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    Clinical Trial Results:
    Secukinumab In patients with moderate to severe active, chronic plaque psoriasis who have failed on tumor necrosis factor alpha (TNFα) antaGoNists: A clinical Trial EvalUating Treatment REsults

    Summary
    EudraCT number
    		 2013-001855-11
    Trial protocol
    		 GB   IE  
    Global end of trial date
    12 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Feb 2018
    First version publication date
    02 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457AGB01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01961609
    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 4163241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 4163241111,
    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
    12 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of secukinumab (300mg) treatment with respect to PASI 75 response rate after 16 weeks treatment, by assessing the percentage (%) of patients achieving PASI 75 after 16 weeks compared to baseline (defined as PASI status at Week 0).
    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
    09 Oct 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
    Ireland: 12
    Country: Number of subjects enrolled
    United Kingdom: 223
    Worldwide total number of subjects
    235
    EEA total number of subjects
    235
    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)
    223
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study consisted of 3 periods: initiation, maintenance 1 and maintenance 2. During the initiation period, participants received secukinumab 150 mg or 300 mg for 16 weeks.

    Pre-assignment
    Screening details
    		 For both maintenance periods 1 and 2, after 16 weeks and 48 weeks, respectively, responders at both the 150 mg and 300 mg doses continued on their initiation doses during maintenance periods 1 and 2. Non-responders at 150 mg were uptitrated to 300 mg. Non-responders at 300 mg returned to routine treatment under the care of their usual clinician.

    Period 1
    Period 1 title
    Initiation (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab (AIN457) 300 mg
    Arm description
    		 Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.

    Arm title
    		 Secukinumab (AIN457) 150 mg
    Arm description
    		 Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.

    Number of subjects in period 1
    		Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg
    Started
    119
    116
    Safety set
    118
    115
    Full analysis set
    118
    115
    Completed
    107
    103
    Not completed
    12
    13
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    3
    5
         Randomized but not treated
    1
    1
         Protocol deviation
    1
    -
         Administrative problems
    1
    -
         Abnormal lab values
    -
    1
         Missing
    3
    2
         Lack of efficacy
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab (AIN457) 300 mg
    Reporting group description
    		 Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.

    Reporting group title
    Secukinumab (AIN457) 150 mg
    Reporting group description
    		 Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.

    Reporting group values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg Total
    Number of subjects
    		 119 116 235
    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)
    		 114 109 223
        From 65-84 years
    		 5 7 12
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 46.6 ( 11.63 ) 44.6 ( 11.73 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 51 52 103
        Male
    		 68 64 132

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab (AIN457) 300 mg
    Reporting group description
    		 Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.

    Reporting group title
    Secukinumab (AIN457) 150 mg
    Reporting group description
    		 Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician.

    Subject analysis set title
    Secukinumab (AIN457) 300 mg subgroup 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy

    Subject analysis set title
    Secukinumab (AIN457) 300 mg subgroup 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response

    Subject analysis set title
    Secukinumab (AIN457) 300 mg subgroup 3
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who have tried and failed more than one anti-TNFalpha therapies

    Subject analysis set title
    Secukinumab (AIN457) 150 mg subgroup 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy

    Subject analysis set title
    Secukinumab (AIN457) 150 mg subgroup 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response

    Subject analysis set title
    Secukinumab (AIN457) 150 mg subgroup 3
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who have tried and failed more than one anti-TNFalpha therapies

    Subject analysis set title
    Secukinumab (AIN457A) 300 mg subgroups 1 and 2 combined
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who experienced an IR after trying first anti-TNFalpha therapy and participants who had initially experienced an adequate response after trying the first anti-TNFalpha therapy but then had subsequently lost that response.

    Subject analysis set title
    Secukinumab (AIN457) 150 mg subgroups 1 and 2 combined
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who experienced an IR after trying first anti-TNFalpha therapy and participants who had initially experienced an adequate response after trying the first anti-TNFalpha therapy but then had subsequently lost that response.

    Subject analysis set title
    Secukinumab (AIN457) 150 mg - 300 mg (Maintanence period 1)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16.

    Subject analysis set title
    Secukinumab (AIN457) 150 mg - 300 mg (Maintenance period 2)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Non-responders at secukinumab 150 mg from maintenance 1 period were uptitrated to secukinumab 300 mg at week 48.

    Primary: Percentage of secukinumab 300 mg participants achieving PASI 75 at 16 weeks

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    End point title
    		 Percentage of secukinumab 300 mg participants achieving PASI 75 at 16 weeks [1] [2]
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.
    End point type
    Primary
    End point timeframe
    16 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis applies to the Secukinumab (AIN457) 300 mg group only. Non-inferiority/equivalence test = No P-Value: <0.0001 Method of estimation: 2-sided binomial exact test Estimated value: 65.3 percent (A Bonferroni adjustment adjusting for 8 analyses have been applied.) 99.375% Confidence interval, 2-sided: 52.4 to 76.7
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All arms do not apply to this end point.
    End point values
    		 Secukinumab (AIN457) 300 mg
    Number of subjects analysed
    118
    Units: Percentage of participants
        number (not applicable)
    65.3
    No statistical analyses for this end point

    Secondary: Percentage of secukinumab 150 mg participants achieving PASI 75 at 16 weeks

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    End point title
    		 Percentage of secukinumab 150 mg participants achieving PASI 75 at 16 weeks [3]
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.
    End point type
    Secondary
    End point timeframe
    16 Weeks
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All arms do not apply to this end point.
    End point values
    		 Secukinumab (AIN457) 150 mg
    Number of subjects analysed
    115
    Units: Percentage of participants
        number (not applicable)
    44.3
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving PASI 75 according to 3 key participant subgroups (Primary Inadequate Response (IR), Secondary IR and IR after more than one anti-TNFalpha therapies) at 16 weeks

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    End point title
    		 Percentage of participants achieving PASI 75 according to 3 key participant subgroups (Primary Inadequate Response (IR), Secondary IR and IR after more than one anti-TNFalpha therapies) at 16 weeks
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.
    End point type
    Secondary
    End point timeframe
    16 Weeks
    End point values
    		 Secukinumab (AIN457) 300 mg subgroup 1 Secukinumab (AIN457) 300 mg subgroup 2 Secukinumab (AIN457) 300 mg subgroup 3 Secukinumab (AIN457) 150 mg subgroup 1 Secukinumab (AIN457) 150 mg subgroup 2 Secukinumab (AIN457) 150 mg subgroup 3
    Number of subjects analysed
    14
    44
    44
    18
    42
    37
    Units: Percentage of participants
        number (not applicable)
    71.4
    70.5
    47.7
    38.9
    61.9
    32.4
    No statistical analyses for this end point

    Secondary: Percentage of participants achieiving PASI 75 - Initiation Period

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    End point title
    		 Percentage of participants achieiving PASI 75 - Initiation Period
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.
    End point type
    Secondary
    End point timeframe
    2 ,4, 8, 12 and 16 Weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg
    Number of subjects analysed
    118
    115
    Units: Percentage of participants
    number (not applicable)
        Week 2
    1.7
    2.6
        Week 4
    27.1
    18.3
        Week 8
    60.2
    40.0
        Week 12
    61.9
    52.2
        Week 16
    65.3
    44.3
    No statistical analyses for this end point

    Secondary: Percentage of participants achieiving PASI 75 - Maintenance 1 Period

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    End point title
    		 Percentage of participants achieiving PASI 75 - Maintenance 1 Period
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.
    End point type
    Secondary
    End point timeframe
    16, 24 and 48 Weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg Secukinumab (AIN457) 150 mg - 300 mg (Maintanence period 1)
    Number of subjects analysed
    107
    66
    37
    Units: Percentage of participants
    number (not applicable)
        Week 16
    72.0
    75.8
    2.7
        Week 24
    61.7
    68.2
    13.5
        Week 48
    52.3
    39.4
    8.1
    No statistical analyses for this end point

    Secondary: Percentage of participants achieiving PASI 75 - Maintenance 2 Period

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    End point title
    		 Percentage of participants achieiving PASI 75 - Maintenance 2 Period
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.
    End point type
    Secondary
    End point timeframe
    48 and 72 Weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg Secukinumab (AIN457) 150 mg - 300 mg (Maintanence period 1) Secukinumab (AIN457) 150 mg - 300 mg (Maintenance period 2)
    Number of subjects analysed
    83
    31
    16
    24
    Units: Percentage of participants
    number (not applicable)
        Week 48
    65.1
    80.6
    18.8
    4.2
        Week 72
    65.1
    58.1
    25.0
    37.5
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving PASI 50 and PASI 90 - Initiation Period

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    End point title
    		 Percentage of participants achieving PASI 50 and PASI 90 - Initiation Period
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
    End point type
    Secondary
    End point timeframe
    2, 4, 8, 12, 16 Weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg
    Number of subjects analysed
    118
    115
    Units: Percentage of participants
    number (not applicable)
        PASI 50, week 2
    28.0
    25.2
        PASI 50, week 4
    63.6
    57.4
        PASI 50, week 8
    84.7
    67.8
        PASI 50, week 12
    82.2
    69.6
        PASI 50, week 16
    82.2
    65.2
        PASI 90, week 2
    0
    0
        PASI 90, week 4
    6.8
    4.3
        PASI 90, week 8
    25.4
    20.0
        PASI 90, week 12
    38.1
    25.2
        PASI 90, week 16
    41.5
    20.0
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving PASI 50 and PASI 90 - Maintenance 1 Period

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    End point title
    		 Percentage of participants achieving PASI 50 and PASI 90 - Maintenance 1 Period
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
    End point type
    Secondary
    End point timeframe
    16, 24 and 48 Weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg Secukinumab (AIN457) 150 mg - 300 mg (Maintanence period 1)
    Number of subjects analysed
    107
    66
    37
    Units: Percentage of participants
    number (not applicable)
        PASI 50, week 16
    89.7
    95.5
    24.3
        PASI 50, week 24
    80.4
    89.4
    54.1
        PASI 50, week 48
    70.1
    65.2
    32.4
        PASI 90, week 16
    45.8
    34.8
    0
        PASI 90, week 24
    39.3
    37.9
    2.7
        PASI 90, week 48
    31.8
    18.2
    5.4
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving PASI 50 and PASI 90 - Maintenance 2 Period

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    End point title
    		 Percentage of participants achieving PASI 50 and PASI 90 - Maintenance 2 Period
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.
    End point type
    Secondary
    End point timeframe
    48 and 72 Weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg Secukinumab (AIN457) 150 mg - 300 mg (Maintanence period 1) Secukinumab (AIN457) 150 mg - 300 mg (Maintenance period 2)
    Number of subjects analysed
    83
    31
    16
    24
    Units: Percentage of participants
    number (not applicable)
        PASI 50, week 48
    88.0
    96.8
    75.0
    50.0
        PASI 50, week 72
    74.7
    80.6
    37.5
    70.8
        PASI 90, week 48
    41.0
    38.7
    12.5
    0
        PASI 90, week 72
    38.6
    22.6
    18.8
    16.7
    No statistical analyses for this end point

    Secondary: Percentage of participants who have failed on one anti-TNFα achieving PASI 75 (subgroups 1 and 2 combined) at 16 weeks

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    End point title
    		 Percentage of participants who have failed on one anti-TNFα achieving PASI 75 (subgroups 1 and 2 combined) at 16 weeks
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.
    End point type
    Secondary
    End point timeframe
    16 Weeks
    End point values
    		 Secukinumab (AIN457A) 300 mg subgroups 1 and 2 combined Secukinumab (AIN457) 150 mg subgroups 1 and 2 combined
    Number of subjects analysed
    58
    60
    Units: Percentage of participants
        number (not applicable)
    70.7
    55.0
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving NICE continuation criteria (PASI 75 or PASI 50 plus a 5 point improvement in DLQI) at 16 weeks

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    End point title
    		 Percentage of participants achieving NICE continuation criteria (PASI 75 or PASI 50 plus a 5 point improvement in DLQI) at 16 weeks
    End point description
    PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
    End point type
    Secondary
    End point timeframe
    16 Weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg
    Number of subjects analysed
    118
    115
    Units: Percentage of participants
        number (not applicable)
    81.4
    60.9
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Dermatology Life Quality Index (DLQI)Total scores - Initiation Period

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    End point title
    		 Mean change from baseline in Dermatology Life Quality Index (DLQI)Total scores - Initiation Period
    End point description
    The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    12 and 16 weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg
    Number of subjects analysed
    118
    115
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 12, initiation (n=111,108)
    -15.6 ( 7.49 )
    -13.2 ( 7.36 )
        Week 16, initiation (n=109,103)
    -16.1 ( 6.80 )
    -12.3 ( 7.68 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Dermatology Life Quality Index (DLQI)Total scores - Maintenance 1 Period

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    End point title
    		 Mean change from baseline in Dermatology Life Quality Index (DLQI)Total scores - Maintenance 1 Period
    End point description
    The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    16, 24 and 48 weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg Secukinumab (AIN457) 150 mg - 300 mg (Maintanence period 1)
    Number of subjects analysed
    107
    66
    37
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 16, maintenance 1 (n=106,64,36)
    -16.3 ( 6.67 )
    -15.9 ( 6.31 )
    -6.1 ( 5.86 )
        Week 24, maintenance 1(n=102,64,35)
    -15.7 ( 7.25 )
    -14.4 ( 6.73 )
    -8.7 ( 6.01 )
        Week 48, maintenance 1 (n=86, 55, 19)
    -16.2 ( 8.06 )
    -11.5 ( 8.14 )
    -9.8 ( 6.76 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Dermatology Life Quality Index (DLQI)Total scores - Maintenance 2 Period

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    End point title
    		 Mean change from baseline in Dermatology Life Quality Index (DLQI)Total scores - Maintenance 2 Period
    End point description
    The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    48 and 72 weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg Secukinumab (AIN457) 150 mg - 300 mg (Maintanence period 1) Secukinumab (AIN457) 150 mg - 300 mg (Maintenance period 2)
    Number of subjects analysed
    83
    31
    16
    24
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 48, maintenance 2 (n=79,30,16,24)
    -17.2 ( 7.33 )
    -14.7 ( 6.19 )
    -11.5 ( 5.98 )
    -7.7 ( 8.80 )
        Week 72, maintenance 2 (n=74,26,12,21)
    -17.0 ( 7.27 )
    -13.0 ( 5.62 )
    -11.3 ( 4.77 )
    -15.0 ( 8.76 )
    No statistical analyses for this end point

    Secondary: Mean EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) health state assessment scores (from 0 to 100) - Initiation Period

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    End point title
    		 Mean EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) health state assessment scores (from 0 to 100) - Initiation Period
    End point description
    The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.
    End point type
    Secondary
    End point timeframe
    12 and 16 weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg
    Number of subjects analysed
    118
    115
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 12, initiation(n=110,106)
    76.25 ( 18.612 )
    72.92 ( 20.004 )
        Week 16, initiation (n=108,103)
    76.30 ( 21.580 )
    75.25 ( 19.100 )
    No statistical analyses for this end point

    Secondary: Mean EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) health state assessment scores (from 0 to 100) - Maintenance 1 Period

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    End point title
    		 Mean EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) health state assessment scores (from 0 to 100) - Maintenance 1 Period
    End point description
    The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.
    End point type
    Secondary
    End point timeframe
    16, 24 and 48 weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg Secukinumab (AIN457) 150 mg - 300 mg (Maintanence period 1)
    Number of subjects analysed
    107
    66
    37
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 16, maintenance 1 (n=105,64,37)
    77.33 ( 20.665 )
    80.48 ( 16.099 )
    67.03 ( 20.657 )
        Week 24, maintenance 1 (n=102,64,35)
    79.16 ( 18.587 )
    80.05 ( 16.345 )
    69.14 ( 19.587 )
        Week 48, maintenance 1 (n=86,55,19)
    77.73 ( 21.598 )
    76.07 ( 20.413 )
    70.37 ( 18.038 )
    No statistical analyses for this end point

    Secondary: Mean EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) health state assessment scores (from 0 to 100) - Maintenance 2 Period

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    End point title
    		 Mean EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) health state assessment scores (from 0 to 100) - Maintenance 2 Period
    End point description
    The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.
    End point type
    Secondary
    End point timeframe
    48 and 72 weeks
    End point values
    		 Secukinumab (AIN457) 300 mg Secukinumab (AIN457) 150 mg Secukinumab (AIN457) 150 mg - 300 mg (Maintanence period 1) Secukinumab (AIN457) 150 mg - 300 mg (Maintenance period 2)
    Number of subjects analysed
    83
    31
    16
    24
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 48, maintenance 2 (n=79,30,16,24)
    80.22 ( 19.200 )
    83.87 ( 11.337 )
    74.50 ( 14.855 )
    67.63 ( 24.912 )
        Week 72, maintenance 2 (n=73,26,12,21)
    78.24 ( 19.792 )
    80.88 ( 17.635 )
    77.67 ( 16.615 )
    79.67 ( 18.680 )
    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 reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    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
    18.0
    Reporting groups
    Reporting group title
    Secukinumab 150mg
    Reporting group description
    		 Secukinumab 150mg

    Reporting group title
    Secukinumab 300mg
    Reporting group description
    		 Secukinumab 300mg

    Serious adverse events
    		 Secukinumab 150mg Secukinumab 300mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 115 (12.17%)
    24 / 179 (13.41%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Diabetic macroangiopathy
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         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
    Chills
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocution
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         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 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Pregnancy of partner
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Alcoholic seizure
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 115 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug withdrawal convulsions
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 115 (0.87%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis alcoholic
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    0 / 115 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash erythematous
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (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
    Glomerulonephritis proliferative
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         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 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 115 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 115 (0.87%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 115 (1.74%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (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 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval abscess
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Secukinumab 150mg Secukinumab 300mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    88 / 115 (76.52%)
    152 / 179 (84.92%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 115 (0.00%)
    9 / 179 (5.03%)
         occurrences all number
    0
    10
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 115 (6.96%)
    7 / 179 (3.91%)
         occurrences all number
    9
    7
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    3 / 115 (2.61%)
    0 / 179 (0.00%)
         occurrences all number
    3
    0
    Fatigue
         subjects affected / exposed
    9 / 115 (7.83%)
    8 / 179 (4.47%)
         occurrences all number
    28
    11
    Influenza like illness
         subjects affected / exposed
    8 / 115 (6.96%)
    7 / 179 (3.91%)
         occurrences all number
    8
    10
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    3 / 115 (2.61%)
    6 / 179 (3.35%)
         occurrences all number
    3
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 115 (9.57%)
    20 / 179 (11.17%)
         occurrences all number
    11
    26
    Dyspnoea
         subjects affected / exposed
    1 / 115 (0.87%)
    4 / 179 (2.23%)
         occurrences all number
    1
    4
    Nasal congestion
         subjects affected / exposed
    3 / 115 (2.61%)
    4 / 179 (2.23%)
         occurrences all number
    3
    5
    Oropharyngeal pain
         subjects affected / exposed
    9 / 115 (7.83%)
    29 / 179 (16.20%)
         occurrences all number
    13
    39
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 115 (0.00%)
    4 / 179 (2.23%)
         occurrences all number
    0
    4
    Psychiatric disorders
    Depression
         subjects affected / exposed
    6 / 115 (5.22%)
    4 / 179 (2.23%)
         occurrences all number
    7
    4
    Insomnia
         subjects affected / exposed
    1 / 115 (0.87%)
    5 / 179 (2.79%)
         occurrences all number
    1
    5
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 115 (1.74%)
    6 / 179 (3.35%)
         occurrences all number
    2
    6
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 115 (0.87%)
    5 / 179 (2.79%)
         occurrences all number
    1
    5
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 115 (2.61%)
    6 / 179 (3.35%)
         occurrences all number
    3
    7
    Blood glucose increased
         subjects affected / exposed
    4 / 115 (3.48%)
    3 / 179 (1.68%)
         occurrences all number
    4
    4
    Blood triglycerides increased
         subjects affected / exposed
    2 / 115 (1.74%)
    4 / 179 (2.23%)
         occurrences all number
    3
    4
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 115 (0.87%)
    7 / 179 (3.91%)
         occurrences all number
    1
    7
    Lipase increased
         subjects affected / exposed
    1 / 115 (0.87%)
    6 / 179 (3.35%)
         occurrences all number
    1
    6
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 115 (1.74%)
    4 / 179 (2.23%)
         occurrences all number
    3
    5
    Fall
         subjects affected / exposed
    2 / 115 (1.74%)
    7 / 179 (3.91%)
         occurrences all number
    2
    10
    Joint injury
         subjects affected / exposed
    3 / 115 (2.61%)
    3 / 179 (1.68%)
         occurrences all number
    3
    3
    Limb injury
         subjects affected / exposed
    0 / 115 (0.00%)
    4 / 179 (2.23%)
         occurrences all number
    0
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 115 (1.74%)
    9 / 179 (5.03%)
         occurrences all number
    2
    9
    Headache
         subjects affected / exposed
    27 / 115 (23.48%)
    28 / 179 (15.64%)
         occurrences all number
    57
    44
    Lethargy
         subjects affected / exposed
    3 / 115 (2.61%)
    5 / 179 (2.79%)
         occurrences all number
    4
    6
    Migraine
         subjects affected / exposed
    4 / 115 (3.48%)
    2 / 179 (1.12%)
         occurrences all number
    5
    3
    Paraesthesia
         subjects affected / exposed
    3 / 115 (2.61%)
    2 / 179 (1.12%)
         occurrences all number
    4
    3
    Eye disorders
    Dry eye
         subjects affected / exposed
    3 / 115 (2.61%)
    5 / 179 (2.79%)
         occurrences all number
    3
    6
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 115 (2.61%)
    4 / 179 (2.23%)
         occurrences all number
    3
    4
    Abdominal pain upper
         subjects affected / exposed
    1 / 115 (0.87%)
    5 / 179 (2.79%)
         occurrences all number
    1
    6
    Diarrhoea
         subjects affected / exposed
    14 / 115 (12.17%)
    16 / 179 (8.94%)
         occurrences all number
    17
    21
    Dyspepsia
         subjects affected / exposed
    7 / 115 (6.09%)
    7 / 179 (3.91%)
         occurrences all number
    7
    7
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 115 (0.00%)
    4 / 179 (2.23%)
         occurrences all number
    0
    4
    Mouth ulceration
         subjects affected / exposed
    1 / 115 (0.87%)
    5 / 179 (2.79%)
         occurrences all number
    1
    5
    Nausea
         subjects affected / exposed
    2 / 115 (1.74%)
    19 / 179 (10.61%)
         occurrences all number
    11
    21
    Toothache
         subjects affected / exposed
    3 / 115 (2.61%)
    2 / 179 (1.12%)
         occurrences all number
    3
    6
    Vomiting
         subjects affected / exposed
    6 / 115 (5.22%)
    12 / 179 (6.70%)
         occurrences all number
    8
    12
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    3 / 115 (2.61%)
    5 / 179 (2.79%)
         occurrences all number
    4
    6
    Hyperhidrosis
         subjects affected / exposed
    0 / 115 (0.00%)
    4 / 179 (2.23%)
         occurrences all number
    0
    4
    Intertrigo
         subjects affected / exposed
    3 / 115 (2.61%)
    2 / 179 (1.12%)
         occurrences all number
    3
    3
    Pruritus
         subjects affected / exposed
    3 / 115 (2.61%)
    4 / 179 (2.23%)
         occurrences all number
    4
    7
    Pruritus generalised
         subjects affected / exposed
    3 / 115 (2.61%)
    1 / 179 (0.56%)
         occurrences all number
    5
    1
    Psoriasis
         subjects affected / exposed
    15 / 115 (13.04%)
    28 / 179 (15.64%)
         occurrences all number
    17
    36
    Rash
         subjects affected / exposed
    4 / 115 (3.48%)
    6 / 179 (3.35%)
         occurrences all number
    4
    7
    Urticaria
         subjects affected / exposed
    3 / 115 (2.61%)
    1 / 179 (0.56%)
         occurrences all number
    3
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 115 (7.83%)
    19 / 179 (10.61%)
         occurrences all number
    16
    25
    Arthritis
         subjects affected / exposed
    4 / 115 (3.48%)
    2 / 179 (1.12%)
         occurrences all number
    4
    2
    Back pain
         subjects affected / exposed
    8 / 115 (6.96%)
    16 / 179 (8.94%)
         occurrences all number
    8
    22
    Joint swelling
         subjects affected / exposed
    3 / 115 (2.61%)
    9 / 179 (5.03%)
         occurrences all number
    3
    9
    Musculoskeletal pain
         subjects affected / exposed
    4 / 115 (3.48%)
    4 / 179 (2.23%)
         occurrences all number
    4
    7
    Musculoskeletal stiffness
         subjects affected / exposed
    3 / 115 (2.61%)
    0 / 179 (0.00%)
         occurrences all number
    4
    0
    Myalgia
         subjects affected / exposed
    1 / 115 (0.87%)
    8 / 179 (4.47%)
         occurrences all number
    2
    9
    Neck pain
         subjects affected / exposed
    1 / 115 (0.87%)
    5 / 179 (2.79%)
         occurrences all number
    2
    5
    Pain in extremity
         subjects affected / exposed
    3 / 115 (2.61%)
    11 / 179 (6.15%)
         occurrences all number
    3
    15
    Tendonitis
         subjects affected / exposed
    4 / 115 (3.48%)
    0 / 179 (0.00%)
         occurrences all number
    4
    0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 115 (0.00%)
    4 / 179 (2.23%)
         occurrences all number
    0
    4
    Conjunctivitis
         subjects affected / exposed
    2 / 115 (1.74%)
    7 / 179 (3.91%)
         occurrences all number
    3
    9
    Ear infection
         subjects affected / exposed
    7 / 115 (6.09%)
    7 / 179 (3.91%)
         occurrences all number
    10
    8
    Folliculitis
         subjects affected / exposed
    1 / 115 (0.87%)
    4 / 179 (2.23%)
         occurrences all number
    1
    4
    Gastroenteritis
         subjects affected / exposed
    3 / 115 (2.61%)
    3 / 179 (1.68%)
         occurrences all number
    3
    3
    Influenza
         subjects affected / exposed
    5 / 115 (4.35%)
    9 / 179 (5.03%)
         occurrences all number
    5
    10
    Lower respiratory tract infection
         subjects affected / exposed
    6 / 115 (5.22%)
    14 / 179 (7.82%)
         occurrences all number
    7
    16
    Nasopharyngitis
         subjects affected / exposed
    27 / 115 (23.48%)
    52 / 179 (29.05%)
         occurrences all number
    41
    69
    Oral candidiasis
         subjects affected / exposed
    2 / 115 (1.74%)
    7 / 179 (3.91%)
         occurrences all number
    3
    12
    Oral herpes
         subjects affected / exposed
    6 / 115 (5.22%)
    5 / 179 (2.79%)
         occurrences all number
    6
    6
    Otitis externa
         subjects affected / exposed
    3 / 115 (2.61%)
    2 / 179 (1.12%)
         occurrences all number
    5
    7
    Pharyngitis
         subjects affected / exposed
    1 / 115 (0.87%)
    5 / 179 (2.79%)
         occurrences all number
    1
    5
    Sinusitis
         subjects affected / exposed
    3 / 115 (2.61%)
    12 / 179 (6.70%)
         occurrences all number
    3
    17
    Tinea pedis
         subjects affected / exposed
    1 / 115 (0.87%)
    4 / 179 (2.23%)
         occurrences all number
    1
    4
    Tonsillitis
         subjects affected / exposed
    4 / 115 (3.48%)
    3 / 179 (1.68%)
         occurrences all number
    4
    3
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 115 (6.96%)
    9 / 179 (5.03%)
         occurrences all number
    9
    9
    Urinary tract infection
         subjects affected / exposed
    4 / 115 (3.48%)
    10 / 179 (5.59%)
         occurrences all number
    7
    14
    Viral upper respiratory tract infection
         subjects affected / exposed
    6 / 115 (5.22%)
    11 / 179 (6.15%)
         occurrences all number
    13
    16
    Vulvovaginal candidiasis
         subjects affected / exposed
    6 / 115 (5.22%)
    8 / 179 (4.47%)
         occurrences all number
    8
    13
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    3 / 115 (2.61%)
    0 / 179 (0.00%)
         occurrences all number
    3
    0
    Gout
         subjects affected / exposed
    3 / 115 (2.61%)
    1 / 179 (0.56%)
         occurrences all number
    3
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    4 / 115 (3.48%)
    2 / 179 (1.12%)
         occurrences all number
    4
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Aug 2013
    The main purpose of this amendment was that female patients were required to use two effective forms of contraception and male patients were required to use one effective form of contraception
    28 Nov 2013
    The main purposes of this amendment were the primary endpoint was changed from 12 weeks to 16 weeks; 12 weeks efficacy was included as a secondary endpoint; the option of up titration at for patients on the 150mg dose secukinumab to 300mg if they were not achieving the NICE criteria; and administrative changes.
    03 Jul 2014
    The main purpose of this amendment was to further evaluate: secukinumab safety, efficacy and tolerability for a further 24 weeks; patient response in those patients not achieving adequate efficacy on 150mg secukinumab at Week 48, when up-titrated to 300mg; PASI 50, 75 and 90 response at 24, 48 and 72 weeks; and previous exposure to Ustekinumab no longer an exclusion criteria.
    22 Feb 2016
    Minor administrative updates were made to the protocol including: an updated author and steering committee list; minor corrections to the numbering of days for maintenance period 2; Updates to the patient exposure and post-marketing experience information; Update to the use of the results and interim analysis; Clarification on the acceptable duration of concomitant mild-moderate topical steroids; Clarification on prohibited meds; Correction to the description of the statistical model, hypothesis and method of analysis section

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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