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    Clinical Trial Results:
    Open-label, multicenter, dose-escalating phase II study to investigate the safety, tolerability, and early signs of efficacy of subcutaneous administrations of Tadekinig alfa (IL-18BP) in patients with Adult -onset Still’s Disease (AoSD) during 12 weeks

    Summary
    EudraCT number
    		 2014-002500-24
    Trial protocol
    		 DE  
    Global end of trial date
    28 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Aug 2017
    First version publication date
    12 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AOSD.2014.001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AB2 Bio Ltd.
    Sponsor organisation address
    EPFL Innovation Park, Building B, 4th floor, Lausanne, Switzerland, CH-1015
    Public contact
    Eduardo Schiffrin, Medical Director, AB2 Bio Ltd., +41 21693 82 83, eduardo.schiffrin@ab2bio.com
    Scientific contact
    Eduardo Schiffrin, Medical Director, AB2 Bio Ltd., +41 21693 82 83, eduardo.schiffrin@ab2bio.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Apr 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safe use of Tadekinig alfa in AoSD patients
    Protection of trial subjects
    In order to enhance patients’ compliance, local skin treatment was proposed to the patients to mitigate local inflammatory reactions at the injection site. The patient completed a daily diary recording daily symptoms at the injection site and other unusual remarkable symptom to continuously assess patient wellbeing and safety. Finally, temporal treatment interruptions have been allowed in case of fever of any signs of undergoing infections unrelated to the treated condition.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Feb 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Switzerland: 2
    Worldwide total number of subjects
    23
    EEA total number of subjects
    21
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    20
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 After the subject has agreed to participation by signing the consent, an inclusion/exclusion checklist will be completed by the physician. Demographics and history Physical examination, vital signs, and SDAI, assessment of 44 joints Routine lab testing (ESR, CRP, hematology and clinical chemistry, urinalysis, TB testing, Serology) Coagulation

    Pre-assignment period milestones
    Number of subjects started
    		 33 [1]
    Number of subjects completed
    		 23

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening Failure: 10
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The worldwide number corresponds to the number of patients enrolled (23) and not to the number of patients screened (33).
    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1 / 80 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tadekinig alfa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients will receive the treatments three times a week (TIW). The 80mg cohort will receive 1ml of the study product. Patients of the 160mg dose cohort will receive 2 vials. The 320mg cohort, received 4 vials.

    Arm title
    		 Cohort 1 / 80-160 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tadekinig alfa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients will receive the treatments three times a week (TIW). The 80mg cohort will receive 1ml of the study product. Patients of the 160mg dose cohort will receive 2 vials. The 320mg cohort, received 4 vials.

    Arm title
    		 Cohort 2 / 160 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tadekinig alfa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients will receive the treatments three times a week (TIW). The 80mg cohort will receive 1ml of the study product. Patients of the 160mg dose cohort will receive 2 vials. The 320mg cohort, received 4 vials.

    Arm title
    		 Cohort 2 / 160-320 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tadekinig alfa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients will receive the treatments three times a week (TIW). The 80mg cohort will receive 1ml of the study product. Patients of the 160mg dose cohort will receive 2 vials. The 320mg cohort, received 4 vials.

    Number of subjects in period 1
    		Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Started
    4
    6
    12
    1
    Completed
    3
    5
    7
    1
    Not completed
    1
    1
    5
    0
         Consent withdrawn by subject
    -
    -
    1
    -
         Adverse event, non-fatal
    1
    1
    3
    -
         Other
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1 / 80 mg
    Reporting group description
    		 -

    Reporting group title
    Cohort 1 / 80-160 mg
    Reporting group description
    		 -

    Reporting group title
    Cohort 2 / 160 mg
    Reporting group description
    		 -

    Reporting group title
    Cohort 2 / 160-320 mg
    Reporting group description
    		 -

    Reporting group values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg Total
    Number of subjects
    		 4 6 12 1 23
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2 6 11 1 20
        From 65-84 years
    		 2 0 1 0 3
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 55 (31 to 65) 41.7 (24 to 58) 41.9 (21 to 77) 30 (30 to 30) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3 9 1 16
        Male
    		 1 3 3 0 7

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1 / 80 mg
    Reporting group description
    		 -

    Reporting group title
    Cohort 1 / 80-160 mg
    Reporting group description
    		 -

    Reporting group title
    Cohort 2 / 160 mg
    Reporting group description
    		 -

    Reporting group title
    Cohort 2 / 160-320 mg
    Reporting group description
    		 -

    Primary: Body temperature

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    End point title
    		 Body temperature [1]
    End point description
    End point type
    Primary
    End point timeframe
    At 12 weeks
    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: The analysis that have been performed are descriptive statistics.
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    6
    9
    1
    Units: °C
        arithmetic mean (full range (min-max))
    35.8 (35 to 37)
    36.3 (36 to 37)
    36.6 (36 to 38)
    35.9 (35.9 to 35.9)
    No statistical analyses for this end point

    Primary: Heart rate

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    End point title
    		 Heart rate [2]
    End point description
    End point type
    Primary
    End point timeframe
    At 12 weeks
    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: The analysis that have been performed are descriptive statistics.
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    6
    9
    1
    Units: bpm
        arithmetic mean (full range (min-max))
    83 (73 to 90)
    86.5 (71 to 100)
    82.4 (69 to 101)
    81 (81 to 81)
    No statistical analyses for this end point

    Primary: Systolic blood pressure

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    End point title
    		 Systolic blood pressure [3]
    End point description
    End point type
    Primary
    End point timeframe
    At 12 weeks
    Notes
    [3] - 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: The analysis that have been performed are descriptive statistics.
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    6
    9
    1
    Units: mmHg
        arithmetic mean (full range (min-max))
    116 (106 to 134)
    122.5 (108 to 150)
    123.6 (99 to 148)
    112 (112 to 112)
    No statistical analyses for this end point

    Primary: Diastolic blood pressure

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    End point title
    		 Diastolic blood pressure [4]
    End point description
    End point type
    Primary
    End point timeframe
    At 12 weeks
    Notes
    [4] - 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: The analysis that have been performed are descriptive statistics.
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    6
    9
    1
    Units: mmHg
        arithmetic mean (full range (min-max))
    71.7 (62 to 90)
    80.8 (69 to 100)
    75 (51 to 100)
    82 (82 to 82)
    No statistical analyses for this end point

    Primary: lymph node enlargement

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    End point title
    		 lymph node enlargement [5]
    End point description
    End point type
    Primary
    End point timeframe
    At 12 weeks
    Notes
    [5] - 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: The analysis that have been performed are descriptive statistics.
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: Number of patients
        normal
    3
    6
    8
    1
        abnormal
    0
    0
    1
    0
        not done
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: liver and spleen

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    End point title
    		 liver and spleen [6]
    End point description
    End point type
    Primary
    End point timeframe
    At 12 weeks
    Notes
    [6] - 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: The analysis that have been performed are descriptive statistics
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: Number of patients
        normal
    3
    6
    8
    1
        abnormal
    0
    0
    0
    0
        not done
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Immunogenicity - rfIL-18BP antibodies

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    End point title
    		 Immunogenicity - rfIL-18BP antibodies [7]
    End point description
    Number of patients with samples that screened positive in the ADA assay
    End point type
    Primary
    End point timeframe
    Visit = V6 (Follow-up)
    Notes
    [7] - 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: The analysis that have been performed are descriptive statistics.
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: Nb of patients with positive samples
        Yes
    4
    4
    7
    1
        No
    0
    2
    4
    0
    No statistical analyses for this end point

    Primary: Injection site reaction - pain

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    End point title
    		 Injection site reaction - pain [8]
    End point description
    End point type
    Primary
    End point timeframe
    Visit = V6 (follow-up)
    Notes
    [8] - 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: The analysis that have been performed are descriptive statistics.
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: Number of patients
        none
    3
    6
    8
    1
        mild
    1
    0
    0
    0
        moderate
    0
    0
    0
    0
        severe
    0
    0
    1
    0
        missing
    0
    0
    2
    0
    No statistical analyses for this end point

    Primary: 12-lead ECG : Performance of ECG

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    End point title
    		 12-lead ECG : Performance of ECG [9]
    End point description
    End point type
    Primary
    End point timeframe
    Visit = V5 (12 weeks)
    Notes
    [9] - 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: The analysis that have been performed are descriptive statistics.
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: number of patients
        normal
    2
    5
    8
    1
        abnormal, not clinically significant
    1
    1
    1
    0
        abnormal, clinically significant
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Skin rash - Change compared to Baseline

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    End point title
    		 Skin rash - Change compared to Baseline
    End point description
    All subjects were analyzed but not all subjects had skin rash at baseline, 7/10 in Cohort 1 and 6/13 in Cohort 2.
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: Number of patients
        unchanged
    1
    1
    6
    1
        slightly decreased
    0
    0
    0
    0
        markedly decreased
    0
    0
    1
    0
        slightly increased
    0
    0
    0
    0
        markedly increased
    0
    1
    1
    0
        resolved
    2
    4
    1
    0
    No statistical analyses for this end point

    Secondary: 44 joint count assessment and possible findings - swelling, tenderness

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    End point title
    		 44 joint count assessment and possible findings - swelling, tenderness
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: Number of patients
        no
    3
    0
    1
    1
        yes
    0
    6
    8
    0
    No statistical analyses for this end point

    Secondary: Serum CRP - absolute change from baseline

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    End point title
    		 Serum CRP - absolute change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    At week 12
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: percent
        arithmetic mean (full range (min-max))
    0.8 (-48 to 43)
    3.2 (-121 to 137)
    -25.4 (-72 to 2)
    -21.7 (-21.7 to -21.7)
    No statistical analyses for this end point

    Secondary: Serum amyloid - SAA assessment

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    End point title
    		 Serum amyloid - SAA assessment
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: ng/ml
        arithmetic mean (full range (min-max))
    539689.63 (5488.8 to 1570747.1)
    440916.82 (10437.8 to 866008.4)
    114679.1 (2668.1 to 692619.6)
    15112.5 (15112.5 to 15112.5)
    No statistical analyses for this end point

    Secondary: Ferritin - absolute change from baseline

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    End point title
    		 Ferritin - absolute change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: percent
        arithmetic mean (full range (min-max))
    -230 (-487 to 22)
    393.1 (-1000 to 3721)
    -143 (-408 to -19)
    -32.3 (-32.3 to -32.3)
    No statistical analyses for this end point

    Secondary: SDAI - absolute change from baseline

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    End point title
    		 SDAI - absolute change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: percent
        arithmetic mean (full range (min-max))
    -8.1 (-22 to 0)
    -7.2 (-37 to 20)
    -13.2 (-24 to 10)
    -12.7 (-12.7 to -12.7)
    No statistical analyses for this end point

    Secondary: SAA assessment: S100A8/A9

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    End point title
    		 SAA assessment: S100A8/A9
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    5
    8
    1
    Units: ng/ml
        arithmetic mean (full range (min-max))
    3466.33 (1663 to 6113)
    10544.4 (996 to 28381)
    3905.75 (1385 to 6298)
    2666 (2666 to 2666)
    No statistical analyses for this end point

    Secondary: SAA assessment: S100A12

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    End point title
    		 SAA assessment: S100A12
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    5
    8
    1
    Units: ng/ml
        arithmetic mean (full range (min-max))
    42.5 (26.3 to 68.2)
    204.5 (15.4 to 482.5)
    70.98 (22.3 to 155.3)
    29.3 (29.3 to 29.3)
    No statistical analyses for this end point

    Secondary: Leucocytes

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    End point title
    		 Leucocytes
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    6
    8
    1
    Units: /nl
        arithmetic mean (full range (min-max))
    7.63 (5 to 9.8)
    10.07 (7 to 13)
    9.29 (6.7 to 12.2)
    9.3 (9.3 to 9.3)
    No statistical analyses for this end point

    Secondary: Interleukin 18

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    End point title
    		 Interleukin 18
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    5
    8
    1
    Units: pg/ml
        arithmetic mean (full range (min-max))
    450.33 (255 to 695)
    4274.2 (481 to 15290)
    957 (366 to 2358)
    1992 (1992 to 1992)
    No statistical analyses for this end point

    Secondary: Interleukin 18 binding protein

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    End point title
    		 Interleukin 18 binding protein
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    5
    8
    1
    Units: pg/ml
        arithmetic mean (full range (min-max))
    1281114.67 (1071971 to 1457679)
    1178679.8 (126244 to 2760364)
    2070073.63 (838155 to 4083179)
    9371548 (9371548 to 9371548)
    No statistical analyses for this end point

    Secondary: Interleukin 18 free

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    End point title
    		 Interleukin 18 free [10]
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No results are available for the other arm(s).
    End point values
    		 Cohort 1 / 80-160 mg
    Number of subjects analysed
    1
    Units: pg/ml
        arithmetic mean (full range (min-max))
    35.7 (35.7 to 35.7)
    No statistical analyses for this end point

    Secondary: Interleukin 1ra

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    End point title
    		 Interleukin 1ra
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    5
    8
    1
    Units: ng/l
        arithmetic mean (full range (min-max))
    31.3 (20.1 to 41.9)
    54.48 (49.5 to 66.2)
    31.18 (17.6 to 43)
    48 (48 to 48)
    No statistical analyses for this end point

    Secondary: Interleukin 6

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    End point title
    		 Interleukin 6
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    5
    7
    1
    Units: pg/ml
        arithmetic mean (full range (min-max))
    2.87 (1 to 4.5)
    7.18 (1.3 to 21.4)
    2.09 (0.4 to 6.1)
    1.1 (1.1 to 1.1)
    No statistical analyses for this end point

    Secondary: TNF-alpha

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    End point title
    		 TNF-alpha
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    5
    8
    1
    Units: pg/ml
        arithmetic mean (full range (min-max))
    3.08 (2.87 to 3.38)
    5.25 (1.9 to 14.93)
    2.3 (1.16 to 3.67)
    2.21 (2.21 to 2.21)
    No statistical analyses for this end point

    Secondary: Triglycerides

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    End point title
    		 Triglycerides
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    3
    6
    8
    1
    Units: mmol/l
        arithmetic mean (full range (min-max))
    1.9 (1.22 to 3.19)
    1.41 (0.64 to 2.83)
    1.06 (0.54 to 1.89)
    0.95 (0.95 to 0.95)
    No statistical analyses for this end point

    Secondary: Therapeutic response at V5 (week 12)

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    End point title
    		 Therapeutic response at V5 (week 12)
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg Cohort 2 / 160-320 mg
    Number of subjects analysed
    4
    6
    12
    1
    Units: number of patients
        No
    2
    5
    7
    0
        Yes
    2
    1
    2
    1
        Unknown
    0
    0
    3
    0
    No statistical analyses for this end point

    Secondary: Prednisone : Maximum dose during treatment

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    End point title
    		 Prednisone : Maximum dose during treatment [11]
    End point description
    End point type
    Secondary
    End point timeframe
    During treatment
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No results are available for the other arm(s).
    End point values
    		 Cohort 1 / 80 mg Cohort 1 / 80-160 mg Cohort 2 / 160 mg
    Number of subjects analysed
    3
    5
    10
    Units: mg/day
        arithmetic mean (full range (min-max))
    17.5 (15 to 22.5)
    29.5 (7.5 to 80)
    22 (5 to 60)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Tadekinig alfa 80 mg
    Reporting group description
    		 -

    Reporting group title
    Tadekinig alfa 160 mg
    Reporting group description
    		 -

    Reporting group title
    Tadekinig alfa 320 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Tadekinig alfa 80 mg Tadekinig alfa 160 mg Tadekinig alfa 320 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 19 (5.26%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    Eye disorders
    Toxic optic neuropathy
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spondylolisthesis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tadekinig alfa 80 mg Tadekinig alfa 160 mg Tadekinig alfa 320 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 10 (80.00%)
    18 / 19 (94.74%)
    1 / 1 (100.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 19 (10.53%)
    1 / 1 (100.00%)
         occurrences all number
    155
    155
    155
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 19 (15.79%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155
    Condition aggravated
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 19 (15.79%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155
    Injection site erythema
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 19 (10.53%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155
    Injection site reaction
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 19 (10.53%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155
    Fatigue
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 19 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155
    Pain
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 19 (10.53%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 19 (10.53%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 19 (10.53%)
    1 / 1 (100.00%)
         occurrences all number
    155
    155
    155
    Vomiting
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 19 (10.53%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    1 / 1 (100.00%)
         occurrences all number
    155
    155
    155
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 10 (10.00%)
    4 / 19 (21.05%)
    1 / 1 (100.00%)
         occurrences all number
    155
    155
    155
    Juvenile idiopathic arthritis
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 19 (10.53%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155
    Pain in extremity
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    1 / 1 (100.00%)
         occurrences all number
    155
    155
    155
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 19 (5.26%)
    1 / 1 (100.00%)
         occurrences all number
    155
    155
    155
    Bronchitis
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 19 (5.26%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155
    Gastroenteritis
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 19 (5.26%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155
    Oral herpes
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 19 (5.26%)
    0 / 1 (0.00%)
         occurrences all number
    155
    155
    155

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Feb 2015
    Protocol version 2.0 dated 25 February 2015
    28 Aug 2015
    Protocol version 3.0 dated 28 August 2015
    27 Jan 2016
    Protocol version 4.0 dated 27 January 2016 - As of January 2016, the dose 320mg is stopped. Before this protocol amendment, one patient was escalated from 160mg to 320mg. This patient will continue the study under this dose

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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