Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized, double-blind, placebo controlled, multicenter study of subcutaneous secukinumab, to demonstrate efficacy after twelve weeks of treatment and to assess safety, tolerability and long-term efficacy up to one year in subjects with moderate to severe chronic plaque-type psoriasis with or without psoriatic arthritis comorbidity

    Summary
    EudraCT number
    		 2016-000524-25
    Trial protocol
    		 HU  
    Global end of trial date
    20 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Dec 2019
    First version publication date
    02 Dec 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457A2318
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03066609
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH4002, 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
    20 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    the main objective for this trial was to demonstrate the superiority of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis in terms of both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoints) at Week 12 compared to placebo.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2017
    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
    China: 441
    Country: Number of subjects enrolled
    Hungary: 23
    Country: Number of subjects enrolled
    Malaysia: 12
    Country: Number of subjects enrolled
    Philippines: 18
    Country: Number of subjects enrolled
    Thailand: 35
    Country: Number of subjects enrolled
    Turkey: 14
    Worldwide total number of subjects
    543
    EEA total number of subjects
    23
    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)
    531
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 664 patients were screened and 543 patients were randomized to one of three treatment groups in the induction period: secukinumab 300 mg (n=272), secukinumab 150 mg (n=136), and placebo (n=135)

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 543
    Number of subjects completed
    		 543

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

    Arms
    Are arms mutually exclusive
    Yes

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

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg for subcutaneous injection was supplied in a 150 mg 1 mL pre-filled syringe.

    Arm title
    		 Secukinumab 300mg
    Arm description
    		 Secukinumab 300mg s.c.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg for subcutaneous injection was supplied in a 150 mg 1 mL pre-filled syringe. two injections of the 150 mg dose

    Arm title
    		 placebo
    Arm description
    		 Placebo to secukinumab s.c
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab placebo for sc injection was supplied as a 1 mL pre-filled syringe matching the appearance of 150 mg secukinumab syringe

    Number of subjects in period 1
    		Secukinumab 150mg Secukinumab 300mg placebo
    Started
    136
    272
    135
    Completed
    134
    270
    133
    Not completed
    2
    2
    2
         Adverse event, non-fatal
    2
    2
    -
         Pregnancy
    -
    -
    1
         Lack of efficacy
    -
    -
    1
    Period 2
    Period 2 title
    MAINTENANCE
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

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

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg for subcutaneous injection was supplied in a 150 mg 1 mL pre-filled syringe.

    Arm title
    		 Secukinumab 300mg
    Arm description
    		 Secukinumab 300mg s.c.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg for subcutaneous injection was supplied in a 150 mg 1 mL pre-filled syringe. two injections of the 150 mg dose

    Arm title
    		 placebo - placebo
    Arm description
    		 Placebo patients who remained on Placebo after week 12
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab placebo for sc injection was supplied as a 1 mL pre-filled syringe matching the appearance of 150 mg secukinumab syringe

    Arm title
    		 Placebo - secukinumab 300mg
    Arm description
    		 patients switched to Secukinumab (AIN457) at week 12
    Arm type
    		 placebo switched to experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 150 mg for subcutaneous injection was supplied in a 150 mg 1 mL pre-filled syringe. 2 injections of 150 mg. Switch after placebo for 12 weeks.

    Number of subjects in period 2
    		Secukinumab 150mg Secukinumab 300mg placebo - placebo Placebo - secukinumab 300mg
    Started
    134
    270
    4
    129
    Completed
    127
    266
    2
    126
    Not completed
    7
    4
    2
    3
         Adverse event, non-fatal
    -
    -
    -
    1
         Pregnancy
    1
    -
    -
    -
         Subject or guardian decision
    4
    2
    1
    1
         Lost to follow-up
    -
    1
    1
    -
         Lack of efficacy
    2
    1
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab 150mg
    Reporting group description
    		 Secukinumab 150mg s.c.

    Reporting group title
    Secukinumab 300mg
    Reporting group description
    		 Secukinumab 300mg s.c.

    Reporting group title
    placebo
    Reporting group description
    		 Placebo to secukinumab s.c

    Reporting group values
    		 Secukinumab 150mg Secukinumab 300mg placebo Total
    Number of subjects
    		 136 272 135 543
    Age categorical
    Based on Induction Period
    Units: Subjects
        Adults (< 65)
    		 133 265 133 531
        From 65-84 years
    		 3 7 2 12
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41 ( 11.39 ) 39.9 ( 12.35 ) 40.1 ( 11.01 ) -
    Sex: Female, Male
    Based on Induction Period
    Units: Subjects
        Female
    		 37 67 27 131
        Male
    		 99 205 108 412
    Race/Ethnicity, Customized
    Ethnicity Based on Induction Period
    Units: Subjects
        East Asian
    		 109 220 109 438
        Southeast Asian
    		 19 32 16 67
        South Asian
    		 1 0 0 1
        West Asian
    		 0 3 0 3
        other
    		 6 17 10 33
        not reported
    		 1 0 0 1
    Race/Ethnicity, Customized
    Race
    Units: Subjects
        Caucasian
    		 7 20 10 37
        Asian
    		 129 252 125 506

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Secukinumab 150mg
    Reporting group description
    		 Secukinumab 150mg s.c.

    Reporting group title
    Secukinumab 300mg
    Reporting group description
    		 Secukinumab 300mg s.c.

    Reporting group title
    placebo
    Reporting group description
    		 Placebo to secukinumab s.c
    Reporting group title
    Secukinumab 150mg
    Reporting group description
    		 Secukinumab 150mg s.c.

    Reporting group title
    Secukinumab 300mg
    Reporting group description
    		 Secukinumab 300mg s.c.

    Reporting group title
    placebo - placebo
    Reporting group description
    		 Placebo patients who remained on Placebo after week 12

    Reporting group title
    Placebo - secukinumab 300mg
    Reporting group description
    		 patients switched to Secukinumab (AIN457) at week 12

    Primary: Psoriasis Area and Severity Index (PASI) 75 (multiple imputation)

    		 Close Top of page
    End point title
    		 Psoriasis Area and Severity Index (PASI) 75 (multiple imputation)
    End point description
    Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Secukinumab 150mg Secukinumab 300mg placebo
    Number of subjects analysed
    136
    272
    135
    Units: participants
    112
    254
    6
    Statistical analysis title
    		 PASI 75 Secukinumab 150 mg / Placebo
    Statistical analysis description
    PASI 75
    Comparison groups
    Secukinumab 150mg v placebo
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    153.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 54.02
         upper limit
    		 438.67
    Statistical analysis title
    		 PASI 75 Secukinumab 300 mg / Placebo
    Statistical analysis description
    PASI 75
    Comparison groups
    Secukinumab 300mg v placebo
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    557.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 187.2
         upper limit
    		 1663.4

    Primary: Investigator`s Global Assessment (IGA) mod 2011 0/1 (multiple imputation)

    		 Close Top of page
    End point title
    		 Investigator`s Global Assessment (IGA) mod 2011 0/1 (multiple imputation)
    End point description
    Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator’s Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Secukinumab 150mg Secukinumab 300mg placebo
    Number of subjects analysed
    136
    272
    135
    Units: participants
    92
    214
    4
    Statistical analysis title
    		 IGA 150 mg / Placebo
    Statistical analysis description
    IGA
    Comparison groups
    Secukinumab 150mg v placebo
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    75.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.81
         upper limit
    		 222.72
    Statistical analysis title
    		 IGA Secukinumab 300 mg / Placebo
    Statistical analysis description
    IGA
    Comparison groups
    Secukinumab 300mg v placebo
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    149.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 51.83
         upper limit
    		 432.42

    Secondary: Psoriasis Area and Severity Index (PASI) 90 (multiple imputation)

    		 Close Top of page
    End point title
    		 Psoriasis Area and Severity Index (PASI) 90 (multiple imputation)
    End point description
    Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Secukinumab 150mg Secukinumab 300mg placebo
    Number of subjects analysed
    136
    272
    135
    Units: participants
    85
    210
    2
    Statistical analysis title
    		 PASI 90 Secukinumab 300 mg / Placebo
    Statistical analysis description
    PASI 90
    Comparison groups
    Secukinumab 300mg v placebo
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    246.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 58.41
         upper limit
    		 1037.1
    Statistical analysis title
    		 PASI 90 Secukinumab 150 mg / Placebo
    Statistical analysis description
    PASI 90
    Comparison groups
    Secukinumab 150mg v placebo
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    114.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.94
         upper limit
    		 489.59

    Secondary: efficacy of secukinumab in maintaining PASI 75 response at Week 52 in subjects who were PASI 75 responders at Week 12 (multiple imputation)

    		 Close Top of page
    End point title
    		 efficacy of secukinumab in maintaining PASI 75 response at Week 52 in subjects who were PASI 75 responders at Week 12 (multiple imputation) [1]
    End point description
    Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    End point type
    Secondary
    End point timeframe
    Week 52
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were only 4 patients in the placebo arm after week 12, therefore the analyses was not performed
    End point values
    		 Secukinumab 150mg Secukinumab 300mg
    Number of subjects analysed
    110
    242
    Units: participants
    94
    235
    No statistical analyses for this end point

    Secondary: efficacy of secukinumab in maintaining IGA mod 2011 0 or 1 response at Week 52 in subjects who were IGA mod 2011 0 or 1 responders at Week 12 (multiple imputation)

    		 Close Top of page
    End point title
    		 efficacy of secukinumab in maintaining IGA mod 2011 0 or 1 response at Week 52 in subjects who were IGA mod 2011 0 or 1 responders at Week 12 (multiple imputation) [2]
    End point description
    Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator’s Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
    End point type
    Secondary
    End point timeframe
    Week 52
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were only 4 patients in the placebo arm after week 12, therefore the analyses was not performed
    End point values
    		 Secukinumab 150mg Secukinumab 300mg
    Number of subjects analysed
    91
    206
    Units: participants
    65
    162
    No statistical analyses for this end point

    Secondary: PASI 50/75/90/100 and IGA mod 2011 0 or 1 response over time (multiple imputation)

    		 Close Top of page
    End point title
    		 PASI 50/75/90/100 and IGA mod 2011 0 or 1 response over time (multiple imputation)
    End point description
    Number (%) of subjects with PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response
    End point type
    Secondary
    End point timeframe
    week 1, week 12, week 24, week 52
    End point values
    		 Secukinumab 150mg Secukinumab 300mg placebo Placebo - secukinumab 300mg
    Number of subjects analysed
    136
    272
    135
    129
    Units: participants
        Week 1 IGA 0/1
    0
    1
    0
    0
        Week 1 PASI 50
    5
    25
    1
    0
        Week 1 PASI 75
    0
    0
    0
    0
        Week 1 PASI 90
    0
    0
    0
    0
        Week 1 PASI 100
    0
    0
    0
    0
        Week 12 IGA 0/1
    92
    214
    4
    0
        Week 12 PASI 50
    130
    267
    16
    0
        Week 12 PASI 75
    112
    254
    6
    0
        Week 12 PASI 90
    85
    210
    2
    0
        Week 12 PASI 100
    28
    81
    1
    0
        Week 16 IGA 0/1
    100
    219
    2
    32
        Week 16 PASI 50
    134
    270
    4
    108
        Week 16 PASI 75
    124
    261
    3
    72
        Week 16 PASI 90
    98
    233
    2
    22
        Week 16 PASI 100
    39
    99
    0
    3
        Week 24 IGA 0/1
    91
    217
    1
    88
        Week 24 PASI 50
    135
    271
    4
    123
        Week 24 PASI 75
    123
    257
    2
    113
        Week 24 PASI 90
    93
    230
    2
    94
        Week 24 PASI 100
    47
    107
    0
    31
        Week 52 IGA 0/1
    79
    194
    0
    96
        Week 52 PASI 50
    128
    269
    4
    126
        Week 52 PASI 75
    111
    259
    4
    119
        Week 52 PASI 90
    86
    218
    1
    101
        Week 52 PASI 100
    42
    110
    1
    55
    No statistical analyses for this end point

    Secondary: American Collage of Rheumatology (ACR) Response 20/50/70

    		 Close Top of page
    End point title
    		 American Collage of Rheumatology (ACR) Response 20/50/70
    End point description
    Percentage of patients who achieved ACR 20/50/70 at Week 12 and up to Week 52. The subset of patients who had active PsA at baseline included 7 patients in the secukinumab 150 mg group, 17 patients in the secukinumab 300 mg group and 4 patients in the placebo group. ACR 20, 50 or 70 responses correspond, respectively, to at least 20%, 50% or 70% improvement in comparison with baseline in the number of tender and swollen joint counts, in addition to similar improvements in at least three of five other measure of disability or disease activity
    End point type
    Secondary
    End point timeframe
    week 12, week 24, week 52
    End point values
    		 Secukinumab 150mg Secukinumab 300mg placebo Placebo - secukinumab 300mg
    Number of subjects analysed
    7
    17
    4
    4
    Units: participants
        Week 12 ACR 20
    4
    13
    0
    0
        Week 12 ACR 50
    3
    12
    0
    0
        Week 12 ACR 70
    2
    6
    0
    0
        Week 24 ACR 20
    5
    14
    0
    2
        Week 24 ACR 50
    4
    10
    0
    1
        Week 24 ACR 70
    2
    6
    0
    1
        Week 52 ACR 20
    4
    13
    0
    3
        Week 52 ACR 50
    3
    11
    0
    2
        Week 52 ACR 70
    2
    8
    0
    0
    No statistical analyses for this end point

    Secondary: Time to PASI 75 response up to Week 12

    		 Close Top of page
    End point title
    		 Time to PASI 75 response up to Week 12 [3]
    End point description
    Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    End point type
    Secondary
    End point timeframe
    week 12
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Since only 3.7 % of the placebo patients achieved PASI 75 Response by week 12, this was not analysed
    End point values
    		 Secukinumab 150mg Secukinumab 300mg
    Number of subjects analysed
    136
    272
    Units: days
        median (confidence interval 95%)
    57 (51 to 57)
    55 (29 to 57)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    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
    AIN457 300 mg
    Reporting group description
    		 AIN457 300 mg

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

    Reporting group title
    Any AIN457 dose
    Reporting group description
    		 Any AIN457 dose

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Any AIN457 300 mg
    Reporting group description
    		 Any AIN457 300 mg

    Serious adverse events
    		 AIN457 300 mg AIN457 150 mg Any AIN457 dose Placebo Any AIN457 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 272 (3.31%)
    5 / 136 (3.68%)
    19 / 537 (3.54%)
    2 / 135 (1.48%)
    14 / 401 (3.49%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon adenoma
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 136 (0.74%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Comminuted fracture
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic vascular disorder
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 136 (0.74%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 136 (0.74%)
    2 / 537 (0.37%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 136 (0.74%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth impacted
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 136 (0.74%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic mass
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythrodermic psoriasis
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 136 (0.74%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    0 / 537 (0.00%)
    1 / 135 (0.74%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Glomerulonephritis chronic
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 136 (0.00%)
    0 / 537 (0.00%)
    1 / 135 (0.74%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    2 / 272 (0.74%)
    0 / 136 (0.00%)
    2 / 537 (0.37%)
    0 / 135 (0.00%)
    2 / 401 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 136 (0.00%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    1 / 401 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 136 (0.74%)
    1 / 537 (0.19%)
    0 / 135 (0.00%)
    0 / 401 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 AIN457 300 mg AIN457 150 mg Any AIN457 dose Placebo Any AIN457 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    221 / 272 (81.25%)
    115 / 136 (84.56%)
    427 / 537 (79.52%)
    71 / 135 (52.59%)
    312 / 401 (77.81%)
    Investigations
    Blood uric acid increased
         subjects affected / exposed
    4 / 272 (1.47%)
    4 / 136 (2.94%)
    10 / 537 (1.86%)
    5 / 135 (3.70%)
    6 / 401 (1.50%)
         occurrences all number
    7
    4
    14
    5
    10
    C-reactive protein increased
         subjects affected / exposed
    11 / 272 (4.04%)
    7 / 136 (5.15%)
    20 / 537 (3.72%)
    3 / 135 (2.22%)
    13 / 401 (3.24%)
         occurrences all number
    14
    9
    25
    3
    16
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    10 / 272 (3.68%)
    2 / 136 (1.47%)
    14 / 537 (2.61%)
    1 / 135 (0.74%)
    12 / 401 (2.99%)
         occurrences all number
    14
    2
    18
    1
    16
    Vascular disorders
    Hypertension
         subjects affected / exposed
    19 / 272 (6.99%)
    5 / 136 (3.68%)
    27 / 537 (5.03%)
    4 / 135 (2.96%)
    22 / 401 (5.49%)
         occurrences all number
    20
    5
    29
    4
    24
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 272 (3.68%)
    4 / 136 (2.94%)
    14 / 537 (2.61%)
    2 / 135 (1.48%)
    10 / 401 (2.49%)
         occurrences all number
    18
    5
    23
    4
    18
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    14 / 272 (5.15%)
    4 / 136 (2.94%)
    22 / 537 (4.10%)
    1 / 135 (0.74%)
    18 / 401 (4.49%)
         occurrences all number
    15
    4
    24
    1
    20
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    31 / 272 (11.40%)
    13 / 136 (9.56%)
    55 / 537 (10.24%)
    12 / 135 (8.89%)
    42 / 401 (10.47%)
         occurrences all number
    40
    23
    81
    28
    58
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    18 / 272 (6.62%)
    9 / 136 (6.62%)
    31 / 537 (5.77%)
    4 / 135 (2.96%)
    22 / 401 (5.49%)
         occurrences all number
    21
    12
    38
    4
    26
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    17 / 272 (6.25%)
    13 / 136 (9.56%)
    38 / 537 (7.08%)
    2 / 135 (1.48%)
    25 / 401 (6.23%)
         occurrences all number
    18
    15
    41
    2
    26
    Oropharyngeal pain
         subjects affected / exposed
    25 / 272 (9.19%)
    16 / 136 (11.76%)
    48 / 537 (8.94%)
    3 / 135 (2.22%)
    32 / 401 (7.98%)
         occurrences all number
    33
    20
    68
    3
    48
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    20 / 272 (7.35%)
    10 / 136 (7.35%)
    35 / 537 (6.52%)
    0 / 135 (0.00%)
    25 / 401 (6.23%)
         occurrences all number
    30
    11
    46
    0
    35
    Pruritus
         subjects affected / exposed
    32 / 272 (11.76%)
    12 / 136 (8.82%)
    48 / 537 (8.94%)
    11 / 135 (8.15%)
    36 / 401 (8.98%)
         occurrences all number
    36
    15
    56
    13
    41
    Psoriasis
         subjects affected / exposed
    3 / 272 (1.10%)
    6 / 136 (4.41%)
    9 / 537 (1.68%)
    0 / 135 (0.00%)
    3 / 401 (0.75%)
         occurrences all number
    3
    7
    10
    0
    3
    Urticaria
         subjects affected / exposed
    24 / 272 (8.82%)
    12 / 136 (8.82%)
    42 / 537 (7.82%)
    0 / 135 (0.00%)
    30 / 401 (7.48%)
         occurrences all number
    28
    16
    51
    0
    35
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 272 (4.04%)
    4 / 136 (2.94%)
    16 / 537 (2.98%)
    3 / 135 (2.22%)
    12 / 401 (2.99%)
         occurrences all number
    13
    5
    19
    3
    14
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    18 / 272 (6.62%)
    6 / 136 (4.41%)
    32 / 537 (5.96%)
    0 / 135 (0.00%)
    26 / 401 (6.48%)
         occurrences all number
    23
    6
    38
    0
    32
    Influenza
         subjects affected / exposed
    28 / 272 (10.29%)
    17 / 136 (12.50%)
    55 / 537 (10.24%)
    4 / 135 (2.96%)
    38 / 401 (9.48%)
         occurrences all number
    47
    31
    101
    5
    70
    Nasopharyngitis
         subjects affected / exposed
    44 / 272 (16.18%)
    15 / 136 (11.03%)
    72 / 537 (13.41%)
    5 / 135 (3.70%)
    57 / 401 (14.21%)
         occurrences all number
    59
    18
    92
    5
    74
    Pharyngitis
         subjects affected / exposed
    24 / 272 (8.82%)
    14 / 136 (10.29%)
    49 / 537 (9.12%)
    7 / 135 (5.19%)
    35 / 401 (8.73%)
         occurrences all number
    34
    22
    69
    13
    47
    Rhinitis
         subjects affected / exposed
    14 / 272 (5.15%)
    2 / 136 (1.47%)
    18 / 537 (3.35%)
    1 / 135 (0.74%)
    16 / 401 (3.99%)
         occurrences all number
    14
    4
    20
    1
    16
    Tinea pedis
         subjects affected / exposed
    20 / 272 (7.35%)
    5 / 136 (3.68%)
    30 / 537 (5.59%)
    1 / 135 (0.74%)
    25 / 401 (6.23%)
         occurrences all number
    23
    6
    34
    1
    28
    Tonsillitis
         subjects affected / exposed
    14 / 272 (5.15%)
    5 / 136 (3.68%)
    21 / 537 (3.91%)
    1 / 135 (0.74%)
    16 / 401 (3.99%)
         occurrences all number
    16
    5
    23
    1
    18
    Upper respiratory tract infection
         subjects affected / exposed
    67 / 272 (24.63%)
    41 / 136 (30.15%)
    138 / 537 (25.70%)
    13 / 135 (9.63%)
    97 / 401 (24.19%)
         occurrences all number
    98
    67
    208
    14
    141
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    2 / 272 (0.74%)
    0 / 136 (0.00%)
    2 / 537 (0.37%)
    5 / 135 (3.70%)
    2 / 401 (0.50%)
         occurrences all number
    2
    0
    2
    5
    2
    Hyperlipidaemia
         subjects affected / exposed
    22 / 272 (8.09%)
    11 / 136 (8.09%)
    34 / 537 (6.33%)
    11 / 135 (8.15%)
    23 / 401 (5.74%)
         occurrences all number
    22
    11
    34
    11
    23
    Hyperuricaemia
         subjects affected / exposed
    56 / 272 (20.59%)
    25 / 136 (18.38%)
    101 / 537 (18.81%)
    17 / 135 (12.59%)
    76 / 401 (18.95%)
         occurrences all number
    85
    35
    148
    18
    113

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jun 2017
    The aim of this amendment was to introduce a provision for a Week 16 analysis. This analysis included primary endpoint data at Week 12 and in addition data at Week 16 visit. This amendment also introduced the provision for additional subsequent interim analyses that may be conducted to fulfill any request from Health Authorities. In addition, this amendment was used to clarify minor inconsistencies between various protocol sections, and correct minor errors; these did not affect the study design or population.

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

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

    European Medicines Agency © 1995-Fri Apr 19 20:31:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA