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    Clinical Trial Results:
    An open-label, single-arm, active-treatment, efficacy and safety study of canakinumab (ACZ885) administered for at least 48 weeks in Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA)

    Summary
    EudraCT number
    		 2018-002355-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    01 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Feb 2019
    First version publication date
    15 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CACZ885G1301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02396212
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma, AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma, AG, +41 613241111, novartis.email@novartis.com
    Scientific contact
    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
    01 Aug 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives were: - to evaluate the efficacy of canakinumab, defined as the proportion of patients who achieved a minimum a ACR ped 30 criteria at Week 8; - to evaluate the proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully at Week 28.
    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 May 2015
    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
    Japan: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    0
    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)
    1
    Children (2-11 years)
    12
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 It was planned to enroll approximately 20 patients in this study. There were19 patients enrolled and data from all patients were analyzed.

    Pre-assignment
    Screening details
    		 It was planned to enroll approximately 20 patients in this stud. There were19 patients enrolled and data from all patients were analyzed.

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

    Arms
    Arm title
    		 Canakinumab 4 mg/kg every 4 weeks
    Arm description
    		 All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    ACZ885
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Canakinumab 4 mg/kg subcutaneously every 4 weeks

    Number of subjects in period 1
    		Canakinumab 4 mg/kg every 4 weeks
    Started
    19
    Completed
    16
    Not completed
    3
         Adverse event, non-fatal
    1
         Lack of efficacy
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Canakinumab 4 mg/kg every 4 weeks
    Reporting group description
    		 All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg.

    Reporting group values
    		 Canakinumab 4 mg/kg every 4 weeks Total
    Number of subjects
    		 19 19
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 1 1
        Children (2-11 years)
    		 12 12
        Adolescents (12-17 years)
    		 5 5
        Adults (18-64 years)
    		 1 1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 9.9 ( 4.47 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 13 13
        Male
    		 6 6
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 19 19

    End points

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    End points reporting groups
    Reporting group title
    Canakinumab 4 mg/kg every 4 weeks
    Reporting group description
    		 All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg.

    Primary: Percentage of participants who achieved a minimum adapted American College of Rheumatology (ACR) Pediatric 30 criteria

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    End point title
    		 Percentage of participants who achieved a minimum adapted American College of Rheumatology (ACR) Pediatric 30 criteria [1]
    End point description
    To evaluate the efficacy of canakinumab, defined as the percentage of patients who achieved a minimum adapted ACR Pediatric 30 criteria at Week 8
    End point type
    Primary
    End point timeframe
    Week 8
    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 analysis was planned for this 1-arm study.
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: Percentage of participants
    19
    No statistical analyses for this end point

    Primary: Percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully

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    End point title
    		 Percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully [2]
    End point description
    To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully at Week 28
    End point type
    Primary
    End point timeframe
    Week 28
    Notes
    [2] - 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 analysis was planned for this 1-arm study.
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: Participants
    14
    No statistical analyses for this end point

    Secondary: Percentage of participants who met the adapted ACR Pediatric 30/50/70/90/100 criteria of canakinumab over time

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    End point title
    		 Percentage of participants who met the adapted ACR Pediatric 30/50/70/90/100 criteria of canakinumab over time
    End point description
    To evaluate the efficacy (percentage of participants who met the adapted ACR Pediatric 30/50/70/90/100 criteria) of canakinumab over time; EOS means End of study which is performed at study completion
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 28, 48, 96, 144, end of study (EOS)
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: Percentage of Participants
    number (not applicable)
        Week 4 adapted ACR Pediatric 30
    94.7
        Week 4 adapted ACR Pediatric 50
    94.7
        Week 4 adapted ACR Pediatric 70
    94.7
        Week 4 adapted ACR Pediatric 90
    84.2
        Week 4 adapted ACR Pediatric 100
    47.4
        Week 8 adapted ACR Pediatric 30
    100.0
        Week 8 adapted ACR Pediatric 50
    100.0
        Week 8 adapted ACR Pediatric 70
    100.0
        Week 8 adapted ACR Pediatric 90
    89.5
        Week 8 adapted ACR Pediatric 100
    68.4
        Week 28 adapted ACR Pediatric 30
    100.0
        Week 28 adapted ACR Pediatric 50
    100.0
        Week 28 adapted ACR Pediatric 70
    100.0
        Week 28 adapted ACR Pediatric 90
    100.0
        Week 28 adapted ACR Pediatric 100
    56.3
        Week 48 adapted ACR Pediatric 30
    100.0
        Week 48 adapted ACR Pediatric 50
    100.0
        Week 48 adapted ACR Pediatric 70
    100.0
        Week 48 adapted ACR Pediatric 90
    87.5
        Week 48 adapted ACR Pediatric 100
    68.8
        Week 96 adapted ACR Pediatric 30
    100.0
        Week 96 adapted ACR Pediatric 50
    100.0
        Week 96 adapted ACR Pediatric 70
    100.0
        Week 96 adapted ACR Pediatric 90
    93.8
        Week 96 adapted ACR Pediatric 100
    62.5
        Week 144 adapted ACR Pediatric 30
    100.0
        Week 144 adapted ACR Pediatric 50
    100.0
        Week144 adapted ACR Pediatric 70
    100.0
        Week 144 adapted ACR Pediatric 90
    100.0
        Week 144 adapted ACR Pediatric 100
    80.0
        Week EOS adapted ACR Pediatric 30
    89.5
        End of Study (EOS) adapted ACR Pediatric 50
    89.5
        EOS adapted ACR Pediatric 70
    89.5
        EOS adapted ACR Pediatric 90
    84.2
        EOS adapted ACR Pediatric 100
    63.2
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: Physician’s Global Assessment of disease activity

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    End point title
    		 Absolute change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: Physician’s Global Assessment of disease activity
    End point description
    ACR component, Physician’s Global Assessment of disease activity on a 0 - 100 mm VAS by visit is the first response variable in the ACR ped criteria. The a ACR ped 30 criteria were used to determine efficacy and were defined as improvement from baseline of at least 30% in at least 3 of response variables 1 to 6 and no intermittent fever (i.e., axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 4
    -60.2 ( 32.27 )
        Week 8
    -62.2 ( 28.23 )
        Week 28 (n = 16)
    -62.2 ( 28.61 )
        Week 48 (n = 16)
    -63.9 ( 28.81 )
        Week 96 (n = 16)
    -63.1 ( 26.99 )
        Week 144 (n = 5)
    -61.0 ( 37.24 )
        EOS
    -61.4 ( 31.05 )
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: CHAQ: Parent’s Global Assessment of patient's overall well-being as part of CHAQ

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    End point title
    		 Absolute change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: CHAQ: Parent’s Global Assessment of patient's overall well-being as part of CHAQ
    End point description
    ACR component, Parent’s Global Assessment of patient's overall well-being as part of CHAQ on a 0 - 100 mm VAS by visit is the second response variable in the ACR ped criteria. The a ACR ped 30 criteria were used to determine efficacy and were defined as improvement from baseline of at least 30% in at least 3 of response variables 1 to 6 and no intermittent fever (i.e., axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 4
    -64.4 ( 40.80 )
        Week 8
    -73.5 ( 24.0 )
        Week 28 (n = 16)
    -71.9 ( 23.13 )
        Week 48 (n = 16)
    -68.6 ( 28.67 )
        Week 96 (n = 16)
    -68.4 ( 27.72 )
        Week 144 (n = 5)
    -72.8 ( 25.65 )
        EOS
    -68.1 ( 26.29 )
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: CHAQ: Functional Ability Score

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    End point title
    		 Absolute change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: CHAQ: Functional Ability Score
    End point description
    ACR component, Disability Score as part of CHAQ per functional ability score (range from 0 to 3) is the third response variable in the ACR ped criteria. The a ACR ped 30 criteria were used to determine efficacy and were defined as improvement from baseline of at least 30% in at least 3 of response variables 1 to 6 and no intermittent fever (i.e., axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 4
    -0.833 ( 0.7750 )
        Week 8
    -0.912 ( 0.7338 )
        Week 28 (n = 16)
    -0.998 ( 0.7871 )
        Week 48 (n = 16)
    -1.013 ( 0.7963 )
        Week 96 (n = 16)
    -0.951 ( 0.8381 )
        Week 144 (n = 5)
    -1.026 ( 0.9465 )
        EOS
    -0.938 ( 0.7682 )
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: Number of joints with active arthritis

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    End point title
    		 Absolute change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: Number of joints with active arthritis
    End point description
    ACR component, Number of joints with active arthritis is the forth response variable in the ACR ped criteria. The a ACR ped 30 criteria were used to determine efficacy and were defined as improvement from baseline of at least 30% in at least 3 of response variables 1 to 6 and no intermittent fever (i.e., axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 4
    -5.2 ( 4.87 )
        Week 8
    -6.2 ( 7.71 )
        Week 28 (n = 16)
    -4.4 ( 3.44 )
        Week 48 (n = 16)
    -4.4 ( 3.44 )
        Week 96 (n = 16)
    -4.4 ( 3.18 )
        Week 144 (n = 5)
    -5.2 ( 2.68 )
        EOS
    -5.6 ( 8.10 )
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: Number of joints with limitation of motion

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    End point title
    		 Absolute change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: Number of joints with limitation of motion
    End point description
    ACR component, Number of joints with limitation of motion is the fifth response variable in the ACR ped criteria. The a ACR ped 30 criteria were used to determine efficacy and were defined as improvement from baseline of at least 30% in at least 3 of response variables 1 to 6 and no intermittent fever (i.e., axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 4
    -3.9 ( 4.02 )
        Week 8
    -4.2 ( 4.30 )
        Week 28 (n = 16)
    -3.4 ( 3.79 )
        Week 48 (n = 16)
    -3.5 ( 3.78 )
        Week 96 (n = 16)
    -3.4 ( 3.59 )
        Week 144 (n = 5)
    -3.8 ( 2.86 )
        EOS
    -3.7 ( 4.81 )
    No statistical analyses for this end point

    Secondary: Number of participants having fever in the adapted ACR pediatric criteria of canakinumab over time

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    End point title
    		 Number of participants having fever in the adapted ACR pediatric criteria of canakinumab over time
    End point description
    ACR component, Number of participants having fever is the seventh response variable in the ACR ped criteria. The a ACR ped 30 criteria were used to determine efficacy and were defined as improvement from baseline of at least 30% in at least 3 of response variables 1 to 6 and no intermittent fever (i.e., axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 3, Weeks 2, 56, 124
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: participants
        Baseline
    19
        Day 3
    16
        Week 2
    2
        Week 8
    0
        Week 28 (n = 16)
    0
        Week 48 (n = 16)
    0
        Week 56 (n = 16)
    1
        Week 96 (n = 16)
    0
        Week 124 (n = 8)
    1
        Week 144 (n = 5)
    0
        EOS
    0
    No statistical analyses for this end point

    Secondary: Percentage change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: Standardized CRP

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    End point title
    		 Percentage change from baseline in the adapted ACR pediatric criteria of canakinumab over time: ACR component: Standardized CRP
    End point description
    ACR component, Standardized CRP is the sixth response variable in the ACR ped criteria. CRP values were standardized to a normal range of 0 to 10 mg/L. The a ACR ped 30 criteria were used to determine efficacy and were defined as improvement from baseline of at least 30% in at least 3 of response variables 1 to 6 and no intermittent fever (i.e., axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: Percentage change
    arithmetic mean (standard deviation)
        Baseline
    357.79 ( 359.408 )
        Week 4
    -89.45 ( 41.431 )
        Week 8
    -96.95 ( 6.915 )
        Week 28 (n = 16)
    -98.19 ( 2.567 )
        Week 48 (n = 16)
    -97.64 ( 6.333 )
        Week 96 (n = 16)
    -97.95 ( 3.730 )
        Week 144 (n = 5)
    -98.58 ( 1.330 )
        EOS
    -89.71 ( 20.717 )
    No statistical analyses for this end point

    Secondary: Percentage of participants who had flares with canakinumab treatment over time

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    End point title
    		 Percentage of participants who had flares with canakinumab treatment over time
    End point description
    Flare was defined by at least 1 of the following: Reappearance of SJIA-related (e.g., not due to infection) fever (> 38°C) lasting for at least 2 consecutive days &/OR Flare according to the JIA pediatric criteria for flare (all criteria must be met): ≥ 30% worsening in at least 3 of the 6 response variables and ≥ 30% improvement in at not more than 1 of the 6 response variables if the physician’s or parent’s global assessment is 1of 3 response variables used to define flare, worsening of ≥ 20 mm must be present, if the number of active joints or joints with limitation of motion is one of 3 response variables used to define flare, worsening in ≥ 2 joints must be present if CRP is used to define flare, CRP must be > 30 mg/L
    End point type
    Secondary
    End point timeframe
    > Day3, to <= Week164
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: Percentage of participants
    number (not applicable)
        >Day 3 =<Week 2
    5.3
        >Week 2 =<Week 4
    5.3
        >Week 4 =<Week 8
    5.3
        >Week 8 =<Week 12 (n = 18)
    5.6
        >Week 12 =<Week 16 (n = 18)
    5.6
        >Week 92 =<Week 96 (n = 16)
    6.3
        >Week 104 =<Week 108 (n = 13)
    7.7
        >Week 120 =<Week 124 (n = 8)
    12.5
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieved inactive disease (with and without duration of morning stiffness) with canakinumab treatment over time

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    End point title
    		 Percentage of participants who achieved inactive disease (with and without duration of morning stiffness) with canakinumab treatment over time
    End point description
    Inactive disease was defined as meeting all of the following: No joints with active arthritis; No fever (body temperature ≤ 38°C); No rheumatoid rash, serositis, splenomegaly, hepatomegaly or generalized lymphadenopathy attributable to JIA; Normal CRP; Physician’s global assessment of disease activity score ≤ 10 mm
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 28, 48, 96, 144, EOS
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: Percentage of participants
    number (not applicable)
        Week 4
    63.2
        Week 8
    63.2
        Week 28 (n = 16)
    75.0
        Week 48 (n = 16)
    75.0
        Week 96 (n = 16)
    75.0
        Week 144 (n = 5)
    80.0
        EOS
    68.4
    No statistical analyses for this end point

    Secondary: Percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully over time

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    End point title
    		 Percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully over time
    End point description
    To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully over time
    End point type
    Secondary
    End point timeframe
    Weeks 28, 48, 96, 144, EOS
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: Percentage of perticipants
    number (not applicable)
        Week 28 (n = 16)
    87.5
        Week 48 (n = 16)
    81.3
        Week 96 (n = 16)
    87.5
        Week 144 (n = 5)
    100.0
        EOS (n = 18)
    66.7
    No statistical analyses for this end point

    Secondary: Absolute change from baseline of corticosteroids dose reduction with canakinumab treatment over time

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    End point title
    		 Absolute change from baseline of corticosteroids dose reduction with canakinumab treatment over time
    End point description
    To evaluate corticosteroids dose reduction with canakinumab treatment over time
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 28, 48, 96, 144, EOS
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: mg/kg/day
    arithmetic mean (standard deviation)
        Week 28 (n = 16)
    -0.133 ( 0.1676 )
        Week 48 (n = 16)
    -0.195 ( 0.2317 )
        Week 96 (n = 16)
    -0.226 ( 0.2618 )
        Week 144 (n = 5)
    -0.296 ( 0.2545 )
        EOS (n = 18)
    -0.171 ( 0.2334 )
    No statistical analyses for this end point

    Secondary: Serum concentration of canakinumab and total IL-1 beta

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    End point title
    		 Serum concentration of canakinumab and total IL-1 beta
    End point description
    To evaluate serum concentration (mean, standard deviation) of canakinumab and total IL-1 beta
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 24, 48, 72, 96, end of study
    End point values
    		 Canakinumab 4 mg/kg every 4 weeks
    Number of subjects analysed
    19
    Units: μg/mL
    arithmetic mean (standard deviation)
        Baseline
    0.01 ( 0.05 )
        Week 4
    15.7 ( 5.9 )
        Week 24 (n = 16)
    31.3 ( 11.5 )
        Week 48 (n = 16)
    31.1 ( 9.08 )
        Week 72 (n = 16)
    30.6 ( 8.95 )
        Week 96 (n = 16)
    29.5 ( 8.49 )
        EOS
    28.3 ( 6.41 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected fro First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 39 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    ACZ885
    Reporting group description
    		 ACZ885

    Serious adverse events
    		 ACZ885
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 19 (52.63%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Histiocytosis haematophagic
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Somatic symptom disorder
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Still's disease
         subjects affected / exposed
    6 / 19 (31.58%)
         occurrences causally related to treatment / all
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ACZ885
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 19 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Histiocytic necrotising lymphadenitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Injection site pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Injection site reaction
         subjects affected / exposed
    5 / 19 (26.32%)
         occurrences all number
    7
    Malaise
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    5
    Vessel puncture site pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    19
    Nasal obstruction
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pneumomediastinum
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    4
    Amylase increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood cholesterol increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood creatine phosphokinase decreased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood uric acid increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Intraocular pressure increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    White blood cell count decreased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Arthropod sting
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Ligament sprain
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    6
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 19 (31.58%)
         occurrences all number
    17
    Neuropathy peripheral
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Tremor
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Leukopenia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Lymphadenitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Motion sickness
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Eye disorders
    Chalazion
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Colitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    6 / 19 (31.58%)
         occurrences all number
    6
    Dental caries
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Enterocolitis
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    5 / 19 (26.32%)
         occurrences all number
    13
    Hepatic steatosis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Alopecia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blister
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Dermatitis atopic
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Dry skin
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Eczema
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    4
    Eczema asteatotic
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Haemorrhage subcutaneous
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Macule
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Purpura
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Urticaria
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    5
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Back pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Joint range of motion decreased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Limb discomfort
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    4
    Neck pain
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Pain in extremity
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Still's disease
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Tenosynovitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Infections and infestations
    Angular cheilitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    5
    Gastroenteritis
         subjects affected / exposed
    6 / 19 (31.58%)
         occurrences all number
    7
    Gastroenteritis viral
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Herpes zoster
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hordeolum
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    4
    Impetigo
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    4
    Lice infestation
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    12 / 19 (63.16%)
         occurrences all number
    47
    Otitis media acute
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Skin infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    7
    Viral infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Viral pharyngitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyperalbuminaemia
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Hyperamylasaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    8
    Hyperlipidaemia
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Hyperuricaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Hypocalcaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hypoproteinaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1

    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.
    None reported
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    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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