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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, multicenter study to demonstrate the efficacy at 16 weeks of secukinumab 150 and 300 mg s.c. and to assess safety, tolerability and long-term efficacy up to 132 weeks in subjects with moderate to severe palmoplantar psoriasis Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.

    Summary
    EudraCT number
    		 2012-005412-25
    Trial protocol
    		 ES   PT   NO   SK   BE   GB   NL   FI   HU  
    Global end of trial date
    02 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jul 2018
    First version publication date
    19 Jul 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457A2312
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01806597
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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
    02 Nov 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate the superiority of secukinumab 150 mg and/or 300 mg compared to placebo in patients with moderate to severe palmoplantar psoriasis as assessed by the palmoplantar Investigator’s Global Assessment (ppIGA) at Week 16.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jun 2013
    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
    Australia: 22
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Canada: 20
    Country: Number of subjects enrolled
    Finland: 7
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Hungary: 19
    Country: Number of subjects enrolled
    Israel: 19
    Country: Number of subjects enrolled
    Netherlands: 15
    Country: Number of subjects enrolled
    Norway: 6
    Country: Number of subjects enrolled
    Portugal: 12
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Slovakia: 10
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Turkey: 10
    Country: Number of subjects enrolled
    United States: 23
    Worldwide total number of subjects
    205
    EEA total number of subjects
    91
    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)
    176
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All randomized patients were included in the FAS for efficacy analyses. 6 patients who were randomized to AIN457 150 mg group and 5 patients who were randomized to AIN457 300 mg group were excluded from the Safety set as patients did not receive any dose of study drug during Treatment Period 2 (on or after Week 16).

    Period 1
    Period 1 title
    Treatment Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 150mg
    Arm description
    		 AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab 150 mg
    Investigational medicinal product code
    AIN457
    Other name
    secukinumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg

    Arm title
    		 AIN457 300 mg
    Arm description
    		 AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab 300 mg
    Investigational medicinal product code
    AIN457
    Other name
    secukinumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg

    Arm title
    		 Placebo
    Arm description
    		 placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Placebo
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    placebo

    Number of subjects in period 1
    		AIN457 150mg AIN457 300 mg Placebo
    Started
    68
    69
    68
    Completed
    63
    64
    63
    Not completed
    5
    5
    5
         Consent withdrawn by subject
    3
    2
    2
         Physician decision
    -
    1
    -
         Adverse event, non-fatal
    1
    1
    2
         Lack of efficacy
    1
    -
    1
         Protocol deviation
    -
    1
    -
    Period 2
    Period 2 title
    Treatment Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 150mg
    Arm description
    		 AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab 150 mg
    Investigational medicinal product code
    AIN457
    Other name
    secukinumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg

    Arm title
    		 AIN457 300 mg
    Arm description
    		 AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab 300 mg
    Investigational medicinal product code
    AIN457
    Other name
    secukinumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg

    Arm title
    		 Placebo - AIN457 150 mg
    Arm description
    		 all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Placebo
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg

    Arm title
    		 Placebo - AIN457 300mg
    Arm description
    		 all placebo patients who were re-randomized to AIN457 300 mg at re-randomization
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Placebo
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg

    Arm title
    		 Placebo
    Arm description
    		 placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Placebo
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    placebo

    Number of subjects in period 2
    		AIN457 150mg AIN457 300 mg Placebo - AIN457 150 mg Placebo - AIN457 300mg Placebo
    Started
    63
    64
    31
    31
    1
    Completed
    24
    44
    17
    20
    0
    Not completed
    39
    20
    14
    11
    1
         Adverse event, serious fatal
    1
    -
    -
    -
    -
         Consent withdrawn by subject
    10
    5
    6
    5
    -
         Physician decision
    1
    1
    -
    -
    -
         Adverse event, non-fatal
    9
    6
    4
    3
    1
         study terminated by sponsor
    -
    1
    -
    1
    -
         Lost to follow-up
    2
    -
    -
    -
    -
         Lack of efficacy
    12
    5
    3
    1
    -
         Protocol deviation
    2
    -
    -
    -
    -
         non-compliance with study treatment
    2
    2
    1
    1
    -
    Period 3
    Period 3 title
    Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Any AIN457 150mg
    Arm description
    		 AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab 150 mg
    Investigational medicinal product code
    AIN457
    Other name
    secukinumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg

    Arm title
    		 Any AIN457 300 mg
    Arm description
    		 AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab 300 mg
    Investigational medicinal product code
    AIN457
    Other name
    secukinumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg

    Arm title
    		 Placebo
    Arm description
    		 placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Placebo
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    placebo

    Number of subjects in period 3
    		Any AIN457 150mg Any AIN457 300 mg Placebo
    Started
    77
    84
    3
    Completed
    67
    82
    3
    Not completed
    10
    2
    0
         Consent withdrawn by subject
    4
    1
    -
         Physician decision
    1
    -
    -
         Adverse event, non-fatal
    2
    -
    -
         Lost to follow-up
    2
    -
    -
         Lack of efficacy
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AIN457 150mg
    Reporting group description
    		 AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks

    Reporting group title
    AIN457 300 mg
    Reporting group description
    		 AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.

    Reporting group values
    		 AIN457 150mg AIN457 300 mg Placebo Total
    Number of subjects
    		 68 69 68 205
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 56 60 60 176
        From 65-84 years
    		 12 9 8 29
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.4 ± 12.56 48.8 ± 14.21 50.9 ± 12.95 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 28 31 34 93
        Male
    		 40 38 34 112
    Subject analysis sets

    Subject analysis set title
    Placebo - AIN457 300 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all placebo patients who were re-randomized to secukinumab 300 mg at re-randomization.

    Subject analysis set title
    Placebo - AIN 150mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all placebo patients who were re-randomized to AIN457 150 mg at re-randomization

    Subject analysis sets values
    		 Placebo - AIN457 300 mg Placebo - AIN 150mg
    Number of subjects
    31
    31
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    29
    27
        From 65-84 years
    2
    4
        85 years and over
    0
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    Gender, Male/Female
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    AIN457 150mg
    Reporting group description
    		 AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks

    Reporting group title
    AIN457 300 mg
    Reporting group description
    		 AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
    Reporting group title
    AIN457 150mg
    Reporting group description
    		 AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks

    Reporting group title
    AIN457 300 mg
    Reporting group description
    		 AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks

    Reporting group title
    Placebo - AIN457 150 mg
    Reporting group description
    		 all placebo patients who were re-randomized to secukinumab 150 mg at re-randomization

    Reporting group title
    Placebo - AIN457 300mg
    Reporting group description
    		 all placebo patients who were re-randomized to AIN457 300 mg at re-randomization

    Reporting group title
    Placebo
    Reporting group description
    		 placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.
    Reporting group title
    Any AIN457 150mg
    Reporting group description
    		 AIN457 150mg sub-cutaneous (s.c.) injection plus a placebo AIN457 s.c. injection once weekly for 5 weeks followed by dosing every 4 weeks

    Reporting group title
    Any AIN457 300 mg
    Reporting group description
    		 AIN457 300 mg (2 s.c. injections of the 150 mg dose) once weekly for 5 weeks followed by dosing every 4 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 placebo AIN457 (2 sc injections) once weekly for 5 weeks, followed by dosing every 4 weeks.

    Subject analysis set title
    Placebo - AIN457 300 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all placebo patients who were re-randomized to secukinumab 300 mg at re-randomization.

    Subject analysis set title
    Placebo - AIN 150mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all placebo patients who were re-randomized to AIN457 150 mg at re-randomization

    Primary: Percentages of participants with palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 response after 16 weeks of treatment

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    End point title
    		 Percentages of participants with palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 response after 16 weeks of treatment
    End point description
    palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 AIN457 150mg AIN457 300 mg Placebo
    Number of subjects analysed
    68
    68
    68
    Units: Percentages of participants
        number (not applicable)
    22
    33.3
    1.5
    Statistical analysis title
    		 Statistical analysis of ppIGA 0 or 1 response
    Statistical analysis description
    Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (<90 kg or ≥90 kg).
    Comparison groups
    AIN457 150mg v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    19.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.4
         upper limit
    		 154.6
    Statistical analysis title
    		 Statistical analysis of ppIGA 0 or 1 response
    Statistical analysis description
    Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (<90 kg or ≥90 kg).
    Comparison groups
    AIN457 300 mg v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    29.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.1
         upper limit
    		 211.9

    Secondary: Percentages of participants with palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 response - treatment period I

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    End point title
    		 Percentages of participants with palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 response - treatment period I
    End point description
    ppIGA: Palmoplantar Ivestigator’s Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
    End point type
    Secondary
    End point timeframe
    Week 1, week 2, week 4, week, 8, week 12, week 16
    End point values
    		 AIN457 150mg AIN457 300 mg Placebo
    Number of subjects analysed
    68
    69
    68
    Units: Percentages of participants
    number (not applicable)
        Week 1
    1.5
    1.4
    0
        Week 2
    1.5
    7.2
    0
        Week 4
    4.4
    8.7
    0
        Week 8
    17.6
    26.1
    0
        Week 12
    20.6
    33.3
    1.5
        Week 16
    22.1
    33.3
    1.5
    No statistical analyses for this end point

    Secondary: Percentages of subjects with ppIGA 0 or 1 response (observed cases) - treatment period II

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    End point title
    		 Percentages of subjects with ppIGA 0 or 1 response (observed cases) - treatment period II
    End point description
    ppIGA: Palmoplantar Ivestigator’s Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
    End point type
    Secondary
    End point timeframe
    Week 20, Week 28, Week 32, Week 64, Week 132
    End point values
    		 AIN457 150mg AIN457 300 mg Placebo Placebo - AIN457 300 mg Placebo - AIN 150mg
    Number of subjects analysed
    68
    69
    1
    31
    31
    Units: Percentages of participants
    number (not applicable)
        Week 20
    32.4
    33.3
    0.0
    9.7
    12.9
        Week 28
    29.4
    44.9
    100.0
    51.6
    32.3
        Week 32
    29.4
    42.0
    0.0
    41.9
    35.5
        Week 64
    26.5
    46.4
    0.0
    48.4
    29.0
        Week 132
    22.1
    27.5
    0.0
    35.5
    12.9
    No statistical analyses for this end point

    Secondary: Percentages of subjects with ppIGA 0 or 1 response (observed cases) - entire treatment period

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    End point title
    		 Percentages of subjects with ppIGA 0 or 1 response (observed cases) - entire treatment period
    End point description
    ppIGA: Palmoplantar Ivestigator’s Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
    End point type
    Secondary
    End point timeframe
    Week 16, Week 24, Week 28, Week 80
    End point values
    		 AIN457 150mg AIN457 300 mg Placebo Placebo - AIN457 300 mg Placebo - AIN 150mg
    Number of subjects analysed
    68
    69
    6
    31
    31
    Units: Percentages of participants
    number (not applicable)
        Week 16
    23.4
    37.7
    25.0
    0
    0
        Week 24
    40.7
    44.1
    100.0
    36.7
    20.0
        Week 28
    34.5
    50.8
    0
    48.3
    20.0
        Week 80
    41.7
    65.3
    0
    68.2
    45.0
    No statistical analyses for this end point

    Secondary: Absolute change from baseline for palmoplantar Psoriasis Area and Severity Index (ppPASI) score -treatment period I

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    End point title
    		 Absolute change from baseline for palmoplantar Psoriasis Area and Severity Index (ppPASI) score -treatment period I
    End point description
    Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75, 90 and 100 were defined as participants achieving ≥ 75%, 90% or 100%
    End point type
    Secondary
    End point timeframe
    Week 1, Week 2, Week 4, Week 8, Week 12, Week 16
    End point values
    		 AIN457 150mg AIN457 300 mg Placebo
    Number of subjects analysed
    68
    69
    68
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 1
    -1.13 ± 4.797
    -2.22 ± 4.334
    -0.85 ± 3.355
        Week 2
    -3.11 ± 7.669
    -5.32 ± 6.120
    -1.90 ± 5.434
        Week 4
    -6.69 ± 9.890
    -9.18 ± 9.734
    -3.95 ± 7.424
        Week 8
    -9.74 ± 12.779
    -11.30 ± 11.954
    -3.22 ± 8.316
        Week 12
    -10.15 ± 14.409
    -12.83 ± 12.286
    -3.07 ± 8.479
        Week 16
    -9.41 ± 15.984
    -13.35 ± 12.941
    -2.43 ± 8.527
    No statistical analyses for this end point

    Secondary: Absolute change from baseline for palmoplantar Psoriasis Area and Severity Index (ppPASI) score (observed cases) - entire treatment set

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    End point title
    		 Absolute change from baseline for palmoplantar Psoriasis Area and Severity Index (ppPASI) score (observed cases) - entire treatment set
    End point description
    Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75, 90 and 100 were defined as participants achieving ≥ 75%, 90% or 100%
    End point type
    Secondary
    End point timeframe
    Week 16, Week 32, Week 80, Week 132
    End point values
    		 AIN457 150mg AIN457 300 mg Placebo Placebo - AIN457 300 mg Placebo - AIN 150mg
    Number of subjects analysed
    68
    69
    6
    31
    31
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 16
    -8.97 ± 15.624
    -12.67 ± 12.074
    -7.15 ± 4.479
    -3.11 ± 7.983
    -1.57 ± 8.880
        Week 32
    -16.29 ± 14.307
    -17.43 ± 13.104
    -11.40 ± 999
    -15.09 ± 12.625
    -15.49 ± 11.570
        Week 80
    -18.05 ± 15.232
    -19.27 ± 14.258
    -999 ± 999
    -16.70 ± 10.441
    -13.71 ± 14.560
        Week 132
    -16.74 ± 14.658
    -19.16 ± 11.688
    -999 ± 999
    -13.82 ± 5.844
    -17.07 ± 11.728
    No statistical analyses for this end point

    Secondary: Number of participants developing anti-secukinumab antibodies

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    End point title
    		 Number of participants developing anti-secukinumab antibodies [1]
    End point description
    To investigate the development of immunogenicity against secukinumab
    End point type
    Secondary
    End point timeframe
    Over time up to week 132
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There was no statistics involved with this endpoint.
    End point values
    		 AIN457 150mg AIN457 300 mg Placebo - AIN457 300 mg Placebo - AIN 150mg
    Number of subjects analysed
    68
    69
    31
    31
    Units: Number of participants
    2
    2
    3
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Any AIN457 150 mg
    Reporting group description
    		 Any AIN457 150 mg

    Reporting group title
    Any AIN457 300 mg
    Reporting group description
    		 Any AIN457 300 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Any AIN457 dose
    Reporting group description
    		 Any AIN457 dose

    Serious adverse events
    		 Any AIN457 150 mg Any AIN457 300 mg Placebo Any AIN457 dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 99 (19.19%)
    13 / 100 (13.00%)
    2 / 68 (2.94%)
    32 / 199 (16.08%)
         number of deaths (all causes)
    1
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leiomyoma
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Miscarriage of partner
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture displacement
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral nerve injury
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    1 / 68 (1.47%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    2 / 99 (2.02%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    3 / 199 (1.51%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis stenosans
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis of male external genital organ
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective keratitis
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    1 / 68 (1.47%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Any AIN457 150 mg Any AIN457 300 mg Placebo Any AIN457 dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    75 / 99 (75.76%)
    68 / 100 (68.00%)
    30 / 68 (44.12%)
    143 / 199 (71.86%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Melanocytic naevus
         subjects affected / exposed
    2 / 99 (2.02%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    3 / 199 (1.51%)
         occurrences all number
    2
    1
    0
    3
    Seborrhoeic keratosis
         subjects affected / exposed
    4 / 99 (4.04%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    4
    0
    0
    4
    Vascular disorders
    Haematoma
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Hypertension
         subjects affected / exposed
    5 / 99 (5.05%)
    3 / 100 (3.00%)
    0 / 68 (0.00%)
    8 / 199 (4.02%)
         occurrences all number
    5
    3
    0
    8
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Fatigue
         subjects affected / exposed
    4 / 99 (4.04%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    5 / 199 (2.51%)
         occurrences all number
    4
    1
    0
    5
    Influenza like illness
         subjects affected / exposed
    1 / 99 (1.01%)
    3 / 100 (3.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    1
    3
    0
    4
    Injection site haematoma
         subjects affected / exposed
    2 / 99 (2.02%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    3 / 199 (1.51%)
         occurrences all number
    2
    1
    0
    3
    Injection site reaction
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Oedema peripheral
         subjects affected / exposed
    5 / 99 (5.05%)
    4 / 100 (4.00%)
    0 / 68 (0.00%)
    9 / 199 (4.52%)
         occurrences all number
    5
    4
    0
    9
    Peripheral swelling
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    1 / 68 (1.47%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    1
    2
    Pyrexia
         subjects affected / exposed
    4 / 99 (4.04%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    5 / 199 (2.51%)
         occurrences all number
    5
    1
    0
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 99 (3.03%)
    2 / 100 (2.00%)
    1 / 68 (1.47%)
    5 / 199 (2.51%)
         occurrences all number
    3
    2
    1
    5
    Dyspnoea
         subjects affected / exposed
    3 / 99 (3.03%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    3
    1
    0
    4
    Oropharyngeal pain
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    1 / 68 (1.47%)
    4 / 199 (2.01%)
         occurrences all number
    2
    2
    1
    4
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Depression
         subjects affected / exposed
    2 / 99 (2.02%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    3 / 199 (1.51%)
         occurrences all number
    2
    1
    0
    3
    Investigations
    Weight increased
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Muscle strain
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    2
    3
    0
    5
    Procedural pain
         subjects affected / exposed
    1 / 99 (1.01%)
    4 / 100 (4.00%)
    0 / 68 (0.00%)
    5 / 199 (2.51%)
         occurrences all number
    1
    6
    0
    7
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    2 / 68 (2.94%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    8
    1
    Headache
         subjects affected / exposed
    10 / 99 (10.10%)
    11 / 100 (11.00%)
    6 / 68 (8.82%)
    21 / 199 (10.55%)
         occurrences all number
    15
    14
    16
    29
    Paraesthesia
         subjects affected / exposed
    2 / 99 (2.02%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    3 / 199 (1.51%)
         occurrences all number
    2
    1
    0
    3
    Eye disorders
    Blepharitis
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    1 / 68 (1.47%)
    4 / 199 (2.01%)
         occurrences all number
    2
    2
    1
    4
    Constipation
         subjects affected / exposed
    3 / 99 (3.03%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    3 / 199 (1.51%)
         occurrences all number
    3
    0
    0
    3
    Dental caries
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    1 / 68 (1.47%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    1
    2
    Diarrhoea
         subjects affected / exposed
    4 / 99 (4.04%)
    4 / 100 (4.00%)
    0 / 68 (0.00%)
    8 / 199 (4.02%)
         occurrences all number
    4
    5
    0
    9
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 99 (3.03%)
    3 / 100 (3.00%)
    1 / 68 (1.47%)
    6 / 199 (3.02%)
         occurrences all number
    3
    3
    1
    6
    Nausea
         subjects affected / exposed
    3 / 99 (3.03%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    6
    1
    0
    7
    Toothache
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    2
    3
    0
    5
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    2 / 99 (2.02%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    3 / 199 (1.51%)
         occurrences all number
    2
    1
    0
    3
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    2 / 68 (2.94%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    2
    1
    Actinic keratosis
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    3
    0
    0
    3
    Dermatitis
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Dermatitis contact
         subjects affected / exposed
    3 / 99 (3.03%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    3 / 199 (1.51%)
         occurrences all number
    3
    0
    0
    3
    Eczema
         subjects affected / exposed
    4 / 99 (4.04%)
    2 / 100 (2.00%)
    1 / 68 (1.47%)
    6 / 199 (3.02%)
         occurrences all number
    4
    2
    1
    6
    Pruritus
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    1 / 68 (1.47%)
    4 / 199 (2.01%)
         occurrences all number
    2
    2
    1
    4
    Psoriasis
         subjects affected / exposed
    12 / 99 (12.12%)
    11 / 100 (11.00%)
    4 / 68 (5.88%)
    23 / 199 (11.56%)
         occurrences all number
    12
    12
    4
    24
    Pustular psoriasis
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    2 / 68 (2.94%)
    0 / 199 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Rash
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    4
    2
    0
    6
    Skin mass
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Urticaria
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    2
    2
    0
    4
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    3 / 99 (3.03%)
    2 / 100 (2.00%)
    0 / 68 (0.00%)
    5 / 199 (2.51%)
         occurrences all number
    3
    2
    0
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 99 (5.05%)
    4 / 100 (4.00%)
    4 / 68 (5.88%)
    9 / 199 (4.52%)
         occurrences all number
    6
    5
    5
    11
    Arthritis
         subjects affected / exposed
    3 / 99 (3.03%)
    0 / 100 (0.00%)
    1 / 68 (1.47%)
    3 / 199 (1.51%)
         occurrences all number
    3
    0
    1
    3
    Back pain
         subjects affected / exposed
    2 / 99 (2.02%)
    10 / 100 (10.00%)
    2 / 68 (2.94%)
    12 / 199 (6.03%)
         occurrences all number
    2
    10
    2
    12
    Muscle spasms
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    2
    2
    0
    4
    Musculoskeletal pain
         subjects affected / exposed
    4 / 99 (4.04%)
    3 / 100 (3.00%)
    2 / 68 (2.94%)
    7 / 199 (3.52%)
         occurrences all number
    4
    3
    2
    7
    Myalgia
         subjects affected / exposed
    4 / 99 (4.04%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    5 / 199 (2.51%)
         occurrences all number
    6
    1
    0
    7
    Osteoarthritis
         subjects affected / exposed
    4 / 99 (4.04%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    5 / 199 (2.51%)
         occurrences all number
    4
    1
    0
    5
    Pain in extremity
         subjects affected / exposed
    5 / 99 (5.05%)
    1 / 100 (1.00%)
    1 / 68 (1.47%)
    6 / 199 (3.02%)
         occurrences all number
    5
    1
    1
    6
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 99 (1.01%)
    3 / 100 (3.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    1
    3
    0
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    1 / 68 (1.47%)
    4 / 199 (2.01%)
         occurrences all number
    4
    2
    1
    6
    Cellulitis
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    2
    3
    0
    5
    Conjunctivitis
         subjects affected / exposed
    2 / 99 (2.02%)
    3 / 100 (3.00%)
    0 / 68 (0.00%)
    5 / 199 (2.51%)
         occurrences all number
    2
    3
    0
    5
    Folliculitis
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    3
    0
    0
    3
    Gastroenteritis
         subjects affected / exposed
    5 / 99 (5.05%)
    4 / 100 (4.00%)
    0 / 68 (0.00%)
    9 / 199 (4.52%)
         occurrences all number
    5
    4
    0
    9
    Genital infection fungal
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Impetigo
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Influenza
         subjects affected / exposed
    4 / 99 (4.04%)
    7 / 100 (7.00%)
    4 / 68 (5.88%)
    11 / 199 (5.53%)
         occurrences all number
    4
    9
    4
    13
    Localised infection
         subjects affected / exposed
    0 / 99 (0.00%)
    3 / 100 (3.00%)
    0 / 68 (0.00%)
    3 / 199 (1.51%)
         occurrences all number
    0
    3
    0
    3
    Nasopharyngitis
         subjects affected / exposed
    14 / 99 (14.14%)
    8 / 100 (8.00%)
    4 / 68 (5.88%)
    22 / 199 (11.06%)
         occurrences all number
    20
    19
    4
    39
    Oral candidiasis
         subjects affected / exposed
    0 / 99 (0.00%)
    5 / 100 (5.00%)
    0 / 68 (0.00%)
    5 / 199 (2.51%)
         occurrences all number
    0
    5
    0
    5
    Oral herpes
         subjects affected / exposed
    3 / 99 (3.03%)
    2 / 100 (2.00%)
    1 / 68 (1.47%)
    5 / 199 (2.51%)
         occurrences all number
    4
    4
    1
    8
    Pharyngitis
         subjects affected / exposed
    3 / 99 (3.03%)
    6 / 100 (6.00%)
    0 / 68 (0.00%)
    9 / 199 (4.52%)
         occurrences all number
    3
    9
    0
    12
    Rhinitis
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    2
    2
    0
    4
    Sinusitis
         subjects affected / exposed
    1 / 99 (1.01%)
    3 / 100 (3.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    1
    3
    0
    4
    Skin infection
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 100 (2.00%)
    1 / 68 (1.47%)
    4 / 199 (2.01%)
         occurrences all number
    3
    2
    1
    5
    Tinea pedis
         subjects affected / exposed
    5 / 99 (5.05%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    6 / 199 (3.02%)
         occurrences all number
    6
    1
    0
    7
    Tonsillitis
         subjects affected / exposed
    1 / 99 (1.01%)
    3 / 100 (3.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    1
    3
    0
    4
    Tooth abscess
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 68 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    2
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 99 (10.10%)
    20 / 100 (20.00%)
    3 / 68 (4.41%)
    30 / 199 (15.08%)
         occurrences all number
    16
    27
    3
    43
    Urinary tract infection
         subjects affected / exposed
    3 / 99 (3.03%)
    7 / 100 (7.00%)
    0 / 68 (0.00%)
    10 / 199 (5.03%)
         occurrences all number
    3
    7
    0
    10
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 99 (2.02%)
    1 / 100 (1.00%)
    0 / 68 (0.00%)
    3 / 199 (1.51%)
         occurrences all number
    3
    1
    0
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    2 / 68 (2.94%)
    1 / 199 (0.50%)
         occurrences all number
    1
    0
    2
    1
    Dyslipidaemia
         subjects affected / exposed
    1 / 99 (1.01%)
    3 / 100 (3.00%)
    0 / 68 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    1
    3
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jan 2015
    The purpose of Amendment 1 was to provide continued treatment to patients for an additional 52 weeks (overall up to 132 weeks). This extension of treatment allowed for safety, tolerability, and efficacy data to be collected from the participating patients over a longer period of time.
    12 Mar 2015
    The purpose of Amendment 2 was to allow, on ethical grounds, patients who completed the Week 80 visit before implementation of Amendment 1 at sites to continue receiving study medication as the study treatment was not yet commercially available in all participating countries.

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.
    For support, Contact us.
    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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