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    Clinical Trial Results:
    A 52-Week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis – amended with an optional extension treatment period of up to a total of 148 weeks

    Summary
    EudraCT number
    		 2013-003086-34
    Trial protocol
    		 SE   GB   AT   ES   DE   BE   IT   PL  
    Global end of trial date
    31 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jun 2018
    First version publication date
    16 Jun 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457A3301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02008890
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    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
    31 May 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2017
    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 s.c. and/or 300 mg s.c. in patients with moderate to severe chronic PPP at Week 16 with respect to the palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate (ppPASI 75) compared to placebo.
    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
    26 Dec 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
    Austria: 14
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    France: 21
    Country: Number of subjects enrolled
    Germany: 90
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Poland: 24
    Country: Number of subjects enrolled
    Russian Federation: 21
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    Sweden: 16
    Country: Number of subjects enrolled
    United Kingdom: 24
    Worldwide total number of subjects
    237
    EEA total number of subjects
    216
    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)
    197
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 337 patients were screened, and 237 of these patients completed the screening phase and were randomized to treatment.

    Pre-assignment
    Screening details
    		 Period 1 (Baseline to Week 16): patients were randomized to AIN457 150 mg, AIN457 300 mg or Placebo Period 2 (Week 16 to Week 52): Placebo non-responders were re-randomized at Week 16 to AIN457 150 mg or AIN457 300 mg Extension Period (Week 52 to Week 148): Placebo responders (assessed at Week 16) were not eligible to enter the Extension Period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 150mg
    Arm description
    		 Secukinumab 150mg at each dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 150 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg, provided as: one PFS of 150 mg dose and one PFS of Placebo dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Arm title
    		 AIN457 300mg
    Arm description
    		 Secukinumab 300mg at each dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 300 mg, provided as: two PFS of 150 mg dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Arm title
    		 Placebo
    Arm description
    		 Placebo at each dosing.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo, provided as: two PFS of Placebo dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Number of subjects in period 1
    		AIN457 150mg AIN457 300mg Placebo
    Started
    80
    79
    78
    Completed
    65
    64
    66
    Not completed
    15
    15
    12
         Consent withdrawn by subject
    7
    7
    5
         Physician decision
    1
    -
    1
         Adverse event, non-fatal
    6
    8
    6
         Pregnancy
    1
    -
    -
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 150mg
    Arm description
    		 Secukinumab 150mg at each dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 150mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg, provided as: one PFS of 150 mg dose and one PFS of Placebo dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Arm title
    		 AIN457 300mg
    Arm description
    		 Secukinumab 300mg at each dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 300 mg, provided as: two PFS of 150 mg dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Arm title
    		 Placebo - AIN457 150 mg
    Arm description
    		 Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 150mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg, provided as: one PFS of 150 mg dose and one PFS of Placebo dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Arm title
    		 Placebo - AIN457 300 mg
    Arm description
    		 Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 300 mg, provided as: two PFS of 150 mg dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Arm title
    		 Placebo
    Arm description
    		 Placebo at each dosing.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo, provided as: two PFS of Placebo dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Number of subjects in period 2 [1]
    		AIN457 150mg AIN457 300mg Placebo - AIN457 150 mg Placebo - AIN457 300 mg Placebo
    Started
    65
    64
    27
    28
    10
    Completed
    38
    49
    13
    20
    9
    Not completed
    27
    15
    14
    8
    1
         Consent withdrawn by subject
    11
    8
    7
    2
    -
         Physician decision
    4
    -
    2
    1
    -
         Adverse event, non-fatal
    12
    7
    5
    5
    -
         Lost to follow-up
    -
    -
    -
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Patients originally randomized to Placebo (in Period 1) and considered non-responders at Week 16 were re-randomized to AIN457 150 mg or AIN457 300 mg for the subsequent periods leading to inconsistencies when reporting the data.
    Period 3
    Period 3 title
    Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    At Week 52, the investigator was unblinded in relation to the placebo; however blinding regarding the dose groups of active treatment (secukinumab 150 mg and 300 mg) was maintained until the end of the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 150mg
    Arm description
    		 Secukinumab 150mg at each dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 150mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg, provided as: one PFS of 150 mg dose and one PFS of Placebo dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Arm title
    		 AIN457 300mg
    Arm description
    		 Secukinumab 300mg at each dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 300 mg, provided as: two PFS of 150 mg dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Arm title
    		 Placebo - AIN457 150 mg
    Arm description
    		 Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 150mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg, provided as: one PFS of 150 mg dose and one PFS of Placebo dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Arm title
    		 Placebo - AIN457 300 mg
    Arm description
    		 Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 300 mg, provided as: two PFS of 150 mg dose, labeled as "AIN457 150 mg/1 mL/Placebo"

    Number of subjects in period 3 [2]
    		AIN457 150mg AIN457 300mg Placebo - AIN457 150 mg Placebo - AIN457 300 mg
    Started
    31
    36
    10
    17
    Completed
    26
    31
    6
    13
    Not completed
    5
    5
    4
    4
         Consent withdrawn by subject
    3
    2
    4
    2
         Adverse event, non-fatal
    1
    3
    -
    2
         Lost to follow-up
    1
    -
    -
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Patients originally randomized to Placebo (in Period 1) and considered non-responders at Week 16 were re-randomized to AIN457 150 mg or AIN457 300 mg for the subsequent periods leading to inconsistencies when reporting the data.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    AIN457 150mg
    Reporting group description
    		 Secukinumab 150mg at each dosing.

    Reporting group title
    AIN457 300mg
    Reporting group description
    		 Secukinumab 300mg at each dosing.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo at each dosing.

    Reporting group values
    		 AIN457 150mg AIN457 300mg Placebo Total
    Number of subjects
    		 80 79 78 237
    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)
    		 65 62 70 197
        From 65-84 years
    		 15 17 8 40
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 50.7 ( 13.68 ) 50.6 ( 14.77 ) 52.9 ( 11.33 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 63 64 59 186
        Male
    		 17 15 19 51
    Race/Ethnicity, Customized
    Units: Subjects
        Black|
    		 1 0 1 2
        Caucasian|
    		 78 78 76 232
        Missing|
    		 1 0 1 2
        Other|
    		 0 1 0 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    AIN457 150mg
    Reporting group description
    		 Secukinumab 150mg at each dosing.

    Reporting group title
    AIN457 300mg
    Reporting group description
    		 Secukinumab 300mg at each dosing.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo at each dosing.
    Reporting group title
    AIN457 150mg
    Reporting group description
    		 Secukinumab 150mg at each dosing.

    Reporting group title
    AIN457 300mg
    Reporting group description
    		 Secukinumab 300mg at each dosing.

    Reporting group title
    Placebo - AIN457 150 mg
    Reporting group description
    		 Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.

    Reporting group title
    Placebo - AIN457 300 mg
    Reporting group description
    		 Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo at each dosing.
    Reporting group title
    AIN457 150mg
    Reporting group description
    		 Secukinumab 150mg at each dosing.

    Reporting group title
    AIN457 300mg
    Reporting group description
    		 Secukinumab 300mg at each dosing.

    Reporting group title
    Placebo - AIN457 150 mg
    Reporting group description
    		 Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.

    Reporting group title
    Placebo - AIN457 300 mg
    Reporting group description
    		 Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.

    Primary: palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate (ppPASI 75) at Week 16 (period 1)

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    End point title
    		 palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate (ppPASI 75) at Week 16 (period 1)
    End point description
    The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.
    End point type
    Primary
    End point timeframe
    Baseline to Week 16
    End point values
    		 AIN457 150mg AIN457 300mg Placebo
    Number of subjects analysed
    80
    79
    78
    Units: Percent
        number (not applicable)
    17.5
    26.6
    14.1
    Statistical analysis title
    		 ppPASI 75 response rate at Week 16
    Comparison groups
    AIN457 150mg v Placebo
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5722
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 3.53
    Statistical analysis title
    		 ppPASI 75 response rate at Week 16
    Comparison groups
    AIN457 300mg v Placebo
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0411
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 6.6

    Secondary: ppPASI: absolute change from baseline to Week 16

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    End point title
    		 ppPASI: absolute change from baseline to Week 16
    End point description
    A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 AIN457 150mg AIN457 300mg Placebo
    Number of subjects analysed
    68
    69
    70
    Units: points
    arithmetic mean (standard deviation)
        Baseline|
    21.79 ( 8.211 )
    23.01 ( 10.787 )
    23.10 ( 10.198 )
        Change from Baseline to Week 16|
    -6.99 ( 10.904 )
    -9.74 ( 12.130 )
    -6.73 ( 9.868 )
    Statistical analysis title
    		 ppPASI 75 change from baseline to Week 16
    Comparison groups
    AIN457 150mg v Placebo
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9431
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.59
         upper limit
    		 3.47
    Statistical analysis title
    		 ppPASI 75 change from baseline to Week 16
    Comparison groups
    AIN457 300mg v Placebo
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1576
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.14
         upper limit
    		 0.88

    Secondary: ppPASI 75 response over time (Period 1)

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    End point title
    		 ppPASI 75 response over time (Period 1)
    End point description
    A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 AIN457 150mg AIN457 300mg Placebo
    Number of subjects analysed
    80
    79
    78
    Units: percent
    number (not applicable)
        Week 1|
    0
    1.3
    1.3
        Week 2|
    1.3
    1.3
    0
        Week 3|
    2.6
    5.4
    0
        Week 4|
    6.5
    9.1
    1.4
        Week 8|
    13.0
    13.3
    9.6
        Week 12|
    14.7
    23.9
    10.1
        Week 16|
    17.5
    26.6
    14.1
    No statistical analyses for this end point

    Secondary: ppPASI 75 response over time (Period 2)

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    End point title
    		 ppPASI 75 response over time (Period 2)
    End point description
    A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.
    End point type
    Secondary
    End point timeframe
    Week 16 to Week 52
    End point values
    		 AIN457 150mg AIN457 300mg Placebo - AIN457 150 mg Placebo - AIN457 300 mg Placebo
    Number of subjects analysed
    64
    64
    27
    28
    10
    Units: percent
    number (not applicable)
        Week 16|
    18.8
    31.3
    0
    0
    90.0
        Week 20|
    20.3
    31.3
    7.7
    17.9
    80.0
        Week 24|
    30.2
    37.5
    19.2
    38.5
    80.0
        Week 32|
    36.4
    48.3
    25.0
    44.0
    80.0
        Week 40|
    44.4
    56.4
    37.5
    50.0
    70.0
        Week 48|
    52.4
    58.0
    40.0
    47.4
    60.0
        Week 52|
    57.9
    58.8
    50.0
    60.0
    66.7
    No statistical analyses for this end point

    Secondary: ppPASI 75 response over time (Extension Period)

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    End point title
    		 ppPASI 75 response over time (Extension Period)
    End point description
    A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.
    End point type
    Secondary
    End point timeframe
    Week 52 to Week 148
    End point values
    		 AIN457 150mg AIN457 300mg Placebo - AIN457 150 mg Placebo - AIN457 300 mg
    Number of subjects analysed
    31
    36
    10
    17
    Units: percent
    number (not applicable)
        Week 52|
    64.5
    63.9
    50.0
    64.7
        Week 64|
    56.7
    66.7
    40.0
    82.4
        Week 76|
    68.2
    67.7
    62.5
    60.0
        Week 88|
    88.2
    80.0
    42.9
    75.0
        Week 100|
    100.0
    75.0
    33.3
    54.5
        Week 112|
    100.0
    75.0
    60.0
    66.7
        Week 124|
    93.3
    78.3
    40.0
    70.0
        Week 136|
    93.3
    77.3
    40.0
    66.7
        Week 148|
    100.0
    78.3
    75.0
    77.8
    No statistical analyses for this end point

    Secondary: Most frequent Adverse Events - Period 1 (patient's safety)

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    End point title
    		 Most frequent Adverse Events - Period 1 (patient's safety)
    End point description
    Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16 (Period 1)
    End point values
    		 AIN457 150mg AIN457 300mg Placebo
    Number of subjects analysed
    80
    79
    78
    Units: percent
    number (not applicable)
        Nasopharyngitis|
    10.0
    20.3
    14.1
        Pustular psoriasis|
    12.5
    16.5
    5.1
        Headache|
    5.0
    12.7
    14.1
        Pruritus|
    6.3
    8.9
    5.1
        Psoriasis|
    6.3
    5.1
    3.8
        Urinary tract infection|
    2.5
    5.1
    3.8
        Cough|
    6.3
    3.8
    0
        Folliculitis|
    3.8
    5.1
    1.3
        Nausea|
    3.8
    5.1
    0
        Oral herpes|
    5.0
    1.3
    0
        Rash pustular|
    5.0
    1.3
    0
    No statistical analyses for this end point

    Secondary: Most frequent Adverse Events - Period 2 (patient's safety)

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    End point title
    		 Most frequent Adverse Events - Period 2 (patient's safety)
    End point description
    Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
    End point type
    Secondary
    End point timeframe
    Week 16 to Week 52 (Period 2)
    End point values
    		 AIN457 150mg AIN457 300mg Placebo - AIN457 150 mg Placebo - AIN457 300 mg Placebo
    Number of subjects analysed
    64
    64
    27
    28
    10
    Units: percent
    number (not applicable)
        Nasopharyngitis|
    12.5
    21.9
    11.1
    21.4
    10.0
        Pustular psoriasis|
    18.8
    10.9
    14.8
    21.4
    10.0
        Bronchitis|
    4.7
    9.4
    3.7
    10.7
    0.0
        Headache|
    4.7
    6.3
    3.7
    7.1
    0.0
        Eczema|
    1.6
    9.4
    7.4
    0.0
    0.0
        Psoriasis|
    3.1
    4.7
    7.4
    0.0
    20.0
        Pruritus|
    3.1
    4.7
    0.0
    7.1
    10.0
        Folliculitis|
    3.1
    6.3
    0.0
    3.6
    0.0
        Pain in extremity|
    0.0
    7.8
    7.4
    0.0
    0.0
        Cough|
    0.0
    6.3
    0.0
    3.6
    0.0
        Sinusitis|
    0.0
    1.6
    7.4
    3.6
    10.0
        Skin infection|
    1.6
    3.1
    7.4
    0.0
    0.0
        Urinary tract infection|
    0.0
    4.7
    7.4
    0.0
    0.0
        Pruritus generalised|
    1.6
    1.6
    7.4
    0.0
    0.0
        Rash|
    0.0
    6.3
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Most frequent Adverse Events - extension period (patient's safety)

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    End point title
    		 Most frequent Adverse Events - extension period (patient's safety)
    End point description
    Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
    End point type
    Secondary
    End point timeframe
    Week 52 to Week 148 (extension period)
    End point values
    		 AIN457 150mg AIN457 300mg
    Number of subjects analysed
    31 [1]
    36 [2]
    Units: percent
    number (not applicable)
        Viral upper respiratory tract infection|
    12.2
    18.9
        Headache|
    7.3
    5.7
        Upper respiratory tract infection|
    2.4
    9.4
        Urinary tract infection|
    9.8
    3.8
        Diarrhoea|
    4.9
    5.7
        Tonsillitis|
    2.4
    5.7
        Ear infection|
    7.3
    0.0
        Oropharyngeal pain|
    0.0
    5.7
    Notes
    [1] - Includes 10 additional "Placebo-AIN457 150 mg patients". Actual number analyzed is 41.
    [2] - Includes 17 additional "Placebo-AIN457 300 mg patients". Actual number analyzed is 53.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV).  All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Initial AIN457 150 mg
    Reporting group description
    		 AEs for patients randomized to Secukinumab 150 mg at start of study.

    Reporting group title
    Initial AIN457 300 mg
    Reporting group description
    		 AEs for patients randomized to Secukinumab 300 mg at start of study.

    Reporting group title
    Placebo
    Reporting group description
    		 AEs for patients randomized to Placebo at start of study while treated with Placebo (AEs that occurred after re-randomization to Secukinumab are not counted in this group).

    Reporting group title
    AIN457 150 mg in any period
    Reporting group description
    		 AEs for patients initially randomized to AIN457 150mg and placebo non-responder re-randomized to AIN457 150 mg at Week 16

    Reporting group title
    AIN457 300 mg in any period
    Reporting group description
    		 AEs for patients initially randomized to AIN457 300mg and placebo non-responder re-randomized to AIN457 300 mg at Week 16

    Reporting group title
    Any Secukinumab
    Reporting group description
    		 Any Secukinumab

    Serious adverse events
    		 Initial AIN457 150 mg Initial AIN457 300 mg Placebo AIN457 150 mg in any period AIN457 300 mg in any period Any Secukinumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 80 (11.25%)
    13 / 79 (16.46%)
    5 / 78 (6.41%)
    11 / 107 (10.28%)
    17 / 107 (15.89%)
    28 / 214 (13.08%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tonsil cancer
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hip arthroplasty
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug ineffective
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 214 (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
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    1 / 107 (0.93%)
    2 / 214 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 214 (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
    Gastrointestinal disorders
    Abdominal mass
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 214 (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
    Erythema multiforme
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pustular psoriasis
         subjects affected / exposed
    1 / 80 (1.25%)
    4 / 79 (5.06%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    4 / 107 (3.74%)
    5 / 214 (2.34%)
         occurrences causally related to treatment / all
    0 / 1
    4 / 5
    0 / 0
    0 / 1
    4 / 5
    4 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 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
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash pustular
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superinfection bacterial
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    1 / 107 (0.93%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    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: 2%
    Non-serious adverse events
    		 Initial AIN457 150 mg Initial AIN457 300 mg Placebo AIN457 150 mg in any period AIN457 300 mg in any period Any Secukinumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    73 / 80 (91.25%)
    73 / 79 (92.41%)
    53 / 78 (67.95%)
    92 / 107 (85.98%)
    94 / 107 (87.85%)
    186 / 214 (86.92%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    2 / 214 (0.93%)
         occurrences all number
    2
    0
    0
    2
    0
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 80 (2.50%)
    5 / 79 (6.33%)
    3 / 78 (3.85%)
    3 / 107 (2.80%)
    6 / 107 (5.61%)
    9 / 214 (4.21%)
         occurrences all number
    2
    5
    3
    3
    6
    9
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    1 / 78 (1.28%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    3
    1
    0
    3
    3
    Chest pain
         subjects affected / exposed
    2 / 80 (2.50%)
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    2 / 107 (1.87%)
    1 / 107 (0.93%)
    3 / 214 (1.40%)
         occurrences all number
    2
    1
    1
    2
    1
    3
    Fatigue
         subjects affected / exposed
    1 / 80 (1.25%)
    3 / 79 (3.80%)
    3 / 78 (3.85%)
    1 / 107 (0.93%)
    3 / 107 (2.80%)
    4 / 214 (1.87%)
         occurrences all number
    1
    7
    3
    1
    7
    8
    Feeling hot
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    2 / 78 (2.56%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 214 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    Injection site urticaria
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    4
    0
    0
    4
    4
    Pyrexia
         subjects affected / exposed
    4 / 80 (5.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    4 / 107 (3.74%)
    1 / 107 (0.93%)
    5 / 214 (2.34%)
         occurrences all number
    4
    1
    0
    4
    1
    5
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    2
    0
    0
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 80 (6.25%)
    8 / 79 (10.13%)
    0 / 78 (0.00%)
    5 / 107 (4.67%)
    9 / 107 (8.41%)
    14 / 214 (6.54%)
         occurrences all number
    5
    10
    0
    5
    11
    16
    Oropharyngeal pain
         subjects affected / exposed
    1 / 80 (1.25%)
    4 / 79 (5.06%)
    2 / 78 (2.56%)
    2 / 107 (1.87%)
    6 / 107 (5.61%)
    8 / 214 (3.74%)
         occurrences all number
    1
    5
    2
    2
    7
    9
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    3 / 107 (2.80%)
    3 / 214 (1.40%)
         occurrences all number
    0
    1
    0
    0
    3
    3
    Depression
         subjects affected / exposed
    3 / 80 (3.75%)
    1 / 79 (1.27%)
    2 / 78 (2.56%)
    3 / 107 (2.80%)
    1 / 107 (0.93%)
    4 / 214 (1.87%)
         occurrences all number
    3
    1
    2
    3
    1
    4
    Insomnia
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 79 (2.53%)
    2 / 78 (2.56%)
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    3 / 214 (1.40%)
         occurrences all number
    1
    2
    2
    1
    2
    3
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 80 (2.50%)
    2 / 79 (2.53%)
    1 / 78 (1.28%)
    2 / 107 (1.87%)
    2 / 107 (1.87%)
    4 / 214 (1.87%)
         occurrences all number
    3
    2
    1
    3
    2
    5
    Blood pressure increased
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    3 / 214 (1.40%)
         occurrences all number
    1
    2
    0
    1
    2
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    2 / 78 (2.56%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    2
    3
    0
    2
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    3 / 214 (1.40%)
         occurrences all number
    1
    2
    0
    1
    2
    3
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    3 / 107 (2.80%)
    4 / 214 (1.87%)
         occurrences all number
    1
    2
    0
    1
    4
    5
    Tachycardia
         subjects affected / exposed
    2 / 80 (2.50%)
    2 / 79 (2.53%)
    1 / 78 (1.28%)
    2 / 107 (1.87%)
    2 / 107 (1.87%)
    4 / 214 (1.87%)
         occurrences all number
    2
    2
    1
    2
    2
    4
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 79 (1.27%)
    2 / 78 (2.56%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    1
    2
    0
    3
    3
    Dizziness
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 79 (1.27%)
    2 / 78 (2.56%)
    2 / 107 (1.87%)
    2 / 107 (1.87%)
    4 / 214 (1.87%)
         occurrences all number
    1
    1
    3
    2
    2
    4
    Headache
         subjects affected / exposed
    7 / 80 (8.75%)
    12 / 79 (15.19%)
    10 / 78 (12.82%)
    9 / 107 (8.41%)
    15 / 107 (14.02%)
    24 / 214 (11.21%)
         occurrences all number
    12
    32
    14
    14
    36
    50
    Migraine
         subjects affected / exposed
    2 / 80 (2.50%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    1 / 107 (0.93%)
    3 / 214 (1.40%)
         occurrences all number
    2
    2
    0
    2
    2
    4
    Sciatica
         subjects affected / exposed
    2 / 80 (2.50%)
    3 / 79 (3.80%)
    2 / 78 (2.56%)
    2 / 107 (1.87%)
    4 / 107 (3.74%)
    6 / 214 (2.80%)
         occurrences all number
    2
    4
    2
    2
    5
    7
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    2 / 214 (0.93%)
         occurrences all number
    2
    0
    1
    2
    0
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 80 (2.50%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    3 / 107 (2.80%)
    3 / 107 (2.80%)
    6 / 214 (2.80%)
         occurrences all number
    3
    2
    0
    4
    4
    8
    Aphthous ulcer
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    3 / 214 (1.40%)
         occurrences all number
    2
    2
    0
    2
    2
    4
    Constipation
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    3 / 107 (2.80%)
    0 / 107 (0.00%)
    3 / 214 (1.40%)
         occurrences all number
    3
    0
    0
    3
    0
    3
    Dental caries
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    2
    0
    0
    2
    2
    Diarrhoea
         subjects affected / exposed
    5 / 80 (6.25%)
    8 / 79 (10.13%)
    4 / 78 (5.13%)
    5 / 107 (4.67%)
    9 / 107 (8.41%)
    14 / 214 (6.54%)
         occurrences all number
    5
    9
    6
    5
    11
    16
    Nausea
         subjects affected / exposed
    3 / 80 (3.75%)
    6 / 79 (7.59%)
    0 / 78 (0.00%)
    4 / 107 (3.74%)
    7 / 107 (6.54%)
    11 / 214 (5.14%)
         occurrences all number
    3
    10
    0
    4
    11
    15
    Vomiting
         subjects affected / exposed
    2 / 80 (2.50%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    2 / 107 (1.87%)
    4 / 214 (1.87%)
         occurrences all number
    2
    3
    0
    2
    3
    5
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 80 (1.25%)
    4 / 79 (5.06%)
    1 / 78 (1.28%)
    1 / 107 (0.93%)
    4 / 107 (3.74%)
    5 / 214 (2.34%)
         occurrences all number
    1
    5
    1
    1
    5
    6
    Dermatitis contact
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    3 / 107 (2.80%)
    0 / 107 (0.00%)
    3 / 214 (1.40%)
         occurrences all number
    4
    0
    0
    4
    0
    4
    Dermatitis psoriasiform
         subjects affected / exposed
    2 / 80 (2.50%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    1 / 107 (0.93%)
    3 / 214 (1.40%)
         occurrences all number
    2
    1
    0
    2
    1
    3
    Drug eruption
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    2 / 214 (0.93%)
         occurrences all number
    2
    0
    0
    2
    0
    2
    Dyshidrotic eczema
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    3 / 107 (2.80%)
    0 / 107 (0.00%)
    3 / 214 (1.40%)
         occurrences all number
    3
    0
    0
    3
    0
    3
    Eczema
         subjects affected / exposed
    3 / 80 (3.75%)
    7 / 79 (8.86%)
    3 / 78 (3.85%)
    5 / 107 (4.67%)
    7 / 107 (6.54%)
    12 / 214 (5.61%)
         occurrences all number
    3
    20
    3
    5
    20
    25
    Hyperkeratosis
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    2
    0
    0
    2
    2
    Intertrigo
         subjects affected / exposed
    3 / 80 (3.75%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    3 / 107 (2.80%)
    2 / 107 (1.87%)
    5 / 214 (2.34%)
         occurrences all number
    3
    3
    0
    3
    3
    6
    Lichen planus
         subjects affected / exposed
    2 / 80 (2.50%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    1 / 107 (0.93%)
    3 / 214 (1.40%)
         occurrences all number
    3
    1
    0
    3
    1
    4
    Pruritus
         subjects affected / exposed
    6 / 80 (7.50%)
    11 / 79 (13.92%)
    4 / 78 (5.13%)
    6 / 107 (5.61%)
    13 / 107 (12.15%)
    19 / 214 (8.88%)
         occurrences all number
    8
    11
    5
    8
    13
    21
    Pruritus generalised
         subjects affected / exposed
    2 / 80 (2.50%)
    2 / 79 (2.53%)
    1 / 78 (1.28%)
    4 / 107 (3.74%)
    2 / 107 (1.87%)
    6 / 214 (2.80%)
         occurrences all number
    2
    2
    1
    4
    2
    6
    Psoriasis
         subjects affected / exposed
    5 / 80 (6.25%)
    7 / 79 (8.86%)
    5 / 78 (6.41%)
    7 / 107 (6.54%)
    7 / 107 (6.54%)
    14 / 214 (6.54%)
         occurrences all number
    5
    7
    5
    7
    7
    14
    Pustular psoriasis
         subjects affected / exposed
    19 / 80 (23.75%)
    16 / 79 (20.25%)
    4 / 78 (5.13%)
    24 / 107 (22.43%)
    23 / 107 (21.50%)
    47 / 214 (21.96%)
         occurrences all number
    22
    22
    4
    27
    30
    57
    Rash
         subjects affected / exposed
    1 / 80 (1.25%)
    5 / 79 (6.33%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    6 / 107 (5.61%)
    7 / 214 (3.27%)
         occurrences all number
    1
    5
    0
    1
    6
    7
    Seborrhoeic dermatitis
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    3 / 107 (2.80%)
    0 / 107 (0.00%)
    3 / 214 (1.40%)
         occurrences all number
    3
    0
    1
    3
    0
    3
    Skin exfoliation
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    1 / 107 (0.93%)
    3 / 214 (1.40%)
         occurrences all number
    2
    0
    0
    2
    1
    3
    Skin fissures
         subjects affected / exposed
    0 / 80 (0.00%)
    3 / 79 (3.80%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    3 / 107 (2.80%)
    3 / 214 (1.40%)
         occurrences all number
    0
    4
    0
    0
    4
    4
    Urticaria
         subjects affected / exposed
    0 / 80 (0.00%)
    4 / 79 (5.06%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    5 / 107 (4.67%)
    6 / 214 (2.80%)
         occurrences all number
    0
    7
    0
    1
    8
    9
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    1 / 78 (1.28%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    2
    1
    0
    2
    2
    Proteinuria
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    3 / 107 (2.80%)
    0 / 107 (0.00%)
    3 / 214 (1.40%)
         occurrences all number
    2
    0
    0
    3
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 80 (6.25%)
    4 / 79 (5.06%)
    5 / 78 (6.41%)
    6 / 107 (5.61%)
    4 / 107 (3.74%)
    10 / 214 (4.67%)
         occurrences all number
    6
    6
    5
    8
    6
    14
    Back pain
         subjects affected / exposed
    4 / 80 (5.00%)
    7 / 79 (8.86%)
    4 / 78 (5.13%)
    5 / 107 (4.67%)
    8 / 107 (7.48%)
    13 / 214 (6.07%)
         occurrences all number
    5
    8
    4
    6
    11
    17
    Musculoskeletal pain
         subjects affected / exposed
    3 / 80 (3.75%)
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    4 / 107 (3.74%)
    1 / 107 (0.93%)
    5 / 214 (2.34%)
         occurrences all number
    3
    1
    1
    4
    1
    5
    Pain in extremity
         subjects affected / exposed
    2 / 80 (2.50%)
    7 / 79 (8.86%)
    6 / 78 (7.69%)
    4 / 107 (3.74%)
    7 / 107 (6.54%)
    11 / 214 (5.14%)
         occurrences all number
    2
    9
    6
    4
    9
    13
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 79 (0.00%)
    2 / 78 (2.56%)
    1 / 107 (0.93%)
    0 / 107 (0.00%)
    1 / 214 (0.47%)
         occurrences all number
    1
    0
    2
    1
    0
    1
    Spinal pain
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    2
    0
    0
    2
    2
    Tendonitis
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    2
    0
    0
    2
    2
    Infections and infestations
    Bacterial vaginosis
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    2 / 214 (0.93%)
         occurrences all number
    2
    0
    0
    2
    0
    2
    Bronchitis
         subjects affected / exposed
    5 / 80 (6.25%)
    6 / 79 (7.59%)
    1 / 78 (1.28%)
    6 / 107 (5.61%)
    11 / 107 (10.28%)
    17 / 214 (7.94%)
         occurrences all number
    8
    7
    1
    9
    15
    24
    Cellulitis
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    3 / 214 (1.40%)
         occurrences all number
    1
    2
    0
    1
    2
    3
    Conjunctivitis
         subjects affected / exposed
    4 / 80 (5.00%)
    3 / 79 (3.80%)
    0 / 78 (0.00%)
    4 / 107 (3.74%)
    4 / 107 (3.74%)
    8 / 214 (3.74%)
         occurrences all number
    4
    4
    0
    4
    5
    9
    Cystitis
         subjects affected / exposed
    3 / 80 (3.75%)
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    4 / 107 (3.74%)
    2 / 107 (1.87%)
    6 / 214 (2.80%)
         occurrences all number
    4
    5
    1
    6
    7
    13
    Ear infection
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    4 / 107 (3.74%)
    0 / 107 (0.00%)
    4 / 214 (1.87%)
         occurrences all number
    1
    0
    0
    8
    0
    8
    Eczema impetiginous
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    2 / 214 (0.93%)
         occurrences all number
    2
    0
    0
    2
    0
    2
    Erysipelas
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    3 / 214 (1.40%)
         occurrences all number
    1
    2
    0
    1
    2
    3
    Folliculitis
         subjects affected / exposed
    5 / 80 (6.25%)
    8 / 79 (10.13%)
    1 / 78 (1.28%)
    5 / 107 (4.67%)
    9 / 107 (8.41%)
    14 / 214 (6.54%)
         occurrences all number
    6
    12
    1
    6
    13
    19
    Fungal skin infection
         subjects affected / exposed
    2 / 80 (2.50%)
    2 / 79 (2.53%)
    1 / 78 (1.28%)
    2 / 107 (1.87%)
    2 / 107 (1.87%)
    4 / 214 (1.87%)
         occurrences all number
    3
    2
    1
    3
    2
    5
    Furuncle
         subjects affected / exposed
    2 / 80 (2.50%)
    2 / 79 (2.53%)
    1 / 78 (1.28%)
    2 / 107 (1.87%)
    2 / 107 (1.87%)
    4 / 214 (1.87%)
         occurrences all number
    2
    2
    1
    2
    2
    4
    Gastroenteritis
         subjects affected / exposed
    2 / 80 (2.50%)
    3 / 79 (3.80%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    3 / 107 (2.80%)
    5 / 214 (2.34%)
         occurrences all number
    2
    5
    0
    2
    5
    7
    Impetigo
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    2
    0
    0
    2
    2
    Influenza
         subjects affected / exposed
    5 / 80 (6.25%)
    3 / 79 (3.80%)
    2 / 78 (2.56%)
    5 / 107 (4.67%)
    3 / 107 (2.80%)
    8 / 214 (3.74%)
         occurrences all number
    5
    4
    2
    5
    4
    9
    Laryngitis
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    2 / 78 (2.56%)
    0 / 107 (0.00%)
    0 / 107 (0.00%)
    0 / 214 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Localised infection
         subjects affected / exposed
    1 / 80 (1.25%)
    3 / 79 (3.80%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    3 / 107 (2.80%)
    4 / 214 (1.87%)
         occurrences all number
    1
    3
    0
    1
    3
    4
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    2 / 107 (1.87%)
    3 / 214 (1.40%)
         occurrences all number
    0
    2
    0
    1
    2
    3
    Oral candidiasis
         subjects affected / exposed
    0 / 80 (0.00%)
    5 / 79 (6.33%)
    2 / 78 (2.56%)
    0 / 107 (0.00%)
    5 / 107 (4.67%)
    5 / 214 (2.34%)
         occurrences all number
    0
    6
    2
    0
    6
    6
    Oral herpes
         subjects affected / exposed
    4 / 80 (5.00%)
    3 / 79 (3.80%)
    0 / 78 (0.00%)
    4 / 107 (3.74%)
    3 / 107 (2.80%)
    7 / 214 (3.27%)
         occurrences all number
    4
    3
    0
    4
    3
    7
    Otitis externa
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    2 / 214 (0.93%)
         occurrences all number
    3
    0
    0
    3
    0
    3
    Paronychia
         subjects affected / exposed
    2 / 80 (2.50%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    1 / 107 (0.93%)
    3 / 214 (1.40%)
         occurrences all number
    4
    1
    0
    4
    1
    5
    Pharyngitis
         subjects affected / exposed
    3 / 80 (3.75%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    4 / 107 (3.74%)
    1 / 107 (0.93%)
    5 / 214 (2.34%)
         occurrences all number
    3
    1
    0
    4
    1
    5
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    3 / 107 (2.80%)
    4 / 214 (1.87%)
         occurrences all number
    2
    2
    0
    2
    3
    5
    Rash pustular
         subjects affected / exposed
    3 / 80 (3.75%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    3 / 107 (2.80%)
    1 / 107 (0.93%)
    4 / 214 (1.87%)
         occurrences all number
    3
    1
    0
    3
    1
    4
    Sinusitis
         subjects affected / exposed
    1 / 80 (1.25%)
    3 / 79 (3.80%)
    1 / 78 (1.28%)
    3 / 107 (2.80%)
    4 / 107 (3.74%)
    7 / 214 (3.27%)
         occurrences all number
    1
    3
    1
    3
    5
    8
    Skin bacterial infection
         subjects affected / exposed
    3 / 80 (3.75%)
    3 / 79 (3.80%)
    1 / 78 (1.28%)
    3 / 107 (2.80%)
    4 / 107 (3.74%)
    7 / 214 (3.27%)
         occurrences all number
    3
    3
    1
    3
    4
    7
    Skin infection
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 79 (2.53%)
    1 / 78 (1.28%)
    3 / 107 (2.80%)
    2 / 107 (1.87%)
    5 / 214 (2.34%)
         occurrences all number
    1
    3
    1
    3
    3
    6
    Staphylococcal skin infection
         subjects affected / exposed
    3 / 80 (3.75%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    3 / 107 (2.80%)
    1 / 107 (0.93%)
    4 / 214 (1.87%)
         occurrences all number
    4
    1
    0
    4
    1
    5
    Subcutaneous abscess
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    2 / 107 (1.87%)
    0 / 107 (0.00%)
    2 / 214 (0.93%)
         occurrences all number
    2
    0
    0
    2
    0
    2
    Tinea pedis
         subjects affected / exposed
    1 / 80 (1.25%)
    3 / 79 (3.80%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    4 / 107 (3.74%)
    5 / 214 (2.34%)
         occurrences all number
    1
    3
    0
    1
    4
    5
    Tonsillitis
         subjects affected / exposed
    3 / 80 (3.75%)
    3 / 79 (3.80%)
    0 / 78 (0.00%)
    3 / 107 (2.80%)
    5 / 107 (4.67%)
    8 / 214 (3.74%)
         occurrences all number
    3
    3
    0
    3
    5
    8
    Tooth abscess
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    1 / 107 (0.93%)
    3 / 107 (2.80%)
    4 / 214 (1.87%)
         occurrences all number
    1
    2
    0
    1
    3
    4
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 80 (5.00%)
    7 / 79 (8.86%)
    4 / 78 (5.13%)
    4 / 107 (3.74%)
    8 / 107 (7.48%)
    12 / 214 (5.61%)
         occurrences all number
    4
    9
    4
    4
    10
    14
    Urinary tract infection
         subjects affected / exposed
    5 / 80 (6.25%)
    5 / 79 (6.33%)
    3 / 78 (3.85%)
    7 / 107 (6.54%)
    6 / 107 (5.61%)
    13 / 214 (6.07%)
         occurrences all number
    5
    8
    3
    8
    10
    18
    Viral upper respiratory tract infection
         subjects affected / exposed
    17 / 80 (21.25%)
    31 / 79 (39.24%)
    12 / 78 (15.38%)
    20 / 107 (18.69%)
    40 / 107 (37.38%)
    60 / 214 (28.04%)
         occurrences all number
    29
    47
    15
    33
    60
    93
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 80 (1.25%)
    3 / 79 (3.80%)
    1 / 78 (1.28%)
    1 / 107 (0.93%)
    3 / 107 (2.80%)
    4 / 214 (1.87%)
         occurrences all number
    1
    8
    1
    1
    8
    9
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    3 / 107 (2.80%)
    0 / 107 (0.00%)
    3 / 214 (1.40%)
         occurrences all number
    2
    0
    0
    3
    0
    3
    Hypercholesterolaemia
         subjects affected / exposed
    4 / 80 (5.00%)
    1 / 79 (1.27%)
    3 / 78 (3.85%)
    4 / 107 (3.74%)
    1 / 107 (0.93%)
    5 / 214 (2.34%)
         occurrences all number
    4
    1
    3
    4
    1
    5
    Hyperlipidaemia
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    0 / 107 (0.00%)
    2 / 107 (1.87%)
    2 / 214 (0.93%)
         occurrences all number
    0
    2
    0
    0
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Oct 2014
    The amendment was issued to provide continued treatment for patients who were on active therapy during Treatment period 2 of the trial and were eligible and willing to continue with extension of treatment.

    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
    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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