4.65%)
         occurrences all number
    97
    2
    Abdominal discomfort
         subjects affected / exposed
    17 / 132 (12.88%)
    2 / 43 (4.65%)
         occurrences all number
    120
    3
    Tongue pruritus
         subjects affected / exposed
    12 / 132 (9.09%)
    5 / 43 (11.63%)
         occurrences all number
    133
    11
    Lip oedema
         subjects affected / exposed
    7 / 132 (5.30%)
    1 / 43 (2.33%)
         occurrences all number
    20
    2
    Diarrhoea
         subjects affected / exposed
    16 / 132 (12.12%)
    8 / 43 (18.60%)
         occurrences all number
    26
    19
    Abdominal pain upper
         subjects affected / exposed
    14 / 132 (10.61%)
    5 / 43 (11.63%)
         occurrences all number
    44
    6
    Lip pain
         subjects affected / exposed
    7 / 132 (5.30%)
    0 / 43 (0.00%)
         occurrences all number
    21
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    67 / 132 (50.76%)
    14 / 43 (32.56%)
         occurrences all number
    300
    62
    Urticaria
         subjects affected / exposed
    48 / 132 (36.36%)
    9 / 43 (20.93%)
         occurrences all number
    156
    27
    Erythema
         subjects affected / exposed
    34 / 132 (25.76%)
    5 / 43 (11.63%)
         occurrences all number
    69
    5
    Rash
         subjects affected / exposed
    21 / 132 (15.91%)
    8 / 43 (18.60%)
         occurrences all number
    38
    18
    Angioedema
         subjects affected / exposed
    13 / 132 (9.85%)
    4 / 43 (9.30%)
         occurrences all number
    87
    7
    Eczema
         subjects affected / exposed
    12 / 132 (9.09%)
    11 / 43 (25.58%)
         occurrences all number
    25
    18
    Dry skin
         subjects affected / exposed
    6 / 132 (4.55%)
    4 / 43 (9.30%)
         occurrences all number
    8
    5
    Dermatitis atopic
         subjects affected / exposed
    3 / 132 (2.27%)
    4 / 43 (9.30%)
         occurrences all number
    3
    5
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    11 / 132 (8.33%)
    1 / 43 (2.33%)
         occurrences all number
    15
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    15 / 132 (11.36%)
    5 / 43 (11.63%)
         occurrences all number
    31
    25
    Nasopharyngitis
         subjects affected / exposed
    44 / 132 (33.33%)
    12 / 43 (27.91%)
         occurrences all number
    77
    21
    Rhinitis
         subjects affected / exposed
    20 / 132 (15.15%)
    7 / 43 (16.28%)
         occurrences all number
    51
    17
    Viral infection
         subjects affected / exposed
    18 / 132 (13.64%)
    7 / 43 (16.28%)
         occurrences all number
    24
    10
    Upper respiratory tract infection
         subjects affected / exposed
    17 / 132 (12.88%)
    11 / 43 (25.58%)
         occurrences all number
    21
    12
    Gastroenteritis
         subjects affected / exposed
    12 / 132 (9.09%)
    5 / 43 (11.63%)
         occurrences all number
    13
    6
    Gastroenteritis viral
         subjects affected / exposed
    7 / 132 (5.30%)
    0 / 43 (0.00%)
         occurrences all number
    8
    0
    Influenza
         subjects affected / exposed
    4 / 132 (3.03%)
    3 / 43 (6.98%)
         occurrences all number
    4
    3
    Respiratory tract infection
         subjects affected / exposed
    3 / 132 (2.27%)
    3 / 43 (6.98%)
         occurrences all number
    4
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jan 2017
    Amendment 1 Main Changes: • Revised inclusion criteria • Optional substudy added as exploratory endpoint
    26 Sep 2017
    Amendment 2 Main Changes: • Added end of study definition. • Modified exclusion criteria • Modified contraception procedures • Moved basophil activation test from optional substudy to main study • Added: Details on emergency unblinding procedure, protocol deviations and adverse event reporting.
    28 Aug 2018
    Amendment 3 Main Changes: • Removed basophil activation test as a study objective and endpoint. • Clarified subject eligibility for enrollment in ARC008 • Modified dose adjustment guidelines • Removed requirement for a daily diary during 6-month GI AE safety follow-up • Provided instructions in the event of early study closure.

    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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