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    Clinical Trial Results:
    Study to evaluate the effect of different pre-seasonal BM32 dosing schedules on the induction of a protective allergen-specific IgG Immune response

    Summary
    EudraCT number
    		 2015-004551-43
    Trial protocol
    		 AT  
    Global end of trial date
    04 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2018
    First version publication date
    31 Oct 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CS-BM32-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02643641
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biomay AG
    Sponsor organisation address
    Lazarettgasse 19, Vienna, Austria, 1090
    Public contact
    Product Development Department, Biomay AG, 0043 17966296101, a.neubauer@biomay.com
    Scientific contact
    Product Development Department, Biomay AG, 0043 17966296101, a.neubauer@biomay.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
    13 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the level of allergen-specific IgG4 and IgG1 antibodies at the peak of the grass pollen season comparing the different dosing schedules of BM32 at the dose of 20µg per API with placebo.
    Protection of trial subjects
    This trial was conducted in accordance to the principles of GCP, ensuring that the rights, safety and well-being of patients are protected and in consistency with the the Declaration of Helsinki. Inclusion and exclusion criteria were carefully defined in order to protect subjects from contraindications, interactions with other medication and risk factors associated with the investigational medicinal product. Throughout the study safety was assessed, such as occurrence of AEs, vital signs, lung function, concomitant medication and physical examinations. A pregnancy test was performed at screening,before each administration of IMP and 3-5 weeks after the last IMP administration.
    Background therapy
    		 Subjects were instructed to use their normally prescribed allergy medication if needed during the grass pollen season.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Dec 2015
    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
    Austria: 130
    Worldwide total number of subjects
    130
    EEA total number of subjects
    130
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    130
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects with grass pollen allergy but otherwise healthy have been screened. Based on results of Safety Lab, SPT or ImmunoCAP tests performed at visit 1 non- eligible subjects were identified and excluded as screening failures

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BM32 3x
    Arm description
    		 5 subcutaneous injections with sequence: Placebo, Placebo, BM32, BM32,BM32
    Arm type
    		 Experimental

    Investigational medicinal product name
    BM32
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BM32 is an equimolar combination of four active ingredients (APIs) BM321, BM322, BM325, and BM326 and was administered at a dose containing of 20µg of each of the four APIs.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3 mg/ml aluminum hydroxide.

    Arm title
    		 BM32 4x
    Arm description
    		 5 subcutaneous injections with sequence: Placebo, BM32, BM32, BM32,BM32
    Arm type
    		 Experimental

    Investigational medicinal product name
    BM32
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BM32 is an equimolar combination of four active ingredients (APIs) BM321, BM322, BM325, and BM326 and was administered at a dose containing of 20µg of each of the four APIs.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3 mg/ml aluminum hydroxide.

    Arm title
    		 BM32 5x
    Arm description
    		 5 subcutaneous injections with sequence: BM32, BM32, BM32, BM32,BM32
    Arm type
    		 Experimental

    Investigational medicinal product name
    BM32
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BM32 is an equimolar combination of four active ingredients (APIs) BM321, BM322, BM325, and BM326 and was administered at a dose containing of 20µg of each of the four APIs.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3 mg/ml aluminum hydroxide.

    Arm title
    		 Placebo
    Arm description
    		 5 subcutaneous injections with sequence: Placebo, Placebo, Placebo, Placebo,Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3 mg/ml aluminum hydroxide.

    Number of subjects in period 1
    		BM32 3x BM32 4x BM32 5x Placebo
    Started
    33
    32
    31
    34
    Completed
    33
    32
    31
    34

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    BM32 3x
    Reporting group description
    		 5 subcutaneous injections with sequence: Placebo, Placebo, BM32, BM32,BM32

    Reporting group title
    BM32 4x
    Reporting group description
    		 5 subcutaneous injections with sequence: Placebo, BM32, BM32, BM32,BM32

    Reporting group title
    BM32 5x
    Reporting group description
    		 5 subcutaneous injections with sequence: BM32, BM32, BM32, BM32,BM32

    Reporting group title
    Placebo
    Reporting group description
    		 5 subcutaneous injections with sequence: Placebo, Placebo, Placebo, Placebo,Placebo

    Reporting group values
    		 BM32 3x BM32 4x BM32 5x Placebo Total
    Number of subjects
    		 33 32 31 34 130
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 33 32 31 34 130
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 28 (18 to 56) 33 (18 to 58) 28 (19 to 57) 33 (18 to 56) -
    Gender categorical
    Units: Subjects
        Female
    		 17 20 22 17 76
        Male
    		 16 12 9 17 54
    Subject analysis sets

    Subject analysis set title
    SA
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who were randomized and received at least one dose of the trial medication (verum or placebo).

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects of the SA set with measurement of the primary efficacy variable at Visit 3 and Visit 8.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects of the FA set for whom no relevant protocol deviations were documented

    Subject analysis sets values
    		 SA FAS PP
    Number of subjects
    130
    124
    115
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    130
    124
    115
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    30 (18 to 58)
    31 (18 to 58)
    31 (18 to 58)
    Gender categorical
    Units: Subjects
        Female
    76
    73
    67
        Male
    54
    51
    48

    End points

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    End points reporting groups
    Reporting group title
    BM32 3x
    Reporting group description
    		 5 subcutaneous injections with sequence: Placebo, Placebo, BM32, BM32,BM32

    Reporting group title
    BM32 4x
    Reporting group description
    		 5 subcutaneous injections with sequence: Placebo, BM32, BM32, BM32,BM32

    Reporting group title
    BM32 5x
    Reporting group description
    		 5 subcutaneous injections with sequence: BM32, BM32, BM32, BM32,BM32

    Reporting group title
    Placebo
    Reporting group description
    		 5 subcutaneous injections with sequence: Placebo, Placebo, Placebo, Placebo,Placebo

    Subject analysis set title
    SA
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who were randomized and received at least one dose of the trial medication (verum or placebo).

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects of the SA set with measurement of the primary efficacy variable at Visit 3 and Visit 8.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects of the FA set for whom no relevant protocol deviations were documented

    Primary: EP1 (FAS) : Median change in IgG1 levels against allergens Phl p 1 and Phl p 5

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    End point title
    		 EP1 (FAS) : Median change in IgG1 levels against allergens Phl p 1 and Phl p 5
    End point description
    Median change in IgG1 levels (sum of Phl p 1- and Phl p 5-specific IgG1) between Visit 3 (V3; before treatment) and Visit 8 (V8; after treatment)
    End point type
    Primary
    End point timeframe
    Change in IgG1 levels between Visit 3 (before 1st treatment) and Visit 8 (after last treatment)
    End point values
    		 BM32 3x BM32 4x BM32 5x Placebo
    Number of subjects analysed
    32
    30
    30
    32
    Units: µg/mL
        median (confidence interval 95%)
    40.15 (19.23 to 59.79)
    29.9 (19.6 to 45.66)
    46.61 (21.76 to 86.72)
    0.00 (0.00 to 1.70)
    Statistical analysis title
    		 EP1 (FAS) Median Test BM32 3x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    BM32 3x v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    40.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.23
         upper limit
    		 59.79
    Variability estimate
    Standard deviation
    Dispersion value
    89.38
    Notes
    [1] - comparison to placebo
    Statistical analysis title
    		 EP1 (FAS) Median Test BM32 4x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    Placebo v BM32 4x
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    29.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.6
         upper limit
    		 45.66
    Variability estimate
    Standard deviation
    Dispersion value
    38.49
    Notes
    [2] - comparison to placebo
    Statistical analysis title
    		 EP1 (FAS) Median Test BM32 5x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    Placebo v BM32 5x
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    46.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.76
         upper limit
    		 86.72
    Variability estimate
    Standard deviation
    Dispersion value
    143.89
    Notes
    [3] - comparison to placebo

    Primary: EP1 (PP) : Median change in IgG1 levels against allergens Phl p 1 and Phl p 5

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    End point title
    		 EP1 (PP) : Median change in IgG1 levels against allergens Phl p 1 and Phl p 5
    End point description
    Change in IgG1 levels (sum of Phl p 1- and Phl p 5-specific IgG1) between Visit 3 (V3; before treatment) and Visit 8 (V8; after treatment)
    End point type
    Primary
    End point timeframe
    Change in IgG1 levels between Visit 3 (before 1st treatment) and Visit 8 (after last treatment)
    End point values
    		 BM32 3x BM32 4x BM32 5x Placebo
    Number of subjects analysed
    29
    29
    25
    32
    Units: µg/mL
        median (confidence interval 95%)
    36.30 (18.64 to 61.00)
    28.79 (19.60 to 53.41)
    46.71 (22.97 to 87.32)
    0.00 (0.00 to 1.70)
    Statistical analysis title
    		 EP1 (PP) Median Test BM32 3x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    BM32 3x v Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    36.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.64
         upper limit
    		 61
    Variability estimate
    Standard deviation
    Dispersion value
    85.48
    Notes
    [4] - comparison to placebo
    Statistical analysis title
    		 EP1 (PP) Median Test BM32 4x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    Placebo v BM32 4x
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    28.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.6
         upper limit
    		 53.41
    Variability estimate
    Standard deviation
    Dispersion value
    39.16
    Notes
    [5] - comparison to placebo
    Statistical analysis title
    		 EP1 (PP) Median Test BM32 5x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    Placebo v BM32 5x
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    46.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.97
         upper limit
    		 87.32
    Variability estimate
    Standard deviation
    Dispersion value
    83.41
    Notes
    [6] - comparison to placebo

    Primary: EP2 (FAS) : Median change in IgG4 levels against allergens Phl p 1 and Phl p 5

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    End point title
    		 EP2 (FAS) : Median change in IgG4 levels against allergens Phl p 1 and Phl p 5
    End point description
    Change in IgG4 levels (sum of Phl p 1- and Phl p 5-specific IgG1) between Visit 3 (V3; before treatment) and Visit 8 (V8; after treatment)
    End point type
    Primary
    End point timeframe
    Change in IgG4 levels between Visit 3 (before 1st treatment) and Visit 8 (after last treatment)
    End point values
    		 BM32 3x BM32 4x BM32 5x Placebo
    Number of subjects analysed
    32
    30
    30
    32
    Units: µg/mL
        median (confidence interval 95%)
    7.92 (5.36 to 29.74)
    11.54 (6.07 to 16.71)
    71.23 (20.71 to 193.10)
    0.00 (0.00 to 2.50)
    Statistical analysis title
    		 EP2 (FAS) Median Test BM32 3x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    BM32 3x v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    7.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.36
         upper limit
    		 29.74
    Variability estimate
    Standard deviation
    Dispersion value
    240.75
    Notes
    [7] - comparison to placebo
    Statistical analysis title
    		 EP2 (FAS) Median Test BM32 4x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    Placebo v BM32 4x
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    11.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.07
         upper limit
    		 16.71
    Variability estimate
    Standard deviation
    Dispersion value
    96.79
    Notes
    [8] - comparison to placebo
    Statistical analysis title
    		 EP2 (FAS) Median Test BM32 5x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    Placebo v BM32 5x
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    71.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.71
         upper limit
    		 193.1
    Variability estimate
    Standard deviation
    Dispersion value
    438.29
    Notes
    [9] - comparison to placebo

    Primary: EP2 (PP) : Median change in IgG4 levels against allergens Phl p 1 and Phl p 5

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    End point title
    		 EP2 (PP) : Median change in IgG4 levels against allergens Phl p 1 and Phl p 5
    End point description
    Change in IgG4 levels (sum of Phl p 1- and Phl p 5-specific IgG1) between Visit 3 (V3; before treatment) and Visit 8 (V8; after treatment)
    End point type
    Primary
    End point timeframe
    Change in IgG4 levels between Visit 3 (before 1st treatment) and Visit 8 (after last treatment)
    End point values
    		 BM32 3x BM32 4x BM32 5x Placebo
    Number of subjects analysed
    29
    29
    25
    32
    Units: µg/mL
        median (confidence interval 95%)
    7.61 (3.86 to 29.74)
    11.06 (6.07 to 16.71)
    48.27 (21.16 to 193.10)
    0.00 (0.00 to 2.50)
    Statistical analysis title
    		 EP2 (PP) Median Test BM32 3x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    BM32 3x v Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    7.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.86
         upper limit
    		 29.74
    Variability estimate
    Standard deviation
    Dispersion value
    233.37
    Notes
    [10] - comparison to placebo
    Statistical analysis title
    		 EP2 (PP) Median Test BM32 4x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    Placebo v BM32 4x
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    11.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.07
         upper limit
    		 16.71
    Variability estimate
    Standard deviation
    Dispersion value
    97.16
    Notes
    [11] - comparison to placebo
    Statistical analysis title
    		 EP2 (PP) Median Test BM32 5x
    Statistical analysis description
    Based on the observed variance heterogeneity between the placebo and verum groups the non-parametric median test was used to compare the medians of placebo against any of the three verum groups for the analysis of the primary endpoint.
    Comparison groups
    Placebo v BM32 5x
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    P-value
    		 < 0.0001
    Method
    		 Median Test
    Parameter type
    		 Median difference (final values)
    Point estimate
    48.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.16
         upper limit
    		 193.1
    Variability estimate
    Standard deviation
    Dispersion value
    409.26
    Notes
    [12] - comparison to placebo

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the whole study from V1 (screeening) up to V12 (safety follow up visit)
    Adverse event reporting additional description
    Safety and tolerability of the different BM32 dosing regimen and schedules of the different study arms were assessed. Separately, the occurrence of immunotherapy-specific adverse events (local and systemic) were evaluated.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    BM32 3x
    Reporting group description
    		 -

    Reporting group title
    BM32 4x
    Reporting group description
    		 -

    Reporting group title
    BM32 5x
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 BM32 3x BM32 4x BM32 5x Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 34 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rectal cancer
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BM32 3x BM32 4x BM32 5x Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 33 (75.76%)
    29 / 32 (90.63%)
    24 / 31 (77.42%)
    32 / 34 (94.12%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 33 (6.06%)
    3 / 32 (9.38%)
    0 / 31 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    3
    4
    0
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 32 (6.25%)
    0 / 31 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Injection site erythema
         subjects affected / exposed
    13 / 33 (39.39%)
    12 / 32 (37.50%)
    12 / 31 (38.71%)
    6 / 34 (17.65%)
         occurrences all number
    29
    25
    27
    15
    Injection site pain
         subjects affected / exposed
    6 / 33 (18.18%)
    2 / 32 (6.25%)
    3 / 31 (9.68%)
    6 / 34 (17.65%)
         occurrences all number
    11
    4
    4
    16
    Injection site pruritus
         subjects affected / exposed
    12 / 33 (36.36%)
    18 / 32 (56.25%)
    11 / 31 (35.48%)
    1 / 34 (2.94%)
         occurrences all number
    23
    36
    33
    1
    Injection site swelling
         subjects affected / exposed
    17 / 33 (51.52%)
    20 / 32 (62.50%)
    14 / 31 (45.16%)
    6 / 34 (17.65%)
         occurrences all number
    37
    49
    44
    11
    Injection site warmth
         subjects affected / exposed
    2 / 33 (6.06%)
    2 / 32 (6.25%)
    3 / 31 (9.68%)
    0 / 34 (0.00%)
         occurrences all number
    3
    2
    5
    0
    Pyrexia
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    2 / 34 (5.88%)
         occurrences all number
    2
    0
    1
    2
    Injection site induration
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 32 (9.38%)
    2 / 31 (6.45%)
    2 / 34 (5.88%)
         occurrences all number
    4
    8
    3
    4
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    17 / 33 (51.52%)
    23 / 32 (71.88%)
    14 / 31 (45.16%)
    20 / 34 (58.82%)
         occurrences all number
    19
    29
    18
    25
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 32 (9.38%)
    0 / 31 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    3
    0
    2
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 32 (6.25%)
    1 / 31 (3.23%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    3 / 33 (9.09%)
    2 / 32 (6.25%)
    3 / 31 (9.68%)
    1 / 34 (2.94%)
         occurrences all number
    3
    2
    3
    1
    Nasopharyngitis
         subjects affected / exposed
    5 / 33 (15.15%)
    6 / 32 (18.75%)
    5 / 31 (16.13%)
    5 / 34 (14.71%)
         occurrences all number
    5
    8
    6
    5
    Sinusitis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    2 / 31 (6.45%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    2
    1
    Tonsillitis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    2 / 31 (6.45%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    2
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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