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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis

    Summary
    EudraCT number
    		 2015-005021-39
    Trial protocol
    		 GB   CZ  
    Global end of trial date
    19 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Apr 2020
    First version publication date
    03 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457F2308
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02896127
    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
    Study Lead, 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
    19 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the efficacy of secukinumab 150 mg s.c. at Week 16 is superior to placebo in subjects with active AS based on the proportion of subjects achieving an ASAS20 (Assessment of SpondyloArthritis International Society criteria) response. The results were reported in the 16-week CAIN457F2308 CSR dated 09-Jan-2019 and are not repeated in detail in this 52-week report.
    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
    18 Oct 2016
    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
    China: 327
    Country: Number of subjects enrolled
    Czech Republic: 55
    Country: Number of subjects enrolled
    United Kingdom: 35
    Country: Number of subjects enrolled
    Korea, Republic of: 41
    Worldwide total number of subjects
    458
    EEA total number of subjects
    90
    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)
    455
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Majority of subjects completed 52 weeks of treatment

    Pre-assignment
    Screening details
    		 Four out of the 153 assigned to the placebo group discontinued before Week 16

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab
    Arm description
    		 Secukinumab 150 mg s.c.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS

    Arm title
    		 Placebo
    Arm description
    		 Placebo s.c.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo s.c.

    Number of subjects in period 1
    		Secukinumab Placebo
    Started
    305
    153
    Completed
    278
    142
    Not completed
    27
    11
         Physician decision
    1
    1
         Consent withdrawn by subject
    12
    4
         Adverse event, non-fatal
    9
    2
         Technical problems
    1
    -
         Pregnancy
    2
    -
         Lost to follow-up
    -
    1
         Lack of efficacy
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab
    Reporting group description
    		 Secukinumab 150 mg s.c.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo s.c.

    Reporting group values
    		 Secukinumab Placebo Total
    Number of subjects
    		 305 153 458
    Age Categorical
    The mean age of participants was 34.4 years
    Units:
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 303 152 455
        >=65 years
    		 2 1 3
    Sex: Female, Male
    FAS
    Units:
        Female
    		 53 21 74
        Male
    		 252 132 384
    Race/Ethnicity, Customized
    FAS
    Units: Subjects
        Asian
    		 239 130 369
        White
    		 64 23 87
        Other
    		 2 0 2
    Subject analysis sets

    Subject analysis set title
    Placebo - AIN457 150 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo - AIN457 150mg

    Subject analysis set title
    Placebo - AIN457 150mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    placebo plus AIN457 150mg

    Subject analysis set title
    Placebo - AIN457 150mg s.c.
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo - AIN457 150mg s.c.

    Subject analysis set title
    Placebo - AIN457 150mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo - AIN457 150mg

    Subject analysis set title
    Placebo - AIN457 150mg s.c.
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo plus AIN457 150mg s.c.

    Subject analysis set title
    Placebo - AIN5457 150mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    placebo plus AIN457

    Subject analysis sets values
    		 Placebo - AIN457 150 mg Placebo - AIN457 150mg Placebo - AIN457 150mg s.c. Placebo - AIN457 150mg Placebo - AIN457 150mg s.c. Placebo - AIN5457 150mg
    Number of subjects
    146
    146
    146
    149
    149
    146
    Age Categorical
    The mean age of participants was 34.4 years
    Units:
        <=18 years
    0
    0
    0
    0
    0
    0
        Between 18 and 65 years
        >=65 years
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    Sex: Female, Male
    FAS
    Units:
        Female
        Male
    Race/Ethnicity, Customized
    FAS
    Units: Subjects
        Asian
        White
        Other

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab
    Reporting group description
    		 Secukinumab 150 mg s.c.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo s.c.

    Subject analysis set title
    Placebo - AIN457 150 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo - AIN457 150mg

    Subject analysis set title
    Placebo - AIN457 150mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    placebo plus AIN457 150mg

    Subject analysis set title
    Placebo - AIN457 150mg s.c.
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo - AIN457 150mg s.c.

    Subject analysis set title
    Placebo - AIN457 150mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo - AIN457 150mg

    Subject analysis set title
    Placebo - AIN457 150mg s.c.
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo plus AIN457 150mg s.c.

    Subject analysis set title
    Placebo - AIN5457 150mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    placebo plus AIN457

    Primary: The proportion of participants who achieve an ASAS 20 response (Assessment of SpondyloArthritis International Society criteria)

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    End point title
    		 The proportion of participants who achieve an ASAS 20 response (Assessment of SpondyloArthritis International Society criteria)
    End point description
    ASAS20 response is defined as an improvement of ≥20% and ≥1 units on a scale of 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    305
    153
    Units: participants
    178
    56
    Statistical analysis title
    		 Proportion of participants with ASAS20 response
    Comparison groups
    Placebo v Secukinumab
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.65
         upper limit
    		 3.69

    Secondary: The proportion of participants who achieve an ASAS40 response

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    End point title
    		 The proportion of participants who achieve an ASAS40 response
    End point description
    ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab Placebo Placebo - AIN457 150 mg
    Number of subjects analysed
    294
    146
    146
    Units: participants
    138
    27
    27
    No statistical analyses for this end point

    Secondary: Change in hsCRP over time

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    End point title
    		 Change in hsCRP over time
    End point description
    hsCRP is measured as a marker of inflammation from blood samples during the study
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab Placebo Placebo - AIN457 150mg
    Number of subjects analysed
    295
    146
    146
    Units: scores
        arithmetic mean (standard deviation)
    -11.78 ± 22.919
    -0.79 ± 20.023
    -0.79 ± 20.023
    No statistical analyses for this end point

    Secondary: The proportion of participants who achieve an ASAS 5/6

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    End point title
    		 The proportion of participants who achieve an ASAS 5/6
    End point description
    The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab Placebo Placebo - AIN457 150mg s.c.
    Number of subjects analysed
    295
    146
    146
    Units: percent of participants
        number (confidence interval 95%)
    50.5 (44.7 to 56.3)
    19.2 (13.3 to 26.7)
    19.2 (13.3 to 26.7)
    No statistical analyses for this end point

    Secondary: Participants with BASDAI response at 16 weeks

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    End point title
    		 Participants with BASDAI response at 16 weeks
    End point description
    The BASDAI or Bath Ankylosing Spondylitis Disease Activity Index consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab Placebo Placebo - AIN457 150mg
    Number of subjects analysed
    295
    149
    149
    Units: percent of participants
        number (confidence interval 95%)
    41.7 (36.0 to 47.6)
    22.6 (16.3 to 30.4)
    22.6 (16.3 to 30.4)
    No statistical analyses for this end point

    Secondary: Change in Short Form (36) - PCS Responders (Improvement of >= 2.5 Points)

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    End point title
    		 Change in Short Form (36) - PCS Responders (Improvement of >= 2.5 Points)
    End point description
    The Physical Component Summary (PCS) SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab Placebo Placebo - AIN457 150mg
    Number of subjects analysed
    301
    149
    149
    Units: percent of participants
        number (confidence interval 95%)
    71.8 (66.3 to 76.7)
    61.1 (52.7 to 68.8)
    61.1 (52.7 to 68.8)
    No statistical analyses for this end point

    Secondary: Change in Short Form (36) - MCS Responders (Improvement of >= 2.5 Points)

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    End point title
    		 Change in Short Form (36) - MCS Responders (Improvement of >= 2.5 Points)
    End point description
    The Mental Component Summary (MCS) SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab Placebo Placebo - AIN457 150mg
    Number of subjects analysed
    301
    149
    149
    Units: percent of participants
        number (confidence interval 95%)
    60.5 (54.7 to 66.0)
    55.0 (46.7 to 63.1)
    55.0 (46.7 to 63.1)
    No statistical analyses for this end point

    Secondary: Change in ASQoL score over time

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    End point title
    		 Change in ASQoL score over time
    End point description
    The Ankylosing Spondylitis Quality of Life (ASQoL) is an instrument to assess health-related quality of life among adult patients with Ankylosing Spondylitis
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab Placebo Placebo - AIN457 150mg s.c.
    Number of subjects analysed
    305
    153
    149
    Units: scores
        arithmetic mean (standard deviation)
    -4.6 ± 4.98
    -2.6 ± 4.28
    -2.6 ± 4.28
    No statistical analyses for this end point

    Secondary: The proportion of patients who achieve an ASAS partial remission

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    End point title
    		 The proportion of patients who achieve an ASAS partial remission
    End point description
    The The Assessment in SpondyloArthritis International Society (ASAS) partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab Placebo Placebo - AIN5457 150mg
    Number of subjects analysed
    294
    146
    146
    Units: percent of participants
        number (confidence interval 95%)
    17.7 (13.6 to 22.6)
    7.5 (4.0 to 13.4)
    7.5 (4.0 to 13.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Any AIN457 150 mg
    Reporting group description
    		 Any AIN457 150 mg

    Serious adverse events
    		 Placebo Any AIN457 150 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 153 (1.96%)
    33 / 453 (7.28%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Cyst
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Mediastinal cyst
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         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
    Electric injury
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve injury
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin injury
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular injury
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Bronchogenic cyst
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Lacunar infarction
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness neurosensory
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Iridocyclitis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Appendix disorder
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 453 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb mass
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 153 (0.00%)
    3 / 453 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 453 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 453 (0.22%)
         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
    		 Placebo Any AIN457 150 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 153 (39.22%)
    282 / 453 (62.25%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 153 (1.96%)
    24 / 453 (5.30%)
         occurrences all number
    4
    33
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 153 (1.31%)
    10 / 453 (2.21%)
         occurrences all number
    2
    11
    Protein urine present
         subjects affected / exposed
    0 / 153 (0.00%)
    11 / 453 (2.43%)
         occurrences all number
    0
    13
    White blood cell count decreased
         subjects affected / exposed
    0 / 153 (0.00%)
    17 / 453 (3.75%)
         occurrences all number
    0
    33
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 153 (1.96%)
    11 / 453 (2.43%)
         occurrences all number
    3
    11
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 153 (2.61%)
    5 / 453 (1.10%)
         occurrences all number
    4
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 153 (0.00%)
    12 / 453 (2.65%)
         occurrences all number
    0
    12
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 153 (0.65%)
    15 / 453 (3.31%)
         occurrences all number
    1
    19
    Diarrhoea
         subjects affected / exposed
    6 / 153 (3.92%)
    35 / 453 (7.73%)
         occurrences all number
    8
    49
    Mouth ulceration
         subjects affected / exposed
    2 / 153 (1.31%)
    18 / 453 (3.97%)
         occurrences all number
    3
    22
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    3 / 153 (1.96%)
    24 / 453 (5.30%)
         occurrences all number
    3
    25
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 153 (1.96%)
    10 / 453 (2.21%)
         occurrences all number
    3
    11
    Oropharyngeal pain
         subjects affected / exposed
    2 / 153 (1.31%)
    18 / 453 (3.97%)
         occurrences all number
    2
    21
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 153 (0.00%)
    10 / 453 (2.21%)
         occurrences all number
    0
    11
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 153 (3.27%)
    13 / 453 (2.87%)
         occurrences all number
    6
    16
    Back pain
         subjects affected / exposed
    4 / 153 (2.61%)
    7 / 453 (1.55%)
         occurrences all number
    5
    8
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 153 (6.54%)
    46 / 453 (10.15%)
         occurrences all number
    10
    57
    Pharyngitis
         subjects affected / exposed
    1 / 153 (0.65%)
    14 / 453 (3.09%)
         occurrences all number
    1
    15
    Upper respiratory tract infection
         subjects affected / exposed
    29 / 153 (18.95%)
    145 / 453 (32.01%)
         occurrences all number
    38
    215
    Urinary tract infection
         subjects affected / exposed
    5 / 153 (3.27%)
    16 / 453 (3.53%)
         occurrences all number
    6
    20
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    1 / 153 (0.65%)
    12 / 453 (2.65%)
         occurrences all number
    1
    13
    Hyperlipidaemia
         subjects affected / exposed
    1 / 153 (0.65%)
    26 / 453 (5.74%)
         occurrences all number
    1
    27

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Mar 2018
    Amendment 1 Due to changes in the regulatory environment in China, a primary endpoint analysis can be implemented and used for submission purpose. This will allow a much earlier (approximately 9 months) submission than originally planned. To enable this, an additional analysis will be performed after all patients have completed the Week 16 for the primary endpoint assessments. Although unblinding will occur after the Week 16 database lock, the original randomization to active treatment vs placebo will continue to remain blinded to all investigators, site personnel and patients until all patients have completed the study (Week 60 Follow up) and the final database lock has occurred.

    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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