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    Clinical Trial Results:
    A randomized, double-blind, placebo- and active controlled multicenter trial to demonstrate efficacy of subcutaneous secukinumab compared to placebo and etanercept (in a single-blinded arm) after twelve weeks of treatment, and to assess the safety, tolerability, and long-term efficacy in subjects from 6 to less than 18 years of age with severe chronic plaque psoriasis

    Summary
    EudraCT number
    		 2014-005663-32
    Trial protocol
    		 LV   EE   DE   BE   ES   HU   FR   GB   PL   IT  
    Global end of trial date
    30 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2023
    First version publication date
    15 Oct 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457A2310
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02471144
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, 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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000380-PIP01-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the superiority of secukinumab (low and high dose) in pediatric patients with severe chronic plaque psoriasis with respect to both PASI 75 and IGA mod 2011 0/1 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
    29 Sep 2015
    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
    Estonia: 11
    Country: Number of subjects enrolled
    Latvia: 4
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Israel: 10
    Country: Number of subjects enrolled
    Poland: 28
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Guatemala: 10
    Country: Number of subjects enrolled
    Japan: 5
    Country: Number of subjects enrolled
    Germany: 25
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Colombia: 9
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Egypt: 11
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    United States: 2
    Country: Number of subjects enrolled
    Russian Federation: 13
    Worldwide total number of subjects
    162
    EEA total number of subjects
    100
    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)
    37
    Adolescents (12-17 years)
    125
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants took part in 57 investigative sites in 19 countries.

    Pre-assignment
    Screening details
    		 The screening period of up to 4 weeks was used to assess eligibility of the patients and to taper patients off prohibited medications.

    Period 1
    Period 1 title
    Induction Period (Up to Week 12)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 Low Dose (Induction Period)
    Arm description
    		 Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) s.c. at each dosing.

    Arm title
    		 AIN457 High Dose (Induction Period)
    Arm description
    		 Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) s.c. at each dosing.

    Arm title
    		 Placebo (Induction Period)
    Arm description
    		 Patients received matching placebo to secukinumab at each dosing
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received placebo s.c. at each dosing.

    Arm title
    		 Etanercept Comparator (Induction Period)
    Arm description
    		 Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Etanercept Comparator
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg).

    Number of subjects in period 1
    		AIN457 Low Dose (Induction Period) AIN457 High Dose (Induction Period) Placebo (Induction Period) Etanercept Comparator (Induction Period)
    Started
    40
    40
    41
    41
    Completed
    39
    38
    39
    40
    Not completed
    1
    2
    2
    1
         Adverse Event
    -
    1
    1
    -
         Protocol Deviation
    -
    -
    1
    -
         Subject/Guardian Decision
    1
    1
    -
    -
         Lack of efficacy
    -
    -
    -
    1
    Period 2
    Period 2 title
    Maintenance Period (Week 12 to Week 52)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 Low Dose (Maintenance Period)
    Arm description
    		 Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) s.c. at each dosing.

    Arm title
    		 AIN457 High Dose (Maintenance Period)
    Arm description
    		 Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) s.c. at each dosing.

    Arm title
    		 Placebo-AIN457 Low Dose (Maintenance Period)
    Arm description
    		 Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study.

    Arm title
    		 Placebo-AIN457 High Dose (Maintenance Period
    Arm description
    		 Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study.

    Arm title
    		 Etanercept Comparator (Maintenance Period)
    Arm description
    		 Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Etanercept Comparator
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg).

    Number of subjects in period 2 [1]
    		AIN457 Low Dose (Maintenance Period) AIN457 High Dose (Maintenance Period) Placebo-AIN457 Low Dose (Maintenance Period) Placebo-AIN457 High Dose (Maintenance Period Etanercept Comparator (Maintenance Period)
    Started
    39
    38
    16
    18
    40
    Completed
    38
    37
    15
    16
    34
    Not completed
    1
    1
    1
    2
    6
         Adverse Event
    1
    -
    1
    -
    1
         Protocol Deviation
    -
    -
    -
    2
    1
         Pregnancy
    -
    -
    -
    -
    1
         Lack of efficacy
    -
    1
    -
    -
    3
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Due to change of treatment and/or stopping of arms between periods, the number of subjects starting the period is not consistent with the number completing the preceding period.
    Period 3
    Period 3 title
    Extension Period (Week 52 to Week 236)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Any AIN457 Low Dose (Extension Period)
    Arm description
    		 Includes patients from the AIN457 Low Dose and from the Placebo-AIN457 Low Dose groups
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) s.c. at each dosing. Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study.

    Arm title
    		 Any AIN457 High Dose (Extension Period)
    Arm description
    		 Includes patients from the AIN457 High Dose and from the Placebo-AIN457 High Dose groups
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) s.c. at each dosing. Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study.

    Number of subjects in period 3 [2]
    		Any AIN457 Low Dose (Extension Period) Any AIN457 High Dose (Extension Period)
    Started
    53
    53
    Completed
    39
    43
    Not completed
    14
    10
         Technical problems
    1
    -
         Adverse event, non-fatal
    2
    2
         Pregnancy
    2
    -
         Subject/Guardian Decision
    3
    3
         Lost to follow-up
    -
    2
         Lack of efficacy
    6
    3
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Due to change of treatment and/or stopping of arms between periods, the number of subjects starting the period is not consistent with the number completing the preceding period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AIN457 Low Dose (Induction Period)
    Reporting group description
    		 Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

    Reporting group title
    AIN457 High Dose (Induction Period)
    Reporting group description
    		 Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

    Reporting group title
    Placebo (Induction Period)
    Reporting group description
    		 Patients received matching placebo to secukinumab at each dosing

    Reporting group title
    Etanercept Comparator (Induction Period)
    Reporting group description
    		 Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)

    Reporting group values
    		 AIN457 Low Dose (Induction Period) AIN457 High Dose (Induction Period) Placebo (Induction Period) Etanercept Comparator (Induction Period) Total
    Number of subjects
    		 40 40 41 41 162
    Age Categorical
    Age Categorical
    Units: Participants
        <12 years
    		 8 9 10 10 37
        >=12 years
    		 32 31 31 31 125
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 13.7 ( 2.92 ) 13.2 ( 3.21 ) 13.7 ( 3.27 ) 13.5 ( 2.94 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 27 23 22 25 97
        Male
    		 13 17 19 16 65
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 34 34 36 30 134
        Black
    		 1 1 0 0 2
        Asian
    		 1 2 1 3 7
        Native American
    		 3 3 3 8 17
        Other
    		 1 0 1 0 2
    Subject analysis sets

    Subject analysis set title
    AIN457 Low Dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

    Subject analysis set title
    AIN457 High Dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients received matching placebo to secukinumab at each dosing

    Subject analysis set title
    Etanercept
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)

    Subject analysis set title
    Placebo - AIN457 Low Dose
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study

    Subject analysis set title
    Placebo - AIN457 High Dose
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study

    Subject analysis sets values
    		 AIN457 Low Dose AIN457 High Dose Placebo Etanercept Placebo - AIN457 Low Dose Placebo - AIN457 High Dose
    Number of subjects
    40
    40
    41
    41
    16
    18
    Age Categorical
    Age Categorical
    Units: Participants
        <12 years
    8
    9
    10
    10
        >=12 years
    32
    31
    31
    31
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    13.7 ( 2.92 )
    13.2 ( 3.21 )
    13.7 ( 3.27 )
    13.5 ( 2.94 )
    ( )
    ( )
    Sex: Female, Male
    Units: Participants
        Female
    27
    23
    22
    25
        Male
    13
    17
    19
    16
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    34
    34
    36
    30
        Black
    1
    1
    0
    0
        Asian
    1
    2
    1
    3
        Native American
    3
    3
    3
    8
        Other
    1
    0
    1
    0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    AIN457 Low Dose (Induction Period)
    Reporting group description
    		 Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

    Reporting group title
    AIN457 High Dose (Induction Period)
    Reporting group description
    		 Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

    Reporting group title
    Placebo (Induction Period)
    Reporting group description
    		 Patients received matching placebo to secukinumab at each dosing

    Reporting group title
    Etanercept Comparator (Induction Period)
    Reporting group description
    		 Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)
    Reporting group title
    AIN457 Low Dose (Maintenance Period)
    Reporting group description
    		 Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

    Reporting group title
    AIN457 High Dose (Maintenance Period)
    Reporting group description
    		 Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

    Reporting group title
    Placebo-AIN457 Low Dose (Maintenance Period)
    Reporting group description
    		 Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study

    Reporting group title
    Placebo-AIN457 High Dose (Maintenance Period
    Reporting group description
    		 Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study

    Reporting group title
    Etanercept Comparator (Maintenance Period)
    Reporting group description
    		 Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)
    Reporting group title
    Any AIN457 Low Dose (Extension Period)
    Reporting group description
    		 Includes patients from the AIN457 Low Dose and from the Placebo-AIN457 Low Dose groups

    Reporting group title
    Any AIN457 High Dose (Extension Period)
    Reporting group description
    		 Includes patients from the AIN457 High Dose and from the Placebo-AIN457 High Dose groups

    Subject analysis set title
    AIN457 Low Dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

    Subject analysis set title
    AIN457 High Dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients received matching placebo to secukinumab at each dosing

    Subject analysis set title
    Etanercept
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)

    Subject analysis set title
    Placebo - AIN457 Low Dose
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study

    Subject analysis set title
    Placebo - AIN457 High Dose
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study

    Primary: Number and Percentage of Participants achieving a 75% Improvement from Baseline in PASI Score at week 12

    		 Close Top of page
    End point title
    		 Number and Percentage of Participants achieving a 75% Improvement from Baseline in PASI Score at week 12
    End point description
    Psoriasis Area and Severity Index (PASI):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, trunk, upper limbs and lower limbs); 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,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number) of patients who have achieved a 75% or more reduction in their PASI score from baseline.
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 AIN457 Low Dose AIN457 High Dose Placebo Etanercept
    Number of subjects analysed
    40
    40
    41
    41
    Units: Participants
    32
    31
    6
    26
    Statistical analysis title
    		 PASI score
    Comparison groups
    AIN457 Low Dose v Placebo
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    25.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.08
         upper limit
    		 114.66
    Statistical analysis title
    		 PASI score
    Comparison groups
    AIN457 High Dose v Placebo
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    22.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.31
         upper limit
    		 98.93

    Primary: Number and Percentage of Participants who showed Investigator's Global Assessment (IGA) mod 2011 response of 0 or 1 at week 12

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    End point title
    		 Number and Percentage of Participants who showed Investigator's Global Assessment (IGA) mod 2011 response of 0 or 1 at week 12
    End point description
    IGA: The IGA mod 2011 scale has following different scores for the state of disease: 0: Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe
    End point type
    Primary
    End point timeframe
    12 Weeks
    End point values
    		 AIN457 Low Dose AIN457 High Dose Placebo Etanercept
    Number of subjects analysed
    40
    40
    40
    41
    Units: Participants
    28
    24
    2
    14
    Statistical analysis title
    		 Investigator's Global Assessment (IGA)
    Comparison groups
    AIN457 High Dose v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    32.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.48
         upper limit
    		 329.52
    Statistical analysis title
    		 Investigator's Global Assessment (IGA)
    Comparison groups
    AIN457 Low Dose v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    51.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.02
         upper limit
    		 538.64

    Secondary: Number and Percentage of Participants achieving a 90% Improvement from baseline in PASI score at week 12

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    End point title
    		 Number and Percentage of Participants achieving a 90% Improvement from baseline in PASI score at week 12
    End point description
    Psoriasis Area and Severity Index (PASI):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, trunk, upper limbs and lower limbs); 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,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 90 represents the percentage (or number) of patients who have achieved a 90% or more reduction in their PASI score from baseline.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 AIN457 Low Dose AIN457 High Dose Placebo Etanercept
    Number of subjects analysed
    40
    40
    41
    41
    Units: Participants
    29
    27
    1
    12
    Statistical analysis title
    		 PASI score
    Comparison groups
    AIN457 High Dose v Placebo
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    67.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 50.8
         upper limit
    		 80.9
    Statistical analysis title
    		 PASI score
    Comparison groups
    AIN457 Low Dose v Placebo
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    72.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 55.9
         upper limit
    		 84.9

    Secondary: Number and Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in PASI Score and IGA mod 2011 score of 0 or 1 up to Week 12 (Induction)

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    End point title
    		 Number and Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in PASI Score and IGA mod 2011 score of 0 or 1 up to Week 12 (Induction)
    End point description
    Psoriasis Area and Severity Index (PASI):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, trunk, upper limbs and lower limbs); 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, Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). PASI will be assessed/calculated as per standard procedure. IGA: The IGA mod 2011 scale has following different scores for the state of disease: 0: Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8
    End point values
    		 AIN457 Low Dose AIN457 High Dose Placebo Etanercept
    Number of subjects analysed
    40
    40
    41
    41
    Units: Participants
        Week 4- IGA 0/1
    6
    13
    0
    1
        Week 4- PASI 50
    26
    28
    6
    19
        Week 4- PASI 75
    13
    22
    0
    5
        Week 4- PASI 90
    5
    9
    0
    1
        Week 4- PASI 100
    3
    3
    0
    0
        Week 8- IGA 0/1
    21
    18
    0
    6
        Week 8- PASI 50
    32
    32
    11
    30
        Week 8- PASI 75
    27
    26
    1
    15
        Week 8- PASI 90
    20
    20
    0
    4
        Week 8-PASI 100
    9
    7
    0
    2
    No statistical analyses for this end point

    Secondary: Number and Percentage of Participants achieving a 50%, 100% Improvement from baseline in PASI score at week 12

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    End point title
    		 Number and Percentage of Participants achieving a 50%, 100% Improvement from baseline in PASI score at week 12
    End point description
    Psoriasis Area and Severity Index (PASI):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, trunk, upper limbs and lower limbs); 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,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 50 represents the percentage (or number) of patients who have achieved a 50% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 AIN457 Low Dose AIN457 High Dose Placebo Etanercept
    Number of subjects analysed
    40
    40
    41
    41
    Units: Participants
        PASI 50
    34
    34
    9
    34
        PASI 100
    12
    11
    0
    7
    No statistical analyses for this end point

    Secondary: Number and Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in PASI Score and IGA mod 2011 score of 0 or 1 Up to Week 52 (Maintenance)

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    End point title
    		 Number and Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in PASI Score and IGA mod 2011 score of 0 or 1 Up to Week 52 (Maintenance)
    End point description
    Psoriasis Area and Severity Index (PASI):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, trunk, upper limbs and lower limbs); 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, Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). PASI will be assessed/calculated as per standard procedure. IGA: The IGA mod 2011 scale has following different scores for the state of disease: 0: Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe
    End point type
    Secondary
    End point timeframe
    Weeks 16, 20, 24, 36, 48 and 52
    End point values
    		 AIN457 Low Dose AIN457 High Dose Etanercept Placebo - AIN457 Low Dose Placebo - AIN457 High Dose
    Number of subjects analysed
    40
    40
    41
    16
    18
    Units: Participants
        Week 16- IGA 0/1
    32
    28
    19
    5
    8
        Week 16- PASI 50
    37
    35
    30
    11
    16
        Week 16- PASI 75
    36
    32
    26
    5
    11
        Week 16- PASI 90
    33
    30
    16
    4
    7
        Week 16- PASI 100
    19
    14
    8
    0
    1
        Week 20- IGA 0/1
    33
    28
    21
    12
    13
        Week 20- PASI 50
    38
    36
    32
    15
    17
        Week 20- PASI 75
    38
    35
    29
    13
    15
        Week 20- PASI 90
    33
    30
    19
    12
    12
        Week 20- PASI 100
    20
    16
    8
    5
    4
        Week 24- IGA 0/1
    35
    30
    20
    14
    14
        Week 24- PASI 50
    38
    37
    31
    15
    16
        Week 24- PASI 75
    37
    35
    26
    15
    14
        Week 24- PASI 90
    33
    31
    19
    13
    12
        Week 24- PASI 100
    22
    17
    9
    7
    6
        Week 36- IGA 0/1
    32
    29
    21
    14
    14
        Week 36- PASI 50
    37
    37
    31
    16
    16
        Week 36- PASI 75
    35
    35
    26
    16
    16
        Week 36-PASI 90
    32
    31
    18
    10
    7
        Week 36-PASI 100
    17
    20
    10
    10
    7
        Week 48- IGA 0/1
    28
    28
    21
    14
    14
        Week 48-PASI 50
    38
    35
    31
    15
    15
        Week 48- PASI 75
    35
    35
    27
    14
    15
        Week 48- PASI 90
    29
    30
    23
    12
    14
        Week 48- PASI 100
    16
    18
    12
    10
    8
        Week 52- 1GA 0/1
    29
    30
    23
    14
    13
        Week 52- PASI 50
    39
    37
    32
    15
    17
        Week 52- PASI 75
    35
    35
    28
    14
    17
        Week 52- PASI 90
    30
    32
    21
    13
    14
        Week 52- PASI 100
    16
    19
    9
    10
    10
    No statistical analyses for this end point

    Secondary: Change From Baseline in Psoriasis Area & Severity Index (PASI) score at Week 12

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    End point title
    		 Change From Baseline in Psoriasis Area & Severity Index (PASI) score at Week 12
    End point description
    Psoriasis Area and Severity Index (PASI):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, trunk, upper limbs and lower limbs); 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,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number)of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 AIN457 Low Dose AIN457 High Dose Placebo Etanercept
    Number of subjects analysed
    39
    39
    40
    41
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -22.27 ( 8.518 )
    -22.67 ( 11.904 )
    -7.94 ( 9.396 )
    -20.91 ( 10.055 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants in IGA mod 2011 Score Categories at Week 12

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    End point title
    		 Percentage of Participants in IGA mod 2011 Score Categories at Week 12
    End point description
    IGA: The IGA mod 2011 scale has following different scores for the state of disease: 0: Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 AIN457 Low Dose AIN457 High Dose Placebo Etanercept
    Number of subjects analysed
    40
    40
    41
    41
    Units: Participants
        Week 12- IGA Category: Clear
    12
    11
    0
    7
        Week 12- IGA Category: Almost Clear
    14
    13
    2
    7
        Week 12- IGA Category: Mild Disease
    8
    7
    4
    18
        Week 12- IGA Category: Moderate Disease
    3
    4
    11
    6
        Week 12- IGA Category: Severe Disease
    2
    4
    23
    3
    No statistical analyses for this end point

    Secondary: Change From Baseline in Psoriasis Area & Severity Index (PASI) scores at Week 52

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    End point title
    		 Change From Baseline in Psoriasis Area & Severity Index (PASI) scores at Week 52
    End point description
    Psoriasis Area and Severity Index (PASI):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, trunk, upper limbs and lower limbs); 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,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number)of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 AIN457 Low Dose AIN457 High Dose Etanercept Placebo - AIN457 Low Dose Placebo - AIN457 High Dose
    Number of subjects analysed
    39
    39
    41
    16
    18
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -25.26 ( 7.150 )
    -25.75 ( 8.593 )
    -21.16 ( 11.779 )
    -28.49 ( 7.984 )
    -24.69 ( 5.520 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants in IGA mod 2011 Score Categories at Week 52

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    End point title
    		 Percentage of Participants in IGA mod 2011 Score Categories at Week 52
    End point description
    IGA: The IGA mod 2011 scale has following different scores for the state of disease: 0: Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 AIN457 Low Dose AIN457 High Dose Etanercept Placebo - AIN457 Low Dose Placebo - AIN457 High Dose
    Number of subjects analysed
    40
    40
    41
    16
    18
    Units: Participants
        Week 52- IGA Category: Clear
    16
    20
    9
    10
    10
        Week 52- IGA Category: Almost Clear
    13
    10
    14
    4
    4
        Week 52- IGA Category: Mild Disease
    7
    4
    9
    2
    4
        Week 52- IGA Category: Moderate Disease
    2
    2
    4
    0
    0
        Week 52- IGA Category: Severe Disease
    1
    3
    5
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score Up to Week 12 (Induction)

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    End point title
    		 Percentage Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score Up to Week 12 (Induction)
    End point description
    The CDLQI measures functional disability of subjects with dermatological disorders who are less than 18 years of age and it has been utilized as a relevant clinical measure in atopic dermatitis, as well as other dermatitis clinical trials. The CDLQI is a simple, validated, self-administered 10-item questionnaire. The instrument contains six functional scales (i.e., symptoms and feeling, leisure, school or holidays, personal relationships, sleep and treatment). The questions are based on the preceding week to permit accurate recall. For the CDLQI, each question will be answered on a 4-point Likert scale scored from 0 to 3. Seven scores will be derived from the CDLQI: the total score of each of the six dimensions as well as the total score over all items. The higher the score, the more quality of life is impaired.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12
    End point values
    		 AIN457 Low Dose AIN457 High Dose Placebo Etanercept
    Number of subjects analysed
    40
    40
    41
    41
    Units: percentage change of score
    arithmetic mean (standard deviation)
        Week 4
    -47.71 ( 45.743 )
    -50.71 ( 37.003 )
    1.67 ( 104.216 )
    -35.13 ( 56.832 )
        Week 8
    -61.60 ( 54.371 )
    -66.97 ( 32.040 )
    -17.77 ( 66.451 )
    -42.73 ( 54.026 )
        Week 12
    -67.43 ( 41.602 )
    -62.5 ( 50.08 )
    -18.48 ( 80.018 )
    -62.80 ( 34.419 )
    No statistical analyses for this end point

    Secondary: Percentage Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score Up to Week 52 (Maintenance)

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    End point title
    		 Percentage Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score Up to Week 52 (Maintenance)
    End point description
    The CDLQI measures functional disability of subjects with dermatological disorders who are less than 18 years of age and it has been utilized as a relevant clinical measure in atopic dermatitis, as well as other dermatitis clinical trials. The CDLQI is a simple, validated, self-administered 10-item questionnaire. The instrument contains six functional scales (i.e., symptoms and feeling, leisure, school or holidays, personal relationships, sleep and treatment). The questions are based on the preceding week to permit accurate recall. For the CDLQI, each question will be answered on a 4-point Likert scale scored from 0 to 3. Seven scores will be derived from the CDLQI: the total score of each of the six dimensions as well as the total score over all items. The higher the score, the more quality of life is impaired.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 36, 52
    End point values
    		 AIN457 Low Dose AIN457 High Dose Etanercept Placebo - AIN457 Low Dose Placebo - AIN457 High Dose
    Number of subjects analysed
    40
    40
    41
    16
    18
    Units: percentage change of score
    arithmetic mean (standard deviation)
        Week 24
    -73.7 ( 55.02 )
    -53.9 ( 74.63 )
    -55.0 ( 44.98 )
    40.3 ( 477.93 )
    -73.8 ( 53.09 )
        Week 36
    -79.0 ( 31.99 )
    -56.2 ( 107.65 )
    -47.7 ( 45.01 )
    -89.5 ( 19.11 )
    -69.4 ( 46.46 )
        Week 52
    -80.9 ( 39.38 )
    -58.6 ( 77.56 )
    -53.4 ( 56.99 )
    -89.0 ( 15.73 )
    -86.0 ( 23.19 )
    No statistical analyses for this end point

    Secondary: Number and Percentage of participants achieving a Children's DLQI score of 0 or 1 over time up to Week 52 (Maintenance)

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    End point title
    		 Number and Percentage of participants achieving a Children's DLQI score of 0 or 1 over time up to Week 52 (Maintenance)
    End point description
    The CDLQI measures functional disability of subjects with dermatological disorders who are less than 18 years of age and it has been utilized as a relevant clinical measure in atopic dermatitis, as well as other dermatitis clinical trials. The CDLQI is a simple, validated, self-administered 10-item questionnaire. The instrument contains six functional scales (i.e., symptoms and feeling, leisure, school or holidays, personal relationships, sleep and treatment). The questions are based on the preceding week to permit accurate recall. For the CDLQI, each question will be answered on a 4-point Likert scale scored from 0 to 3. Seven scores will be derived from the CDLQI: the total score of each of the six dimensions as well as the total score over all items. The higher the score, the more quality of life is impaired.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 36, 52
    End point values
    		 AIN457 Low Dose AIN457 High Dose Etanercept Placebo - AIN457 Low Dose Placebo - AIN457 High Dose
    Number of subjects analysed
    40
    40
    41
    16
    18
    Units: Participants
        Week 24
    19
    17
    17
    8
    9
        Week 36
    21
    21
    12
    9
    8
        Week 52
    20
    22
    16
    8
    11
    No statistical analyses for this end point

    Secondary: Number and Percentage of participants achieving a Children's DLQI score of 0 or 1 over time up to Week 12 (Induction)

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    End point title
    		 Number and Percentage of participants achieving a Children's DLQI score of 0 or 1 over time up to Week 12 (Induction)
    End point description
    The CDLQI measures functional disability of subjects with dermatological disorders who are less than 18 years of age and it has been utilized as a relevant clinical measure in atopic dermatitis, as well as other dermatitis clinical trials. The CDLQI is a simple, validated, self-administered 10-item questionnaire. The instrument contains six functional scales (i.e., symptoms and feeling, leisure, school or holidays, personal relationships, sleep and treatment). The questions are based on the preceding week to permit accurate recall. For the CDLQI, each question will be answered on a 4-point Likert scale scored from 0 to 3. Seven scores will be derived from the CDLQI: the total score of each of the six dimensions as well as the total score over all items. The higher the score, the more quality of life is impaired.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12
    End point values
    		 AIN457 Low Dose AIN457 High Dose Placebo Etanercept
    Number of subjects analysed
    40
    40
    41
    41
    Units: Participants
        Week 4
    8
    11
    2
    9
        Week 8
    15
    19
    7
    10
        Week 12
    17
    19
    6
    15
    No statistical analyses for this end point

    Secondary: Number and Percentage of participants with clinically important reduction in disability as evaluated by CHAQ questionnaire over time at Week 12

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    End point title
    		 Number and Percentage of participants with clinically important reduction in disability as evaluated by CHAQ questionnaire over time at Week 12
    End point description
    The CHAQ questionnaire is only done for children who in addition to psoriasis are also suffering from psoriatic arthritis. The questionnaire is completed by parent or legal guardian. It consists of multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. The person completing the questionnaire chooses from four response categories, ranging from ‘without any difficulty’ to ‘unable to do’. Additionally two visual analog scales (overall well-being and pain of patient) must be performed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 AIN457 Low Dose AIN457 High Dose Placebo Etanercept
    Number of subjects analysed
    4
    2
    2
    3
    Units: Participants
    2
    0
    0
    2
    No statistical analyses for this end point

    Secondary: Number and Percentage of participants with clinically important reduction in disability as evaluated by CHAQ questionnaire over time at Week 52

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    End point title
    		 Number and Percentage of participants with clinically important reduction in disability as evaluated by CHAQ questionnaire over time at Week 52
    End point description
    The CHAQ questionnaire is only done for children who in addition to psoriasis are also suffering from psoriatic arthritis. The questionnaire is completed by parent or legal guardian. It consists of multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. The person completing the questionnaire chooses from four response categories, ranging from ‘without any difficulty’ to ‘unable to do’. Additionally two visual analog scales (overall well-being and pain of patient) must be performed.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 AIN457 Low Dose AIN457 High Dose Etanercept Placebo - AIN457 Low Dose Placebo - AIN457 High Dose
    Number of subjects analysed
    4
    1
    3
    2
    1
    Units: Participants
    2
    0
    2
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from first dose until end of study treatment plus 16 weeks post- treatment follow-up period. In total up to 252 weeks for AIN457 low and high dose, 28 weeks for Placebo and 68 weeks for Etanercept).
    Adverse event reporting additional description
    Adverse Events are reported according to the actual treatment received at the onset of the AE.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Any AIN457 low dose
    Reporting group description
    		 Includes patients from the AIN457 Low Dose and from the Placebo-AIN457 Low Dose groups. AEs were collected for up to 252 weeks.

    Reporting group title
    Any AIN457 high dose
    Reporting group description
    		 Includes patients from the AIN457 High Dose and from the Placebo-AIN457 High Dose groups. AEs were collected for up to 252 weeks.

    Reporting group title
    Etanercept
    Reporting group description
    		 Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg). AEs were collected for up to 68 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received matching placebo to secukinumab at each dosing. AEs were collected for up to 28 weeks (12 weeks if participant switched to AIN457 at week 12).

    Reporting group title
    Any AIN457 dose
    Reporting group description
    		 Any AIN457 dose AEs were collected for up to 252 weeks.

    Serious adverse events
    		 Any AIN457 low dose Any AIN457 high dose Etanercept Placebo Any AIN457 dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 56 (12.50%)
    8 / 58 (13.79%)
    6 / 41 (14.63%)
    0 / 41 (0.00%)
    15 / 114 (13.16%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 58 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular torsion
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 58 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal toxicity
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 58 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune pancreatitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 58 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 58 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Gallbladder polyp
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 58 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis reactive
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal disease
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 58 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis bacterial
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic shock syndrome
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Lactose intolerance
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Any AIN457 low dose Any AIN457 high dose Etanercept Placebo Any AIN457 dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 56 (85.71%)
    50 / 58 (86.21%)
    30 / 41 (73.17%)
    19 / 41 (46.34%)
    98 / 114 (85.96%)
    Investigations
    Glomerular filtration rate decreased
         subjects affected / exposed
    7 / 56 (12.50%)
    4 / 58 (6.90%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    11 / 114 (9.65%)
         occurrences all number
    9
    4
    2
    0
    13
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 56 (3.57%)
    4 / 58 (6.90%)
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    6 / 114 (5.26%)
         occurrences all number
    2
    4
    2
    0
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 56 (19.64%)
    11 / 58 (18.97%)
    4 / 41 (9.76%)
    4 / 41 (9.76%)
    22 / 114 (19.30%)
         occurrences all number
    35
    22
    4
    6
    57
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 58 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    3 / 114 (2.63%)
         occurrences all number
    3
    0
    0
    1
    3
    Neutropenia
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 58 (1.72%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    4 / 114 (3.51%)
         occurrences all number
    5
    1
    1
    0
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 58 (5.17%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    6 / 114 (5.26%)
         occurrences all number
    6
    3
    0
    1
    9
    Pyrexia
         subjects affected / exposed
    4 / 56 (7.14%)
    6 / 58 (10.34%)
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    10 / 114 (8.77%)
         occurrences all number
    4
    11
    2
    0
    15
    Asthenia
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 58 (5.17%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    4 / 114 (3.51%)
         occurrences all number
    3
    3
    0
    1
    6
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 56 (7.14%)
    6 / 58 (10.34%)
    5 / 41 (12.20%)
    0 / 41 (0.00%)
    10 / 114 (8.77%)
         occurrences all number
    10
    10
    5
    0
    20
    Abdominal pain upper
         subjects affected / exposed
    4 / 56 (7.14%)
    5 / 58 (8.62%)
    4 / 41 (9.76%)
    2 / 41 (4.88%)
    9 / 114 (7.89%)
         occurrences all number
    5
    5
    5
    2
    10
    Dental caries
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 58 (5.17%)
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    4 / 114 (3.51%)
         occurrences all number
    1
    3
    1
    1
    4
    Vomiting
         subjects affected / exposed
    1 / 56 (1.79%)
    5 / 58 (8.62%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    6 / 114 (5.26%)
         occurrences all number
    1
    7
    1
    0
    8
    Toothache
         subjects affected / exposed
    1 / 56 (1.79%)
    4 / 58 (6.90%)
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    5 / 114 (4.39%)
         occurrences all number
    1
    5
    3
    0
    6
    Nausea
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 58 (3.45%)
    4 / 41 (9.76%)
    2 / 41 (4.88%)
    4 / 114 (3.51%)
         occurrences all number
    3
    2
    4
    2
    5
    Diarrhoea
         subjects affected / exposed
    7 / 56 (12.50%)
    7 / 58 (12.07%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    14 / 114 (12.28%)
         occurrences all number
    8
    10
    2
    0
    18
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 56 (1.79%)
    4 / 58 (6.90%)
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    5 / 114 (4.39%)
         occurrences all number
    4
    8
    10
    0
    12
    Menstruation irregular
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 58 (5.17%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    3 / 114 (2.63%)
         occurrences all number
    0
    3
    0
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 56 (7.14%)
    6 / 58 (10.34%)
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    10 / 114 (8.77%)
         occurrences all number
    4
    11
    1
    1
    15
    Nasal congestion
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    4 / 114 (3.51%)
         occurrences all number
    3
    1
    0
    0
    4
    Epistaxis
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 58 (5.17%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    3 / 114 (2.63%)
         occurrences all number
    0
    4
    0
    2
    4
    Cough
         subjects affected / exposed
    4 / 56 (7.14%)
    9 / 58 (15.52%)
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    13 / 114 (11.40%)
         occurrences all number
    4
    11
    2
    0
    15
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    7 / 56 (12.50%)
    1 / 58 (1.72%)
    4 / 41 (9.76%)
    0 / 41 (0.00%)
    8 / 114 (7.02%)
         occurrences all number
    7
    1
    4
    0
    8
    Pruritus
         subjects affected / exposed
    3 / 56 (5.36%)
    5 / 58 (8.62%)
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    8 / 114 (7.02%)
         occurrences all number
    3
    5
    2
    1
    8
    Intertrigo
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    4 / 114 (3.51%)
         occurrences all number
    5
    1
    0
    0
    6
    Seborrhoeic dermatitis
         subjects affected / exposed
    2 / 56 (3.57%)
    4 / 58 (6.90%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    6 / 114 (5.26%)
         occurrences all number
    2
    7
    2
    0
    9
    Acne
         subjects affected / exposed
    8 / 56 (14.29%)
    5 / 58 (8.62%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    13 / 114 (11.40%)
         occurrences all number
    8
    8
    0
    1
    16
    Eczema
         subjects affected / exposed
    3 / 56 (5.36%)
    5 / 58 (8.62%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    8 / 114 (7.02%)
         occurrences all number
    7
    5
    1
    0
    12
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 56 (7.14%)
    5 / 58 (8.62%)
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    9 / 114 (7.89%)
         occurrences all number
    5
    6
    3
    3
    11
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 56 (5.36%)
    6 / 58 (10.34%)
    3 / 41 (7.32%)
    2 / 41 (4.88%)
    9 / 114 (7.89%)
         occurrences all number
    4
    8
    3
    2
    12
    COVID-19
         subjects affected / exposed
    4 / 56 (7.14%)
    5 / 58 (8.62%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    9 / 114 (7.89%)
         occurrences all number
    4
    5
    0
    0
    9
    Conjunctivitis
         subjects affected / exposed
    2 / 56 (3.57%)
    5 / 58 (8.62%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    7 / 114 (6.14%)
         occurrences all number
    2
    7
    1
    0
    9
    Folliculitis
         subjects affected / exposed
    3 / 56 (5.36%)
    4 / 58 (6.90%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    7 / 114 (6.14%)
         occurrences all number
    3
    4
    0
    0
    7
    Gastroenteritis
         subjects affected / exposed
    5 / 56 (8.93%)
    3 / 58 (5.17%)
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    8 / 114 (7.02%)
         occurrences all number
    6
    4
    1
    1
    10
    Gastroenteritis viral
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 58 (1.72%)
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    4 / 114 (3.51%)
         occurrences all number
    3
    1
    2
    1
    4
    Gastrointestinal infection
         subjects affected / exposed
    2 / 56 (3.57%)
    4 / 58 (6.90%)
    0 / 41 (0.00%)
    2 / 41 (4.88%)
    6 / 114 (5.26%)
         occurrences all number
    2
    5
    0
    2
    7
    Paronychia
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 58 (5.17%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    4 / 114 (3.51%)
         occurrences all number
    1
    4
    1
    0
    5
    Oral herpes
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 58 (3.45%)
    4 / 41 (9.76%)
    1 / 41 (2.44%)
    5 / 114 (4.39%)
         occurrences all number
    4
    13
    5
    1
    17
    Nasopharyngitis
         subjects affected / exposed
    17 / 56 (30.36%)
    25 / 58 (43.10%)
    11 / 41 (26.83%)
    1 / 41 (2.44%)
    42 / 114 (36.84%)
         occurrences all number
    47
    61
    15
    1
    108
    Influenza
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 58 (0.00%)
    3 / 41 (7.32%)
    3 / 41 (7.32%)
    4 / 114 (3.51%)
         occurrences all number
    6
    0
    4
    3
    6
    Impetigo
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 58 (5.17%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    3 / 114 (2.63%)
         occurrences all number
    0
    3
    3
    0
    3
    Pharyngitis
         subjects affected / exposed
    9 / 56 (16.07%)
    8 / 58 (13.79%)
    3 / 41 (7.32%)
    4 / 41 (9.76%)
    17 / 114 (14.91%)
         occurrences all number
    17
    11
    3
    4
    28
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 56 (5.36%)
    4 / 58 (6.90%)
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    7 / 114 (6.14%)
         occurrences all number
    5
    13
    2
    0
    18
    Urinary tract infection
         subjects affected / exposed
    5 / 56 (8.93%)
    2 / 58 (3.45%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    7 / 114 (6.14%)
         occurrences all number
    8
    3
    1
    0
    11
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 56 (12.50%)
    3 / 58 (5.17%)
    3 / 41 (7.32%)
    3 / 41 (7.32%)
    10 / 114 (8.77%)
         occurrences all number
    18
    5
    7
    3
    23
    Tonsillitis
         subjects affected / exposed
    11 / 56 (19.64%)
    7 / 58 (12.07%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    18 / 114 (15.79%)
         occurrences all number
    18
    9
    1
    0
    27
    Sinusitis
         subjects affected / exposed
    4 / 56 (7.14%)
    2 / 58 (3.45%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    6 / 114 (5.26%)
         occurrences all number
    4
    2
    1
    0
    6
    Rhinitis
         subjects affected / exposed
    5 / 56 (8.93%)
    7 / 58 (12.07%)
    1 / 41 (2.44%)
    4 / 41 (9.76%)
    12 / 114 (10.53%)
         occurrences all number
    6
    9
    1
    4
    15
    Respiratory tract infection
         subjects affected / exposed
    3 / 56 (5.36%)
    4 / 58 (6.90%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    7 / 114 (6.14%)
         occurrences all number
    4
    4
    0
    0
    8
    Pharyngotonsillitis
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 58 (1.72%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    5 / 114 (4.39%)
         occurrences all number
    4
    1
    0
    0
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2015
    The protocol was amended to provide more details and clarification on the duration of contraception requested during the study and to give option to align the duration on local label requirements.
    10 Feb 2016
    The protocol was amended to modify inclusion criterion 5 to align with the text agreed with the Pediatric Committee (PDCO) of the European Medicines Agency (EMA). Another key purpose of this Amendment, is to include the Childhood Health Assessment Questionnaire (CHAQ©) for those subjects with History of Psoriatic Arthritis. This addition is made following a request by the Japanese Health Authority. Further to that, some protocol text changes were undertaken following requests from IRBs.
    16 Apr 2018
    The protocol was amended to to include an additional Interim Analysis prior to the Week 24 analysis once sufficient safety and pharmacokinetic data have been collected. This analysis aligned with the efficacy extrapolation principle, is expected to provide the basis for a submission package to health authorities (HA), with the intent to allow earlier availability of secukinumab to pediatric patients in countries which accept a submission of clinical data with use of extrapolation methodology. This analysis may be performed before all subjects have reached the primary endpoint. In addition to that, some clarifications, as well as editorial changes were undertaken in the protocol.
    18 Sep 2020
    The protocol was amended to introduce a level of flexibility in drug dispensation, protocol assessments and visit schedule if a major health care event like COVID-19requires it, thus allowing patients to remain in the trial and continue treatment while being monitored for safety. In addition, renal and liver monitoring procedures will no longer be followed for subjects who reach adulthood (≥ 18 years).

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

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

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