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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active ankylosing spondylitis

    Summary
    EudraCT number
    		 2013-001090-24
    Trial protocol
    		 DE   CZ   ES   PT   GR   GB   BE   NO  
    Global end of trial date
    11 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Dec 2018
    First version publication date
    01 Dec 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457F2314
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02008916
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Dec 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate that at least one dose of secukinumab (150 mg s.c. or 300 mg s.c.) at Week 16 is superior to placebo in patients with active AS (despite current or previous NSAID, DMARD and/or anti-TNFα therapy) based on the proportion of patients achieving an ASAS 20 (Assessment of Spondyloarthritis International Society criteria) response.
    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
    14 Jan 2014
    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
    Belgium: 12
    Country: Number of subjects enrolled
    Czech Republic: 42
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Greece: 8
    Country: Number of subjects enrolled
    Mexico: 27
    Country: Number of subjects enrolled
    Portugal: 8
    Country: Number of subjects enrolled
    Russian Federation: 34
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    United States: 24
    Country: Number of subjects enrolled
    Germany: 47
    Worldwide total number of subjects
    226
    EEA total number of subjects
    141
    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)
    221
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were randomized to one of three treatment groups (1:1:1) and planned to be treated for 156 weeks. At Week 16, subjects who were randomized to placebo were re-randomized to secukinumab 150 mg or 300 mg. Patients were enrolled in 54 centers in Germany, Spain, United States, Czech Republic, Belgium, Greece, Mexico, Portugal, Russia and UK

    Pre-assignment
    Screening details
    		 A screening period (SCR) running up to 10 weeks before randomization was used to assess eligibility.

    Period 1
    Period 1 title
    Primary Assessment (up to Week 16)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    This study was a double-blind, double-dummy, randomized treatment trial until the Week 52 analysis was completed and thereafter was open label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c.
    Arm description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Cosentyx®
    Pharmaceutical forms
    Solution for infusion, Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    secukinumab i.v. (10 mg/kg) at BSL, Weeks 2 and 4, followed by secukinumab 150 mg s.c. (1.0 mL) plus placebo s.c. (1.0 mL) every 4 weeks starting at Week 8 through Week 152

    Arm title
    		 Secukinumab 10 mg/kg i.v. / 300 mg s.c.
    Arm description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Cosentyx®
    Pharmaceutical forms
    Solution for infusion, Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    secukinumab i.v. (10 mg/kg) at BSL, Weeks 2 and 4, followed by secukinumab 300 mg s.c. (2 x 1.0 mL) every 4 weeks starting at Week 8 through Week 152

    Arm title
    		 Placebo i.v. and s.c.
    Arm description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, 36 patients were re-randomised to Secukinumab 150mg and 37 patients to Secukinumab 300mg until the end of the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    placebo i.v. at BSL, Weeks 2 and 4, followed by placebo s.c. at Weeks 8 and 12. At Week 16 subjects were re-randomized to receive secukinumab 150 mg plus placebo or secukinumab 300 mg (1:1) every 4 weeks through Week 152.

    Number of subjects in period 1
    		Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c.
    Started
    74
    76
    76
    FAS
    74
    76
    76
    Safety Set
    74
    76
    75
    Completed
    74
    75
    73
    Not completed
    0
    1
    3
         Consent withdrawn by subject
    -
    1
    3
    Period 2
    Period 2 title
    Week 16 - 156
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    This study was a double-blind, double-dummy, randomized treatment trial until the Week 52 analysis was completed and thereafter was open label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c.
    Arm description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Cosentyx®
    Pharmaceutical forms
    Solution for infusion, Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    secukinumab iv (10 mg/kg) at BSL, Weeks 2 and 4, followed by secukinumab 150 mg sc (1.0 mL) plus placebo sc (1.0 mL) every 4 weeks starting at Week 8 through Week 152

    Arm title
    		 Secukinumab 10 mg/kg i.v. / 300 mg s.c.
    Arm description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Cosentyx®
    Pharmaceutical forms
    Solution for infusion, Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    secukinumab i.v. (10 mg/kg) at BSL, Weeks 2 and 4, followed by secukinumab 300 mg s.c. (2 x 1.0 mL) every 4 weeks starting at Week 8 through Week 152

    Arm title
    		 Placebo i.v. and s.c.
    Arm description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, 36 patients were re-randomised to Secukinumab 150mg and 37 patients to Secukinumab 300mg until the end of the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    placebo i.v. at BSL, Weeks 2 and 4, followed by placebo s.c. at Weeks 8 and 12. At Week 16 subjects were re-randomized to receive secukinumab 150 mg plus placebo or secukinumab 300 mg (1:1) every 4 weeks through Week 152.

    Number of subjects in period 2
    		Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c.
    Started
    74
    75
    73
    Completed
    55
    62
    63
    Not completed
    19
    13
    10
         Consent withdrawn by subject
    7
    3
    5
         Physician decision
    -
    1
    -
         Adverse event, non-fatal
    4
    2
    3
         Pregnancy
    -
    1
    -
         Lost to follow-up
    5
    -
    -
         No longer requires treatment
    -
    1
    -
         Lack of efficacy
    3
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab 10 mg/kg i.v. / 150 mg s.c.
    Reporting group description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

    Reporting group title
    Secukinumab 10 mg/kg i.v. / 300 mg s.c.
    Reporting group description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

    Reporting group title
    Placebo i.v. and s.c.
    Reporting group description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, 36 patients were re-randomised to Secukinumab 150mg and 37 patients to Secukinumab 300mg until the end of the study.

    Reporting group values
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c. Total
    Number of subjects
    		 74 76 76 226
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 72 74 75 221
        From 65-84 years
    		 2 2 1 5
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 42.9 ( 11.11 ) 42.1 ( 11.81 ) 42.7 ( 11.43 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 28 26 36 90
        Male
    		 46 50 40 136
    Race/Ethnicity, Customized
    Units: Subjects
        White|
    		 54 52 58 164
        Black or African American|
    		 2 2 1 5
        Asian|
    		 1 2 0 3
        American Indian or Alaska Native|
    		 4 6 5 15
        Unknown|
    		 0 1 0 1
        Other|
    		 13 13 12 38

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab 10 mg/kg i.v. / 150 mg s.c.
    Reporting group description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

    Reporting group title
    Secukinumab 10 mg/kg i.v. / 300 mg s.c.
    Reporting group description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

    Reporting group title
    Placebo i.v. and s.c.
    Reporting group description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, 36 patients were re-randomised to Secukinumab 150mg and 37 patients to Secukinumab 300mg until the end of the study.
    Reporting group title
    Secukinumab 10 mg/kg i.v. / 150 mg s.c.
    Reporting group description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

    Reporting group title
    Secukinumab 10 mg/kg i.v. / 300 mg s.c.
    Reporting group description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

    Reporting group title
    Placebo i.v. and s.c.
    Reporting group description
    		 Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, 36 patients were re-randomised to Secukinumab 150mg and 37 patients to Secukinumab 300mg until the end of the study.

    Primary: Assessment of Spondyloarthritis International Society criteria / ASAS 20 response

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    End point title
    		 Assessment of Spondyloarthritis International Society criteria / ASAS 20 response
    End point description
    ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
    End point type
    Primary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c.
    Number of subjects analysed
    74
    76
    76
    Units: Participants
        Responder
    43
    46
    28
        Non-Responder
    31
    30
    48
    Statistical analysis title
    		 ASAS 20 response
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 150 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0093
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.24
         upper limit
    		 4.69
    Statistical analysis title
    		 ASAS 20 response
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 300 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0037
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.38
         upper limit
    		 5.21

    Secondary: ASAS 40 response

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    End point title
    		 ASAS 40 response
    End point description
    ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c.
    Number of subjects analysed
    74
    76
    76
    Units: Participants
        Responder
    30
    32
    16
        Non-Responder
    44
    44
    60
    Statistical analysis title
    		 ASAS 40 response
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 150 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.01
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.26
         upper limit
    		 5.35
    Statistical analysis title
    		 ASAS 40 response
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 300 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0051
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.36
         upper limit
    		 5.78

    Secondary: Serum hsCRP

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    End point title
    		 Serum hsCRP
    End point description
    Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c.
    Number of subjects analysed
    74
    76
    76
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline|
    15.79 ( 21.075 )
    11.08 ( 13.285 )
    13.91 ( 19.999 )
        Week 16|
    7.68 ( 13.277 )
    4.34 ( 5.433 )
    15.34 ( 21.694 )
        Change from Baseline to Week 16|
    -8.06 ( 21.132 )
    -6.75 ( 13.778 )
    0.57 ( 11.629 )
    Statistical analysis title
    		 Serum hsCRP
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 300 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Relative treatment effect
    Point estimate
    0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 0.6
    Statistical analysis title
    		 Serum hsCRP
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 150 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Relative treatment effect
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 0.68

    Secondary: ASAS 5/6 response

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    End point title
    		 ASAS 5/6 response
    End point description
    ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c.
    Number of subjects analysed
    74
    76
    76
    Units: Participants
        Responder
    31
    30
    11
        Non-Responder
    43
    46
    65
    Statistical analysis title
    		 ASAS 5/6 response
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 300 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0004
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.89
         upper limit
    		 9.38
    Statistical analysis title
    		 ASAS 5/6 response
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 150 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0002
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.01
         upper limit
    		 9.92

    Secondary: Bath Ankylosing Spondylitis Disease Activity Index / BASDAI

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    End point title
    		 Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
    End point description
    BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterise six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI index was used to assess the efficacy of at least one dose of secukinumab versus placebo.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c.
    Number of subjects analysed
    74
    76
    76
    Units: Points
    arithmetic mean (standard deviation)
        Baseline|
    6.958 ( 1.3913 )
    6.963 ( 1.3766 )
    6.907 ( 1.2600 )
        Week 16|
    4.451 ( 2.5623 )
    4.178 ( 2.7038 )
    5.369 ( 2.2574 )
        Change from Baseline to Week 16|
    -2.548 ( 2.4559 )
    -2.796 ( 2.6374 )
    -1.590 ( 2.0084 )
    Statistical analysis title
    		 BASDAI
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 150 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0347
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.39
    Statistical analysis title
    		 BASDAI
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 300 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0018
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 -0.46
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.39

    Secondary: Pre-filled syringe usability

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    End point title
    		 Pre-filled syringe usability
    End point description
    Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits.
    End point type
    Secondary
    End point timeframe
    Week 8 and Week 12
    End point values
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c.
    Number of subjects analysed
    74
    76
    75
    Units: Participants
        Week 8|Successful Self-administration
    72
    73
    71
        Week 12|Successful Self-administration
    74
    75
    72
        Week 8|Unsuccessful Self-administration
    0
    0
    1
        Week 12|Unsuccessful Self-administration
    0
    0
    0
        Week 8|Missing
    2
    3
    3
        Week 12|Missing
    0
    1
    3
    No statistical analyses for this end point

    Secondary: Pre-filled syringe possible hazard

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    End point title
    		 Pre-filled syringe possible hazard
    End point description
    The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits.
    End point type
    Secondary
    End point timeframe
    Week 8 and Week 12
    End point values
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c.
    Number of subjects analysed
    74
    76
    75
    Units: Participants
        Wk8: Was needle stick in a critical area|Yes
    0
    0
    0
        Wk8: Was needle stick in a non-critical area|Yes
    2
    5
    3
        Wk8: Was any part of the device swallowed|Yes
    0
    0
    0
        Wk8: Was allergic reaction to device noticed|Yes
    0
    0
    0
        Wk8: Was pain increased due to bent needle|Yes
    0
    0
    0
        Wk8: Was there breakage of device observed|Yes
    0
    0
    0
        Wk8:Was swallowing of debris observed|Yes
    0
    0
    0
        Wk8:Was any other problem observed|Yes
    1
    0
    0
        Wk8:Was less than the full dose administered|Yes
    0
    0
    0
        Wk12: Was needle stick in a critical area|Yes
    0
    0
    0
        Wk12: Was needle stick in a non-critical area|Yes
    1
    4
    3
        Wk12: Was any part of the device swallowed|Yes
    0
    0
    0
        Wk12: Was allergic reaction to device noticed|Yes
    0
    0
    0
        Wk12: Was pain increased due to bent needle|Yes
    0
    0
    0
        Wk12: Was there breakage of device observed|Yes
    0
    0
    0
        Wk12: Was swallowing of debris observed|Yes
    0
    0
    0
        Wk12: Was any other problem observed|Yes
    1
    1
    0
        Wk12: Was less than the full dose administered|Yes
    0
    0
    0
        Wk8:Was needle stick in a critical area|No
    73
    73
    72
        Wk8: Was needle stick in a non-critical area|No
    71
    68
    69
        Wk8: Was any part of the device swallowed|No
    73
    73
    72
        Wk8: Was allergic reaction to device noticed|No
    73
    73
    72
        Wk8: Was pain increased due to bent needle|No
    73
    73
    72
        Wk8: Was there breakage of device observed|No
    73
    73
    72
        Wk8:Was swallowing of debris observed|No
    73
    73
    72
        Wk8:Was any other problem observed|No
    72
    73
    72
        Wk8:Was less than the full dose administered|No
    73
    73
    72
        Wk12: Was needle stick in a critical area|No
    74
    75
    72
        Wk12: Was needle stick in a non-critical area|No
    73
    71
    69
        Wk12: Was any part of the device swallowed|No
    74
    75
    72
        Wk12: Was allergic reaction to device noticed|No
    74
    75
    72
        Wk12: Was pain increased due to bent needle|No
    74
    75
    72
        Wk12: Was there breakage of device observed|No
    74
    75
    72
        Wk12: Was swallowing of debris observed|No
    74
    75
    72
        Wk12: Was any other problem observed|No
    73
    74
    72
        Wk12: Was less than the full dose administered|No
    74
    75
    72
        Wk8:Was needle stick in a critical area|NA
    1
    3
    3
        Wk8: Was needle stick in a non-critical area|NA
    1
    3
    3
        Wk8: Was any part of the device swallowed|NA
    1
    3
    3
        Wk8: Was allergic reaction to device noticed|NA
    1
    3
    3
        Wk8: Was pain increased due to bent needle|NA
    1
    3
    3
        Wk8: Was there breakage of device observed|NA
    1
    3
    3
        Wk8:Was swallowing of debris observed|NA
    1
    3
    3
        Wk8:Was any other problem observed|NA
    1
    3
    3
        Wk8:Was less than the full dose administered|NA
    1
    3
    3
        Wk12: Was needle stick in a critical area|NA
    0
    1
    3
        Wk12: Was needle stick in a non-critical area|NA
    0
    1
    3
        Wk12: Was any part of the device swallowed|NA
    0
    1
    3
        Wk12: Was allergic reaction to device noticed|NA
    0
    1
    3
        Wk12: Was pain increased due to bent needle|NA
    0
    1
    3
        Wk12: Was there breakage of device observed|NA
    0
    1
    3
        Wk12: Was swallowing of debris observed|NA
    0
    1
    3
        Wk12: Was any other problem observed|NA
    0
    1
    3
        Wk12: Was less than the full dose administered|NA
    0
    1
    3
    No statistical analyses for this end point

    Secondary: Prefilled syringe patient satisfaction assessment

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    End point title
    		 Prefilled syringe patient satisfaction assessment
    End point description
    The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection.
    End point type
    Secondary
    End point timeframe
    16 Weeks
    End point values
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c.
    Number of subjects analysed
    74
    76
    75
    Units: Points
    arithmetic mean (standard deviation)
        Week 0: Feeling about injections|
    7.97 ( 1.946 )
    7.66 ( 2.369 )
    8.01 ( 1.927 )
        Week 8: Feeling about injections|
    7.96 ( 2.538 )
    7.68 ( 2.296 )
    8.24 ( 2.082 )
        Week 12: Feeling about injections|
    8.45 ( 1.968 )
    7.93 ( 2.201 )
    8.25 ( 1.997 )
        Week 16: Feeling about injections|
    8.15 ( 2.337 )
    7.99 ( 2.269 )
    8.41 ( 2.037 )
        Week 0: Self-confidence|
    6.27 ( 2.811 )
    6.66 ( 2.315 )
    6.52 ( 2.273 )
        Week 8: Self-confidence|
    7.08 ( 2.520 )
    6.66 ( 2.855 )
    7.41 ( 2.198 )
        Week 12: Self-confidence|
    7.01 ( 2.603 )
    7.28 ( 2.231 )
    7.42 ( 2.230 )
        Week 16: Self-confidence|
    7.51 ( 2.388 )
    7.23 ( 2.566 )
    7.64 ( 2.192 )
        Week 0: Satisfaction with self-injection|
    5.34 ( 2.692 )
    6.12 ( 2.429 )
    5.30 ( 2.694 )
        Week 8: Satisfaction with self-injection|
    7.67 ( 1.734 )
    7.50 ( 1.667 )
    7.39 ( 2.002 )
        Week 12: Satisfaction with self-injection|
    7.68 ( 1.483 )
    7.50 ( 1.816 )
    7.46 ( 1.780 )
        Week 16: Satisfaction with self-injection|
    7.57 ( 1.741 )
    7.82 ( 1.933 )
    7.67 ( 1.577 )
    No statistical analyses for this end point

    Secondary: ASAS partial remission

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    End point title
    		 ASAS partial remission
    End point description
    ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study, ASAS partial remission was used to assess the efficacy of at least one dose of secukinumab versus placebo.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Secukinumab 10 mg/kg i.v. / 150 mg s.c. Secukinumab 10 mg/kg i.v. / 300 mg s.c. Placebo i.v. and s.c.
    Number of subjects analysed
    74
    76
    76
    Units: Participants
        Responder
    7
    16
    1
        Non-Responder
    67
    60
    75
    Statistical analysis title
    		 ASAS partial remission
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 150 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0593
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 64.42
    Statistical analysis title
    		 ASAS partial remission
    Comparison groups
    Secukinumab 10 mg/kg i.v. / 300 mg s.c. v Placebo i.v. and s.c.
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0046
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    19.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.49
         upper limit
    		 150.79

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
    Adverse event reporting additional description
    Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Any AIN457 150 mg
    Reporting group description
    		 Includes Patients randomized to Secukinumab 150 mg at baseline + patients re-randomized to Secukinumab 150 mg at week 16 (for AEs occurring after re-randomization)

    Reporting group title
    Any AIN457 300 mg
    Reporting group description
    		 Includes Patients randomized to Secukinumab 300 mg at baseline + patients re-randomized to Secukinumab 300 mg at week 16 (for AEs occurring after re-randomization)

    Reporting group title
    Any AIN457
    Reporting group description
    		 Any Secukinumab 150 mg + Any Secukinumab 300 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Includes Patients randomized to Placebo for AEs until time of rerandomization (Week 16) to Secukinumab.

    Serious adverse events
    		 Any AIN457 150 mg Any AIN457 300 mg Any AIN457 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 110 (10.00%)
    11 / 113 (9.73%)
    22 / 223 (9.87%)
    1 / 75 (1.33%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iridocyclitis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vogt-Koyanagi-Harada syndrome
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sacroiliitis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 113 (0.88%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 113 (0.00%)
    1 / 223 (0.45%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 113 (0.88%)
    2 / 223 (0.90%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Any AIN457 150 mg Any AIN457 300 mg Any AIN457 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 110 (78.18%)
    89 / 113 (78.76%)
    175 / 223 (78.48%)
    28 / 75 (37.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    7 / 110 (6.36%)
    5 / 113 (4.42%)
    12 / 223 (5.38%)
    0 / 75 (0.00%)
         occurrences all number
    7
    5
    12
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 110 (4.55%)
    4 / 113 (3.54%)
    9 / 223 (4.04%)
    0 / 75 (0.00%)
         occurrences all number
    5
    4
    9
    0
    Influenza like illness
         subjects affected / exposed
    2 / 110 (1.82%)
    1 / 113 (0.88%)
    3 / 223 (1.35%)
    2 / 75 (2.67%)
         occurrences all number
    2
    1
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 110 (5.45%)
    6 / 113 (5.31%)
    12 / 223 (5.38%)
    2 / 75 (2.67%)
         occurrences all number
    7
    8
    15
    2
    Oropharyngeal pain
         subjects affected / exposed
    7 / 110 (6.36%)
    7 / 113 (6.19%)
    14 / 223 (6.28%)
    0 / 75 (0.00%)
         occurrences all number
    7
    11
    18
    0
    Rhinitis allergic
         subjects affected / exposed
    3 / 110 (2.73%)
    1 / 113 (0.88%)
    4 / 223 (1.79%)
    0 / 75 (0.00%)
         occurrences all number
    3
    1
    4
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 110 (2.73%)
    3 / 113 (2.65%)
    6 / 223 (2.69%)
    1 / 75 (1.33%)
         occurrences all number
    4
    3
    7
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 110 (2.73%)
    2 / 113 (1.77%)
    5 / 223 (2.24%)
    0 / 75 (0.00%)
         occurrences all number
    4
    3
    7
    0
    Injury, poisoning and procedural complications
    Sunburn
         subjects affected / exposed
    0 / 110 (0.00%)
    3 / 113 (2.65%)
    3 / 223 (1.35%)
    0 / 75 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 110 (1.82%)
    4 / 113 (3.54%)
    6 / 223 (2.69%)
    1 / 75 (1.33%)
         occurrences all number
    2
    5
    7
    2
    Headache
         subjects affected / exposed
    12 / 110 (10.91%)
    14 / 113 (12.39%)
    26 / 223 (11.66%)
    5 / 75 (6.67%)
         occurrences all number
    19
    21
    40
    5
    Hypoaesthesia
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 113 (0.00%)
    2 / 223 (0.90%)
    2 / 75 (2.67%)
         occurrences all number
    3
    0
    3
    2
    Migraine
         subjects affected / exposed
    5 / 110 (4.55%)
    1 / 113 (0.88%)
    6 / 223 (2.69%)
    0 / 75 (0.00%)
         occurrences all number
    5
    1
    6
    0
    Paraesthesia
         subjects affected / exposed
    4 / 110 (3.64%)
    0 / 113 (0.00%)
    4 / 223 (1.79%)
    0 / 75 (0.00%)
         occurrences all number
    4
    0
    4
    0
    Eye disorders
    Iritis
         subjects affected / exposed
    0 / 110 (0.00%)
    3 / 113 (2.65%)
    3 / 223 (1.35%)
    0 / 75 (0.00%)
         occurrences all number
    0
    6
    6
    0
    Uveitis
         subjects affected / exposed
    3 / 110 (2.73%)
    5 / 113 (4.42%)
    8 / 223 (3.59%)
    0 / 75 (0.00%)
         occurrences all number
    3
    6
    9
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 110 (0.91%)
    3 / 113 (2.65%)
    4 / 223 (1.79%)
    2 / 75 (2.67%)
         occurrences all number
    1
    4
    5
    2
    Abdominal pain upper
         subjects affected / exposed
    5 / 110 (4.55%)
    3 / 113 (2.65%)
    8 / 223 (3.59%)
    1 / 75 (1.33%)
         occurrences all number
    5
    4
    9
    2
    Diarrhoea
         subjects affected / exposed
    11 / 110 (10.00%)
    9 / 113 (7.96%)
    20 / 223 (8.97%)
    0 / 75 (0.00%)
         occurrences all number
    14
    10
    24
    0
    Food poisoning
         subjects affected / exposed
    2 / 110 (1.82%)
    3 / 113 (2.65%)
    5 / 223 (2.24%)
    0 / 75 (0.00%)
         occurrences all number
    2
    3
    5
    0
    Gastritis
         subjects affected / exposed
    3 / 110 (2.73%)
    1 / 113 (0.88%)
    4 / 223 (1.79%)
    0 / 75 (0.00%)
         occurrences all number
    3
    1
    4
    0
    Nausea
         subjects affected / exposed
    3 / 110 (2.73%)
    4 / 113 (3.54%)
    7 / 223 (3.14%)
    1 / 75 (1.33%)
         occurrences all number
    3
    4
    7
    2
    Toothache
         subjects affected / exposed
    3 / 110 (2.73%)
    2 / 113 (1.77%)
    5 / 223 (2.24%)
    1 / 75 (1.33%)
         occurrences all number
    3
    2
    5
    1
    Vomiting
         subjects affected / exposed
    0 / 110 (0.00%)
    4 / 113 (3.54%)
    4 / 223 (1.79%)
    0 / 75 (0.00%)
         occurrences all number
    0
    4
    4
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 110 (0.91%)
    3 / 113 (2.65%)
    4 / 223 (1.79%)
    0 / 75 (0.00%)
         occurrences all number
    2
    3
    5
    0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    5 / 110 (4.55%)
    3 / 113 (2.65%)
    8 / 223 (3.59%)
    2 / 75 (2.67%)
         occurrences all number
    5
    4
    9
    2
    Arthralgia
         subjects affected / exposed
    14 / 110 (12.73%)
    13 / 113 (11.50%)
    27 / 223 (12.11%)
    2 / 75 (2.67%)
         occurrences all number
    35
    22
    57
    3
    Arthritis
         subjects affected / exposed
    4 / 110 (3.64%)
    3 / 113 (2.65%)
    7 / 223 (3.14%)
    0 / 75 (0.00%)
         occurrences all number
    4
    3
    7
    0
    Back pain
         subjects affected / exposed
    7 / 110 (6.36%)
    12 / 113 (10.62%)
    19 / 223 (8.52%)
    2 / 75 (2.67%)
         occurrences all number
    8
    16
    24
    2
    Fibromyalgia
         subjects affected / exposed
    1 / 110 (0.91%)
    3 / 113 (2.65%)
    4 / 223 (1.79%)
    1 / 75 (1.33%)
         occurrences all number
    1
    3
    4
    1
    Muscle spasms
         subjects affected / exposed
    3 / 110 (2.73%)
    5 / 113 (4.42%)
    8 / 223 (3.59%)
    1 / 75 (1.33%)
         occurrences all number
    4
    5
    9
    1
    Myalgia
         subjects affected / exposed
    3 / 110 (2.73%)
    1 / 113 (0.88%)
    4 / 223 (1.79%)
    0 / 75 (0.00%)
         occurrences all number
    4
    1
    5
    0
    Osteoarthritis
         subjects affected / exposed
    2 / 110 (1.82%)
    4 / 113 (3.54%)
    6 / 223 (2.69%)
    0 / 75 (0.00%)
         occurrences all number
    3
    4
    7
    0
    Pain in extremity
         subjects affected / exposed
    4 / 110 (3.64%)
    2 / 113 (1.77%)
    6 / 223 (2.69%)
    1 / 75 (1.33%)
         occurrences all number
    5
    2
    7
    1
    Spinal pain
         subjects affected / exposed
    4 / 110 (3.64%)
    4 / 113 (3.54%)
    8 / 223 (3.59%)
    0 / 75 (0.00%)
         occurrences all number
    4
    4
    8
    0
    Spondylitis
         subjects affected / exposed
    0 / 110 (0.00%)
    3 / 113 (2.65%)
    3 / 223 (1.35%)
    0 / 75 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Tendonitis
         subjects affected / exposed
    3 / 110 (2.73%)
    1 / 113 (0.88%)
    4 / 223 (1.79%)
    0 / 75 (0.00%)
         occurrences all number
    3
    1
    4
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    14 / 110 (12.73%)
    9 / 113 (7.96%)
    23 / 223 (10.31%)
    1 / 75 (1.33%)
         occurrences all number
    20
    13
    33
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 110 (0.91%)
    3 / 113 (2.65%)
    4 / 223 (1.79%)
    1 / 75 (1.33%)
         occurrences all number
    1
    5
    6
    1
    Ear infection
         subjects affected / exposed
    0 / 110 (0.00%)
    3 / 113 (2.65%)
    3 / 223 (1.35%)
    0 / 75 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 110 (0.91%)
    3 / 113 (2.65%)
    4 / 223 (1.79%)
    0 / 75 (0.00%)
         occurrences all number
    1
    3
    4
    0
    Influenza
         subjects affected / exposed
    3 / 110 (2.73%)
    9 / 113 (7.96%)
    12 / 223 (5.38%)
    0 / 75 (0.00%)
         occurrences all number
    3
    9
    12
    0
    Nasopharyngitis
         subjects affected / exposed
    27 / 110 (24.55%)
    27 / 113 (23.89%)
    54 / 223 (24.22%)
    2 / 75 (2.67%)
         occurrences all number
    61
    54
    115
    2
    Oral herpes
         subjects affected / exposed
    1 / 110 (0.91%)
    3 / 113 (2.65%)
    4 / 223 (1.79%)
    1 / 75 (1.33%)
         occurrences all number
    1
    4
    5
    1
    Pharyngitis
         subjects affected / exposed
    3 / 110 (2.73%)
    6 / 113 (5.31%)
    9 / 223 (4.04%)
    1 / 75 (1.33%)
         occurrences all number
    3
    11
    14
    1
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 110 (0.00%)
    3 / 113 (2.65%)
    3 / 223 (1.35%)
    0 / 75 (0.00%)
         occurrences all number
    0
    4
    4
    0
    Pneumonia
         subjects affected / exposed
    1 / 110 (0.91%)
    3 / 113 (2.65%)
    4 / 223 (1.79%)
    0 / 75 (0.00%)
         occurrences all number
    1
    3
    4
    0
    Pulpitis dental
         subjects affected / exposed
    4 / 110 (3.64%)
    1 / 113 (0.88%)
    5 / 223 (2.24%)
    2 / 75 (2.67%)
         occurrences all number
    4
    2
    6
    2
    Respiratory tract infection
         subjects affected / exposed
    12 / 110 (10.91%)
    10 / 113 (8.85%)
    22 / 223 (9.87%)
    4 / 75 (5.33%)
         occurrences all number
    21
    24
    45
    4
    Rhinitis
         subjects affected / exposed
    6 / 110 (5.45%)
    4 / 113 (3.54%)
    10 / 223 (4.48%)
    0 / 75 (0.00%)
         occurrences all number
    7
    4
    11
    0
    Sinusitis
         subjects affected / exposed
    8 / 110 (7.27%)
    1 / 113 (0.88%)
    9 / 223 (4.04%)
    2 / 75 (2.67%)
         occurrences all number
    12
    1
    13
    2
    Tonsillitis
         subjects affected / exposed
    4 / 110 (3.64%)
    4 / 113 (3.54%)
    8 / 223 (3.59%)
    0 / 75 (0.00%)
         occurrences all number
    4
    4
    8
    0
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 110 (10.91%)
    16 / 113 (14.16%)
    28 / 223 (12.56%)
    2 / 75 (2.67%)
         occurrences all number
    15
    20
    35
    2
    Urinary tract infection
         subjects affected / exposed
    4 / 110 (3.64%)
    6 / 113 (5.31%)
    10 / 223 (4.48%)
    2 / 75 (2.67%)
         occurrences all number
    4
    8
    12
    2
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    4 / 110 (3.64%)
    3 / 113 (2.65%)
    7 / 223 (3.14%)
    0 / 75 (0.00%)
         occurrences all number
    4
    3
    7
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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