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    Clinical Trial Results:
    A 24-week, multicenter, proSpective stUdy to evaluate the PASI 90 clinical response rate and the safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive patients with moderate to severe chronic plaque-type psoriasis (SUPREME) – amended with an extension treatment period of up to 48 weeks

    Summary
    EudraCT number
    		 2014-002865-31
    Trial protocol
    		 IT  
    Global end of trial date
    08 Jun 2017

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457AIT01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02394561
    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 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office,, Novartis Pharma AG, 41 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
    08 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the clinical response in Cw6-negative and Cw6-positive patients treated with secukinumab 300 mg with respect to the Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks, and thereafter for up to 72 weeks
    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
    10 Apr 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 431
    Worldwide total number of subjects
    431
    EEA total number of subjects
    431
    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)
    395
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Five hundred thirty participants were screened and 434 entered the CORE Phase. However, there were 3 patients without Cw6 assessment which was necessary for stratification to the two arms, therefore 431 were considered enrolled.

    Period 1
    Period 1 title
    CORE Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cw6-positive AIN457 300 mg
    Arm description
    		 Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    two subcutaneous injections secukimumab 150 Mg

    Arm title
    		 Cw6-negative AIN457 300 mg
    Arm description
    		 Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN587
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    two subcutaneous injections secukimumab 150 Mg

    Number of subjects in period 1
    		Cw6-positive AIN457 300 mg Cw6-negative AIN457 300 mg
    Started
    185
    246
    Full Analysis set
    185
    246
    Safety set
    185
    246
    ITT set
    184
    246
    Completed
    172
    227
    Not completed
    13
    19
         Adverse event, serious fatal
    -
    1
         Physician decision
    1
    1
         Consent withdrawn by subject
    2
    2
         Adverse event, non-fatal
    7
    9
         Pregnancy
    1
    -
         Lost to follow-up
    1
    -
         Lack of efficacy
    1
    6
    Period 2
    Period 2 title
    Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cw6-positive AIN457 300 mg
    Arm description
    		 Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    two subcutaneous injections secukimumab 150 Mg

    Arm title
    		 Cw6-negative AIN457 300 mg
    Arm description
    		 Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN587
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    two subcutaneous injections secukimumab 150 Mg

    Number of subjects in period 2 [1]
    		Cw6-positive AIN457 300 mg Cw6-negative AIN457 300 mg
    Started
    162
    219
    Completed
    151
    207
    Not completed
    11
    12
         Adverse event, serious fatal
    -
    1
         Physician decision
    -
    2
         Consent withdrawn by subject
    -
    5
         Adverse event, non-fatal
    6
    1
         Lost to follow-up
    1
    -
         Protocol deviation
    1
    -
         Lack of efficacy
    3
    3
    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: Not all patients from the CORE entered the Extension Phase

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cw6-positive AIN457 300 mg
    Reporting group description
    		 Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks

    Reporting group title
    Cw6-negative AIN457 300 mg
    Reporting group description
    		 Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks

    Reporting group values
    		 Cw6-positive AIN457 300 mg Cw6-negative AIN457 300 mg Total
    Number of subjects
    		 185 246 431
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 173 222 395
        From 65-84 years
    		 12 24 36
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.71 ( 13.148 ) 47.18 ( 12.919 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 60 62 122
        Male
    		 125 184 309
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian|
    		 184 241 425
        Asian|
    		 0 1 1
        Native American|
    		 0 1 1
        Unknown|
    		 0 2 2
        Other|
    		 1 1 2
    Time since first diagnosis of psoriasis
    Units: years
        arithmetic mean (standard deviation)
    		 19.63 ( 12.489 ) 17.46 ( 11.343 ) -

    End points

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    End points reporting groups
    Reporting group title
    Cw6-positive AIN457 300 mg
    Reporting group description
    		 Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks

    Reporting group title
    Cw6-negative AIN457 300 mg
    Reporting group description
    		 Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
    Reporting group title
    Cw6-positive AIN457 300 mg
    Reporting group description
    		 Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks

    Reporting group title
    Cw6-negative AIN457 300 mg
    Reporting group description
    		 Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks

    Subject analysis set title
    Difference in % (Cw6-pos vs Cw6-neg)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.

    Subject analysis set title
    All Patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients in the Full Analysis Set.

    Subject analysis set title
    All Patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients in the Safety Set

    Primary: Percentage (%) of patients who reach Psoriasis area severity index (PASI) 90 at 16 weeks - LOCF approach (ITT set)

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    End point title
    		 Percentage (%) of patients who reach Psoriasis area severity index (PASI) 90 at 16 weeks - LOCF approach (ITT set)
    End point description
    PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.
    End point type
    Primary
    End point timeframe
    Baseline up to 16 weeks
    End point values
    		 Cw6-positive AIN457 300 mg Cw6-negative AIN457 300 mg
    Number of subjects analysed
    184
    246
    Units: percentage of participants
        number (confidence interval 95%)
    80.4 (74.0 to 85.9)
    81.7 (76.3 to 86.3)
    Statistical analysis title
    		 PASI 90 differencee
    Comparison groups
    Cw6-positive AIN457 300 mg v Cw6-negative AIN457 300 mg
    Number of subjects included in analysis
    430
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    Parameter type
    		 difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.8
         upper limit
    		 6.2
    Notes
    [1] - The difference in percentage of patients achieving PASI 90 response between the Cw6-positive cohort and the Cw6-negative cohort was H0 = Cw6-positive minus Cw6-negative ≥0.12 and HA = Cw6-positive minus Cw6-negative was < 0.12. The percentage of PASI 90 response by cohort as well as the difference between cohort together with 97.5% upper CI was provided using Clopper Pearson CI method.

    Secondary: Percentage (%) of patients with IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 responders by visit - LOCF approach (ITT set)

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    End point title
    		 Percentage (%) of patients with IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 responders by visit - LOCF approach (ITT set)
    End point description
    IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). PASI 50,75,90,100 represent: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline, ≥ 75% improvement (reduction), ≥ 90% improvement (reduction) and PASI 100 response/remission: complete clearing of psoriasis (PASI=0).
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 72 weeks
    End point values
    		 Cw6-positive AIN457 300 mg Cw6-negative AIN457 300 mg Difference in % (Cw6-pos vs Cw6-neg)
    Number of subjects analysed
    184
    246
    430
    Units: percentage of participants
    number (confidence interval 95%)
        W1 IGA 0/1 n=178,240,418|
    2.2 (0.62 to 5.65)
    2.1 (0.68 to 4.79)
    0.16 (-2.86 to 3.75)
        W1 PASI 50 n=179,240,419|
    13.4 (8.78 to 19.29)
    12.1 (8.24 to 16.89)
    1.32 (-5.02 to 8.09)
        W1 PASI 75 n=179,240,419|
    2.2 (0.61 to 5.62)
    0.4 (0.01 to 2.30)
    1.82 (-0.52 to 5.20)
        W2 IGA 0/1 n=184,246,430|
    8.7 (5.05 to 13.74)
    6.9 (4.08 to 10.83)
    1.79 (-3.29 to 7.36)
        W2 PASI 50 n=184,245,430|
    44.0 (36.73 to 51.51)
    44.5 (38.16 to 50.95)
    -0.47 (-9.84 to 8.98)
        W2 PASI 75n=184,245,430|
    15.8 (10.82 to 21.84)
    10.2 (6.71 to 14.69)
    5.56 (-0.80 to 12.32)
        W2 PASI 90 n=184,245,430|
    3.3 (1.21 to 6.96)
    2.4 (0.90 to 5.25)
    0.81 (-2.49 to 4.71)
        W2 PASI 100 n=184,245,430|
    0.5 (0.01 to 2.99)
    0.4 (0.01 to 2.25)
    0.14 (-1.78 to 2.63)
        W3 IGA 0/1 n=184,246,430|
    24.5 (18.43 to 31.32)
    21.1 (16.21 to 26.78)
    3.32 (-4.58 to 11.46)
        W3 PASI 50 n=184,245,429|
    76.1 (69.26 to 82.06)
    71.8 (65.76 to 77.38)
    4.25 (-4.23 to 12.40)
        W3 PASI 75 n=184,245,429|
    38.6 (31.52 to 46.03)
    34.3 (28.36 to 40.60)
    4.30 (-4.81 to 13.46)
        W3 PASI 90 n=184,245,429|
    13.0 (8.54 to 18.78)
    11.4 (7.73 to 16.09)
    1.61 (-4.55 to 8.19)
        W3 PASI 100 n=184,245,429|
    2.7 (0.89 to 6.23)
    2.4 (0.90 to 5.25)
    0.27 (-2.92 to 4.00)
        W4 IGA 0/1 n=184,246,430|
    42.4 (35.15 to 49.88)
    39.8 (33.67 to 46.25)
    2.55 (-6.75 to 11.89)
        W4 PASI 50 n=184,246,430|
    87.5 (81.84 to 91.91)
    87.4 (82.59 to 91.27)
    0.10 (-6.51 to 6.31)
        W4 PASI 75 n=184,246,430|
    61.4 (53.97 to 68.48)
    57.3 (50.88 to 63.58)
    4.10 (-5.29 to 13.28)
        W4 PASI 90 n=184,246,430|
    27.7 (21.39 to 34.78)
    22.0 (16.94 to 27.65)
    5.77 (-2.40 to 14.10)
        W4 PASI 100 n=184,246,430|
    10.3 (6.33 to 15.66)
    9.8 (6.35 to 14.17)
    0.57 (-5.09 to 6.66)
        W8 IGA 0/1 n=184,246,430|
    72.3 (65.22 to 78.61)
    73.2 (67.17 to 78.60)
    -0.89 (-9.48 to 7.47)
        W8 PASI 50 n=184,246,430|
    95.7 (91.61 to 98.10)
    95.1 (91.63 to 97.45)
    0.53 (-3.97 to 4.59)
        W8 PASI 75 n=184,246,430|
    84.8 (78.76 to 89.64)
    85.0 (79.87 to 89.18)
    -0.18 (-7.26 to 6.53)
        W8 PASI 90 n=184,246,430|
    61.4 (53.97 to 68.48)
    60.6 (54.16 to 66.72)
    0.84 (-8.46 to 10.01)
        W8 PASI 100 n=184,246,430|
    34.8 (27.93 to 42.14)
    34.6 (28.63 to 40.86)
    0.23 (-8.72 to 9.34)
        WK12 IGA 0/1 n=184,246,430|
    81.0 (74.55 to 86.38)
    81.7 (76.30 to 86.33)
    -0.73 (-8.36 to 6.57)
        WK12 PASI 50 n=184,246,430|
    97.3 (93.77 to 99.11)
    97.2 (94.23 to 98.85)
    0.13 (-3.65 to 3.43)
        WK12 PASI 75 n=184,246,430|
    92.9 (88.22 to 96.18)
    90.7 (86.30 to 93.98)
    2.28 (-3.27 to 7.46)
        WK12 PASI 90 n=184,246,430|
    72.8 (65.79 to 79.11)
    73.6 (67.60 to 78.98)
    -0.75 (-9.30 to 7.56)
        WK12 PASI 100 n=184,246,430|
    49.5 (42.02 to 56.91)
    43.9 (37.60 to 50.35)
    5.55 (-3.93 to 14.94)
        WK16 IGA 0/1 n=184,246,430|
    85.3 (79.37 to 90.10)
    86.2 (81.23 to 90.23)
    -0.85 (-7.79 to 5.70)
        WK16 PASI 50 n=184,246,430|
    97.8 (94.53 to 99.40)
    98.8 (96.48 to 99.75)
    -0.95 (-4.33 to 1.70)
        WK16 PASI 75 n=184,246,430|
    94.0 (89.56 to 96.98)
    93.1 (89.17 to 95.92)
    0.93 (-4.16 to 5.60)
        WK16 PASI 90 n=184,246,430|
    80.4 (73.96 to 85.90)
    81.7 (76.30 to 86.33)
    -1.27 (-8.94 to 6.08)
        WK16 PASI 100 n=184,246,430|
    59.2 (51.77 to 66.41)
    53.3 (46.81 to 59.62)
    5.99 (-3.49 to 15.24)
        WK20 IGA0/1 n=184,246,430|
    87.0 (81.22 to 91.46)
    87.4 (82.59 to 91.27)
    -0.44 (-7.11 to 5.83)
        WK20 PASI 50 n=184,246,430|
    97.8 (94.53 to 99.40)
    97.6 (94.77 to 99.10)
    0.27 (-3.27 to 3.34)
        WK20 PASI 75 n=184,246,430|
    94.6 (90.23 to 97.36)
    92.7 (88.68 to 95.61)
    1.88 (-3.14 to 6.53)
        WK20 PASI 90 n=184,246,430|
    81.0 (74.55 to 86.38)
    81.7 (76.30 to 86.33)
    -0.73 (-8.36 to 6.57)
        WK20 PASI 100 n=184,246,430|
    59.8 (52.32 to 66.93)
    57.3 (50.88 to 63.58)
    2.47 (-6.93 to 11.71)
        WK24 IGA 0/1 n=184,246,430|
    89.7 (84.34 to 93.67)
    85.4 (80.32 to 89.54)
    4.31 (-2.21 to 10.45)
        WK24 PASI 50 n=184,246,430|
    97.3 (93.77 to 99.11)
    97.2 (94.23 to 98.85)
    0.13 (-3.65 to 3.43)
        WK24 PASI 75 n=184,246,430|
    94.6 (90.23 to 97.36)
    93.1 (89.17 to 95.92)
    1.48 (-3.51 to 6.07)
        WK24 PASI 90 n=184,246,430|
    84.2 (78.16 to 89.18)
    83.3 (78.08 to 87.77)
    0.91 (-6.35 to 7.79)
        WK24 PASI 100 n=184,246,430|
    62.0 (54.52 to 69.00)
    61.4 (54.99 to 67.50)
    0.57 (-8.71 to 9.71)
        WK36 IGA 0/1 n=161,219,380|
    91.9 (86.59 to 95.63)
    90.9 (86.25 to 94.33)
    1.06 (-5.06 to 6.68)
        WK36 PASI 50 n=161,219,380|
    98.8 (95.58 to 99.85)
    99.1 (96.74 to 99.89)
    -0.33 (-3.57 to 2.19)
        WK36 PASI 75 n=161,219,380|
    94.4 (89.65 to 97.41)
    95.0 (91.19 to 97.47)
    -0.57 (-5.75 to 4.00)
        WK36 PASI 90n=161,219,380|
    88.8 (82.91 to 93.24)
    84.0 (78.48 to 88.61)
    4.80 (-2.39 to 11.54)
        WK36 PASI 100 n=161,219,380|
    65.8 (57.96 to 73.12)
    64.4 (57.65 to 70.72)
    1.45 (-8.27 to 10.95)
        WK48 IGA 0/1 n=115,159,274|
    87.8 (80.42 to 93.18)
    86.8 (80.52 to 91.63)
    1.03 (-7.43 to 8.82)
        WK48 PASI 50n=115,159,274|
    98.3 (93.86 to 99.79)
    98.1 (94.59 to 99.61)
    0.15 (-4.41 to 3.88)
        WK48 PASI 75 n=115,159,274|
    93.9 (87.86 to 97.52)
    91.2 (85.67 to 95.10)
    2.72 (-4.18 to 8.98)
        WK48 PASI 90 n=115,159,274|
    84.3 (76.40 to 90.45)
    80.5 (73.48 to 86.35)
    3.84 (-5.59 to 12.64)
        WK48 PASI 100 n=115,159,274|
    68.7 (59.38 to 77.02)
    61.6 (53.60 to 69.23)
    7.06 (-4.44 to 18.02)
        WK60 IGA 0/1 n=80,118,198|
    87.5 (78.21 to 93.84)
    83.9 (76.00 to 90.02)
    3.60 (-6.97 to 13.09)
        WK60 PASI 50 n=80,119,199|
    96.3 (89.43 to 99.22)
    95.0 (89.35 to 98.13)
    1.29 (-5.94 to 7.34)
        WK60 PASI 75 n=80,119,199|
    90.0 (81.24 to 95.58)
    89.9 (83.05 to 94.68)
    0.08 (-9.42 to 8.37)
        WK60 PASI 90 n=80,119,199|
    82.5 (72.38 to 90.09)
    74.8 (66.01 to 82.30)
    7.71 (-4.27 to 18.58)
        WK60 PASI 100 n=80,119,199|
    65.0 (53.52 to 75.33)
    56.3 (46.91 to 65.37)
    8.70 (-5.19 to 21.80)
        WK72 IGA 0/1 n=41,60,101|
    85.4 (70.83 to 94.43)
    80.0 (67.67 to 89.22)
    5.37 (-10.7 to 19.47)
        WK72 PASI 50 n=41,61,102|
    92.7 (80.08 to 98.46)
    93.4 (84.05 to 98.18)
    -0.76 (-13.5 to 9.55)
        WK72 PASI 75 n=41,61,102|
    85.4 (70.83 to 94.43)
    88.5 (77.78 to 95.26)
    -3.16 (-18.1 to 9.79)
        WK72 PASI 90 n=41,61,102|
    75.6 (59.70 to 87.64)
    73.8 (60.93 to 84.20)
    1.84 (-15.8 to 17.98)
        WK72 PASI 100 n=41,61,102|
    58.5 (42.11 to 73.68)
    50.8 (37.70 to 63.86)
    7.72 (-11.7 to 26.08)
    No statistical analyses for this end point

    Secondary: Percent mean changes from baseline in IGA mod 2011 between cohorts at each time point (LOCF) (ITT)

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    End point title
    		 Percent mean changes from baseline in IGA mod 2011 between cohorts at each time point (LOCF) (ITT)
    End point description
    IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe').
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 72 weeks
    End point values
    		 Cw6-positive AIN457 300 mg Cw6-negative AIN457 300 mg
    Number of subjects analysed
    184
    246
    Units: numbers on a score
    arithmetic mean (standard deviation)
        W1 n=178,240|
    -8.5 ( 16.08 )
    -7.3 ( 17.04 )
        W2 n=184,246|
    -22.4 ( 22.73 )
    -21.6 ( 22.72 )
        W3 n=184,246|
    -38.0 ( 25.45 )
    -36.5 ( 27.20 )
        W4 n=184,246|
    -49.6 ( 29.36 )
    -49.5 ( 29.24 )
        W8 n=184,246|
    -71.2 ( 28.60 )
    -71.2 ( 28.91 )
        W12 n=184,246|
    -78.7 ( 27.31 )
    -79.0 ( 25.37 )
        W16 n=184,246|
    -84.1 ( 24.52 )
    -83.3 ( 22.97 )
        W20 n=184,246|
    -85.3 ( 24.26 )
    -84.5 ( 23.80 )
        W24 n=184,246|
    -86.2 ( 25.17 )
    -84.1 ( 26.34 )
        W36 n=161,219|
    -88.6 ( 22.34 )
    -87.6 ( 23.82 )
        W48 n=115,159|
    -86.2 ( 25.75 )
    -84.9 ( 26.06 )
        W60 n=80,118|
    -83.3 ( 28.44 )
    -81.0 ( 26.97 )
        W72 n=41,60|
    -79.1 ( 32.92 )
    -75.8 ( 29.58 )
    No statistical analyses for this end point

    Secondary: Median time to reach PASI 90 and 75 (ITT)

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    End point title
    		 Median time to reach PASI 90 and 75 (ITT)
    End point description
    Time in days to reach PASI scores of 90 and 75.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 72 weeks
    End point values
    		 Cw6-positive AIN457 300 mg Cw6-negative AIN457 300 mg
    Number of subjects analysed
    184
    246
    Units: days
        PASI 90|
    57
    58
        PASI 75|
    29
    29
    Statistical analysis title
    		 Difference in PASI 90
    Comparison groups
    Cw6-positive AIN457 300 mg v Cw6-negative AIN457 300 mg
    Number of subjects included in analysis
    430
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 = 0.1295
    Method
    		 Logrank
    Confidence interval
    Notes
    [2] - difference between cohorts for PASI 90 using Kaplan-Meier estimate
    Statistical analysis title
    		 Difference in PASI 75
    Comparison groups
    Cw6-positive AIN457 300 mg v Cw6-negative AIN457 300 mg
    Number of subjects included in analysis
    430
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.447 [3]
    Method
    		 Logrank
    Confidence interval
    Notes
    [3] - difference between cohorts for PASI 75 using Kaplan-Meier estimate

    Secondary: Change from baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS)

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    End point title
    		 Change from baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS)
    End point description
    The DLQI total score was calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6- 10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximatly 72 weeks
    End point values
    		 All Patients
    Number of subjects analysed
    431
    Units: numbers in a score
    arithmetic mean (standard deviation)
        Week 16 n=386|
    -8.5 ( 6.79 )
        Week 24 n=420|
    -8.8 ( 7.05 )
        Week 48 n=384|
    -8.9 ( 7.13 )
        Week 72 n=215|
    -8.3 ( 6.70 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean scores of HAD-A and HAD-D (anxiety and depression) (LOCF) (FAS)

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    End point title
    		 Change from baseline in mean scores of HAD-A and HAD-D (anxiety and depression) (LOCF) (FAS)
    End point description
    The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale.. Seven of the items relate to anxiety and seven relate to depression. This outcome measure was specifically developed to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Calculations of scores: each of the 14 items was rated on a 4-point scale (‘Yes, definitely’, ‘Yes, sometimes’, ‘No, not much’ and ‘No, not at all’). All items except 7 and 10 were scored as ‘Yes, definitely’ = 3 to ‘No, not at all’ = 0. Items 7 and 10 were scored as ‘Yes, definitely’ = 0 to ‘No, not at all’ = 3. The HADS consisted of two sub-scores: the HAD-A for anxiety and HAD-D for depression; each sub-score ranged from 0 to 21 points; scores ≥11 indicated the presence of anxious or depressive disorders; scores between 8-10 points were borderline abnormal, and scores of ≤7 indicated that the disorder was not present. HADS questionnaire
    End point type
    Secondary
    End point timeframe
    Baseline up approximately 72 weeks
    End point values
    		 All Patients
    Number of subjects analysed
    431
    Units: numbers on a scale
    arithmetic mean (standard deviation)
        W16 Anxiety n=388|
    -1.7 ( 3.37 )
        W24 Anxiety n=420|
    -2.0 ( 3.38 )
        W48 Anxiety n=384|
    -2.5 ( 3.67 )
        W72 Anxiety n=214|
    -2.3 ( 3.44 )
        W16 Depression n=388|
    -1.3 ( 3.19 )
        W24 Depression n=420|
    -1.4 ( 3.22 )
        W48 Depression n=384|
    -1.5 ( 3.31 )
        W72 Depression n=214|
    -1.7 ( 3.19 )
    No statistical analyses for this end point

    Secondary: Correlation between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS)

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    End point title
    		 Correlation between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS)
    End point description
    PASI score, HADS questionnaire correlation using Spearman rank correlation coefficient
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 72 weeks
    End point values
    		 All Patients
    Number of subjects analysed
    431
    Units: numbers on scores
        Baseline|
    2
        Week 16|
    19
        Week 24|
    18
        Week 48|
    21
        Week 72|
    32
    No statistical analyses for this end point

    Secondary: Changes from baseline in Body Mass Index (Safety Set)

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    End point title
    		 Changes from baseline in Body Mass Index (Safety Set)
    End point description
    Change in Body mass index from baseline for patients with a value at baseline and the respective post-baseline visit
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 72 weeks
    End point values
    		 Cw6-positive AIN457 300 mg Cw6-negative AIN457 300 mg
    Number of subjects analysed
    185
    246
    Units: kg/m2
    arithmetic mean (standard deviation)
        Week 16 n=163,224|
    -0.064 ( 0.7748 )
    -0.047 ( 0.9905 )
        Week 24 n=170,231|
    0.086 ( 1.0213 )
    -0.071 ( 1.2260 )
        Week 48 n=103,141|
    0.302 ( 1.3474 )
    -0.052 ( 1.4991 )
        Week 72 n=29,46|
    0.533 ( 1.8101 )
    -0.015 ( 1.8982 )
    No statistical analyses for this end point

    Secondary: Changes from baseline in Waist Circumference (Safety Set)

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    End point title
    		 Changes from baseline in Waist Circumference (Safety Set)
    End point description
    Change in waist circumference from baseline for patients with a value at baseline and the respective post-baseline visit
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 72 weeks
    End point values
    		 Cw6-positive AIN457 300 mg Cw6-negative AIN457 300 mg
    Number of subjects analysed
    185
    246
    Units: cm
    arithmetic mean (standard deviation)
        Week 16 n=153,210|
    -0.86 ( 3.147 )
    -0.40 ( 3.006 )
        Week 24 n=154,216|
    -0.81 ( 3.689 )
    -0.73 ( 4.119 )
        Week 48 n=95,131|
    -0.76 ( 4.596 )
    -0.72 ( 5.547 )
        Week 72 n=27,43|
    -1.81 ( 4.583 )
    -0.47 ( 4.501 )
    No statistical analyses for this end point

    Secondary: Changes from baseline in Weight (Safety Set)

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    End point title
    		 Changes from baseline in Weight (Safety Set)
    End point description
    Change in weight from baseline for patients with a value at baseline and the respective post-baseline visit
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 72 weeks
    End point values
    		 Cw6-positive AIN457 300 mg Cw6-negative AIN457 300 mg
    Number of subjects analysed
    185
    246
    Units: kg
    arithmetic mean (standard deviation)
        Week 16 n163,224|
    -0.20 ( 2.242 )
    -0.13 ( 2.809 )
        Week 24 n=170,231|
    0.24 ( 3.008 )
    -0.21 ( 3.572 )
        Week 48 n=103,141|
    0.87 ( 3.909 )
    -0.15 ( 4.329 )
        Week 72 n=29,46|
    1.40 ( 4.678 )
    -0.05 ( 5.538 )
    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 up to approximately 72 weeks
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Cw6-Positive AIN457 300 mg
    Reporting group description
    		 Cw6-Positive AIN457 300 mg

    Reporting group title
    Cw6-Negative AIN457 300 mg
    Reporting group description
    		 Cw6-Negative AIN457 300 mg

    Serious adverse events
    		 Cw6-Positive AIN457 300 mg Cw6-Negative AIN457 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 185 (5.41%)
    21 / 246 (8.54%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Scrotal inflammation
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract irritation
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 185 (0.00%)
    2 / 246 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 185 (0.54%)
    2 / 246 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 185 (0.54%)
    2 / 246 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neutropenia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic lesion
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 185 (0.00%)
    3 / 246 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enthesopathy
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscal degeneration
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cw6-Positive AIN457 300 mg Cw6-Negative AIN457 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 185 (10.81%)
    14 / 246 (5.69%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    11 / 185 (5.95%)
    10 / 246 (4.07%)
         occurrences all number
    15
    10
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    12 / 185 (6.49%)
    4 / 246 (1.63%)
         occurrences all number
    16
    4

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Nov 2014
    The primary objective of the study was reworded: “To evaluate the clinical response in Cw6-negative patients compared to Cw6-positive patients treated with secukinumab 300 mg with respect to the PASI 90 response rate after 16 weeks”. Other parts of the protocol, as well as the description of the study rational, were also modified to suit the aim of the study. Population was stratified for different variables that could condition therapeutic response, and appropriately identified TNF-α polymorphism, smoking, BMI and metabolic syndrome. Other items were also corrected or clarified in this amendment: better defined inclusion criteria concerning the psoriasis diagnosis, differentiated the wash-out periods to be used for biological immunomodulating agents before starting treatment with secukinumab, specified the hepatitis B surface antigens and antibodies used for required hepatitis B testing, removed FPG and lipid panel from the “fasting lab assessments”, clarified the number of injections of secukinumab to be administered during the treatment period,
    03 Sep 2015
    This amendment was to provide continued treatment of patients on secukinumab for an additional 48 weeks (overall up to 72 weeks), and thus allowed for safety, tolerability, and efficacy data collection from the participating patients over a longer period of time. Furthermore, as a consequence of the European Medicines Agency’s (EMA) approval in February 2015 of secukinumab “for the treatment of moderate severe plaque psoriasis in adults who are candidates for systemic therapy,” inclusion criterion number 5 was changed in order to guarantee treatment to the population of systemically naïve patients, as per label.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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