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    Clinical Trial Results:
    A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc)

    Summary
    EudraCT number
    2018-003149-41
    Trial protocol
    DE   FR   GB   IT  
    Global end of trial date
    17 May 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Jun 2023
    First version publication date
    23 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IgPro20_2001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04137224
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    CSL Behring
    Sponsor organisation address
    Emil-von-Behring-Strasse 76, Marburg, Germany, 35041
    Public contact
    Trial Registration Coordinator, CSL Behring LLC, +1 610-878-4000, clinicaltrials@cslbehring.com
    Scientific contact
    Trial Registration Coordinator, CSL Behring LLC, +1 610-878-4000, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 May 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in subjects with diffuse cutaneous systemic sclerosis (dcSSc). The pharmacokinetic study aim was to evaluate the relative bioavailability of IgPro20, and characterize pharmacokinetics of IgPro20 and IgPro10, respectively, in subjects with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10 was also evaluated.
    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
    21 Sep 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Australia: 2
    Worldwide total number of subjects
    27
    EEA total number of subjects
    19
    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)
    25
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were enrolled at study centers in Australia, Germany, Italy, Poland, and the United Kingdom from 19 September 2019 to 17 May 2022.

    Pre-assignment
    Screening details
    A total of 30 subjects were screened, of which 27 subjects were enrolled and randomised to Sequence A or Sequence B in this study.

    Period 1
    Period 1 title
    Treatment Period 1 (Week 1 to Week 16)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Sequence A (IgPro20/IgPro10)
    Arm description
    Subjects received IgPro20 of a total dose of 0.5 grams per kilogram (g/kg) over 2 sessions per week as a subcutaneous (SC) injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an intravenous (IV) infusion for up to 16 weeks in Treatment Period 2.
    Arm type
    Experimental

    Investigational medicinal product name
    IgPro20
    Investigational medicinal product code
    Other name
    Hizentra
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A total dose of 0.5 g/kg was administered over 2 sessions per week for up to 16 weeks.

    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
    A total dose of 2 g/kg was administered over 2-5 sessions on consecutive days every 4 weeks for up to 16 weeks.

    Arm title
    Sequence B (IgPro10/IgPro20)
    Arm description
    Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
    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
    A total dose of 2 g/kg was administered over 2-5 sessions on consecutive days every 4 weeks for up to 16 weeks.

    Investigational medicinal product name
    IgPro20
    Investigational medicinal product code
    Other name
    Hizentra
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A total dose of 0.5 g/kg was administered over 2 sessions per week for up to 16 weeks.

    Number of subjects in period 1
    Sequence A (IgPro20/IgPro10) Sequence B (IgPro10/IgPro20)
    Started
    13
    14
    Completed
    12
    13
    Not completed
    1
    1
         Adverse event
    1
    -
         Withdrawal by subject
    -
    1
    Period 2
    Period 2 title
    Treatment Period 2 (Week 17 to Week 32)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Sequence A (IgPro20/IgPro10)
    Arm description
    Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2.
    Arm type
    Experimental

    Investigational medicinal product name
    IgPro20
    Investigational medicinal product code
    Other name
    Hizentra
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A total dose of 0.5 g/kg was administered over 2 sessions per week for up to 16 weeks.

    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
    A total dose of 2 g/kg was administered over 2-5 sessions on consecutive days every 4 weeks for up to 16 weeks.

    Arm title
    Sequence B (IgPro10/IgPro20)
    Arm description
    Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
    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
    A total dose of 2 g/kg was administered over 2-5 sessions on consecutive days every 4 weeks for up to 16 weeks.

    Investigational medicinal product name
    IgPro20
    Investigational medicinal product code
    Other name
    Hizentra
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A total dose of 0.5 g/kg was administered over 2 sessions per week for up to 16 weeks.

    Number of subjects in period 2 [1]
    Sequence A (IgPro20/IgPro10) Sequence B (IgPro10/IgPro20)
    Started
    12
    13
    Completed
    13
    12
    Not completed
    0
    1
         Adverse event
    -
    1
    Joined
    1
    0
         Transferred in from other group/arm
    1
    -
    Notes
    [1] - The number of subjects transferring in and out of the arms in the period are not the same. It is expected the net number of transfers in and out of the arms in a period, will be zero.
    Justification: 13 subjects have started and completed the sequence A in treatment period 2.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sequence A (IgPro20/IgPro10)
    Reporting group description
    Subjects received IgPro20 of a total dose of 0.5 grams per kilogram (g/kg) over 2 sessions per week as a subcutaneous (SC) injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an intravenous (IV) infusion for up to 16 weeks in Treatment Period 2.

    Reporting group title
    Sequence B (IgPro10/IgPro20)
    Reporting group description
    Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.

    Reporting group values
    Sequence A (IgPro20/IgPro10) Sequence B (IgPro10/IgPro20) Total
    Number of subjects
    13 14 27
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.4 ± 12.22 47.4 ± 12.91 -
    Gender categorical
    Units: Subjects
        Female
    10 8 18
        Male
    3 6 9
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0 0 0
        Not Hispanic or Latino
    12 14 26
        Unknown or Not Reported
    1 0 1
    Race
    Units: Subjects
        White
    13 13 26
        Other
    0 1 1
    Subject analysis sets

    Subject analysis set title
    Sequence A: IgPro10
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2.

    Subject analysis set title
    Sequence A: IgPro20
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1.

    Subject analysis set title
    Sequence B: IgPro10
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1.

    Subject analysis set title
    Sequence B: IgPro20
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.

    Subject analysis sets values
    Sequence A: IgPro10 Sequence A: IgPro20 Sequence B: IgPro10 Sequence B: IgPro20
    Number of subjects
    13
    13
    14
    13
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    0 ± 0
    0 ± 0
    0 ± 0
    0 ± 0
    Gender categorical
    Units: Subjects
        Female
    0
    0
    0
    0
        Male
    0
    0
    0
    0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0
    0
    0
    0
        Not Hispanic or Latino
    0
    0
    0
    0
        Unknown or Not Reported
    0
    0
    0
    0
    Race
    Units: Subjects
        White
    0
    0
    0
    0
        Other
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Sequence A (IgPro20/IgPro10)
    Reporting group description
    Subjects received IgPro20 of a total dose of 0.5 grams per kilogram (g/kg) over 2 sessions per week as a subcutaneous (SC) injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an intravenous (IV) infusion for up to 16 weeks in Treatment Period 2.

    Reporting group title
    Sequence B (IgPro10/IgPro20)
    Reporting group description
    Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
    Reporting group title
    Sequence A (IgPro20/IgPro10)
    Reporting group description
    Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2.

    Reporting group title
    Sequence B (IgPro10/IgPro20)
    Reporting group description
    Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.

    Subject analysis set title
    Sequence A: IgPro10
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2.

    Subject analysis set title
    Sequence A: IgPro20
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1.

    Subject analysis set title
    Sequence B: IgPro10
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1.

    Subject analysis set title
    Sequence B: IgPro20
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.

    Primary: Number of Subjects With at Least one Adverse Event (AE) for IgPro20

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    End point title
    Number of Subjects With at Least one Adverse Event (AE) for IgPro20 [1]
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: subjects
    9
    9
    No statistical analyses for this end point

    Primary: Percentage of Subjects With at Least one AE for IgPro20

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    End point title
    Percentage of Subjects With at Least one AE for IgPro20 [2]
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: percentage of subjects
        number (not applicable)
    69.2
    69.2
    No statistical analyses for this end point

    Primary: Number of Subjects With at Least one Treatment-Emergent Adverse Event (TEAE) for IgPro20

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    End point title
    Number of Subjects With at Least one Treatment-Emergent Adverse Event (TEAE) for IgPro20 [3]
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product that does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: subjects
    9
    9
    No statistical analyses for this end point

    Primary: Percentage of Subjects With at Least one TEAE for IgPro20

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    End point title
    Percentage of Subjects With at Least one TEAE for IgPro20 [4]
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: percentage of subjects
        number (not applicable)
    69.2
    69.2
    No statistical analyses for this end point

    Primary: Number of Subjects With at Least one Serious Adverse Event (SAE) for IgPro20

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    End point title
    Number of Subjects With at Least one Serious Adverse Event (SAE) for IgPro20 [5]
    End point description
    An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: subjects
    2
    3
    No statistical analyses for this end point

    Primary: Percentage of Subjects With at Least one SAE for IgPro20

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    End point title
    Percentage of Subjects With at Least one SAE for IgPro20 [6]
    End point description
    An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: percentage of subjects
        number (not applicable)
    15.4
    23.1
    No statistical analyses for this end point

    Primary: Number of Subjects With at Least one Adverse Events of Special Interest (AESI) for IgPro20

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    End point title
    Number of Subjects With at Least one Adverse Events of Special Interest (AESI) for IgPro20 [7]
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: subjects
    0
    1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With at Least one AESI for IgPro20

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    End point title
    Percentage of Subjects With at Least one AESI for IgPro20 [8]
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: percentage of subjects
        number (not applicable)
    0
    7.7
    No statistical analyses for this end point

    Primary: Number of Subjects With AEs Categorized as Infusion Site Reactions (ISRs) for IgPro20

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    End point title
    Number of Subjects With AEs Categorized as Infusion Site Reactions (ISRs) for IgPro20 [9]
    End point description
    ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: subjects
    2
    3
    No statistical analyses for this end point

    Primary: Percentage of Subjects With AEs Categorized as ISRs for IgPro20

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    End point title
    Percentage of Subjects With AEs Categorized as ISRs for IgPro20 [10]
    End point description
    ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    Notes
    [10] - 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: percentage of subjects
        number (not applicable)
    15.4
    23.1
    No statistical analyses for this end point

    Primary: Rate of ISRs per Infusion for IgPro20

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    End point title
    Rate of ISRs per Infusion for IgPro20 [11]
    End point description
    ISR rate per infusion = total number of ISRs across all subjects while on IgPro20 / total number of IgPro20 Infusions across all subjects. ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 and with ISRs were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    Notes
    [11] - 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13 [12]
    13 [13]
    Units: ISRs per infusion
        number (not applicable)
    0.0057
    0.0360
    Notes
    [12] - Overall Number of Units Analysed: 353 Infusions
    [13] - Overall Number of Units Analysed: 333 Infusions
    No statistical analyses for this end point

    Primary: Time to Onset of ISRs for IgPro20

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    End point title
    Time to Onset of ISRs for IgPro20 [14]
    End point description
    ISRs included all events reported within the MedDRA High-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Time to onset of ISR since the start of the treatment period was reported. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    Notes
    [14] - 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    2 [15]
    3 [16]
    Units: days
        median (full range (min-max))
    2 (1 to 3)
    15 (1 to 64)
    Notes
    [15] - Overall Number of Units Analysed: 2 ISRs
    [16] - Overall Number of Units Analysed: 12 ISRs
    No statistical analyses for this end point

    Primary: Duration of ISRs for IgPro20

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    End point title
    Duration of ISRs for IgPro20 [17]
    End point description
    ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 and with ISRs were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    Notes
    [17] - 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    2 [18]
    3 [19]
    Units: minutes
        median (full range (min-max))
    162.0 (162 to 162)
    220.0 (180 to 1170)
    Notes
    [18] - Overall Number of Units Analysed: 2 ISRs
    [19] - Overall Number of Units Analysed: 12 ISRs
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Abnormalities in Laboratory Tests for IgPro20

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    End point title
    Number of Subjects With Clinically Significant Abnormalities in Laboratory Tests for IgPro20 [20]
    End point description
    Abnormality criteria:Hematology-Hemoglobin:<10 g/dL;Platelet count:<75x10^9/L or >500x10^9/L;White Blood Cell Count:<3/>16x10^9/L;Neutrophils:absolute <1.5x10^9/L,differential<40%;Lymphocytes:absolute <0.8x10^9/L,differential <10 or >50%;Biochemistry-Bilirubin:>1.5xupper limit of normal (ULN);Alkaline phosphatase:>2.5xULN;Serum Glutamic-oxalacetic transaminase(SGOT), Aspartate transaminase(AST):>3xULN;Serum glutamic-pyruvic transaminase(SGPT), Alanine transaminase(ALT):>3xULN;Screening:AST/ALT >3xULN and TotalBilirubin >2xULN;Urea nitrogen:>2.5xULN; Creatinine,serum>1.5xbaseline assessment/change >0.3mg/dL;Glucose,blood:<55/>160mg/dL;Calcium:<7/>11.5mg/dL;Total protein: <5/>9g/dL; Albumin:<3g/dL;Sodium:<130/>150mmol/L;Potassium:<3/>5.5mmol/L; Uric acid,serum:>10mg/dL Males,>8mg/dL Females;Gamma Glutamyl Transpeptidase:>2.5xULN;Phosphorus,inorganic:<2.5/>5mg/dL;Lactate dehydrogenase:>3xULN;Urinalysis-Protein:>20mg/dL.Safety set.Subjects who received IgPro20 were analysed.
    End point type
    Primary
    End point timeframe
    Up to last follow up visit (approximately 36 weeks)
    Notes
    [20] - 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Changes in Vital Signs for IgPro20

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    End point title
    Number of Subjects With Clinically Significant Changes in Vital Signs for IgPro20 [21]
    End point description
    Clinically significant abnormality criteria for vital signs included Systolic blood pressure (BP): <100 millimeters of mercury (mmHg) or ≥140 mmHg or ≥140 mmHg and increase >10 from reference visit; Diastolic BP: <50 mmHg or ≥90 mmHg or ≥90 mmHg and increase >10 from reference visit; Pulse rate: <50 beats/minute or ≥120 beats/minute or ≥120 beats/minute and increase >15 from reference visit; Weight (kilograms) ≥10% change (increase and decrease) from baseline assessment; Body temperature: > 39-degree Celsius (°C ) or <35°C (oral, tympanic, axilla or forehead). Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    Notes
    [21] - 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters for IgPro20

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    End point title
    Number of Subjects With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters for IgPro20 [22]
    End point description
    Clinically significant abnormality criteria for ECG parameters included Heart rate: ≤50 or ≥100 beats/minute; PR Interval: ≥200 millisecond (msec); QRS Interval: ≥120 msec; QT: ≥480 msec; QT interval corrected using Bazett' s formula (QTcB): ≤ 500 msec; QT interval corrected using Fridericia's formula (QTcF): >500 msec; QT: increase from baseline ≥ 30; QTcB: increase from baseline < 60 msec; QTcF: increase from baseline ≥ 60. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    Notes
    [22] - 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: subjects
    0
    1
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Abnormalities in Pulmonary Function Tests (PFTs) for IgPro20

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    End point title
    Number of Subjects With Clinically Significant Abnormalities in Pulmonary Function Tests (PFTs) for IgPro20 [23]
    End point description
    PFTs include Spirometry which included forced vital capacity (FVC) % Predicted, considered as clinically significant abnormality when decrease is greater than 10 percentage points from the reference visit. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro20 were analysed.
    End point type
    Primary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    Notes
    [23] - 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: Only the descriptive analysis was planned to be reported for this endpoint.
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Relative Bioavailability (%F) of IgPro20

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    End point title
    Relative Bioavailability (%F) of IgPro20
    End point description
    Relative bioavailability was calculated using Mixed Model Repeated Measures on Log-transformed Dose-normalized area under the curve to the end of the dosing period [AUC0-tau] following administration of the first dose of IgPro20 in the last week of dosing for Sequence A and / or Sequence B. Relative Bioavailability= (AUCtau IgPro20 (SC)/dose of IgPro20 (SC) / (AUCtau of IgPro10 (IV)/dose of IgPro10 (IV)). Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
    End point type
    Secondary
    End point timeframe
    Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    12
    12
    Units: percentage bioavailability
        geometric mean (confidence interval 95%)
    0.831 (0.7343 to 0.9396)
    0.698 (0.6235 to 0.7804)
    No statistical analyses for this end point

    Secondary: Area Under the Concentration Curve to the end of the Dosing Period (AUC0-tau) for IgPro20

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    End point title
    Area Under the Concentration Curve to the end of the Dosing Period (AUC0-tau) for IgPro20
    End point description
    Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
    End point type
    Secondary
    End point timeframe
    Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    12
    11
    Units: hours*grams per litre (h*g/L)
        geometric mean (confidence interval 95%)
    3835.68 (3394.749 to 4333.883)
    3581.08 (3326.635 to 3854.997)
    No statistical analyses for this end point

    Secondary: Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro20

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    End point title
    Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro20
    End point description
    Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
    End point type
    Secondary
    End point timeframe
    Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    12
    12
    Units: h*g/L
        geometric mean (confidence interval 95%)
    5361.61 (4729.962 to 6077.619)
    4898.02 (4437.732 to 5406.046)
    No statistical analyses for this end point

    Secondary: Maximum Plasma Drug Concentration (Cmax) for IgPro20

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    End point title
    Maximum Plasma Drug Concentration (Cmax) for IgPro20
    End point description
    Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
    End point type
    Secondary
    End point timeframe
    Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    12
    12
    Units: g/L
        geometric mean (confidence interval 95%)
    24.237 (21.6041 to 27.1898)
    23.203 (21.7278 to 24.7782)
    No statistical analyses for this end point

    Secondary: Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro10

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    End point title
    Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro10
    End point description
    Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro10 and with data available for endpoint analysis.
    End point type
    Secondary
    End point timeframe
    Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    12
    12
    Units: h*g/L
        geometric mean (confidence interval 95%)
    16942.6 (15097.493 to 19013.345)
    17672.03 (16402.479 to 19039.837)
    No statistical analyses for this end point

    Secondary: Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro10

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    End point title
    Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro10
    End point description
    Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro10 and with data available for endpoint analysis.
    End point type
    Secondary
    End point timeframe
    Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    12
    Units: h*g/L
        geometric mean (confidence interval 95%)
    16520.48 (14742.232 to 18513.218)
    17349.72 (15917.101 to 18911.275)
    No statistical analyses for this end point

    Secondary: Maximum Plasma Drug concentration (Cmax) for IgPro10

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    End point title
    Maximum Plasma Drug concentration (Cmax) for IgPro10
    End point description
    Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
    End point type
    Secondary
    End point timeframe
    Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    12
    Units: g/L
        geometric mean (confidence interval 95%)
    47.142 (41.2538 to 53.8713)
    44.996 (39.2110 to 51.6340)
    No statistical analyses for this end point

    Secondary: Number of Subjects With at Least one AE for IgPro10

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    End point title
    Number of Subjects With at Least one AE for IgPro10
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: subjects
    5
    8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least one AE for IgPro10

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    End point title
    Percentage of Subjects With at Least one AE for IgPro10
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: percentage of subjects
        number (not applicable)
    38.5
    57.1
    No statistical analyses for this end point

    Secondary: Number of Subjects With at Least one TEAE for IgPro10

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    End point title
    Number of Subjects With at Least one TEAE for IgPro10
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: subjects
    5
    8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least one TEAE for IgPro10

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    End point title
    Percentage of Subjects With at Least one TEAE for IgPro10
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: percentage of subjects
        number (not applicable)
    38.5
    57.1
    No statistical analyses for this end point

    Secondary: Number of Subjects With at Least one SAE for IgPro10

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    End point title
    Number of Subjects With at Least one SAE for IgPro10
    End point description
    An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: subjects
    1
    1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least one SAE for IgPro10

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    End point title
    Percentage of Subjects With at Least one SAE for IgPro10
    End point description
    An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: percentage of subjects
        number (not applicable)
    7.7
    7.1
    No statistical analyses for this end point

    Secondary: Number of Subjects With at Least one AESI for IgPro10

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    End point title
    Number of Subjects With at Least one AESI for IgPro10
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least one AESIs for IgPro10

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    End point title
    Percentage of Subjects With at Least one AESIs for IgPro10
    End point description
    AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With AEs Categorized as ISRs for IgPro10

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    End point title
    Number of Subjects With AEs Categorized as ISRs for IgPro10
    End point description
    ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With AEs Categorized as ISRs for IgPro10

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    End point title
    Percentage of Subjects With AEs Categorized as ISRs for IgPro10
    End point description
    ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in Laboratory Tests for IgPro10

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    End point title
    Number of Subjects With Clinically Significant Abnormalities in Laboratory Tests for IgPro10
    End point description
    Abnormality criteria:Hematology-Hemoglobin:<10 g/dL;Platelet count:<75x10^9/L or >500x10^9/L;White Blood Cell Count:<3/>16x10^9/L;Neutrophils:absolute <1.5x10^9/L,differential<40%;Lymphocytes:absolute <0.8x10^9/L,differential <10 or >50%;Biochemistry-Bilirubin:>1.5xupper limit of normal (ULN);Alkaline phosphatase:>2.5xULN;Serum Glutamic-oxalacetic transaminase(SGOT), Aspartate transaminase(AST):>3xULN;Serum glutamic-pyruvic transaminase(SGPT), Alanine transaminase(ALT):>3xULN;Screening:AST/ALT >3xULN and TotalBilirubin >2xULN;Urea nitrogen:>2.5xULN; Creatinine,serum>1.5xbaseline assessment/change >0.3mg/dL;Glucose,blood:<55/>160mg/dL;Calcium:<7/>11.5mg/dL;Total protein: <5/>9g/dL; Albumin:<3g/dL;Sodium:<130/>150mmol/L;Potassium:<3/>5.5mmol/L; Uric acid,serum:>10mg/dL Males,>8mg/dL Females;Gamma Glutamyl Transpeptidase:>2.5xULN;Phosphorus,inorganic:<2.5/>5mg/dL;Lactate dehydrogenase:>3xULN;Urinalysis-Protein:>20mg/dL.Safety set.Subjects who received IgPro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Changes in Vital Signs for IgPro10

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    End point title
    Number of Subjects With Clinically Significant Changes in Vital Signs for IgPro10
    End point description
    Clinically significant abnormality criteria for vital signs included Systolic blood pressure (BP): <100 millimeters of mercury (mmHg) or ≥140 mmHg or ≥140 mmHg and increase >10 from reference visit; Diastolic BP: <50 mmHg or ≥90 mmHg or ≥90 mmHg and increase >10 from reference visit; Pulse rate: <50 beats/minute or ≥120 beats/minute or ≥120 beats/minute and increase >15 from reference visit; Weight (kilograms) ≥10% change (increase and decrease) from baseline assessment; Body temperature: > 39-degree Celsius (°C ) or <35°C (oral, tympanic, axilla or forehead). Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in ECG Parameters for IgPro10

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    End point title
    Number of Subjects With Clinically Significant Abnormalities in ECG Parameters for IgPro10
    End point description
    Clinically significant abnormality criteria for ECG parameters included Heart rate: ≤50 or ≥100 beats/minute; PR Interval: ≥200 millisecond (msec); QRS Interval: ≥120 msec; QT: ≥480 msec; QT interval corrected using Bazett' s formula (QTcB): ≤ 500 msec; QT interval corrected using Fridericia's formula (QTcF): >500 msec; QT: increase from baseline ≥ 30; QTcB: increase from baseline < 60 msec; QTcF: increase from baseline ≥ 60. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in PFTs for IgPro10

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    End point title
    Number of Subjects With Clinically Significant Abnormalities in PFTs for IgPro10
    End point description
    PFTs include Spirometry which included forced vital capacity (FVC) % Predicted, considered as clinically significant abnormality when decrease is greater than 10 percentage points from the reference visit. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro10 were analysed.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug through last follow-up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro10 Sequence B: IgPro10
    Number of subjects analysed
    13
    14
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A

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    End point title
    Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A
    End point description
    Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed. ‘Number analysed (n)’ indicates the number of subjects with data available for analysis at the specified time point.
    End point type
    Secondary
    End point timeframe
    Pre-injection in Weeks 5, 9, 13 and 14
    End point values
    Sequence A: IgPro20
    Number of subjects analysed
    13
    Units: g/L
    geometric mean (full range (min-max))
        Week 5 (n=12)
    22.046 (16.69 to 63.70)
        Week 9
    21.950 (14.71 to 30.51)
        Week 13 (n=12)
    22.354 (16.98 to 31.36)
        Week 14 (n=12)
    21.814 (14.49 to 27.93)
    No statistical analyses for this end point

    Secondary: Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B

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    End point title
    Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B
    End point description
    Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. ’Number of subjects analysed’ indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
    End point type
    Secondary
    End point timeframe
    Pre-injection at Week 21, 25, 29, and 30
    End point values
    Sequence B: IgPro20
    Number of subjects analysed
    12
    Units: g/L
    geometric mean (full range (min-max))
        Week 21
    20.427 (12.82 to 25.48)
        Week 25
    21.603 (16.92 to 30.49)
        Week 29
    21.903 (18.89 to 28.47)
        Week 30
    20.497 (18.15 to 23.59)
    No statistical analyses for this end point

    Secondary: Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A

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    End point title
    Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A
    End point description
    Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed. ‘Number analysed (n)’ indicates the number of subjects with data available for analysis at the specified time point.
    End point type
    Secondary
    End point timeframe
    Pre-infusion at Weeks 21, 25 and 29
    End point values
    Sequence A: IgPro10
    Number of subjects analysed
    13
    Units: g/L
    geometric mean (full range (min-max))
        Week 21 (n=12)
    16.123 (9.69 to 34.70)
        Week 25
    17.497 (8.80 to 54.96)
        Week 29
    16.838 (8.51 to 58.16)
    No statistical analyses for this end point

    Secondary: Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B

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    End point title
    Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B
    End point description
    Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. 'Number of subjects analysed’ indicates the number of subjects who received IgPro10 and with data available for endpoint analysis. 'Number analysed (n)’ indicates the number of subjects with data available for analysis at the specified time point.
    End point type
    Secondary
    End point timeframe
    Pre-infusion at Week 5, 9 and 13
    End point values
    Sequence B: IgPro20
    Number of subjects analysed
    13
    Units: g/L
    geometric mean (full range (min-max))
        Week 5 (n=12)
    17.104 (12.77 to 24.04)
        Week 9
    17.744 (13.92 to 23.36)
        Week 13
    17.113 (12.89 to 25.43)
    No statistical analyses for this end point

    Other pre-specified: Rate of ISRs per Subject for IgPro20

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    End point title
    Rate of ISRs per Subject for IgPro20
    End point description
    9999= Data was not collected for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    From first dose of study drug through last follow up visit (up to 36 weeks)
    End point values
    Sequence A: IgPro20 Sequence B: IgPro20
    Number of subjects analysed
    13
    13
    Units: percent
        number (not applicable)
    9999
    9999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug through last follow up visit (up to 36 weeks)
    Adverse event reporting additional description
    Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Sequence A: IgPro10
    Reporting group description
    Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2.

    Reporting group title
    Sequence A: IgPro20
    Reporting group description
    Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1.

    Reporting group title
    Sequence B: IgPro10
    Reporting group description
    Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1.

    Reporting group title
    Sequence B: IgPro20
    Reporting group description
    Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.

    Serious adverse events
    Sequence A: IgPro10 Sequence A: IgPro20 Sequence B: IgPro10 Sequence B: IgPro20
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 13 (15.38%)
    1 / 14 (7.14%)
    3 / 13 (23.08%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Viral infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Sequence A: IgPro10 Sequence A: IgPro20 Sequence B: IgPro10 Sequence B: IgPro20
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 13 (38.46%)
    8 / 13 (61.54%)
    8 / 14 (57.14%)
    6 / 13 (46.15%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Infusion site pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    2
    Infusion site swelling
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    3
    Infusion site haemorrhage
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Infusion site reaction
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Infusion site vesicles
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Injection site hypersensitivity
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection site mass
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infusion site discharge
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Infusion site erosion
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Infusion site erythema
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    1
    Dyspnoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cough
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    1
    Fall
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin abrasion
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    5 / 14 (35.71%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    11
    0
    Anosmia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    2
    Sciatica
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    2 / 14 (14.29%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Abdominal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 13 (15.38%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Nausea
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    2 / 14 (14.29%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    3
    1
    Toothache
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    1
    Abdominal distension
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Colitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eructation
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haematemesis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Saliva altered
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    2 / 14 (14.29%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dermatitis psoriasiform
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lichenoid keratosis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Night sweats
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Purpura
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Scleroderma associated digital ulcer
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    1
    Skin exfoliation
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Umbilical erythema
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    1
    0
    2
    Gingivitis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jul 2019
    • Addition of text regarding identified risk of Thromboembolic events (TEE) in treatment population, including new exclusion criteria, monitoring, and study stopping rules • Expansion of hemolysis testing as a safety assessment during IgPro20 treatment • Clarification of timing for study endpoint measures • Addition of exclusion criterion to address use of contraception by potential male subjects • Addition of exclusion criteria to address subjects with potential risks of TEE • Addition of deoxy ribonucleic acid (DNA) and ribonucleic acid (RNA) as biomarkers and additional collection of whole blood to obtain DNA and RNA • Addition of TEEs as an AESI.
    07 Nov 2019
    • Modification of Primary and Secondary Endpoints to include summaries of TEAEs, SAEs, and AESIs • Addition of rules for stopping infusion of IgPro20 or IgPro10 and discontinuation of treatment • Addition of text and assessments to monitor renal safety • Addition and classification of hemolysis and potential acute renal injury as AESIs • Addition of guidance regarding the maximum infusion rate for subjects with renal dysfunction • Addition of maximum doses of IgPro20 and IgPro10, based on body weight • Removal of DLCO assessment at Baseline • Clarification of the method of scoring for manual muscle testing • Addition of interim analysis.
    21 Oct 2020
    • Defined adjustments that are effective during the Coronavirus disease 2019 (COVID-19) pandemic and provided detailed guidance and procedures that allowed investigators the flexibility to complete critical protocol safety and efficacy assessments while limiting subject exposure to COVID-19 at study sites.
    22 Feb 2021
    • Added guidance regarding dispensing Investigational product (IP) to subjects during a state of emergency or public health crisis • Added an option for remote visits during a state of emergency or public health crisis • Revised contingencies that were effective during a state of emergency or a public health crisis.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    21 Apr 2020
    Due to COVID-19, enrollment was stopped on 1 Apr 2020, with study timelines re-baselining 25 Jun 2020.
    25 Jun 2020

    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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