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    Clinical Trial Results:
    Prospective open-label single-arm study of the pharmacokinetics (PK) and safety of intravenous IgPro10 in Japanese subjects with primary immunodeficiency

    Summary
    EudraCT number
    		 2016-001631-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Dec 2018
    First version publication date
    30 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IgPro10_3004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CSL Behring KK
    Sponsor organisation address
    1-7-12 Shinonome Koto-ku, Tokyo, Japan,
    Public contact
    Trial Registration Coordinator, CSL Behring, clinicaltrials@cslbehring.com
    Scientific contact
    Trial Registration Coordinator, CSL Behring, clinicaltrials@cslbehring.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
    24 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the pharmacokinetics of immunoglobulin G (IgG) following intravenous IgPro10 dosing in Japanese primary immune deficiency (PID) subjects after a standard wash-in/wash-out period of 12 weeks.
    Protection of trial subjects
    This study was carried out in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines and standard operating procedures for clinical research and development at CSL Behring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Apr 2017
    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: 11
    Worldwide total number of subjects
    11
    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)
    0
    Children (2-11 years)
    1
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    8
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a prospective phase 3, open-label, single-arm study designed to assess the PK and safety of IgPro10 in Japanese subjects with PID. Male or female subjects with a diagnosis of PID and aged ≥ 6 years were enrolled into the study.

    Pre-assignment
    Screening details
    		 Enrolled subjects received 3- or 4 weekly infusions of IgPro10 based on their pre-study treatment schedule as prescribed by the treating physician.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IgPro10 (3-weekly)
    Arm description
    		 Ready to use 10% liquid formulation of polyvalent human IgG via intravenous infusion. Dosing expected to be between 200 to 600 mg/kg body weight per dosing cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IgPro10
    Investigational medicinal product code
    Other name
    Privigen
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    As with the subject’s previous regular intravenous immunoglobulin (IVIG) doses; expected to be between 200 to 600 mg/kg body weight per dosing cycle of 3-weekly intravenous (IV) infusions of IgPro10.

    Arm title
    		 IgPro10 (4-weekly)
    Arm description
    		 Ready to use 10% liquid formulation of polyvalent human IgG via intravenous infusion. Dosing expected to be between 200 to 600 mg/kg body weight per dosing cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IgPro10
    Investigational medicinal product code
    Other name
    Privigen
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    As with the subject’s previous regular IVIG doses; expected to be between 200 to 600 mg/kg body weight per dosing cycle of 4-weekly IV infusions of IgPro10.

    Number of subjects in period 1
    		IgPro10 (3-weekly) IgPro10 (4-weekly)
    Started
    2
    9
    Completed
    2
    8
    Not completed
    0
    1
         To avoid the use of prohibited conmed
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 11 11
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 1 1
        Adolescents (12-17 years)
    		 1 1
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 29.5 ( 16.95 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    IgPro10 (3-weekly)
    Reporting group description
    		 Ready to use 10% liquid formulation of polyvalent human IgG via intravenous infusion. Dosing expected to be between 200 to 600 mg/kg body weight per dosing cycle.

    Reporting group title
    IgPro10 (4-weekly)
    Reporting group description
    		 Ready to use 10% liquid formulation of polyvalent human IgG via intravenous infusion. Dosing expected to be between 200 to 600 mg/kg body weight per dosing cycle.

    Subject analysis set title
    Pharmacokinetic Analysis Set (PKAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects of the SAF without any major deviations related to IgPro10 administration and for whom at least 1 measureable IgG concentration was available following IgPro10 infusion.

    Subject analysis set title
    Safety Analysis Set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the full analysis set who received at least one dose or a partial dose of IgPro10.

    Primary: Minimum concentration (Cmin) of IgG following intravenous IgPro10 dosing (PKAS)

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    End point title
    		 Minimum concentration (Cmin) of IgG following intravenous IgPro10 dosing (PKAS) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Before infusion on Day 85 and up to approximately 21 days (for 3 week cycle) and up to approximately 28 days (for 4 week cycle) after infusion
    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: Descriptive statistics were used for the primary endpoint.
    End point values
    		 IgPro10 (3-weekly) IgPro10 (4-weekly)
    Number of subjects analysed
    2
    8
    Units: g/L
        arithmetic mean (standard deviation)
    10.570 ( 3.2244 )
    8.529 ( 3.8866 )
    No statistical analyses for this end point

    Primary: Maximum concentration (Cmax) of IgG following intravenous IgPro10 dosing (PKAS)

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    End point title
    		 Maximum concentration (Cmax) of IgG following intravenous IgPro10 dosing (PKAS) [2]
    End point description
    End point type
    Primary
    End point timeframe
    Before infusion on Day 85 and up to approximately 21 days (for 3 week cycle) and up to approximately 28 days (for 4 week cycle) after infusion
    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: Descriptive statistics were used for the primary endpoint.
    End point values
    		 IgPro10 (3-weekly) IgPro10 (4-weekly)
    Number of subjects analysed
    2
    8
    Units: g/L
        arithmetic mean (standard deviation)
    16.610 ( 3.6911 )
    14.198 ( 5.5348 )
    No statistical analyses for this end point

    Primary: Time to reach maximum concentration (Tmax) of IgG following intravenous IgPro10 dosing (PKAS)

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    End point title
    		 Time to reach maximum concentration (Tmax) of IgG following intravenous IgPro10 dosing (PKAS) [3]
    End point description
    End point type
    Primary
    End point timeframe
    Before infusion on Day 85 and up to approximately 21 days (for 3 week cycle) and up to approximately 28 days (for 4 week cycle) after infusion
    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: Descriptive statistics were used for the primary endpoint.
    End point values
    		 IgPro10 (3-weekly) IgPro10 (4-weekly)
    Number of subjects analysed
    2
    8
    Units: Hours
        median (full range (min-max))
    1.192 (0.92 to 1.47)
    1.142 (0.62 to 23.37)
    No statistical analyses for this end point

    Primary: Area under the concentration-time curve from time zero to the last sample (AUC0-last) following intravenous IgPro10 dosing (PKAS)

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    End point title
    		 Area under the concentration-time curve from time zero to the last sample (AUC0-last) following intravenous IgPro10 dosing (PKAS) [4]
    End point description
    End point type
    Primary
    End point timeframe
    Before infusion on Day 85 and up to approximately 21 days (for 3 week cycle) and up to approximately 28 days (for 4 week cycle) after infusion
    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: Descriptive statistics were used for the primary endpoint.
    End point values
    		 IgPro10 (3-weekly) IgPro10 (4-weekly)
    Number of subjects analysed
    2
    8
    Units: g*h/L
        arithmetic mean (standard deviation)
    5971.0220 ( 1378.2901 )
    6590.9626 ( 2633.1854 )
    No statistical analyses for this end point

    Primary: Total body clearance (CL) of IgG following intravenous IgPro10 dosing (PKAS)

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    End point title
    		 Total body clearance (CL) of IgG following intravenous IgPro10 dosing (PKAS) [5]
    End point description
    End point type
    Primary
    End point timeframe
    Before infusion on Day 85 and up to approximately 21 days (for 3 week cycle) and up to approximately 28 days (for 4 week cycle) after infusion
    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: Descriptive statistics were used for the primary endpoint.
    End point values
    		 IgPro10 (3-weekly) IgPro10 (4-weekly)
    Number of subjects analysed
    2
    8
    Units: mL/h
        arithmetic mean (standard deviation)
    2.5278 ( 0.6455 )
    2.5315 ( 0.9954 )
    No statistical analyses for this end point

    Secondary: Percentage of subjects with treatment emergent adverse events (AEs)

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    End point title
    		 Percentage of subjects with treatment emergent adverse events (AEs)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 4 months after first infusion of IgPro10
    End point values
    		 Safety Analysis Set (SAF)
    Number of subjects analysed
    11
    Units: Percent
    number (not applicable)
        any AEs
    72.7
        mild AEs
    45.5
        moderate AEs
    27.3
        severe AEs
    0
        serious AEs
    0
        causally-related AEs
    9.1
        not causally-related AEs
    72.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Safety Analysis Set
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Analysis Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Analysis Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 11 (72.73%)
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Skin abrasion
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    General disorders and administration site conditions
    Infusion site discomfort
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Gastrointestinal disorders
    Retained deciduous tooth
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Aug 2016
    -Removal of one PK sampling period
    03 Jul 2017
    -Modifications of the virology assessment to change the tests for HIV and HCV

    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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