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    Clinical Trial Results:
    An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis

    Summary
    EudraCT number
    		 2018-002521-30
    Trial protocol
    		 DE   ES   PL   BE   IT  
    Global end of trial date
    07 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 May 2025
    First version publication date
    18 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457F2304E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03769168
    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)
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Nov 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this extension study was to provide continuous treatment with secukinumab in pre-filled syringe (PFS) for patients who completed the core study F2304 Week 104 and opted to enter the extension study to obtain further long-term efficacy, safety, and tolerability information
    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
    07 Jun 2019
    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
    Belgium: 3
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Russian Federation: 15
    Country: Number of subjects enrolled
    South Africa: 3
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Türkiye: 8
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    54
    EEA total number of subjects
    25
    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)
    20
    Adolescents (12-17 years)
    34
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited in 24 centers across 9 countries

    Pre-assignment
    Screening details
    		 One participant enrolled with planned treatment secukinumab 150 mgdiscontinued the study before receiving study treatment due to physician decision. This participant is not included in the analyses.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1- Secukinumab 75 mg
    Arm description
    		 Participants were planned to initially receive secukinumab 75mg subcutaneously once every four weeks. If the signs and symptoms of the participants were not adequately controlled with the 75mg dose, as determined by the investigator, the dose could be escalated to 150mg subcutaneously. For patients weighing 50kg and over, the dose could further be escalated to 300mg subcutaneously every four weeks. The dose escalation from secukinumab 75mg subcutaneously to 300mg subcutaneously was to be implemented in two steps, with the first step being an increase to 150mg subcutaneously, followed by another escalation to 300mg subcutaneously, based on the judgement of the investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab solution for subcutaneous injections was provided in PFS.Initially, participants continued to receive secukinumab at either 75 mg (in0.5mL) every 4 weeks, consistent with their dosage at the Week 100 visitof the core study. The dose could be escalated from 75 mg to 150 mg forpatients whose signs and symptoms were not fully controlled, as judged bythe investigator, with the current 75 mg dose. Furthermore, the dose couldalso be escalated to 300 mg every 4 weeks for patients weighing 50kg andover who were currently on the 150 mg dose and whose signs andsymptoms were not well-controlled, as judged by the investigator. The doseescalation from secukinumab 75 mg to 300 mg was to be implemented intwo steps (first 150 mg and then 300 mg based on the investigator'sjudgment). At each study treatment time point, one or two subcutaneousinjections in the form of PFS were administered.

    Arm title
    		 Group 2 - Secukinumab 150 mg
    Arm description
    		 Participants were planned to initially receive secukinumab 150mg subcutaneously once every four weeks. If the signs and symptoms of the participants were not adequately controlled with the 150mg dose, as determined by the investigator, the dose could be escalated to 300mg subcutaneously.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab solution for subcutaneous injections was provided in PFS.Initially, participants continued to receive secukinumab at 150 mg (in 1mL)every 4 weeks, consistent with their dosage at the Week 100 visit of thecore study. The dose could be escalated to 300 mg every 4 weeks forpatients weighing 50kg and over who were currently on the 150 mg doseand whose signs and symptoms were not well-controlled, as judged by theinvestigator. At each study treatment time point, one or two subcutaneousinjections in the form of PFS were administered.

    Number of subjects in period 1
    		Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg
    Started
    19
    35
    Completed
    10
    12
    Not completed
    9
    23
         Post study access to treatment
    3
    11
         Physician decision
    1
    3
         Subject Decision
    2
    4
         Adverse event, non-fatal
    -
    1
         Lack of efficacy
    2
    4
         Guardian decision
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1- Secukinumab 75 mg
    Reporting group description
    		 Participants were planned to initially receive secukinumab 75mg subcutaneously once every four weeks. If the signs and symptoms of the participants were not adequately controlled with the 75mg dose, as determined by the investigator, the dose could be escalated to 150mg subcutaneously. For patients weighing 50kg and over, the dose could further be escalated to 300mg subcutaneously every four weeks. The dose escalation from secukinumab 75mg subcutaneously to 300mg subcutaneously was to be implemented in two steps, with the first step being an increase to 150mg subcutaneously, followed by another escalation to 300mg subcutaneously, based on the judgement of the investigator.

    Reporting group title
    Group 2 - Secukinumab 150 mg
    Reporting group description
    		 Participants were planned to initially receive secukinumab 150mg subcutaneously once every four weeks. If the signs and symptoms of the participants were not adequately controlled with the 150mg dose, as determined by the investigator, the dose could be escalated to 300mg subcutaneously.

    Reporting group values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total
    Number of subjects
    		 19 35 54
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 15 5 20
        Adolescents (12-17 years)
    		 4 30 34
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 9.5 ( 3.49 ) 14.1 ( 2.02 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 8 10 18
        Male
    		 11 25 36
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 19 33 52
        Other
    		 0 2 2
    Subject analysis sets

    Subject analysis set title
    Total Secukinumab Dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Total participants from Group 1 and Group 2

    Subject analysis sets values
    		 Total Secukinumab Dose
    Number of subjects
    54
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    20
        Adolescents (12-17 years)
    34
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    12.5 ( 3.40 )
    Sex: Female, Male
    Units: Participants
        Female
    18
        Male
    36
    Race/Ethnicity, Customized
    Units: Subjects
        White
    52
        Other
    2

    End points

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    End points reporting groups
    Reporting group title
    Group 1- Secukinumab 75 mg
    Reporting group description
    		 Participants were planned to initially receive secukinumab 75mg subcutaneously once every four weeks. If the signs and symptoms of the participants were not adequately controlled with the 75mg dose, as determined by the investigator, the dose could be escalated to 150mg subcutaneously. For patients weighing 50kg and over, the dose could further be escalated to 300mg subcutaneously every four weeks. The dose escalation from secukinumab 75mg subcutaneously to 300mg subcutaneously was to be implemented in two steps, with the first step being an increase to 150mg subcutaneously, followed by another escalation to 300mg subcutaneously, based on the judgement of the investigator.

    Reporting group title
    Group 2 - Secukinumab 150 mg
    Reporting group description
    		 Participants were planned to initially receive secukinumab 150mg subcutaneously once every four weeks. If the signs and symptoms of the participants were not adequately controlled with the 150mg dose, as determined by the investigator, the dose could be escalated to 300mg subcutaneously.

    Subject analysis set title
    Total Secukinumab Dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Total participants from Group 1 and Group 2

    Primary: Percentage of participants with Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 response

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    End point title
    		 Percentage of participants with Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 response [1]
    End point description
    The JIA ACR response criteria consisted of 6 core criteria: - Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). - Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). - Functional ability (CHAQ: Childhood Health Assessment Questionnaire): 30 questions across 8 domains assessing the child’s functional abilities. The total score was calculated as the average of the scores for each domain. It ranged from 0 (no disability) to 3 (very severe disability). - Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. - Number of joints with limited range of motion, ranging from 0 to 69. - Index of inflammation: C-reactive Protein (CRP) levels The JIA ACR 30 response was achieved if 3 of any 6 core set variables improved by at least 30% from baseline of the core study, and no more than 1 variable worsening more than 30%
    End point type
    Primary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this primary endpoint
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 104
    100 (79.1 to 100)
    100 (87.7 to 100)
    100 (91.7 to 100)
        Week 116
    100 (79.1 to 100)
    96.9 (82.0 to 99.8)
    98.9 (88.2 to 99.9)
        Week 128
    100 (78.1 to 100)
    100 (86.3 to 100)
    100 (90.9 to 100)
        Week 140
    100 (78.1 to 100)
    100 (87.0 to 100)
    100 (91.3 to 100)
        Week 156
    94.7 (71.9 to 99.7)
    100 (87.0 to 100)
    98.1 (88.4 to 99.9)
        Week 180
    94.7 (71.9 to 99.7)
    97.0 (82.5 to 99.8)
    96.2 (85.7 to 99.3)
        Week 208
    100 (78.1 to 100)
    100 (86.3 to 100)
    100 (90.9 to 100)
        Week 232
    94.1 (69.2 to 99.7)
    100 (84.5 to 100)
    97.7 (86.5 to 99.9)
        Week 260
    92.9 (64.2 to 99.6)
    96.2 (78.4 to 99.8)
    95.0 (81.8 to 99.1)
        Week 284
    100 (73.2 to 100)
    95.7 (76.0 to 99.8)
    97.3 (84.2 to 99.9)
        Week 308
    100 (69.9 to 100)
    100 (77.1 to 100)
    100 (85.4 to 100)
        Week 312
    90.0 (54.1 to 99.5)
    100 (69.9 to 100)
    95.5 (75.1 to 99.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants with JIA ACR 50 response

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    End point title
    		 Percentage of participants with JIA ACR 50 response
    End point description
    The JIA ACR response criteria consisted of 6 core criteria: - Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). - Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). - Functional ability (CHAQ): 30 questions across 8 domains assessing the child’s functional abilities. The total score was calculated as the average of the scores for each domain (0 [no disability] to 3 [very severe disability]). - Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. - Number of joints with limited range of motion, ranging from 0 to 69. - Index of inflammation: CRP levels The JIA ACR 50 responses were achieved if 3 of any 6 core set variables improved by at least 50% from baseline of the core study, and no more than 1 variable worsening > 30%
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 104
    94.7 (71.9 to 99.7)
    94.3 (79.5 to 99.0)
    94.4 (83.7 to 98.6)
        Week 116
    100 (79.1 to 100)
    93.8 (77.8 to 98.9)
    96.1 (85.4 to 99.3)
        Week 128
    94.4 (74.2 to 98.7)
    93.5 (77.2 to 98.9)
    93.9 (82.1 to 98.4)
        Week 140
    100 (78.1 to 100)
    90.9 (74.5 to 97.6)
    94.1 (82.8 to 98.5)
        Week 156
    94.7 (71.9 to 99.7)
    87.9 (70.9 to 96.0)
    90.4 (78.2 to 96.4)
        Week 180
    94.7 (71.9 to 99.7)
    93.9 (78.4 to 98.9)
    94.2 (83.1 to 98.5)
        Week 208
    100 (78.1 to 100)
    90.3 (73.1 to 97.5)
    93.9 (82.1 to 98.4)
        Week 232
    94.1 (69.2 to 99.7)
    96.3 (79.1 to 99.8)
    95.5 (83.3 to 99.2)
        Week 260
    92.9 (64.2 to 99.6)
    96.2 (78.4 to 99.8)
    95.0 (81.8 to 99.1)
        Week 284
    100 (73.2 to 100)
    95.7 (76.0 to 99.8)
    97.3 (84.2 to 99.9)
        Week 308
    100 (69.9 to 100)
    100 (77.1 to 100)
    100 (85.4 to 100)
        Week 312
    90.0 (54.1 to 99.5)
    100 (69.9 to 100)
    95.5 (75.1 to 99.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants with JIA ACR 70 response

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    End point title
    		 Percentage of participants with JIA ACR 70 response
    End point description
    The JIA ACR response criteria consisted of 6 core criteria: - Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). - Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). - Functional ability (CHAQ): 30 questions across 8 domains assessing the child’s functional abilities. The total score was calculated as the average of the scores for each domain (0 [no disability] to 3 [very severe disability]). - Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. - Number of joints with limited range of motion, ranging from 0 to 69. - Index of inflammation: CRP levels The JIA ACR 70 responses were achieved if 3 of any 6 core set variables improved by at least 70%, from baseline of the core study, and no more than 1 variable worsening > 30%
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 104
    94.7 (71.9 to 99.7)
    82.9 (65.7 to 92.8)
    87.0 (74.5 to 94.2)
        Week 116
    94.7 (71.9 to 99.7)
    90.6 (73.8 to 97.5)
    92.2 (80.3 to 97.5)
        Week 128
    94.4 (70.6 to 99.7)
    90.3 (73.1 to 97.5)
    91.8 (79.5 to 97.4)
        Week 140
    88.9 (63.9 to 98.1)
    84.8 (67.3 to 94.3)
    86.3 (73.1 to 93.8)
        Week 156
    94.7 (71.9 to 99.7)
    84.8 (67.3 to 94.3)
    88.5 (75.9 to 95.2)
        Week 180
    89.5 (65.5 to 98.2)
    81.8 (63.9 to 92.4)
    84.6 (71.4 to 92.7)
        Week 208
    94.4 (70.6 to 99.7)
    90.3 (73.1 to 97.5)
    91.8 (79.5 to 97.4)
        Week 232
    88.2 (62.3 to 97.9)
    85.2 (65.4 to 95.1)
    86.4 (72.0 to 94.3)
        Week 260
    92.9 (64.2 to 99.6)
    96.2 (78.4 to 99.8)
    95.0 (81.8 to 99.1)
        Week 284
    100 (73.2 to 100)
    95.7 (76.0 to 99.8)
    97.3 (84.2 to 99.9)
        Week 308
    100 (69.9 to 100)
    100 (77.1 to 100)
    100 (85.4 to 100)
        Week 312
    90.0 (54.1 to 99.5)
    83.3 (50.9 to 97.1)
    86.4 (64.0 to 96.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants with JIA ACR 90 response

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    End point title
    		 Percentage of participants with JIA ACR 90 response
    End point description
    The JIA ACR response criteria consisted of 6 core criteria: - Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). - Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). - Functional ability (CHAQ): 30 questions across 8 domains assessing the child’s functional abilities. The total score was calculated as the average of the scores for each domain (0 [no disability] to 3 [very severe disability]). - Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. - Number of joints with limited range of motion, ranging from 0 to 69. - Index of inflammation: CRP levels The JIA ACR 90 responses were achieved if 3 of any 6 core set variables improved by at least 90% from baseline of the core study, and no more than 1 variable worsening > 30%
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 104
    84.2 (59.5 to 95.8)
    74.3 (56.4 to 86.9)
    77.8 (64.1 to 87.5)
        Week 116
    73.7 (48.6 to 89.9)
    75.0 (56.2 to 87.9)
    74.5 (60.1 to 85.2)
        Week 128
    83.3 (57.7 to 95.6)
    77.4 (58.5 to 89.7)
    79.6 (65.2 to 89.3)
        Week 140
    83.3 (57.7 to 95.6)
    72.7 (54.2 to 86.1)
    76.5 (62.2 to 86.8)
        Week 156
    73.7 (48.6 to 89.9)
    75.8 (57.4 to 88.3)
    75.0 (60.8 to 85.5)
        Week 180
    84.2 (59.5 to 95.8)
    69.7 (51.1 to 83.8)
    75.0 (60.8 to 85.5)
        Week 208
    77.8 (51.9 to 92.6)
    71.0 (51.8 to 85.1)
    73.5 (58.7 to 84.6)
        Week 232
    76.5 (49.8 to 92.2)
    81.5 (61.3 to 93.0)
    79.5 (64.2 to 89.7)
        Week 260
    71.4 (42.0 to 90.4)
    84.6 (64.3 to 95.0)
    80.0 (63.9 to 90.4)
        Week 284
    85.7 (56.2 to 97.5)
    95.7 (76.0 to 99.8)
    91.9 (77.0 to 97.9)
        Week 308
    91.7 (59.8 to 99.6)
    88.2 (62.3 to 97.9)
    89.7 (71.5 to 97.3)
        Week 312
    80.0 (44.2 to 96.5)
    83.3 (50.9 to 97.1)
    81.8 (59.0 to 94.0)
    No statistical analyses for this end point

    Secondary: Percentage of participants with JIA ACR 100 response

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    End point title
    		 Percentage of participants with JIA ACR 100 response
    End point description
    The JIA ACR response criteria consisted of 6 core criteria: - Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). - Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). - Functional ability (CHAQ): 30 questions across 8 domains assessing the child’s functional abilities. The total score was calculated as the average of the scores for each domain (0 [no disability] to 3 [very severe disability]). - Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. - Number of joints with limited range of motion, ranging from 0 to 69. - Index of inflammation: CRP levels The JIA ACR 100 responses were achieved if 3 of any 6 core set variables improved with 100% from baseline of the core study, and no more than 1 variable worsening > 30%
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 104
    63.2 (38.6 to 82.8)
    57.1 (39.5 to 73.2)
    59.3 (45.1 to 72.1)
        Week 116
    63.2 (38.6 to 82.8)
    62.5 (43.7 to 78.3)
    62.7 (48.1 to 75.5)
        Week 128
    66.7 (41.2 to 85.6)
    54.8 (36.3 to 72.2)
    59.2 (44.3 to 72.7)
        Week 140
    66.7 (41.2 to 85.6)
    57.6 (39.4 to 74.0)
    60.8 (46.1 to 73.8)
        Week 156
    63.2 (38.6 to 82.8)
    60.6 (42.2 to 76.6)
    61.5 (47.0 to 74.4)
        Week 180
    57.9 (34.0 to 78.9)
    54.5 (36.6 to 71.5)
    55.8 (41.4 to 69.3)
        Week 208
    72.2 (46.4 to 89.3)
    58.1 (39.3 to 74.9)
    63.3 (48.3 to 76.2)
        Week 232
    58.8 (33.5 to 80.6)
    63.0 (42.5 to 79.9)
    61.4 (45.5 to 75.3)
        Week 260
    71.4 (42.0 to 90.4)
    65.4 (44.4 to 82.1)
    67.5 (50.8 to 80.9)
        Week 284
    78.6 (48.8 to 94.3)
    78.3 (55.8 to 91.7)
    78.4 (61.3 to 89.6)
        Week 308
    91.7 (59.8 to 99.6)
    76.5 (49.8 to 92.2)
    82.8 (63.5 to 93.5)
        Week 312
    80.0 (44.2 to 96.5)
    75.0 (42.8 to 93.3)
    77.3 (54.2 to 91.3)
    No statistical analyses for this end point

    Secondary: Number of participants with inactive disease status

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    End point title
    		 Number of participants with inactive disease status
    End point description
    Inactive disease status was confirmed in a patient when all the following conditions were met: - No joints with active arthritis - No uveitis - CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA - Physician’s global assessment of disease activity score ≤ 10mm - Duration of morning stiffness attributable to JIA lasting ≥15 minutes.
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 104
    63.2 (38.6 to 82.8)
    65.7 (47.7 to 80.3)
    64.8 (50.6 to 77.0)
        Week 116
    68.4 (43.5 to 86.4)
    71.9 (53.0 to 85.6)
    70.6 (56.0 to 82.1)
        Week 128
    66.7 (41.2 to 85.6)
    64.5 (45.4 to 80.2)
    65.3 (50.3 to 77.9)
        Week 140
    72.2 (46.4 to 89.3)
    63.6 (45.1 to 79.0)
    66.7 (52.0 to 77.9)
        Week 156
    68.4 (43.5 to 86.4)
    72.7 (54.2 to 86.1)
    71.2 (56.7 to 82.5)
        Week 180
    68.4 (43.5 to 86.4)
    54.5 (36.6 to 71.5)
    59.6 (45.1 to 72.7)
        Week 208
    61.1 (36.1 to 81.7)
    67.7 (48.5 to 82.7)
    65.3 (50.3 to 77.9)
        Week 232
    70.6 (44.0 to 88.6)
    66.7 (46.0 to 82.8)
    68.2 (52.3 to 80.9)
        Week 260
    71.4 (42.0 to 90.4)
    65.4 (44.4 to 82.1)
    67.5 (50.8 to 80.9)
        Week 284
    78.6 (48.8 to 94.3)
    78.3 (55.8 to 91.7)
    78.4 (61.3 to 89.6)
        Week 308
    83.3 (50.9 to 97.1)
    82.4 (55.8 to 95.3)
    82.8 (63.5 to 93.5)
        Week 312
    70.0 (35.4 to 91.9)
    75.0 (42.8 to 93.3)
    72.7 (49.6 to 88.4)
    No statistical analyses for this end point

    Secondary: Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - Physician global assessment of disease activity

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    End point title
    		 Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - Physician global assessment of disease activity
    End point description
    The JIA ACR response criteria consisted of 6 core criteria, one of which was the physician global assessment of disease activity. this assessment was conducted using a 100 mm VAS score, where 0 represented the best disease activity and 100 the worst. The change from baseline of the core study of the physician global assessment of disease activity was measured, with a negative change indicating improvement.
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Week 104
    -40.0 ( 18.39 )
    -42.2 ( 20.43 )
    -41.4 ( 19.59 )
        Week 116
    -40.3 ( 18.42 )
    -41.1 ( 20.35 )
    -40.8 ( 19.46 )
        Week 128
    -40.4 ( 18.55 )
    -41.9 ( 21.33 )
    -41.3 ( 20.17 )
        Week 140
    -39.0 ( 16.75 )
    -42.4 ( 19.18 )
    -41.2 ( 18.26 )
        Week 156
    -39.7 ( 17.09 )
    -40.8 ( 20.72 )
    -40.4 ( 19.50 )
        Week 180
    -38.5 ( 18.20 )
    -38.9 ( 21.71 )
    -38.8 ( 20.31 )
        Week 208
    -39.0 ( 17.06 )
    -41.8 ( 19.45 )
    -40.8 ( 18.48 )
        Week 232
    -38.4 ( 18.20 )
    -42.9 ( 20.86 )
    -41.1 ( 19.78 )
        Week 260
    -37.6 ( 28.75 )
    -45.4 ( 20.74 )
    -42.7 ( 23.78 )
        Week 284
    -43.6 ( 18.96 )
    -42.8 ( 20.53 )
    -43.1 ( 19.68 )
        Week 308
    -43.8 ( 18.76 )
    -40.3 ( 20.51 )
    -41.7 ( 19.53 )
        Week 312
    -44.2 ( 26.58 )
    -47.4 ( 22.05 )
    -46.0 ( 23.67 )
    No statistical analyses for this end point

    Secondary: Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - Parent's or patients' global assessment of overall well-being

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    End point title
    		 Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - Parent's or patients' global assessment of overall well-being
    End point description
    The JIA ACR response criteria included six core components, one of which was the parent's or patients' global assessment of overall well-being. This assessment was conducted using a 100 mm VAS score, where 0 represented “very well” and 100 “very poor”. The change from baseline of the core study in the parent's or patients' global assessment of overall well-being was measured, with a negative change indicating improvement
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Week 104
    -47.1 ( 25.90 )
    -38.6 ( 27.74 )
    -41.6 ( 27.17 )
        Week 116
    -45.4 ( 25.70 )
    -37.7 ( 26.39 )
    -40.5 ( 26.15 )
        Week 128
    -46.8 ( 25.02 )
    -39.1 ( 26.69 )
    -41.8 ( 26.11 )
        Week 140
    -41.1 ( 27.57 )
    -38.7 ( 27.06 )
    -38.7 ( 27.06 )
        Week 156
    -46.1 ( 25.41 )
    -39.2 ( 27.15 )
    -41.8 ( 26.49 )
        Week 180
    -45.5 ( 27.24 )
    -39.8 ( 27.48 )
    -41.9 ( 27.27 )
        Week 208
    -47.6 ( 25.70 )
    -40.3 ( 28.13 )
    -43.0 ( 27.23 )
        Week 232
    -39.6 ( 27.23 )
    -43.4 ( 28.20 )
    -41.9 ( 27.57 )
        Week 260
    -44.8 ( 34.52 )
    -42.8 ( 29.31 )
    -43.5 ( 30.80 )
        Week 284
    -51.6 ( 24.97 )
    -43.2 ( 31.23 )
    -46.4 ( 28.96 )
        Week 308
    -49.8 ( 24.23 )
    -48.5 ( 31.93 )
    -49.1 ( 28.53 )
        Week 312
    -48.9 ( 28.45 )
    -53.5 ( 30.31 )
    -51.4 ( 28.87 )
    No statistical analyses for this end point

    Secondary: Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - Functional ability (CHAQ)

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    End point title
    		 Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - Functional ability (CHAQ)
    End point description
    The JIA ACR response criteria included six core components, one of which was the functional ability, measured by the CHAQ. The CHAQ questionnaire consisted of 30 questions across 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain was scored on a 4-point scale, and the total score was calculated as the average of the scores for each domain. The total score ranged from 0 (no disability) to 3 (very severe disability). The change from baseline of the core study in the CHAQ was measured, with a negative change indicating improvement.
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Week 104
    -0.599 ( 0.5490 )
    -0.636 ( 0.5967 )
    -0.623 ( 0.5754 )
        Week 116
    -0.605 ( 0.5469 )
    -0.617 ( 0.5811 )
    -0.613 ( 0.5631 )
        Week 128
    -0.647 ( 0.5196 )
    -0.685 ( 0.5570 )
    -0.672 ( 0.5388 )
        Week 140
    -0.590 ( 0.4809 )
    -0.648 ( 0.5638 )
    -0.627 ( 0.5318 )
        Week 156
    -0.645 ( 0.5275 )
    -0.644 ( 0.5763 )
    -0.644 ( 0.5537 )
        Week 180
    -0.658 ( 0.5541 )
    -0.625 ( 0.5779 )
    -0.637 ( 0.5641 )
        Week 208
    -0.667 ( 0.4832 )
    -0.625 ( 0.5293 )
    -0.640 ( 0.5082 )
        Week 232
    -0.610 ( 0.5411 )
    -0.681 ( 0.5825 )
    -0.653 ( 0.5615 )
        Week 260
    -0.741 ( 0.5035 )
    -0.649 ( 0.6205 )
    -0.681 ( 0.5773 )
        Week 284
    -0.777 ( 0.5052 )
    -0.652 ( 0.6329 )
    -0.699 ( 0.5837 )
        Week 308
    -0.865 ( 0.4811 )
    -0.794 ( 0.6311 )
    -0.823 ( 0.5655 )
        Week 312
    -0.888 ( 0.5050 )
    -1.000 ( 0.6077 )
    -0.949 ( 0.5532 )
    No statistical analyses for this end point

    Secondary: Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - Number of joints with active arthritis

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    End point title
    		 Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - Number of joints with active arthritis
    End point description
    The JIA ACR response criteria included six core components, one of which was the number of joints with active arthritis. This was determined using the ACR definition, which identifies active arthritis as any joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity. The active joint count ranged from 0 to 73. The change from baseline of the core study in the number of active joints was measured, with a negative change indicating improvement.
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Joints
    arithmetic mean (standard deviation)
        Week 104
    -8.4 ( 11.03 )
    -6.9 ( 5.26 )
    -7.4 ( 7.72 )
        Week 116
    -8.4 ( 11.48 )
    -6.6 ( 4.50 )
    -7.3 ( 7.79 )
        Week 128
    -8.7 ( 11.81 )
    -7.3 ( 5.35 )
    -7.8 ( 8.24 )
        Week 140
    -8.4 ( 11.81 )
    -7.0 ( 5.44 )
    -7.5 ( 8.17 )
        Week 156
    -8.1 ( 9.77 )
    -7.1 ( 5.61 )
    -7.5 ( 7.32 )
        Week 180
    -8.3 ( 11.66 )
    -7.0 ( 5.69 )
    -7.5 ( 8.29 )
        Week 208
    -7.0 ( 6.12 )
    -6.7 ( 5.38 )
    -6.8 ( 5.60 )
        Week 232
    -7.4 ( 8.48 )
    -7.0 ( 5.68 )
    -7.1 ( 6.80 )
        Week 260
    -7.9 ( 10.14 )
    -7.5 ( 5.57 )
    -7.7 ( 7.36 )
        Week 284
    -8.4 ( 11.61 )
    -7.0 ( 5.57 )
    -7.5 ( 8.25 )
        Week 308
    -8.0 ( 9.70 )
    -6.5 ( 4.52 )
    -7.1 ( 7.01 )
        Week 312
    -8.9 ( 11.59 )
    -7.5 ( 5.14 )
    -8.1 ( 8.48 )
    No statistical analyses for this end point

    Secondary: Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - Number of joints with limited range of motion

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    End point title
    		 Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - Number of joints with limited range of motion
    End point description
    The JIA ACR response criteria included six core components, one of which was the number of joints with limited range of motion. A total of 69 joints were assessed for limitation of motion. The change from baseline of the core study in the number of joints with limited range of motion was measured, with a negative change indicating improvement.
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Joints
    arithmetic mean (standard deviation)
        Week 104
    -5.5 ( 6.20 )
    -5.3 ( 4.23 )
    -5.4 ( 4.96 )
        Week 116
    -5.4 ( 6.24 )
    -5.7 ( 4.19 )
    -5.6 ( 4.99 )
        Week 128
    -5.5 ( 6.41 )
    -6.0 ( 4.60 )
    -5.8 ( 5.28 )
        Week 140
    -5.7 ( 6.31 )
    -6.0 ( 4.99 )
    -5.9 ( 5.43 )
        Week 156
    -5.2 ( 5.68 )
    -4.3 ( 8.19 )
    -4.6 ( 7.32 )
        Week 180
    -5.3 ( 6.37 )
    -5.5 ( 4.83 )
    -5.4 ( 5.38 )
        Week 208
    -5.1 ( 5.61 )
    -5.3 ( 3.92 )
    -5.2 ( 4.56 )
        Week 232
    -4.5 ( 5.42 )
    -5.6 ( 3.93 )
    -5.2 ( 4.53 )
        Week 260
    -5.2 ( 6.47 )
    -5.9 ( 3.93 )
    -5.7 ( 4.90 )
        Week 284
    -5.1 ( 5.72 )
    -6.0 ( 3.88 )
    -5.7 ( 4.61 )
        Week 308
    -5.2 ( 5.46 )
    -5.8 ( 3.05 )
    -5.5 ( 4.14 )
        Week 312
    -5.3 ( 6.77 )
    -6.3 ( 3.62 )
    -5.8 ( 5.17 )
    No statistical analyses for this end point

    Secondary: Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - CRP levels

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    End point title
    		 Change from baseline of core study CAIN457F2304 in JIA ACR Core Component - CRP levels
    End point description
    The JIA ACR response criteria included six core components, one of which was CRP levels, an inflammation biomarker. Serum concentrations of CRP were determined, and the change from baseline of the core study was assessed, with negative changes indicating improvement.
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: milligram (mg) / liter (L)
    arithmetic mean (standard deviation)
        Week 104
    -15.238 ( 38.0680 )
    -19.788 ( 36.2920 )
    -18.187 ( 36.6322 )
        Week 116
    -11.201 ( 40.1619 )
    -21.795 ( 37.5991 )
    -17.848 ( 38.5218 )
        Week 128
    -15.027 ( 40.3989 )
    -21.446 ( 38.2870 )
    -19.088 ( 38.7812 )
        Week 140
    -15.867 ( 36.7306 )
    -21.211 ( 37.0123 )
    -19.325 ( 36.6347 )
        Week 156
    -13.622 ( 34.4677 )
    -21.325 ( 37.3081 )
    -18.510 ( 36.1480 )
        Week 180
    -16.131 ( 38.0479 )
    -20.788 ( 36.9842 )
    -19.086 ( 37.0716 )
        Week 208
    -16.907 ( 40.1651 )
    -20.694 ( 38.1014 )
    -19.303 ( 38.4978 )
        Week 232
    -15.015 ( 41.4765 )
    -20.365 ( 38.9746 )
    -18.298 ( 39.5668 )
        Week 260
    -18.746 ( 48.0621 )
    -20.715 ( 42.7106 )
    -20.026 ( 44.0482 )
        Week 284
    -19.974 ( 47.7822 )
    -15.530 ( 59.2045 )
    -17.212 ( 54.5096 )
        Week 308
    -21.052 ( 53.0822 )
    -21.458 ( 47.6825 )
    -21.290 ( 49.0532 )
        Week 312
    -25.915 ( 55.0448 )
    -27.892 ( 53.5661 )
    -26.993 ( 52.9390 )
    No statistical analyses for this end point

    Secondary: Change from baseline of core study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)

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    End point title
    		 Change from baseline of core study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)
    End point description
    The JADAS-27 was used for assessment of disease activity, and it included 4 measures: -Physician global assessment of disease activity (VAS range: 0 to 10; where 0=very good and 100=very poor) -Parent/participant global assessment of well-being (VAS range: 0 to 10; 0=very well and 100=very poor) -Count of joints with active disease (range: 0 to 27; where 0= no disease activity and 27= maximum disease activity) -Index of inflammation determined by CRP concentration, calculated as: (CRP (mg/l) −10)/10. Before calculation, CRP values <10 mg/l were converted to 10 and CRP values >110 mg/l were converted to 110. The normalized scale ranged from 0 to 10; where 0= no disease activity and 10= maximum disease activity. JADAS-27 score was calculated as the sum of the score of its 4 components, ranging from 0 to 57 where 0= no disease activity and 57= maximum disease activity. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement.
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Week 104
    -14.436 ( 7.2274 )
    -13.731 ( 7.4131 )
    -13.979 ( 7.2876 )
        Week 116
    -13.984 ( 7.9693 )
    -13.632 ( 7.0546 )
    -13.763 ( 7.3314 )
        Week 128
    -14.478 ( 7.7217 )
    -14.277 ( 7.3964 )
    -14.348 ( 7.4314 )
        Week 140
    -14.050 ( 7.6609 )
    -14.104 ( 7.3246 )
    -14.085 ( 7.3683 )
        Week 156
    -14.027 ( 6.1256 )
    -14.158 ( 7.4052 )
    -14.111 ( 6.9032 )
        Week 180
    -14.235 ( 7.6622 )
    -13.737 ( 7.5190 )
    -13.919 ( 7.5002 )
        Week 208
    -13.501 ( 5.7531 )
    -13.869 ( 7.3790 )
    -13.734 ( 6.7665 )
        Week 232
    -13.064 ( 6.3732 )
    -14.669 ( 7.6410 )
    -14.049 ( 7.1443 )
        Week 260
    -13.454 ( 8.9326 )
    -15.096 ( 7.9790 )
    -14.521 ( 8.2484 )
        Week 284
    -15.358 ( 7.3767 )
    -14.445 ( 8.4302 )
    -14.791 ( 7.9550 )
        Week 308
    -14.437 ( 6.4218 )
    -14.647 ( 8.3114 )
    -14.560 ( 7.4623 )
        Week 312
    -15.310 ( 8.3332 )
    -17.122 ( 8.2219 )
    -16.298 ( 8.1255 )
    No statistical analyses for this end point

    Secondary: Change from baseline of core study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71)

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    End point title
    		 Change from baseline of core study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71)
    End point description
    The JADAS-27 was used for assessment of disease activity, and it included 4 measures: -Physician global assessment of disease activity (VAS range: 0 to 10; where 0=very good and 100=very poor) -Parent/participant global assessment of well-being (VAS range: 0 to 10; 0=very well and 100=very poor) -Count of joints with active disease (range: 0 to 71; where 0= no disease activity and 71= maximum disease activity) -Index of inflammation determined by CRP concentration, calculated as: (CRP (mg/l) −10)/10. Before calculation, CRP values <10 mg/l were converted to 10 and CRP values >110 mg/l were converted to 110. The normalized scale ranged from 0 to 10; where 0= no disease activity and 10= maximum disease activity. JADAS-27 score was calculated as the sum of the score of its 4 components, ranging from 0 to 101 where 0= no disease activity and 101= maximum disease activity. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement.
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Week 104
    -17.962 ( 13.2770 )
    -16.503 ( 9.0939 )
    -17.016 ( 10.6497 )
        Week 116
    -17.510 ( 14.0289 )
    -16.226 ( 8.2331 )
    -16.704 ( 10.6429 )
        Week 128
    -18.595 ( 14.2989 )
    -17.083 ( 9.1148 )
    -17.619 ( 11.0980 )
        Week 140
    -17.384 ( 13.8172 )
    -16.861 ( 9.0858 )
    -17.046 ( 10.8540 )
        Week 156
    -17.448 ( 11.6294 )
    -16.855 ( 9.1102 )
    -17.072 ( 9.9946 )
        Week 180
    -17.709 ( 13.9552 )
    -16.556 ( 9.4998 )
    -16.977 ( 11.2105 )
        Week 208
    -16.723 ( 8.8183 )
    -16.675 ( 9.0536 )
    -16.693 ( 8.8753 )
        Week 232
    -16.005 ( 10.7335 )
    -17.262 ( 9.3685 )
    -16.776 ( 9.8143 )
        Week 260
    -17.239 ( 13.8602 )
    -18.019 ( 9.7594 )
    -17.746 ( 11.1907 )
        Week 284
    -19.144 ( 13.7107 )
    -17.141 ( 10.3338 )
    -17.899 ( 11.5806 )
        Week 308
    -18.520 ( 12.0126 )
    -17.000 ( 9.1449 )
    -17.629 ( 10.2499 )
        Week 312
    -19.810 ( 14.3124 )
    -19.622 ( 9.0748 )
    -19.707 ( 11.4427 )
    No statistical analyses for this end point

    Secondary: Change from baseline of core study CAIN457F2304 in total enthesitis count

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    End point title
    		 Change from baseline of core study CAIN457F2304 in total enthesitis count
    End point description
    The following 16 entheseal sites were assessed for the presence or absence of tenderness (enthesitis) on each side of the body: • Anterior Entheses: Greater trochanter of the Femur; Medial condyle of the femur; Lateral condyle of the femur • Posterior Entheses: Greater tuberosity of humerus; medial epicondyle of humerus; lateral epicondyle of humerus, Achilles tendon; and calcaneal insertion of the plantar fascia. Tenderness on examination was recorded as either present (1) or absent (0) for each of the 16 sites, The total enthesitis count ranged from 0 to 16. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Enthesitis count
    arithmetic mean (standard deviation)
        Week 104
    -2.5 ( 2.57 )
    -2.3 ( 2.30 )
    -2.4 ( 2.37 )
        Week 116
    -2.4 ( 2.36 )
    -2.3 ( 2.50 )
    -2.4 ( 2.42 )
        Week 128
    -2.4 ( 2.43 )
    -2.3 ( 1.97 )
    -2.3 ( 2.13 )
        Week 140
    -2.5 ( 2.36 )
    -2.7 ( 2.43 )
    -2.6 ( 2.38 )
        Week 156
    -2.7 ( 3.03 )
    -2.5 ( 2.36 )
    -2.2 ( 2.62 )
        Week 180
    -2.6 ( 2.59 )
    -2.5 ( 2.54 )
    -2.5 ( 2.53 )
        Week 208
    -2.4 ( 2.81 )
    -2.3 ( 2.56 )
    2.53 ( 2.63 )
        Week 232
    -2.5 ( 2.85 )
    -2.0 ( 2.28 )
    -2.2 ( 2.49 )
        Week 260
    -2.5 ( 3.54 )
    -2.0 ( 1.36 )
    -2.2 ( 2.37 )
        Week 284
    -2.9 ( 3.05 )
    -2.0 ( 1.52 )
    -2.4 ( 2.21 )
        Week 308
    -3.2 ( 3.07 )
    -2.1 ( 1.25 )
    -2.5 ( 2.21 )
        Week 312
    -2.5 ( 2.32 )
    -2.1 ( 1.44 )
    -2.3 ( 1.86 )
    No statistical analyses for this end point

    Secondary: Change from baseline of core study CAIN457F2304 in total dactylitis count

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    End point title
    		 Change from baseline of core study CAIN457F2304 in total dactylitis count
    End point description
    The dactylitis count was the number of fingers and toes presenting with swelling and inflammation. Swelling and inflammation on examination was recorded as either present (1) or absent (0) for each of the 20 sites, The total dactylitis count ranged from 0 to 20. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement
    End point type
    Secondary
    End point timeframe
    Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    18
    35
    53
    Units: Dactylitis count
    arithmetic mean (standard deviation)
        Week 104
    -1.3 ( 1.94 )
    -0.4 ( 1.97 )
    -0.7 ( 1.99 )
        Week 116
    -1.5 ( 2.04 )
    -0.5 ( 2.05 )
    -0.9 ( 2.08 )
        Week 128
    -1.8 ( 2.39 )
    -0.5 ( 2.23 )
    -0.9 ( 2.35 )
        Week 140
    -1.6 ( 2.42 )
    -0.6 ( 2.09 )
    -1.0 ( 2.24 )
        Week 156
    -1.6 ( 2.23 )
    -0.7 ( 2.07 )
    -1.0 ( 2.15 )
        Week 180
    -1.8 ( 2.41 )
    0.0 ( 4.15 )
    -0.6 ( 3.71 )
        Week 208
    -1.6 ( 2.42 )
    -0.3 ( 0.87 )
    -0.8 ( 1.70 )
        Week 232
    -1.5 ( 2.42 )
    -0.4 ( 0.88 )
    -0.8 ( 1.70 )
        Week 260
    -1.2 ( 2.04 )
    -0.3 ( 0.84 )
    -0.6 ( 1.43 )
        Week 284
    -1.2 ( 2.13 )
    -0.3 ( 0.95 )
    -0.6 ( 1.52 )
        Week 308
    -0.9 ( 1.70 )
    0.1 ( 0.56 )
    -0.3 ( 1.22 )
        Week 312
    -1.1 ( 1.83 )
    -0.2 ( 0.39 )
    -0.6 ( 1.29 )
    No statistical analyses for this end point

    Secondary: Serum concentrations of secukinumab over time

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    End point title
    		 Serum concentrations of secukinumab over time
    End point description
    Serum concentration of secukinumab over time. Blood samples for pharmacokinetics were taken pre-dose at the scheduled time points.
    End point type
    Secondary
    End point timeframe
    Pre-dose at Week 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    16
    26
    42
    Units: microgram (ug)/milliliter (mL)
    arithmetic mean (standard deviation)
        Week 128
    21.4 ( 8.57 )
    26.4 ( 9.78 )
    24.8 ( 9.58 )
        Week 156
    20.8 ( 8.76 )
    26.6 ( 11.6 )
    24.3 ( 10.8 )
        Week 180
    21.0 ( 10.4 )
    25.2 ( 9.28 )
    23.7 ( 9.75 )
        Week 208
    20.5 ( 6.82 )
    26.7 ( 11.4 )
    24.3 ( 10.2 )
        Week 232
    19.7 ( 7.06 )
    24.2 ( 11.6 )
    22.5 ( 10.2 )
        Week 260
    16.0 ( 6.94 )
    25.4 ( 8.99 )
    21.5 ( 9.32 )
        Week 284
    13.5 ( 7.99 )
    27.5 ( 7.48 )
    21.7 ( 10.3 )
        Week 308
    12.5 ( 5.31 )
    27.5 ( 14.7 )
    18.8 ( 12.4 )
        Week 312
    14.6 ( 4.79 )
    25.4 ( 18.5 )
    19.5 ( 13.4 )
    No statistical analyses for this end point

    Secondary: Number of participants with treatment-emergent Anti-Drug Antibodies (ADAs) of secukinumab

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    End point title
    		 Number of participants with treatment-emergent Anti-Drug Antibodies (ADAs) of secukinumab
    End point description
    Number of participants with treatment-emergent Anti-Drug Antibodies (ADAs) of secukinumab. Blood samples were collected for immunogenicity (anti-AIN457 antibodies) assessments.
    End point type
    Secondary
    End point timeframe
    From baseline of the core study up to Week 312. Study week is defined with respect to the core study.
    End point values
    		 Group 1- Secukinumab 75 mg Group 2 - Secukinumab 150 mg Total Secukinumab Dose
    Number of subjects analysed
    19
    35
    54
    Units: Participants
    0
    6
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of secukinumab in the extension study up to 84 daysafter last dose of secukinumab, assessed up to approximately 4 years
    Adverse event reporting additional description
    AEs were reported according to the dose the participants were receiving when the AE started. For non-SAEs, only those with a frequency over 5% are reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Any secukinumab 75 mg
    Reporting group description
    		 Participants who received secukinumab 75 mg dose at any point duringthe extension study

    Reporting group title
    Any secukinumab 300 mg
    Reporting group description
    		 Participants who received secukinumab 300 mg dose at any point duringthe extension study

    Reporting group title
    Any secukinumab
    Reporting group description
    		 Participants who received secukinumab, regardless of dose, at any pointduring the extension study

    Reporting group title
    Any secukinumab 150 mg
    Reporting group description
    		 Participants who received secukinumab 150 mg dose at any point duringthe extension study

    Serious adverse events
    		 Any secukinumab 75 mg Any secukinumab 300 mg Any secukinumab Any secukinumab 150 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    4 / 54 (7.41%)
    4 / 43 (9.30%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Any secukinumab 75 mg Any secukinumab 300 mg Any secukinumab Any secukinumab 150 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 19 (78.95%)
    11 / 16 (68.75%)
    43 / 54 (79.63%)
    28 / 43 (65.12%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Osteochondroma
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    3 / 54 (5.56%)
    3 / 43 (6.98%)
         occurrences all number
    0
    0
    3
    3
    Gait disturbance
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Swelling face
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Pharyngeal erythema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    4 / 54 (7.41%)
    3 / 43 (6.98%)
         occurrences all number
    1
    0
    10
    9
    Cough
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    4 / 54 (7.41%)
    3 / 43 (6.98%)
         occurrences all number
    0
    1
    7
    6
    Bronchospasm
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Psychiatric disorders
    Generalised anxiety disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 16 (12.50%)
    3 / 54 (5.56%)
    1 / 43 (2.33%)
         occurrences all number
    0
    2
    3
    1
    Bacterial test positive
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Basophil count increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    4
    4
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood phosphorus increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Crystal urine present
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Eosinophil count increased
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 16 (12.50%)
    2 / 54 (3.70%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Eosinophil percentage increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Protein urine present
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    High density lipoprotein decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    4 / 54 (7.41%)
    3 / 43 (6.98%)
         occurrences all number
    1
    0
    4
    3
    Fall
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Ligament sprain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    1
    0
    2
    1
    Radius fracture
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Wrist fracture
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Congenital, familial and genetic disorders
    Familial mediterranean fever
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    1
    0
    2
    1
    Headache
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    4 / 54 (7.41%)
    3 / 43 (6.98%)
         occurrences all number
    0
    2
    11
    9
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    1
    0
    2
    1
    Neutropenia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Eye disorders
    Astigmatism
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 16 (12.50%)
    2 / 54 (3.70%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    3 / 54 (5.56%)
    3 / 43 (6.98%)
         occurrences all number
    0
    0
    21
    21
    Diarrhoea
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 16 (6.25%)
    7 / 54 (12.96%)
    5 / 43 (11.63%)
         occurrences all number
    4
    1
    11
    6
    Colitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    3 / 19 (15.79%)
    0 / 16 (0.00%)
    6 / 54 (11.11%)
    4 / 43 (9.30%)
         occurrences all number
    3
    0
    15
    12
    Vomiting
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    3 / 54 (5.56%)
    2 / 43 (4.65%)
         occurrences all number
    1
    0
    4
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Acne
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    3 / 54 (5.56%)
    3 / 43 (6.98%)
         occurrences all number
    0
    0
    3
    3
    Psoriasis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    5
    4
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    1
    0
    5
    4
    Urinary incontinence
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Enthesopathy
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    1
    0
    2
    1
    Back pain
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 16 (0.00%)
    5 / 54 (9.26%)
    3 / 43 (6.98%)
         occurrences all number
    5
    0
    11
    6
    Arthritis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    2 / 54 (3.70%)
    2 / 43 (4.65%)
         occurrences all number
    0
    1
    3
    2
    Arthralgia
         subjects affected / exposed
    4 / 19 (21.05%)
    3 / 16 (18.75%)
    11 / 54 (20.37%)
    7 / 43 (16.28%)
         occurrences all number
    7
    7
    30
    16
    Amplified musculoskeletal pain syndrome
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Exostosis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Groin pain
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 16 (6.25%)
    2 / 54 (3.70%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Joint swelling
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 16 (12.50%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    0
    4
    7
    3
    Temporomandibular pain and dysfunction syndrome
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    1
    0
    3
    2
    Scoliosis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    8 / 54 (14.81%)
    8 / 43 (18.60%)
         occurrences all number
    1
    0
    15
    14
    Juvenile idiopathic arthritis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    3 / 54 (5.56%)
    3 / 43 (6.98%)
         occurrences all number
    0
    0
    3
    3
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    1
    0
    2
    1
    Bacterial infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    3 / 54 (5.56%)
    2 / 43 (4.65%)
         occurrences all number
    2
    0
    4
    2
    COVID-19
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 16 (18.75%)
    13 / 54 (24.07%)
    9 / 43 (20.93%)
         occurrences all number
    1
    3
    13
    9
    Ear infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    2
    1
    Eye infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    4 / 54 (7.41%)
    4 / 43 (9.30%)
         occurrences all number
    0
    0
    5
    5
    Gastrointestinal infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    2
    1
    Pneumonia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    4 / 54 (7.41%)
    4 / 43 (9.30%)
         occurrences all number
    0
    0
    7
    7
    Oral herpes
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 19 (10.53%)
    4 / 16 (25.00%)
    13 / 54 (24.07%)
    8 / 43 (18.60%)
         occurrences all number
    5
    6
    34
    23
    Influenza
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    3
    0
    4
    1
    Herpes simplex
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vaccination site cellulitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 16 (0.00%)
    7 / 54 (12.96%)
    5 / 43 (11.63%)
         occurrences all number
    4
    0
    10
    6
    Tooth abscess
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    4 / 54 (7.41%)
    3 / 43 (6.98%)
         occurrences all number
    0
    1
    6
    5
    Tinea pedis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 16 (6.25%)
    5 / 54 (9.26%)
    2 / 43 (4.65%)
         occurrences all number
    2
    1
    7
    4
    Rhinitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    1
    0
    2
    1
    Varicella
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    2 / 54 (3.70%)
    1 / 43 (2.33%)
         occurrences all number
    1
    0
    2
    1
    Folate deficiency
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Body fat disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    1 / 54 (1.85%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 16 (6.25%)
    2 / 54 (3.70%)
    0 / 43 (0.00%)
         occurrences all number
    1
    2
    3
    0

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    One participant, who was enrolled with planned treatment of secukinumab 150 mg, discontinued the study before receiving any treatment. Due to technical limitations of the form, this participant has not been included in the subject disposition tables.
    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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