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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, multicenter, study to demonstrate the efficacy at 16 weeks of secukinumab 150 and 300 mg s.c. and to assess safety, tolerability and long-term efficacy up to 132 weeks in subjects with moderate to severe nail psoriasis

    Summary
    EudraCT number
    		 2012-005413-40
    Trial protocol
    		 CZ   ES   BE   GR   DK   DE   GB  
    Global end of trial date
    03 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Dec 2017
    First version publication date
    30 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457A2313
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01807520
    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 613421111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613421111,
    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
    03 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate the superiority of secukinumab 150 mg and/or 300 mg to placebo in patients with moderate to severe psoriasis affecting the nails as assessed by NAPSI (NAil Psoriasis Severity Index) at Week 16.
    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
    20 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 23
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Czech Republic: 19
    Country: Number of subjects enrolled
    Denmark: 10
    Country: Number of subjects enrolled
    Germany: 39
    Country: Number of subjects enrolled
    United Kingdom: 26
    Country: Number of subjects enrolled
    Greece: 18
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    United States: 31
    Worldwide total number of subjects
    198
    EEA total number of subjects
    144
    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)
    186
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was made up of 4 periods: screening, treatment period 1, treatment period 2 and post-treatment follow-up.

    Pre-assignment
    Screening details
    		 In treatment period 1, participants were randomized in a 1:1:1 ratio to secukinumab 150mg, secukinumab 300mg or placebo.. In treatment period 2, placebo participants were re-randomized in a 1:1 ratio to secukinumab 150mg or secukinumab 300mg. The follow-up period occurred 8 weeks post treatment period 2 (12 weeks post the last dose of secukinumab).

    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
    		 Investigator, Subject, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 150 mg
    Arm description
    		 Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.

    Arm title
    		 AIN457 300 mg
    Arm description
    		 Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.

    Arm title
    		 Placebo
    Arm description
    		 Participants assigned to placebo were dosed weekly for five weeks, then at Week 8 and Week 12. At Week 16, placebo participants were randomized in a 1:1 ratio, to receive secukinumab either 150 mg or 300 mg and were dosed weekly for five weeks starting at Week 16, then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients assigned to placebo were dosed weekly for five weeks, then at Week 8 and Week 12. At Week 16, placebo patients were randomized in a 1:1 ratio, to receive secukinumab either 150 mg or 300 mg and were dosed weekly for five weeks starting at Week 16, then once every four weeks up to and including Week 132. All doses of study treatment are administered by sub-cutaneous injections.

    Number of subjects in period 1
    		AIN457 150 mg AIN457 300 mg Placebo
    Started
    67
    66
    65
    Full Analysis Set
    67
    66
    65
    Safety Set
    67
    65
    65
    Completed
    63
    65
    58
    Not completed
    4
    1
    7
         Consent withdrawn by subject
    -
    1
    3
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    2
    -
    -
         Protocol deviation
    1
    -
    1
         Lost to follow-up
    1
    -
    -
         Lack of efficacy
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AIN457 150 mg
    Reporting group description
    		 Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.

    Reporting group title
    AIN457 300 mg
    Reporting group description
    		 Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants assigned to placebo were dosed weekly for five weeks, then at Week 8 and Week 12. At Week 16, placebo participants were randomized in a 1:1 ratio, to receive secukinumab either 150 mg or 300 mg and were dosed weekly for five weeks starting at Week 16, then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.

    Reporting group values
    		 AIN457 150 mg AIN457 300 mg Placebo Total
    Number of subjects
    		 67 66 65 198
    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)
    		 63 61 62 186
        From 65-84 years
    		 4 5 3 12
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 43.5 ± 10.94 45.1 ± 12.9 43.6 ± 11.2 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 12 13 13 38
        Male
    		 55 53 52 160

    End points

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    End points reporting groups
    Reporting group title
    AIN457 150 mg
    Reporting group description
    		 Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.

    Reporting group title
    AIN457 300 mg
    Reporting group description
    		 Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, participants received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants assigned to placebo were dosed weekly for five weeks, then at Week 8 and Week 12. At Week 16, placebo participants were randomized in a 1:1 ratio, to receive secukinumab either 150 mg or 300 mg and were dosed weekly for five weeks starting at Week 16, then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.

    Subject analysis set title
    Placebo - AIN157 150 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 150 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.

    Subject analysis set title
    Placebo - AIN457 300 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received placebo weekly for five weeks, and then at Week 8 and Week 12. At Week 16, participants were randomized to receive secukinumab 300 mg and were dosed weekly for five weeks starting at Week 16, and then once every four weeks up to and including Week 132. All doses of study treatment were administered by sub-cutaneous injections.

    Primary: Percentage change from baseline in Nail Psoriasis Severity Index (NAPSI) after 16 weeks of treatment

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    End point title
    		 Percentage change from baseline in Nail Psoriasis Severity Index (NAPSI) after 16 weeks of treatment
    End point description
    The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. The adjusted mean is presented.
    End point type
    Primary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 AIN457 150 mg AIN457 300 mg Placebo
    Number of subjects analysed
    63
    64
    56
    Units: percent change
        arithmetic mean (standard error)
    -38.4 ± 4.54
    -46.1 ± 3.43
    -11.7 ± 4.28
    Statistical analysis title
    		 Change from baseline in NAPSI
    Comparison groups
    AIN457 150 mg v Placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Mixed model reapeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    -26.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.1
         upper limit
    		 -14.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.26
    Statistical analysis title
    		 Change from baseline in NAPSI
    Comparison groups
    AIN457 300 mg v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Mixed model repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    -34.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.2
         upper limit
    		 -23.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.47

    Secondary: Percent change from baseline in NAPSI score

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    End point title
    		 Percent change from baseline in NAPSI score [1]
    End point description
    The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline, 16 weeks, 132 weeks
    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: All arms do not apply.
    End point values
    		 AIN457 150 mg AIN457 300 mg Placebo - AIN157 150 mg Placebo - AIN457 300 mg
    Number of subjects analysed
    67
    65
    29
    29
    Units: percent change
    arithmetic mean (standard deviation)
        Week 16
    -37.9 ± 37.32
    -45.3 ± 27.22
    -15.4 ± 32.79
    -7.8 ± 31.77
        Week 132 (n=67,65,28,29)
    -52.9 ± 42.90
    -70.5 ± 29.2
    -62.9 ± 29.05
    -72.7 ± 22.84
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving Psoriasis Area and Severity Index 75 (PASI75) and Investigator Global Assessment (IGA mod 2011) response 0 or 1 over time up to Week 16 of the treatment compared to placebo and over time up to Week 132

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    End point title
    		 Percentage of participants achieving Psoriasis Area and Severity Index 75 (PASI75) and Investigator Global Assessment (IGA mod 2011) response 0 or 1 over time up to Week 16 of the treatment compared to placebo and over time up to Week 132 [2]
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). The IGA scale referred exclusively to the participant's disease at the time of the assessment. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe. To be considered IGA responder at any point in time, the patient must have an IGA score of 0 or 1 and have achieved a reduction of at least two points on the IGA scale from baseline.
    End point type
    Secondary
    End point timeframe
    16 weeks, 132 weeks
    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: All arms do not apply.
    End point values
    		 AIN457 150 mg AIN457 300 mg
    Number of subjects analysed
    67
    65
    Units: Percentage of participants
    number (not applicable)
        Week 16, PASI 75
    76.6
    87.1
        Week 16, IGA 0/1
    67.8
    74.0
        Week 132, PASI 75
    61.6
    82.7
        Week 132, IGA 0/1
    52.2
    61.2
    No statistical analyses for this end point

    Secondary: Number of participants who develop immunogenicity against secukinumab

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    End point title
    		 Number of participants who develop immunogenicity against secukinumab [3]
    End point description
    The number of participants who tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment. None of the participants had a loss of efficacy and the test was only transiently positive.
    End point type
    Secondary
    End point timeframe
    Week 132
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All arms do not apply.
    End point values
    		 AIN457 150 mg AIN457 300 mg Placebo - AIN157 150 mg Placebo - AIN457 300 mg
    Number of subjects analysed
    67
    65
    29
    29
    Units: Participants
    2
    5
    4
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Any AIN457 150 mg
    Reporting group description
    		 Any AIN457 150 mg

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

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

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

    Serious adverse events
    		 Any AIN457 150 mg Any AIN457 300 mg Placebo Any AIN457 dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 96 (10.42%)
    9 / 94 (9.57%)
    1 / 65 (1.54%)
    19 / 190 (10.00%)
         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)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract subcapsular
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythrodermic psoriasis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 94 (0.00%)
    1 / 65 (1.54%)
    0 / 190 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Eczema impetiginous
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eczema infected
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    1 / 190 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 96 (1.04%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    2 / 2
         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 Placebo Any AIN457 dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    76 / 96 (79.17%)
    79 / 94 (84.04%)
    37 / 65 (56.92%)
    155 / 190 (81.58%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    1
    2
    0
    3
    Skin papilloma
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 94 (2.13%)
    1 / 65 (1.54%)
    3 / 190 (1.58%)
         occurrences all number
    1
    3
    1
    4
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 96 (5.21%)
    4 / 94 (4.26%)
    0 / 65 (0.00%)
    9 / 190 (4.74%)
         occurrences all number
    5
    4
    0
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 96 (4.17%)
    5 / 94 (5.32%)
    0 / 65 (0.00%)
    9 / 190 (4.74%)
         occurrences all number
    4
    5
    0
    9
    Influenza like illness
         subjects affected / exposed
    3 / 96 (3.13%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    3
    2
    0
    5
    Injection site erythema
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 94 (0.00%)
    2 / 65 (3.08%)
    0 / 190 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Pyrexia
         subjects affected / exposed
    3 / 96 (3.13%)
    1 / 94 (1.06%)
    1 / 65 (1.54%)
    4 / 190 (2.11%)
         occurrences all number
    4
    1
    1
    5
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    3
    1
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 96 (1.04%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    2
    3
    0
    5
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    1
    2
    0
    3
    Cough
         subjects affected / exposed
    7 / 96 (7.29%)
    7 / 94 (7.45%)
    2 / 65 (3.08%)
    14 / 190 (7.37%)
         occurrences all number
    7
    8
    2
    15
    Dyspnoea
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    1
    2
    0
    3
    Nasal congestion
         subjects affected / exposed
    2 / 96 (2.08%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    2
    3
    0
    5
    Oropharyngeal pain
         subjects affected / exposed
    4 / 96 (4.17%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    4
    0
    0
    4
    Productive cough
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    2
    0
    0
    2
    Rhinitis allergic
         subjects affected / exposed
    2 / 96 (2.08%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    2
    2
    0
    4
    Rhinorrhoea
         subjects affected / exposed
    0 / 96 (0.00%)
    3 / 94 (3.19%)
    1 / 65 (1.54%)
    3 / 190 (1.58%)
         occurrences all number
    0
    3
    1
    3
    Wheezing
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    0
    2
    0
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    6 / 96 (6.25%)
    0 / 94 (0.00%)
    1 / 65 (1.54%)
    6 / 190 (3.16%)
         occurrences all number
    10
    0
    1
    10
    Depression
         subjects affected / exposed
    3 / 96 (3.13%)
    4 / 94 (4.26%)
    2 / 65 (3.08%)
    7 / 190 (3.68%)
         occurrences all number
    4
    4
    2
    8
    Insomnia
         subjects affected / exposed
    2 / 96 (2.08%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    5 / 190 (2.63%)
         occurrences all number
    2
    4
    0
    6
    Stress
         subjects affected / exposed
    3 / 96 (3.13%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    3
    0
    0
    3
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    2
    3
    0
    5
    Weight increased
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    0
    2
    0
    2
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    0
    3
    Avulsion fracture
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    0
    2
    0
    2
    Contusion
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    1 / 65 (1.54%)
    2 / 190 (1.05%)
         occurrences all number
    2
    0
    1
    2
    Fall
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    3
    0
    0
    3
    Ligament sprain
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    0
    3
    Limb injury
         subjects affected / exposed
    2 / 96 (2.08%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    2
    2
    0
    4
    Skin abrasion
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 94 (0.00%)
    2 / 65 (3.08%)
    0 / 190 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Tendon rupture
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    2
    0
    0
    2
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 96 (1.04%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    2
    3
    0
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 96 (3.13%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    3
    1
    0
    4
    Headache
         subjects affected / exposed
    9 / 96 (9.38%)
    10 / 94 (10.64%)
    4 / 65 (6.15%)
    19 / 190 (10.00%)
         occurrences all number
    15
    14
    6
    29
    Poor quality sleep
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    2
    0
    0
    2
    Sciatica
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    0
    3
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    0
    3
    Eye disorders
    Dry eye
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    2
    0
    0
    2
    Eye irritation
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    2
    0
    0
    2
    Eye pruritus
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    0
    2
    0
    2
    Visual impairment
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    0
    2
    0
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 94 (2.13%)
    2 / 65 (3.08%)
    2 / 190 (1.05%)
         occurrences all number
    0
    2
    2
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    0
    2
    0
    2
    Diarrhoea
         subjects affected / exposed
    5 / 96 (5.21%)
    5 / 94 (5.32%)
    5 / 65 (7.69%)
    10 / 190 (5.26%)
         occurrences all number
    5
    5
    5
    10
    Dyspepsia
         subjects affected / exposed
    3 / 96 (3.13%)
    5 / 94 (5.32%)
    0 / 65 (0.00%)
    8 / 190 (4.21%)
         occurrences all number
    3
    14
    0
    17
    Haemorrhoids
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    3
    1
    0
    4
    Loose tooth
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    3
    0
    0
    3
    Nausea
         subjects affected / exposed
    4 / 96 (4.17%)
    3 / 94 (3.19%)
    1 / 65 (1.54%)
    7 / 190 (3.68%)
         occurrences all number
    4
    3
    1
    7
    Toothache
         subjects affected / exposed
    3 / 96 (3.13%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    3
    1
    0
    4
    Vomiting
         subjects affected / exposed
    3 / 96 (3.13%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    3
    1
    0
    4
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    2 / 96 (2.08%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    2
    2
    0
    4
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    1
    2
    0
    3
    Actinic keratosis
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    1
    3
    0
    4
    Alopecia areata
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    0
    3
    Dermatitis
         subjects affected / exposed
    3 / 96 (3.13%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    3
    0
    0
    3
    Dry skin
         subjects affected / exposed
    3 / 96 (3.13%)
    4 / 94 (4.26%)
    0 / 65 (0.00%)
    7 / 190 (3.68%)
         occurrences all number
    3
    4
    0
    7
    Eczema
         subjects affected / exposed
    1 / 96 (1.04%)
    4 / 94 (4.26%)
    0 / 65 (0.00%)
    5 / 190 (2.63%)
         occurrences all number
    1
    6
    0
    7
    Intertrigo
         subjects affected / exposed
    1 / 96 (1.04%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    1
    3
    0
    4
    Pruritus
         subjects affected / exposed
    5 / 96 (5.21%)
    3 / 94 (3.19%)
    1 / 65 (1.54%)
    8 / 190 (4.21%)
         occurrences all number
    5
    3
    1
    8
    Pruritus generalised
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    1 / 65 (1.54%)
    2 / 190 (1.05%)
         occurrences all number
    2
    0
    1
    2
    Psoriasis
         subjects affected / exposed
    16 / 96 (16.67%)
    6 / 94 (6.38%)
    7 / 65 (10.77%)
    22 / 190 (11.58%)
         occurrences all number
    21
    6
    9
    27
    Seborrhoeic dermatitis
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    2
    0
    0
    2
    Skin fissures
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    2 / 65 (3.08%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    2
    3
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    0
    3
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 96 (4.17%)
    8 / 94 (8.51%)
    2 / 65 (3.08%)
    12 / 190 (6.32%)
         occurrences all number
    4
    10
    2
    14
    Back pain
         subjects affected / exposed
    9 / 96 (9.38%)
    7 / 94 (7.45%)
    1 / 65 (1.54%)
    16 / 190 (8.42%)
         occurrences all number
    9
    8
    1
    17
    Dactylitis
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    0
    2
    0
    2
    Joint swelling
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    3
    0
    0
    3
    Muscle spasms
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    2
    0
    0
    2
    Musculoskeletal pain
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    1
    2
    0
    3
    Pain in extremity
         subjects affected / exposed
    5 / 96 (5.21%)
    1 / 94 (1.06%)
    2 / 65 (3.08%)
    6 / 190 (3.16%)
         occurrences all number
    6
    1
    2
    7
    Psoriatic arthropathy
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    1 / 65 (1.54%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    1
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 96 (4.17%)
    7 / 94 (7.45%)
    0 / 65 (0.00%)
    11 / 190 (5.79%)
         occurrences all number
    6
    8
    0
    14
    Cellulitis
         subjects affected / exposed
    1 / 96 (1.04%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    1
    4
    0
    5
    Conjunctivitis
         subjects affected / exposed
    3 / 96 (3.13%)
    4 / 94 (4.26%)
    0 / 65 (0.00%)
    7 / 190 (3.68%)
         occurrences all number
    4
    6
    0
    10
    Ear infection
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    0
    3
    Erysipelas
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    1 / 65 (1.54%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    1
    3
    Fungal skin infection
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    1 / 65 (1.54%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    1
    3
    Gastroenteritis
         subjects affected / exposed
    6 / 96 (6.25%)
    6 / 94 (6.38%)
    0 / 65 (0.00%)
    12 / 190 (6.32%)
         occurrences all number
    7
    7
    0
    14
    Herpes zoster
         subjects affected / exposed
    3 / 96 (3.13%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    6 / 190 (3.16%)
         occurrences all number
    3
    3
    0
    6
    Hordeolum
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    4
    1
    0
    5
    Influenza
         subjects affected / exposed
    0 / 96 (0.00%)
    6 / 94 (6.38%)
    2 / 65 (3.08%)
    6 / 190 (3.16%)
         occurrences all number
    0
    6
    2
    6
    Localised infection
         subjects affected / exposed
    0 / 96 (0.00%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    0
    3
    0
    3
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 96 (2.08%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    5 / 190 (2.63%)
         occurrences all number
    2
    4
    0
    6
    Nasopharyngitis
         subjects affected / exposed
    25 / 96 (26.04%)
    27 / 94 (28.72%)
    8 / 65 (12.31%)
    52 / 190 (27.37%)
         occurrences all number
    56
    42
    10
    98
    Onychomycosis
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    0
    3
    Oral candidiasis
         subjects affected / exposed
    1 / 96 (1.04%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    1
    5
    0
    6
    Oral herpes
         subjects affected / exposed
    2 / 96 (2.08%)
    2 / 94 (2.13%)
    4 / 65 (6.15%)
    4 / 190 (2.11%)
         occurrences all number
    2
    2
    4
    4
    Otitis externa
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    1
    3
    0
    4
    Pharyngitis
         subjects affected / exposed
    2 / 96 (2.08%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    5 / 190 (2.63%)
         occurrences all number
    2
    3
    0
    5
    Pneumonia
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    2 / 190 (1.05%)
         occurrences all number
    0
    2
    0
    2
    Pulpitis dental
         subjects affected / exposed
    4 / 96 (4.17%)
    4 / 94 (4.26%)
    1 / 65 (1.54%)
    8 / 190 (4.21%)
         occurrences all number
    7
    4
    1
    11
    Respiratory tract infection
         subjects affected / exposed
    2 / 96 (2.08%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    3
    2
    0
    5
    Rhinitis
         subjects affected / exposed
    2 / 96 (2.08%)
    7 / 94 (7.45%)
    0 / 65 (0.00%)
    9 / 190 (4.74%)
         occurrences all number
    2
    9
    0
    11
    Sinusitis
         subjects affected / exposed
    3 / 96 (3.13%)
    6 / 94 (6.38%)
    0 / 65 (0.00%)
    9 / 190 (4.74%)
         occurrences all number
    3
    6
    0
    9
    Skin infection
         subjects affected / exposed
    1 / 96 (1.04%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    4 / 190 (2.11%)
         occurrences all number
    1
    4
    0
    5
    Tinea pedis
         subjects affected / exposed
    5 / 96 (5.21%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    6 / 190 (3.16%)
         occurrences all number
    5
    1
    0
    6
    Tonsillitis
         subjects affected / exposed
    4 / 96 (4.17%)
    4 / 94 (4.26%)
    0 / 65 (0.00%)
    8 / 190 (4.21%)
         occurrences all number
    5
    5
    0
    10
    Tooth abscess
         subjects affected / exposed
    0 / 96 (0.00%)
    3 / 94 (3.19%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    0
    3
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    15 / 96 (15.63%)
    8 / 94 (8.51%)
    2 / 65 (3.08%)
    23 / 190 (12.11%)
         occurrences all number
    18
    16
    2
    34
    Urinary tract infection
         subjects affected / exposed
    3 / 96 (3.13%)
    5 / 94 (5.32%)
    0 / 65 (0.00%)
    8 / 190 (4.21%)
         occurrences all number
    3
    11
    0
    14
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 96 (3.13%)
    2 / 94 (2.13%)
    0 / 65 (0.00%)
    5 / 190 (2.63%)
         occurrences all number
    3
    2
    0
    5
    Vulvovaginal candidiasis
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 94 (1.06%)
    0 / 65 (0.00%)
    3 / 190 (1.58%)
         occurrences all number
    2
    1
    0
    3
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 94 (0.00%)
    1 / 65 (1.54%)
    2 / 190 (1.05%)
         occurrences all number
    2
    0
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jan 2015
    Study title was revised, to reflect the new treatment duration; Sections 1.2, 2.2, 3.1, 3.2, 5.2, 5.4, 5.5.4, 6 and 9.1 were updated with the treatment duration and Figure 3.1 was revised accordingly; Section 3.1: an explanation was added on the need to consent patients before starting extended treatment; Sections 3.5 and 9.6: added Week 16 and Week 80 interim analyses and the possibility of additional interim analyses, if requested by health authorities or for publications purposes; Section 5.5.12: revised, to reflect context of possible early study termination by the sponsor; Section 6: Updated content, including in Table 6-1, to reflect the additional procedures; Sections 6.4.6 and 6.6.6: revised target lesions for photography; Sections 8.4 and 8.5: updated content pertaining to Data Monitoring Committee (DMC) and Adjudication committee; Appendix 2: updated, to include collection of PK and IG samples at additional visits
    12 Mar 2015
    Sections 3.1 and 5.5.5: amended to allow treatment to be extended for patients who had their Week 80 completed before protocol Amendment 1 was implemented at sites and who wished to have their treatment extended; Table 6-1: deleted obsolete statement and amended, to include comment on timing of patients’ consent before treatment was extended.

    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.
    The overall study completed. However, in Spain, the study terminated early in accordance with study protocol amendment 1.
    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.

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