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    Clinical Trial Results:
    A phase 2b randomized, double-blind, placebo controlled, multi-center 12-week study with an additional 40-week follow-up assessment of efficacy, safety and tolerability of M1095 in subjects with moderate to severe chronic plaque-type psoriasis

    Summary
    EudraCT number
    		 2017-004611-38
    Trial protocol
    		 CZ   BG   HU  
    Global end of trial date
    26 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Apr 2021
    First version publication date
    12 Apr 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AV002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03384745
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bond Avillion 2 Development LP
    Sponsor organisation address
    Sarnia House, Le Truchot, St Peter Port, Guernsey, GY1 1GR
    Public contact
    Alun Morris, Avillion LLP , +44 (0)203 764 9530, avillion@avillionllp.com
    Scientific contact
    Alun Morris, Avillion LLP, +44 (0)203 764 9530, avillion@avillionllp.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
    25 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of four dose regimens of M1095 (Solenokimab) compared to placebo on achievement of an Investigator’s Global Assessment (IGA) score of 0 or 1 after 12 weeks of treatment in subjects with moderate to severe chronic plaque-type psoriasis.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles of the International Council for Harmonization (ICH) guideline for Good Clinical Practice (GCP) and the World Medical Association Declaration of Helsinki, 2013, as well as with applicable local regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jul 2018
    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
    Poland: 58
    Country: Number of subjects enrolled
    Bulgaria: 56
    Country: Number of subjects enrolled
    Czechia: 85
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Hungary: 39
    Country: Number of subjects enrolled
    Canada: 74
    Country: Number of subjects enrolled
    United States: 57
    Worldwide total number of subjects
    383
    EEA total number of subjects
    252
    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)
    347
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 47 sites were initiated in Europe (Bulgaria, Czech Republic, Germany, Hungary and Poland) and North America (USA and Canada). Subjects were screened at 42 sites and randomized at 41 sites.

    Pre-assignment
    Screening details
    		 The study consisted of a 4-week screening period (Week -4 to Week 0).

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The study was double-blind, with the subject, investigator and project team staff at the Contract Research Organization remaining blinded throughout.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo / M1095 120 mg
    Arm description
    		 Placebo was given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120 mg was given at Week 12, 14, 16, and every four weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo will be given at Week 0, 1, 2, 3, 4, 6, 8 and 10

    Arm title
    		 Secukinumab
    Arm description
    		 Secukinumab 300 mg was given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    SECUKINUMAB
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

    Arm title
    		 M1095 30 mg
    Arm description
    		 M1095 30 mg was given at Week 0, 2, 4, 8, 12 and every four weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M1095
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

    Arm title
    		 M1095 60 mg
    Arm description
    		 M1095 60 mg was given at Week 0, 2, 4, 8, 12 and every four weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M1095
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

    Arm title
    		 M1095 120 mg - regimen 1
    Arm description
    		 M1095 120 mg was given at Week 0, 2, 4, 8, 12 and every eight weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M1095
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.

    Arm title
    		 M1095 120 mg - regimen 2
    Arm description
    		 M1095 120 mg was given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M1095
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.

    Number of subjects in period 1 [1]
    		Placebo / M1095 120 mg Secukinumab M1095 30 mg M1095 60 mg M1095 120 mg - regimen 1 M1095 120 mg - regimen 2
    Started
    52
    53
    52
    52
    53
    51
    Completed
    45
    49
    51
    48
    45
    43
    Not completed
    7
    4
    1
    4
    8
    8
         Consent withdrawn by subject
    5
    3
    -
    1
    2
    2
         Worsening disease
    -
    -
    -
    -
    -
    1
         Death
    -
    -
    -
    1
    -
    -
         Adverse event
    2
    -
    1
    1
    4
    3
         Lost to follow-up
    -
    1
    -
    1
    1
    2
         Protocol deviation
    -
    -
    -
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 383 subjects were screened resulting in 313 randomized subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo / M1095 120 mg
    Reporting group description
    		 Placebo was given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120 mg was given at Week 12, 14, 16, and every four weeks.

    Reporting group title
    Secukinumab
    Reporting group description
    		 Secukinumab 300 mg was given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

    Reporting group title
    M1095 30 mg
    Reporting group description
    		 M1095 30 mg was given at Week 0, 2, 4, 8, 12 and every four weeks.

    Reporting group title
    M1095 60 mg
    Reporting group description
    		 M1095 60 mg was given at Week 0, 2, 4, 8, 12 and every four weeks.

    Reporting group title
    M1095 120 mg - regimen 1
    Reporting group description
    		 M1095 120 mg was given at Week 0, 2, 4, 8, 12 and every eight weeks.

    Reporting group title
    M1095 120 mg - regimen 2
    Reporting group description
    		 M1095 120 mg was given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.

    Reporting group values
    		 Placebo / M1095 120 mg Secukinumab M1095 30 mg M1095 60 mg M1095 120 mg - regimen 1 M1095 120 mg - regimen 2 Total
    Number of subjects
    		 52 53 52 52 53 51 313
    Age categorical
    Units: Subjects
        <45 Years
    		 20 24 20 24 27 28 143
        ≥45 -<65 Years
    		 29 24 29 23 23 20 148
        ≥65 Years
    		 3 5 3 5 3 3 22
    Gender categorical
    Units: Subjects
        Female
    		 13 15 16 14 10 17 85
        Male
    		 39 38 36 38 43 34 228

    End points

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    End points reporting groups
    Reporting group title
    Placebo / M1095 120 mg
    Reporting group description
    		 Placebo was given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120 mg was given at Week 12, 14, 16, and every four weeks.

    Reporting group title
    Secukinumab
    Reporting group description
    		 Secukinumab 300 mg was given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

    Reporting group title
    M1095 30 mg
    Reporting group description
    		 M1095 30 mg was given at Week 0, 2, 4, 8, 12 and every four weeks.

    Reporting group title
    M1095 60 mg
    Reporting group description
    		 M1095 60 mg was given at Week 0, 2, 4, 8, 12 and every four weeks.

    Reporting group title
    M1095 120 mg - regimen 1
    Reporting group description
    		 M1095 120 mg was given at Week 0, 2, 4, 8, 12 and every eight weeks.

    Reporting group title
    M1095 120 mg - regimen 2
    Reporting group description
    		 M1095 120 mg was given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.

    Primary: IGA Response Rates (NRI) at Week 12

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    End point title
    		 IGA Response Rates (NRI) at Week 12
    End point description
    End point type
    Primary
    End point timeframe
    At Week 12
    End point values
    		 Placebo / M1095 120 mg Secukinumab M1095 30 mg M1095 60 mg M1095 120 mg - regimen 1 M1095 120 mg - regimen 2
    Number of subjects analysed
    52
    53
    52
    52
    53
    51
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 6.8)
    77.4 (63.8 to 87.7)
    48.1 (34.0 to 62.4)
    84.6 (71.9 to 93.1)
    77.4 (63.8 to 87.7)
    88.2 (76.1 to 95.6)
    Statistical analysis title
    		 Secukinumab vs placebo
    Comparison groups
    Placebo / M1095 120 mg v Secukinumab
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - Confidence interval and P-value are derived from two-sided Cochran-Mantel-Haenszel test stratified by actual weight category and prior biologic use stratum. Confidence interval is not presented as it was not evaluable.
    Statistical analysis title
    		 M1095 30 mg vs placebo
    Comparison groups
    Placebo / M1095 120 mg v M1095 30 mg
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - Confidence interval and P-value are derived from two-sided Cochran-Mantel-Haenszel test stratified by actual weight category and prior biologic use stratum. Confidence interval is not presented as it was not evaluable.
    Statistical analysis title
    		 M1095 60 mg vs placebo
    Comparison groups
    M1095 60 mg v Placebo / M1095 120 mg
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - Confidence interval and P-value are derived from two-sided Cochran-Mantel-Haenszel test stratified by actual weight category and prior biologic use stratum. Confidence interval is not presented as it was not evaluable.
    Statistical analysis title
    		 M1095 120 mg - regimen 1 vs placebo
    Comparison groups
    Placebo / M1095 120 mg v M1095 120 mg - regimen 1
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [4] - Confidence interval and P-value are derived from two-sided Cochran-Mantel-Haenszel test stratified by actual weight category and prior biologic use stratum. Confidence interval is not presented as it was not evaluable.
    Statistical analysis title
    		 M1095 120 mg - regimen 2 vs placebo
    Comparison groups
    Placebo / M1095 120 mg v M1095 120 mg - regimen 2
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [5] - Confidence interval and P-value are derived from two-sided Cochran-Mantel-Haenszel test stratified by actual weight category and prior biologic use stratum. Confidence interval is not presented as it was not evaluable.

    Secondary: Number of subjects with treatment emergent adverse events

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    End point title
    		 Number of subjects with treatment emergent adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    Screening until early discontinuation
    End point values
    		 Placebo / M1095 120 mg Secukinumab M1095 30 mg M1095 60 mg M1095 120 mg - regimen 1 M1095 120 mg - regimen 2
    Number of subjects analysed
    49
    53
    52
    52
    53
    51
    Units: Number of subjects
        Any TEAE
    27
    41
    40
    36
    34
    38
        Any trial drug related TEAE
    10
    17
    15
    10
    13
    16
        Any serious TEAE
    1
    2
    4
    5
    3
    3
        Any trial drug related serious TEAE
    1
    1
    0
    0
    0
    0
        Any TEAE leading to treatment interruption
    0
    2
    5
    1
    3
    1
        Any drug related TEAE-treatment interruptions
    0
    1
    1
    0
    0
    0
        Any TEAE leading to treatment discontinuation
    2
    0
    1
    2
    4
    3
        Any TEAE leading to death
    0
    0
    0
    1
    0
    0
        Any trial drug related TEAE leading to death
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Psoriasis Area Severity Index 100 Responses

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    End point title
    		 Percentage of Participants with Psoriasis Area Severity Index 100 Responses
    End point description
    End point type
    Secondary
    End point timeframe
    At Weeks 12, 24, 36, and 48
    End point values
    		 Placebo / M1095 120 mg Secukinumab M1095 30 mg M1095 60 mg M1095 120 mg - regimen 1 M1095 120 mg - regimen 2
    Number of subjects analysed
    52
    53
    52
    52
    53
    51
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 12
    0.0 (0.0 to 6.8)
    28.3 (16.8 to 42.3)
    17.3 (8.2 to 30.3)
    23.1 (12.5 to 36.8)
    37.7 (24.8 to 52.1)
    33.3 (20.8 to 47.9)
        Week 24
    34.6 (22.0 to 49.1)
    34.0 (21.5 to 48.3)
    42.3 (28.7 to 56.8)
    40.4 (27.0 to 54.9)
    43.4 (29.8 to 57.7)
    56.9 (42.2 to 70.7)
        Week 36
    30.8 (18.7 to 45.1)
    39.6 (26.5 to 54.0)
    30.8 (18.7 to 45.1)
    34.6 (22.0 to 49.1)
    35.8 (23.1 to 50.2)
    45.1 (31.1 to 59.7)
        Week 48
    44.2 (30.5 to 58.7)
    43.4 (29.8 to 57.7)
    32.7 (20.3 to 47.1)
    44.2 (30.5 to 58.7)
    49.1 (35.1 to 63.2)
    52.9 (38.5 to 67.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Psoriasis Area Severity Index 90 Responses

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    End point title
    		 Percentage of Participants with Psoriasis Area Severity Index 90 Responses
    End point description
    End point type
    Secondary
    End point timeframe
    Art Week 12, 24, 36, 48
    End point values
    		 Placebo / M1095 120 mg Secukinumab M1095 30 mg M1095 60 mg M1095 120 mg - regimen 1 M1095 120 mg - regimen 2
    Number of subjects analysed
    52
    53
    52
    52
    53
    51
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 12
    0.0 (0.0 to 6.8)
    64.2 (49.8 to 76.9)
    36.5 (23.6 to 51.0)
    65.4 (50.9 to 78.0)
    69.8 (55.7 to 81.7)
    76.5 (62.5 to 87.2)
        Week 24
    69.2 (54.9 to 81.3)
    79.2 (65.9 to 89.2)
    67.3 (52.9 to 79.7)
    90.4 (79.0 to 96.8)
    79.2 (65.9 to 89.2)
    84.3 (71.4 to 93.0)
        Week 36
    71.2 (56.9 to 82.9)
    69.8 (55.7 to 81.7)
    69.2 (54.9 to 81.3)
    73.1 (59.0 to 84.4)
    73.6 (59.7 to 84.7)
    80.4 (66.9 to 90.2)
        Week 48
    76.9 (63.2 to 87.5)
    69.8 (55.7 to 81.7)
    69.2 (54.9 to 81.3)
    80.8 (67.5 to 90.4)
    75.5 (61.7 to 86.2)
    72.5 (58.3 to 84.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Psoriasis Area Severity Index 75 Responses

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    End point title
    		 Percentage of Participants with Psoriasis Area Severity Index 75 Responses
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 12, 24, 36, and 48
    End point values
    		 Placebo / M1095 120 mg Secukinumab M1095 30 mg M1095 60 mg M1095 120 mg - regimen 1 M1095 120 mg - regimen 2
    Number of subjects analysed
    52
    53
    52
    52
    53
    51
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 12
    0.0 (0.0 to 6.8)
    90.6 (79.3 to 96.9)
    65.4 (50.9 to 78.0)
    88.5 (76.6 to 95.6)
    84.9 (72.4 to 93.3)
    90.2 (78.6 to 96.7)
        Week 24
    84.6 (71.9 to 93.1)
    88.7 (77.0 to 95.7)
    94.2 (84.1 to 98.8)
    98.1 (89.7 to 100.0)
    90.6 (79.3 to 96.9)
    92.2 (81.1 to 97.8)
        Week 36
    84.6 (71.9 to 93.1)
    86.8 (74.7 to 94.5)
    94.2 (84.1 to 98.8)
    86.5 (74.2 to 94.4)
    83.0 (70.2 to 91.9)
    88.2 (76.1 to 95.6)
        Week 48
    84.6 (71.9 to 93.1)
    84.9 (72.4 to 93.3)
    84.6 (71.9 to 93.1)
    90.4 (79.0 to 96.8)
    81.1 (68.0 to 90.6)
    80.4 (66.9 to 90.2)
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline in Body Surface Area

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    End point title
    		 Percentage Change from Baseline in Body Surface Area
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 12, 24, 36 and 48
    End point values
    		 Placebo / M1095 120 mg Secukinumab M1095 30 mg M1095 60 mg M1095 120 mg - regimen 1 M1095 120 mg - regimen 2
    Number of subjects analysed
    52
    53
    52
    52
    53
    51
    Units: Change
    least squares mean (standard error)
        Week 12
    2.0 ( 1.20 )
    -19.8 ( 1.21 )
    -18.6 ( 1.20 )
    -21.2 ( 1.21 )
    -20.6 ( 1.19 )
    -21.0 ( 1.22 )
        Week 24
    -20.6 ( 0.85 )
    -22.2 ( 0.85 )
    -24.0 ( 0.85 )
    -24.3 ( 0.85 )
    -23.3 ( 0.84 )
    -23.2 ( 0.86 )
        Week 36
    -22.7 ( 0.77 )
    -22.8 ( 0.77 )
    -23.7 ( 0.77 )
    -24.7 ( 0.77 )
    -23.3 ( 0.76 )
    -23.3 ( 0.78 )
        Week 48
    -23.3 ( 0.77 )
    -23.0 ( 0.78 )
    -24.0 ( 0.77 )
    -24.7 ( 0.78 )
    -23.5 ( 0.77 )
    -23.5 ( 0.78 )
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline in Psoriasis Area Severity Index

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    End point title
    		 Percentage Change from Baseline in Psoriasis Area Severity Index
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 12, 24, 36 and 48
    End point values
    		 Placebo / M1095 120 mg Secukinumab M1095 30 mg M1095 60 mg M1095 120 mg - regimen 1 M1095 120 mg - regimen 2
    Number of subjects analysed
    52
    53
    52
    52
    53
    51
    Units: Percentage change
    least squares mean (standard error)
        Week 12
    1.92 ( 2.725 )
    -89.72 ( 2.730 )
    -78.99 ( 2.724 )
    -91.50 ( 2.729 )
    -88.80 ( 2.698 )
    -91.04 ( 2.755 )
        Week 24
    -86.78 ( 2.315 )
    -90.97 ( 2.320 )
    -92.48 ( 2.314 )
    -96.42 ( 2.319 )
    -91.80 ( 2.292 )
    -94.36 ( 2.340 )
        Week 36
    -88.22 ( 2.503 )
    -90.01 ( 2.507 )
    -90.55 ( 2.502 )
    -95.05 ( 2.506 )
    -90.32 ( 2.477 )
    -93.93 ( 2.530 )
        Week 48
    -89.92 ( 2.306 )
    -90.58 ( 2.310 )
    -92.13 ( 2.305 )
    -95.77 ( 2.309 )
    -91.95 ( 2.282 )
    -93.78 ( 2.330 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening until early discontinuation
    Adverse event reporting additional description
    "Placebo/120mg” group includes data from active treatment only i.e., after Week 12.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo / M1095 120 mg
    Reporting group description
    		 Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120 mg, given at Week 12, 14, 16, and every four weeks.

    Reporting group title
    Secukinumab
    Reporting group description
    		 Secukinumab, 300 mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

    Reporting group title
    M1095 30 mg
    Reporting group description
    		 M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

    Reporting group title
    M1095 60 mg
    Reporting group description
    		 M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

    Reporting group title
    M1095 120 mg - regimen 1
    Reporting group description
    		 M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.

    Reporting group title
    M1095 120 mg - regimen 2
    Reporting group description
    		 M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.

    Serious adverse events
    		 Placebo / M1095 120 mg Secukinumab M1095 30 mg M1095 60 mg M1095 120 mg - regimen 1 M1095 120 mg - regimen 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 53 (3.77%)
    4 / 52 (7.69%)
    5 / 52 (9.62%)
    3 / 53 (5.66%)
    3 / 51 (5.88%)
         number of deaths (all causes)
    0
    0
    0
    1
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Forearm Fracture
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    2 / 52 (3.85%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary Failure
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Neuroglycopenia
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Optic Ischaemic Neuropathy
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Salivary Gland Calculus
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious Pleural Effusion
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal Candidiasis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal Candidiasis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo / M1095 120 mg Secukinumab M1095 30 mg M1095 60 mg M1095 120 mg - regimen 1 M1095 120 mg - regimen 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 49 (32.65%)
    31 / 53 (58.49%)
    25 / 52 (48.08%)
    28 / 52 (53.85%)
    24 / 53 (45.28%)
    25 / 51 (49.02%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 49 (2.04%)
    3 / 53 (5.66%)
    3 / 52 (5.77%)
    3 / 52 (5.77%)
    0 / 53 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    1
    3
    3
    3
    0
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 53 (5.66%)
    0 / 52 (0.00%)
    4 / 52 (7.69%)
    4 / 53 (7.55%)
    1 / 51 (1.96%)
         occurrences all number
    2
    6
    0
    5
    6
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 49 (2.04%)
    3 / 53 (5.66%)
    4 / 52 (7.69%)
    3 / 52 (5.77%)
    4 / 53 (7.55%)
    2 / 51 (3.92%)
         occurrences all number
    1
    5
    8
    6
    5
    2
    Vomiting
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    3 / 52 (5.77%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    2 / 51 (3.92%)
         occurrences all number
    0
    1
    6
    0
    1
    2
    Angular Cheilitis
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    3 / 53 (5.66%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    0
    0
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    5 / 52 (9.62%)
    3 / 52 (5.77%)
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    5
    4
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 53 (3.77%)
    4 / 52 (7.69%)
    6 / 52 (11.54%)
    3 / 53 (5.66%)
    5 / 51 (9.80%)
         occurrences all number
    1
    2
    5
    6
    4
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 53 (3.77%)
    5 / 52 (9.62%)
    0 / 52 (0.00%)
    2 / 53 (3.77%)
    3 / 51 (5.88%)
         occurrences all number
    0
    2
    7
    0
    2
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 49 (14.29%)
    12 / 53 (22.64%)
    7 / 52 (13.46%)
    14 / 52 (26.92%)
    12 / 53 (22.64%)
    6 / 51 (11.76%)
         occurrences all number
    7
    15
    12
    15
    16
    6
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 49 (0.00%)
    5 / 53 (9.43%)
    5 / 52 (9.62%)
    6 / 52 (11.54%)
    6 / 53 (11.32%)
    3 / 51 (5.88%)
         occurrences all number
    0
    6
    5
    8
    7
    3
    Oral Candidiasis
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 53 (0.00%)
    3 / 52 (5.77%)
    3 / 52 (5.77%)
    3 / 53 (5.66%)
    4 / 51 (7.84%)
         occurrences all number
    5
    0
    4
    3
    11
    5
    Tonsillitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    3 / 52 (5.77%)
    2 / 52 (3.85%)
    4 / 53 (7.55%)
    1 / 51 (1.96%)
         occurrences all number
    0
    2
    3
    3
    5
    1
    Influenza
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 53 (1.89%)
    2 / 52 (3.85%)
    3 / 52 (5.77%)
    1 / 53 (1.89%)
    1 / 51 (1.96%)
         occurrences all number
    2
    1
    2
    3
    1
    1
    Rhinitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    2 / 52 (3.85%)
    3 / 52 (5.77%)
    2 / 53 (3.77%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    2
    3
    2
    0
    Oral Fungal Infection
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    4
    0
    0
    1
    0
    3
    Erysipelas
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    2 / 52 (3.85%)
    0 / 52 (0.00%)
    3 / 53 (5.66%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    2
    0
    3
    0
    Otitis Externa
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 53 (1.89%)
    1 / 52 (1.92%)
    3 / 52 (5.77%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    1
    1
    3
    0
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 49 (2.04%)
    3 / 53 (5.66%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    1
    3
    2
    0
    0
    1
    Fungal Skin Infection
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    3 / 53 (5.66%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Apr 2018
    Main updates included clarifications for IMP reconstitution, ICF use for skin evaluation and pregnant partners, and blinding methods, as well as changes to timings of scheduled assessments.
    16 Oct 2018
    Main updates as a result of this amendment included clarifications for eligibility criteria, study endpoints, null hypotheses, unblinding, prohibited treatments for psoriasis, contraception requirements, and ICF use for subject expense reimbursement system.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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