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    Clinical Trial Results:
    A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

    Summary
    EudraCT number
    2015-004457-40
    Trial protocol
    DE   HU   BG   ES   PL  
    Global end of trial date
    15 Nov 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Dec 2019
    First version publication date
    02 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SL0023
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02804763
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SPRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, 1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.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
    31 Jan 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the dose-response for the efficacy of intravenous (iv) dapirolizumab pegol (DZP; 3 dose groups) at week 24 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE) receiving stable standard-of-care treatment.
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Mandatory background medication with either antimalarials, immunosuppressants or corticosteroids as stand-alone treatment or in combination. Other Background therapy as permitted in the protocol.
    Evidence for comparator
    Not Applicable
    Actual start date of recruitment
    02 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Colombia: 18
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Mexico: 13
    Country: Number of subjects enrolled
    Peru: 26
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    Romania: 12
    Country: Number of subjects enrolled
    Russian Federation: 15
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Ukraine: 15
    Country: Number of subjects enrolled
    United States: 53
    Country: Number of subjects enrolled
    Bulgaria: 2
    Worldwide total number of subjects
    182
    EEA total number of subjects
    42
    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)
    178
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll patients in June 2016 and concluded in November 2018.

    Pre-assignment
    Screening details
    The study included a 4-week Screening Period, a 24-week Double-Blind Treatment Period and a 24-week Observational Period. Participant Flow refers to the Randomized Set.

    Period 1
    Period 1 title
    Double-Blind Period (Week 1 to Week 24)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Investigator, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SOC + Placebo iv Q4W
    Arm description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of PBO every 4 weeks (Q4W) for a total of 6 doses.

    Arm title
    SOC + DZP dose 1 iv Q4W
    Arm description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 1 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Dapirolizumab pegol
    Investigational medicinal product code
    DZP
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of DZP dose 1, 2 or 3, every 4 weeks (Q4W) for a total of 6 doses.

    Arm title
    SOC + DZP dose 2 iv Q4W
    Arm description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 2 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Dapirolizumab pegol
    Investigational medicinal product code
    DZP
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of DZP dose 1, 2 or 3, every 4 weeks (Q4W) for a total of 6 doses.

    Arm title
    SOC + DZP dose 3 iv Q4W
    Arm description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 3 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Dapirolizumab pegol
    Investigational medicinal product code
    DZP
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During the 24-week Double-Blind Treatment Period participants received an intravenous (iv) infusion of DZP dose 1, 2 or 3, every 4 weeks (Q4W) for a total of 6 doses.

    Number of subjects in period 1
    SOC + Placebo iv Q4W SOC + DZP dose 1 iv Q4W SOC + DZP dose 2 iv Q4W SOC + DZP dose 3 iv Q4W
    Started
    45
    45
    45
    47
    Completed Week 24
    44
    45
    44
    45
    Finished Wk24 began Observational Period
    44
    44
    44
    45
    Completed
    44
    44
    44
    45
    Not completed
    1
    1
    1
    2
         Consent withdrawal after Week 24
    -
    1
    -
    -
         Adverse event, non-fatal
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    1
    2
    Period 2
    Period 2 title
    Observational Period (Wk 24 to Wk 48)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Participants who completed the 24-week Double-Blind Treatment Period continued into a 24-week Observational Period, during which participants didn't receive study drug but received standard-of-care (SOC) treatment. Sponsor was unblinded during the Observational Period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SOC + Placebo iv Q4W
    Arm description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    SOC + DZP dose 1 iv Q4W
    Arm description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 1 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    SOC + DZP dose 2 iv Q4W
    Arm description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 2 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    SOC + DZP dose 3 iv Q4W
    Arm description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 3 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    SOC + Placebo iv Q4W SOC + DZP dose 1 iv Q4W SOC + DZP dose 2 iv Q4W SOC + DZP dose 3 iv Q4W
    Started
    44
    44
    44
    45
    Completed
    38
    43
    41
    42
    Not completed
    6
    1
    3
    3
         Patient moved out of state
    -
    1
    -
    -
         Consent withdrawn by subject
    4
    -
    2
    2
         Lost to follow-up
    2
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOC + Placebo iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

    Reporting group title
    SOC + DZP dose 1 iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 1 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

    Reporting group title
    SOC + DZP dose 2 iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 2 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

    Reporting group title
    SOC + DZP dose 3 iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 3 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

    Reporting group values
    SOC + Placebo iv Q4W SOC + DZP dose 1 iv Q4W SOC + DZP dose 2 iv Q4W SOC + DZP dose 3 iv Q4W Total
    Number of subjects
    45 45 45 47 182
    Age categorical
    Units: Subjects
        <=18 years
    0 0 0 0 0
        Between 18 and 65 years
    44 44 44 46 178
        >=65 years
    1 1 1 1 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.50 ± 12.79 40.81 ± 11.55 42.77 ± 10.42 38.94 ± 12.92 -
    Gender categorical
    Units: Subjects
        Male
    4 3 5 4 16
        Female
    41 42 40 43 166

    End points

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    End points reporting groups
    Reporting group title
    SOC + Placebo iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

    Reporting group title
    SOC + DZP dose 1 iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 1 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

    Reporting group title
    SOC + DZP dose 2 iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 2 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

    Reporting group title
    SOC + DZP dose 3 iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 3 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
    Reporting group title
    SOC + Placebo iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

    Reporting group title
    SOC + DZP dose 1 iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 1 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

    Reporting group title
    SOC + DZP dose 2 iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 2 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

    Reporting group title
    SOC + DZP dose 3 iv Q4W
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 3 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.

    Subject analysis set title
    SOC + Placebo iv Q4W (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).

    Subject analysis set title
    SOC + DZP dose 1 iv Q4W (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 1 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.

    Subject analysis set title
    SOC + DZP dose 2 iv Q4W (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 2 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.

    Subject analysis set title
    SOC + DZP dose 3 iv Q4W (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 3 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.

    Subject analysis set title
    SOC + Placebo iv Q4W (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).

    Subject analysis set title
    SOC + DZP dose 1 iv Q4W (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 1 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.

    Subject analysis set title
    SOC + DZP dose 2 iv Q4W (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 2 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.

    Subject analysis set title
    SOC + DZP dose 3 iv Q4W (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 3 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.

    Primary: Percentage of participants with British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) (mNRI) response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24

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    End point title
    Percentage of participants with British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) (mNRI) response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24
    End point description
    The primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using Multiple Comparison Procedure – Modelling (MCP-Mod). Four candidate dose-response models were evaluated: a linear model, a logistic model, and 2 Emax models, and the MCP-Mod methodology controlled for multiplicity. BICLA response was defined as meeting all of the following criteria: (1)BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. (2)No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. (3)No worsening in Physician’s Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). (4)No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    SOC + Placebo iv Q4W (FAS) SOC + DZP dose 1 iv Q4W (FAS) SOC + DZP dose 2 iv Q4W (FAS) SOC + DZP dose 3 iv Q4W (FAS)
    Number of subjects analysed
    43
    43
    44
    46
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    0
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Multiple contrast testing (MCP-mod methodology) was used to test for a statistically significant dose-response relationship between the primary endpoint (BICLA at Week 24) and dose, which would indicate a drug effect of DZP over Placebo. The best fitting statistically significant model could be used to estimate the dose needed to achieve desired treatment effect. However, no models were statistically significant at the 0.05 level.
    Comparison groups
    SOC + Placebo iv Q4W (FAS) v SOC + DZP dose 1 iv Q4W (FAS) v SOC + DZP dose 2 iv Q4W (FAS) v SOC + DZP dose 3 iv Q4W (FAS)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0727 [1]
    Method
    MCP-Mod
    Confidence interval
    Notes
    [1] - The lowest p-value (z-statistic with the highest value) was used to establish proof of dose response.

    Secondary: The percentage of participants with BICLA (mNRI) response in the individual dose groups at Week 24

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    End point title
    The percentage of participants with BICLA (mNRI) response in the individual dose groups at Week 24
    End point description
    BICLA response was defined as meeting all of the following criteria: (1)BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. (2)No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. (3)No worsening in Physician’s Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). (4)No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    SOC + Placebo iv Q4W (FAS) SOC + DZP dose 1 iv Q4W (FAS) SOC + DZP dose 2 iv Q4W (FAS) SOC + DZP dose 3 iv Q4W (FAS)
    Number of subjects analysed
    43
    43
    44
    46
    Units: percentage of participants
        number (not applicable)
    37.2
    48.8
    54.5
    52.2
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
    Comparison groups
    SOC + Placebo iv Q4W (FAS) v SOC + DZP dose 1 iv Q4W (FAS)
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2699 [2]
    Method
    Chi-squared
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    3.8
    Notes
    [2] - Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
    Comparison groups
    SOC + Placebo iv Q4W (FAS) v SOC + DZP dose 2 iv Q4W (FAS)
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1036 [3]
    Method
    Chi-squared
    Parameter type
    Odds ratio (OR)
    Point estimate
    2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    4.8
    Notes
    [3] - Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
    Comparison groups
    SOC + Placebo iv Q4W (FAS) v SOC + DZP dose 3 iv Q4W (FAS)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1518 [4]
    Method
    Chi-squared
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.8
         upper limit
    4.3
    Notes
    [4] - Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
    Comparison groups
    SOC + Placebo iv Q4W (FAS) v SOC + DZP dose 1 iv Q4W (FAS)
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Chi-squared
    Parameter type
    Difference vs PBO
    Point estimate
    11.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.2
         upper limit
    32.4
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
    Comparison groups
    SOC + Placebo iv Q4W (FAS) v SOC + DZP dose 2 iv Q4W (FAS)
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Chi-squared
    Parameter type
    Difference vs PBO
    Point estimate
    17.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.3
         upper limit
    38
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
    Comparison groups
    SOC + Placebo iv Q4W (FAS) v SOC + DZP dose 3 iv Q4W (FAS)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Chi-squared
    Parameter type
    Difference vs PBO
    Point estimate
    15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.5
         upper limit
    35.4
    Statistical analysis title
    Statistical analysis 7
    Statistical analysis description
    Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
    Comparison groups
    SOC + Placebo iv Q4W (FAS) v SOC + DZP dose 1 iv Q4W (FAS)
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Chi-squared
    Parameter type
    LS Mean Difference vs PBO
    Point estimate
    11.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.7
         upper limit
    32.5
    Statistical analysis title
    Statistical analysis 8
    Statistical analysis description
    Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
    Comparison groups
    SOC + Placebo iv Q4W (FAS) v SOC + DZP dose 2 iv Q4W (FAS)
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Chi-squared
    Parameter type
    LS Mean Difference vs PBO
    Point estimate
    17.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    38.3
    Statistical analysis title
    Statistical analysis 9
    Statistical analysis description
    Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.
    Comparison groups
    SOC + Placebo iv Q4W (FAS) v SOC + DZP dose 3 iv Q4W (FAS)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Chi-squared
    Parameter type
    LS Mean Difference vs PBO
    Point estimate
    15.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.2
         upper limit
    35.6

    Secondary: Percentage of participants with at least one Adverse Events (AEs)

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    End point title
    Percentage of participants with at least one Adverse Events (AEs)
    End point description
    An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) until end of the study
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: percentage of participants
        number (not applicable)
    66.7
    66.7
    82.2
    74.5
    No statistical analyses for this end point

    Secondary: Percentage of participants with a Serious Adverse Event (SAE)

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    End point title
    Percentage of participants with a Serious Adverse Event (SAE)
    End point description
    A Serious Adverse Event (SAE) must have met 1 or more of the following criteria: •Death •Life threatening •Significant or persistent disability/incapacity •Congenital anomaly/birth defect (including that occurring in a fetus) •Important medical event that, based upon appropriate medical judgment, may have jeopardized the study participant, and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious •Initial inpatient hospitalization or prolongation of hospitalization.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) until end of the study
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: percentage of participants
        number (not applicable)
    13.3
    11.1
    13.3
    10.6
    No statistical analyses for this end point

    Secondary: Percentage of participants with at least one Adverse Events (AEs) of interest

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    End point title
    Percentage of participants with at least one Adverse Events (AEs) of interest
    End point description
    Adverse events of interest (AEOI) were identified by the Investigator based on definitions per protocol, documented on the electronic Case Report Form (eCRF), adequately monitored, and source controlled. AEOI (regardless of seriousness): •Moderate to severe infections, including opportunistic infections and tuberculosis (TB) •Infusion reactions (including hypersensitivity and anaphylaxis) •Thromboembolic events (including but not limited to cardiovascular events, stroke, myocardial infarction, pulmonary embolism, and deep vein thrombosis) •Prespecified neurological events: severe and/or serious headache, positional headache, cranial nerve dysfunction, or signs and symptoms of meningitis (photophobia, neck stiffness) •Malignancies.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) until end of the study
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: percentage of participants
        number (not applicable)
    24.4
    26.7
    28.9
    25.5
    No statistical analyses for this end point

    Secondary: Percentage of participants who permanently withdrew of study drug due to an Adverse Event (AE)

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    End point title
    Percentage of participants who permanently withdrew of study drug due to an Adverse Event (AE)
    End point description
    An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) until end of the study
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: percentage of participants
        number (not applicable)
    8.9
    0
    4.4
    4.3
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Systolic Blood Pressure

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    End point title
    Mean change from baseline in Systolic Blood Pressure
    End point description
    Blood pressure was measured in millimetre of mercury (mmHg). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: mmHg
    arithmetic mean (standard deviation)
        Week 2 (45, 45, 45, 44)
    3.3 ± 12.9
    5.1 ± 10.5
    0.7 ± 10.7
    3.2 ± 9.9
        Week 4 (43, 44, 43, 46)
    0.6 ± 10.8
    1.0 ± 7.9
    -2.0 ± 8.9
    0.6 ± 12.4
        Week 6 (43, 45, 44, 45)
    0.3 ± 11.5
    4.0 ± 9.9
    2.3 ± 11.0
    2.4 ± 10.6
        Week 8 (44, 44, 44, 43)
    0.5 ± 12.4
    3.3 ± 12.6
    -2.4 ± 9.9
    -0.7 ± 11.9
        Week 12 (44, 45, 45, 44)
    -0.7 ± 10.1
    3.2 ± 10.5
    -3.0 ± 11.8
    0.8 ± 9.2
        Week 16 (43, 44, 43, 44)
    2.1 ± 12.3
    2.1 ± 11.6
    -2.8 ± 10.6
    0.9 ± 11.1
        Week 20 (42, 45, 42, 44)
    1.6 ± 9.9
    2.6 ± 9.8
    -1.7 ± 12.3
    1.5 ± 11.3
        Week 24 (43, 44, 44, 44)
    -0.7 ± 14.3
    1.1 ± 13.1
    0.3 ± 11.0
    3.6 ± 9.3
        Week 28 (44, 43, 42, 44)
    1.8 ± 12.3
    3.7 ± 13.1
    0.9 ± 10.5
    2.5 ± 11.8
        Week 32 (44, 44, 43, 45)
    2.2 ± 11.1
    3.0 ± 13.2
    0.4 ± 11.3
    4.3 ± 13.7
        Week 36 (42, 42, 41, 41)
    2.1 ± 11.0
    3.1 ± 12.6
    0.2 ± 10.5
    2.4 ± 12.9
        Week 40 (42, 43, 41, 44)
    -1.0 ± 14.1
    6.2 ± 12.9
    -2.0 ± 11.7
    2.5 ± 11.3
        Week 44 (39, 41, 41, 42)
    0.1 ± 12.6
    3.3 ± 14.1
    1.3 ± 10.4
    4.2 ± 11.8
        Week 48 (38, 42, 40, 42)
    -1.5 ± 11.5
    4.9 ± 14.3
    0.1 ± 10.2
    4.4 ± 12.0
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Diastolic Blood Pressure

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    End point title
    Mean change from baseline in Diastolic Blood Pressure
    End point description
    Blood pressure was measured in millimetre of mercury (mmHg). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: mmHg
    arithmetic mean (standard deviation)
        Week 2 (45, 45, 45, 44)
    2.1 ± 10.5
    1.4 ± 8.6
    1.5 ± 9.3
    2.4 ± 8.2
        Week 4 (43, 44, 43, 46)
    -0.7 ± 7.8
    -1.5 ± 6.3
    -1.7 ± 8.2
    -0.1 ± 8.3
        Week 6 (43, 45, 44, 45)
    1.0 ± 10.0
    1.5 ± 8.6
    1.8 ± 10.0
    1.9 ± 7.9
        Week 8 (44, 44, 44, 43)
    1.1 ± 9.2
    0.4 ± 9.1
    0.1 ± 8.6
    1.0 ± 8.0
        Week 12 (44, 45, 45, 44)
    -0.9 ± 8.4
    -0.3 ± 6.9
    -2.2 ± 9.6
    -0.3 ± 6.9
        Week 16 (43, 44, 43, 44)
    -0.3 ± 8.9
    -1.3 ± 7.6
    -0.7 ± 9.5
    -0.1 ± 7.0
        Week 20 (42, 45, 42, 44)
    1.5 ± 8.1
    -1.1 ± 8.7
    -0.7 ± 9.6
    0.9 ± 8.8
        Week 24 (43, 44, 44, 44)
    1.9 ± 11.2
    1.6 ± 8.7
    2.3 ± 10.7
    0.6 ± 8.7
        Week 28 (44, 43, 42, 44)
    1.5 ± 9.1
    -0.2 ± 8.8
    1.4 ± 8.4
    2.5 ± 8.4
        Week 32 (44, 44, 43, 45)
    2.3 ± 10.1
    2.8 ± 9.3
    0.7 ± 10.2
    2.3 ± 8.1
        Week 36 (42, 42, 41, 41)
    3.4 ± 9.8
    1.4 ± 10.2
    1.4 ± 8.4
    2.2 ± 8.0
        Week 40 (42, 43, 41, 44)
    1.0 ± 9.2
    2.6 ± 7.6
    0.5 ± 9.9
    3.6 ± 8.8
        Week 44 (39, 41, 41, 42)
    0.8 ± 10.2
    1.5 ± 8.1
    0.4 ± 9.4
    2.2 ± 10.3
        Week 48 (38, 42, 40, 42)
    1.4 ± 9.0
    2.3 ± 8.8
    1.1 ± 9.4
    2.4 ± 8.6
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Pulse Rate

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    End point title
    Mean change from baseline in Pulse Rate
    End point description
    Pulse Rate was measured in beats per minute (beats/min). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: beats/min
    arithmetic mean (standard deviation)
        Week 2 (45, 45, 45, 44)
    -0.2 ± 8.3
    0.2 ± 10.4
    2.3 ± 9.7
    -0.9 ± 10.4
        Week 4 (43, 44, 43, 46)
    1.7 ± 9.6
    1.5 ± 8.0
    0.4 ± 8.4
    -3.3 ± 9.7
        Week 6 (43, 45, 44, 45)
    -0.7 ± 10.2
    0.1 ± 8.5
    0.8 ± 8.9
    -0.6 ± 8.8
        Week 8 (44, 44, 44, 43)
    1.3 ± 9.0
    0.3 ± 9.2
    1.4 ± 10.2
    -2.6 ± 10.2
        Week 12 (44, 45, 45, 44)
    0.6 ± 10.3
    1.1 ± 9.8
    -0.3 ± 10.4
    -1.5 ± 9.7
        Week 16 (43, 44, 43, 44)
    -0.8 ± 9.2
    0.3 ± 8.9
    0.9 ± 10.7
    -1.6 ± 10.6
        Week 20 (42, 45, 42, 44)
    0.3 ± 10.6
    1.1 ± 9.9
    0.8 ± 9.5
    0.4 ± 6.6
        Week 24 (43, 44, 44, 44)
    -1.5 ± 10.7
    0.8 ± 10.9
    -0.3 ± 10.2
    -1.0 ± 8.7
        Week 28 (44, 43, 42, 44)
    0.6 ± 11.8
    1.3 ± 10.9
    0.0 ± 9.2
    0.6 ± 8.8
        Week 32 (44, 44, 43, 45)
    0.4 ± 9.8
    1.3 ± 10.9
    0.8 ± 11.4
    -2.1 ± 11.0
        Week 36 (42, 42, 41, 41)
    -0.7 ± 10.9
    0.2 ± 8.3
    0.7 ± 10.4
    -0.2 ± 9.8
        Week 40 (42, 43, 41, 44)
    -0.1 ± 10.9
    -0.1 ± 9.8
    0.6 ± 10.2
    -1.3 ± 9.6
        Week 44 (39, 41, 41, 42)
    -0.2 ± 10.2
    -0.1 ± 9.8
    0.3 ± 11.7
    -0.6 ± 8.9
        Week 48 (38, 42, 40, 42)
    -0.2 ± 11.1
    -0.7 ± 10.6
    -0.9 ± 11.9
    -2.0 ± 7.7
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Temperature

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    End point title
    Mean change from baseline in Temperature
    End point description
    Temperature was measured in Grad Celsius (°C). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: Temperature (C)
    arithmetic mean (standard deviation)
        Week 2 (45, 45, 45, 44)
    -0.1 ± 0.4
    0.0 ± 0.3
    0.1 ± 0.5
    0.0 ± 0.4
        Week 4 (43, 44, 43, 46)
    -0.1 ± 0.4
    0.0 ± 0.4
    0.0 ± 0.4
    0.0 ± 0.3
        Week 6 (43, 45, 44, 45)
    -0.2 ± 0.5
    0.0 ± 0.4
    0.1 ± 0.5
    0.0 ± 0.5
        Week 8 (44, 44, 44, 43)
    -0.1 ± 0.4
    -0.1 ± 0.3
    0.0 ± 0.4
    0.0 ± 0.4
        Week 12 (44, 45, 45, 44)
    -0.1 ± 0.4
    -0.1 ± 0.4
    0.0 ± 0.3
    0.0 ± 0.4
        Week 16 (43, 44, 43, 44)
    -0.1 ± 0.4
    0.0 ± 0.4
    0.0 ± 0.4
    0.0 ± 0.3
        Week 20 (42, 45, 42, 44)
    -0.1 ± 0.4
    0.0 ± 0.4
    0.0 ± 0.4
    0.0 ± 0.5
        Week 24 (43, 44, 44, 44)
    -0.1 ± 0.5
    0.0 ± 0.4
    0.1 ± 0.5
    0.0 ± 0.4
        Week 28 (44, 43,42 , 44)
    0.0 ± 0.4
    0.0 ± 0.4
    0.1 ± 0.5
    0.1 ± 0.5
        Week 32 (44, 44, 43, 45)
    0.0 ± 0.4
    0.0 ± 0.4
    0.1 ± 0.5
    0.0 ± 0.4
        Week 36 (42, 42, 41, 41)
    -0.1 ± 0.3
    0.0 ± 0.6
    0.0 ± 0.4
    0.1 ± 0.4
        Week 40 (42, 43, 41, 44)
    0.0 ± 0.4
    0.0 ± 0.4
    0.0 ± 0.5
    0.1 ± 0.3
        Week 44 (39, 41, 41, 42)
    0.0 ± 0.6
    0.0 ± 0.5
    0.1 ± 0.4
    0.0 ± 0.4
        Week 48 (38, 42, 40, 42)
    -0.1 ± 0.4
    0.0 ± 0.4
    0.0 ± 0.5
    0.0 ± 0.4
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Weight

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    End point title
    Mean change from baseline in Weight
    End point description
    Weight was measured in kilograms (kg). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: kg
    arithmetic mean (standard deviation)
        Week 4 (43, 44, 43, 46)
    0.0 ± 1.0
    0.2 ± 1.0
    0.4 ± 0.9
    0.3 ± 1.2
        Week 8 (44, 44, 43, 43)
    0.3 ± 1.9
    0.6 ± 1.4
    0.6 ± 1.8
    0.4 ± 1.8
        Week 12 (43, 45, 44, 44)
    0.4 ± 2.3
    0.5 ± 1.6
    0.5 ± 2.0
    0.6 ± 2.3
        Week 16 (43, 44, 43, 44)
    0.3 ± 2.3
    0.7 ± 2.3
    0.8 ± 2.3
    0.5 ± 2.4
        Week 20 (42, 45, 42, 44)
    0.3 ± 2.4
    0.7 ± 2.6
    1.0 ± 2.6
    0.5 ± 2.8
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Height

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    End point title
    Mean change from baseline in Height
    End point description
    Height was measured in centimeters (cm). Note: 999 is a placeholder used for values that were not calculated.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: cm
        arithmetic mean (standard deviation)
    999 ± 999
    999 ± 999
    999 ± 999
    999 ± 999
    No statistical analyses for this end point

    Secondary: Number of participants with 12-Lead electrocardiogram (ECG) abnormal findings

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    End point title
    Number of participants with 12-Lead electrocardiogram (ECG) abnormal findings
    End point description
    Twelve-lead ECG assessments should have been performed prior to dosing (if applicable) and prior to obtaining pharmacokinetic (PK) or other laboratory samples. Electrocardiograms were recorded digitally and read by the Investigator for recording in the electronic Case Report Form (eCRF).
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: participants
        Screening
    8
    11
    6
    6
        Week 4
    11
    12
    7
    10
        Week 24
    9
    7
    6
    10
        Week 28
    1
    0
    0
    0
        Week 48
    8
    7
    11
    9
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Hemoglobin

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    End point title
    Mean change from baseline in Hemoglobin
    End point description
    Hemoglobin was measured in grams per liter (g/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: g/L
    arithmetic mean (standard deviation)
        Week 2 (44, 42, 45, 42)
    0.4 ± 6.4
    -1.8 ± 5.8
    -0.7 ± 6.9
    -0.7 ± 6.8
        Week 4 (44, 44, 43, 46)
    -1.0 ± 7.2
    -0.7 ± 7.7
    -1.4 ± 8.6
    -0.8 ± 5.8
        Week 8 (43, 44, 44, 44)
    -0.3 ± 7.3
    -1.9 ± 7.9
    -1.9 ± 8.6
    -1.3 ± 7.4
        Week 12 (44, 44, 44, 44)
    -0.5 ± 9.5
    -0.5 ± 8.5
    -0.5 ± 10.1
    0.2 ± 8.3
        Week 16 (44, 43, 43, 45)
    0.3 ± 10.4
    -0.3 ± 10.0
    -0.8 ± 10.6
    -2.7 ± 8.3
        Week 20 (43, 43, 41, 43)
    -0.7 ± 11.5
    0.3 ± 9.9
    -0.5 ± 10.1
    -2.4 ± 7.2
        Week 24 (42, 43, 44, 44)
    -0.4 ± 9.7
    -0.7 ± 11.2
    -0.7 ± 10.5
    -2.9 ± 8.1
        Week 28 (44, 41, 41, 44)
    0.7 ± 10.6
    -3.4 ± 11.0
    0.0 ± 14.1
    -3.1 ± 9.5
        Week 32 (43, 43, 43, 42)
    1.6 ± 12.5
    -1.3 ± 9.8
    1.0 ± 12.5
    -1.3 ± 9.6
        Week 40 (42, 43, 41, 44)
    0.7 ± 13.5
    -0.3 ± 13.5
    1.9 ± 14.9
    1.1 ± 11.0
        Week 48 (38, 42, 39, 42)
    -0.5 ± 14.3
    -1.5 ± 11.6
    0.9 ± 12.5
    -0.7 ± 10.0
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Hematocrit

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    End point title
    Mean change from baseline in Hematocrit
    End point description
    Hematocrit was measured in volume percentage (%) of red blood cells in blood. Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: volume % of red blood cells
    arithmetic mean (standard deviation)
        Week 2 (44, 42, 45, 42)
    0.42 ± 2.52
    -0.25 ± 2.26
    -0.32 ± 2.37
    0.00 ± 2.71
        Week 4 (44, 44, 43, 46)
    -0.46 ± 2.29
    -0.17 ± 2.75
    -0.79 ± 2.92
    -0.11 ± 2.31
        Week 8 (43, 44, 44, 44)
    -0.27 ± 2.23
    -0.12 ± 2.94
    -0.86 ± 2.72
    -0.42 ± 2.31
        Week 12 (44, 44, 44, 44)
    -0.23 ± 2.67
    -0.13 ± 2.72
    -0.32 ± 3.39
    -0.02 ± 2.54
        Week 16 (44, 43, 43, 45)
    -0.12 ± 2.86
    0.05 ± 3.25
    -0.57 ± 3.32
    -0.84 ± 2.95
        Week 20 (43, 43, 41, 43)
    -0.41 ± 3.20
    0.13 ± 2.99
    -0.42 ± 3.32
    -0.80 ± 2.83
        Week 24 (42, 43, 44, 44)
    -0.09 ± 2.61
    -0.40 ± 3.19
    -0.29 ± 3.14
    -0.76 ± 2.33
        Week 28 (44, 41, 41, 44)
    0.03 ± 2.98
    -1.02 ± 3.23
    -0.22 ± 3.99
    -0.89 ± 2.47
        Week 32 (43, 43, 43, 42)
    0.29 ± 2.89
    -0.62 ± 2.86
    0.17 ± 3.43
    -0.21 ± 2.82
        Week 40 (42, 43, 41, 44)
    -0.20 ± 3.32
    -0.24 ± 4.37
    0.58 ± 4.11
    0.37 ± 2.72
        Week 48 (38, 42, 39, 42)
    -0.59 ± 3.51
    -0.37 ± 3.58
    -0.08 ± 3.21
    -0.11 ± 2.54
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Erythrocytes

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    End point title
    Mean change from baseline in Erythrocytes
    End point description
    Erythrocytes was measured in number of erythrocytes per liter (10^12/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: 10^12 erythrocytes per liter
    arithmetic mean (standard deviation)
        Week 2 (44, 42, 45, 42)
    -0.004 ± 0.246
    -0.035 ± 0.237
    -0.032 ± 0.223
    -0.028 ± 0.237
        Week 4 (44, 44, 43, 46)
    -0.080 ± 0.243
    -0.018 ± 0.293
    -0.052 ± 0.273
    -0.033 ± 0.210
        Week 8 (43, 44, 44, 44)
    -0.039 ± 0.224
    -0.039 ± 0.280
    -0.069 ± 0.262
    -0.044 ± 0.242
        Week 12 (44, 44, 44, 44)
    -0.024 ± 0.271
    0.014 ± 0.292
    -0.010 ± 0.267
    0.019 ± 0.226
        Week 16 (44, 43, 43, 45)
    -0.002 ± 0.312
    0.041 ± 0.360
    0.000 ± 0.302
    -0.051 ± 0.265
        Week 20 (43, 43, 41, 43)
    -0.029 ± 0.333
    0.062 ± 0.309
    -0.001 ± 0.325
    -0.047 ± 0.302
        Week 24 (42, 43, 44, 44)
    0.005 ± 0.308
    0.036 ± 0.312
    0.013 ± 0.319
    -0.038 ± 0.240
        Week 28 (44, 41, 41, 44)
    0.018 ± 0.340
    -0.040 ± 0.304
    0.019 ± 0.346
    -0.050 ± 0.270
        Week 32 (43, 43, 43, 42)
    0.048 ± 0.320
    0.001 ± 0.284
    0.032 ± 0.289
    0.027 ± 0.277
        Week 40 (42, 43, 41, 44)
    -0.005 ± 0.343
    0.042 ± 0.382
    0.054 ± 0.368
    0.060 ± 0.256
        Week 48 (38, 42, 39, 42)
    -0.024 ± 0.332
    -0.018 ± 0.295
    0.017 ± 0.299
    -0.028 ± 0.245
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Volume

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    End point title
    Mean change from baseline in Erythrocytes Mean Corpuscular Volume
    End point description
    Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: Femtolitres (fL)
    arithmetic mean (standard deviation)
        Week 2 (44, 42, 45, 42)
    1.01 ± 2.28
    0.24 ± 2.40
    -0.09 ± 2.66
    0.45 ± 2.96
        Week 4 (44, 44, 43, 46)
    0.60 ± 2.35
    0.08 ± 2.66
    -0.68 ± 2.10
    0.40 ± 3.02
        Week 8 (43, 44, 44, 44)
    0.23 ± 3.48
    -0.30 ± 5.36
    -0.54 ± 2.85
    -0.16 ± 2.79
        Week 12 (44, 44, 44, 44)
    0.06 ± 3.57
    -0.52 ± 3.44
    -0.55 ± 4.67
    -0.57 ± 3.09
        Week 16 (44, 43, 43, 45)
    -0.25 ± 3.41
    -0.65 ± 4.38
    -1.38 ± 4.87
    -0.97 ± 3.62
        Week 20 (43, 43, 41, 43)
    -0.37 ± 3.73
    -0.92 ± 4.58
    -1.00 ± 5.01
    -0.97 ± 3.54
        Week 24 (42, 43, 44, 44)
    -0.23 ± 3.83
    -1.63 ± 4.07
    -0.92 ± 6.51
    -1.05 ± 4.00
        Week 28 (44, 41, 41,44 )
    -0.33 ± 3.61
    -1.40 ± 4.61
    -0.96 ± 6.46
    -1.21 ± 4.91
        Week 32 (43, 43, 43, 42)
    -0.27 ± 4.45
    -1.33 ± 4.32
    -0.45 ± 6.81
    -1.06 ± 4.69
        Week 40 (42, 43, 41, 44)
    -0.36 ± 5.34
    -1.46 ± 4.72
    0.07 ± 6.27
    -0.24 ± 4.85
        Week 48 (38, 42, 39, 42)
    -0.98 ± 5.34
    -0.50 ± 4.97
    -0.63 ± 6.92
    0.34 ± 4.31
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration

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    End point title
    Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
    End point description
    Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: g/L
    arithmetic mean (standard deviation)
        Week 2 (44, 42, 45, 42)
    -2.3 ± 9.8
    -2.6 ± 10.9
    0.7 ± 9.8
    -1.9 ± 10.1
        Week 4 (44, 44, 43, 46)
    1.4 ± 8.7
    -0.9 ± 10.1
    2.7 ± 8.6
    -1.2 ± 12.5
        Week 8 (43, 44, 44, 44)
    1.7 ± 11.5
    -3.8 ± 13.4
    2.1 ± 8.2
    -0.1 ± 11.5
        Week 12 (44, 44, 44, 44)
    0.5 ± 11.1
    -0.6 ± 10.7
    0.6 ± 12.3
    0.5 ± 12.7
        Week 16 (44, 43, 43, 45)
    1.6 ± 13.8
    -1.5 ± 10.1
    2.3 ± 11.3
    -0.2 ± 14.1
        Week 20 (43, 43, 41, 43)
    1.6 ± 12.9
    -0.9 ± 11.3
    2.4 ± 11.2
    0.4 ± 12.6
        Week 24 (42, 43, 44, 44)
    0.0 ± 13.7
    1.0 ± 13.2
    0.4 ± 12.8
    -1.2 ± 13.1
        Week 28 (44, 41, 41, 44)
    1.6 ± 13.4
    -1.3 ± 14.4
    1.7 ± 13.8
    -0.6 ± 16.5
        Week 32 (43, 43, 43, 42)
    1.7 ± 18.9
    1.1 ± 13.8
    1.2 ± 15.0
    -1.4 ± 16.0
        Week 40 (42, 43, 41, 44)
    3.4 ± 17.6
    0.8 ± 16.5
    0.1 ± 15.8
    0.1 ± 15.4
        Week 48 (38, 42, 39, 42)
    3.6 ± 17.1
    -0.6 ± 16.2
    2.9 ± 14.5
    0.0 ± 13.5
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin

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    End point title
    Mean change from baseline in Erythrocytes Mean Corpuscular Hemoglobin
    End point description
    Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: Picograms (pg)
    arithmetic mean (standard deviation)
        Week 2 (44, 42, 45, 42)
    0.12 ± 0.71
    -0.18 ± 0.65
    0.04 ± 0.43
    0.00 ± 0.47
        Week 4 (44, 44, 43, 46)
    0.31 ± 0.63
    -0.06 ± 0.79
    0.04 ± 0.64
    0.02 ± 0.65
        Week 8 (43, 44, 44, 44)
    0.20 ± 0.87
    -0.25 ± 0.87
    0.04 ± 0.81
    -0.04 ± 0.74
        Week 12 (44, 44, 44, 44)
    0.04 ± 1.08
    -0.25 ± 1.03
    -0.09 ± 1.25
    -0.12 ± 0.90
        Week 16 (44, 43, 43, 45)
    0.03 ± 1.43
    -0.36 ± 1.31
    -0.20 ± 1.52
    -0.31 ± 1.19
        Week 20 (43, 43, 41, 43)
    0.00 ± 1.49
    -0.39 ± 1.40
    -0.10 ± 1.63
    -0.26 ± 1.24
        Week 24 (42, 43, 44, 44)
    -0.13 ± 1.57
    -0.43 ± 1.39
    -0.25 ± 1.96
    -0.44 ± 1.42
        Week 28 (44, 41, 41, 44)
    0.01 ± 1.68
    -0.55 ± 1.45
    -0.15 ± 2.09
    -0.44 ± 1.68
        Week 32 (43, 43, 43, 42)
    0.01 ± 2.12
    -0.33 ± 1.28
    -0.06 ± 2.39
    -0.48 ± 1.63
        Week 40 (42, 43, 41, 44)
    0.17 ± 2.50
    -0.40 ± 1.30
    0.03 ± 2.32
    -0.09 ± 2.00
        Week 48 (38, 42, 39, 42)
    0.02 ± 2.58
    -0.21 ± 1.48
    0.06 ± 2.55
    0.10 ± 1.90
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Leukocytes

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    End point title
    Mean change from baseline in Leukocytes
    End point description
    Leukocytes was measured in number of leukocytes per liter (10^9/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: 10^9 leukocytes per liter
    arithmetic mean (standard deviation)
        Week 2 (44, 42, 45, 42)
    0.34 ± 2.45
    0.27 ± 1.23
    0.49 ± 1.46
    0.20 ± 1.62
        Week 4 (44, 44, 43, 46)
    0.10 ± 1.88
    0.27 ± 1.63
    0.25 ± 1.47
    0.52 ± 2.11
        Week 8 (43, 44, 44, 44)
    -0.25 ± 2.12
    0.46 ± 1.41
    -0.05 ± 1.50
    -0.10 ± 1.65
        Week 12 (44, 44, 44, 43)
    -0.27 ± 1.80
    0.18 ± 1.73
    0.17 ± 2.00
    0.23 ± 2.01
        Week 16 (44, 43, 43, 45)
    -0.31 ± 2.18
    0.13 ± 1.55
    0.21 ± 1.69
    -0.20 ± 2.12
        Week 20 (43, 43, 41, 43)
    -0.24 ± 2.27
    -0.06 ± 1.59
    -0.22 ± 1.74
    0.30 ± 2.61
        Week 24 (42, 43, 44, 44)
    -0.22 ± 2.41
    -0.12 ± 1.83
    -0.14 ± 1.75
    -0.34 ± 1.97
        Week 28 (44, 41, 41, 44)
    0.05 ± 2.04
    0.06 ± 1.93
    0.26 ± 2.04
    -0.58 ± 1.70
        Week 32 (43, 43, 43, 42)
    -0.14 ± 2.20
    0.08 ± 1.64
    0.19 ± 1.67
    -0.44 ± 1.68
        Week 40 (42, 43, 41, 44)
    0.17 ± 2.54
    0.04 ± 1.60
    -0.35 ± 1.49
    -0.49 ± 1.96
        Week 48 (38, 42, 39, 42)
    -0.49 ± 1.83
    0.30 ± 1.53
    -0.14 ± 2.06
    -0.62 ± 1.87
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Basophils

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    End point title
    Mean change from baseline in Basophils
    End point description
    Basophils was measured in number of basophils per liter (10^9/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: 10^9 basophils per liter
    arithmetic mean (standard deviation)
        Week 2 (42, 39, 44, 41)
    0.01 ± 0.03
    0.02 ± 0.04
    0.00 ± 0.03
    0.00 ± 0.02
        Week 4 (43, 43, 41, 46)
    0.01 ± 0.03
    0.00 ± 0.03
    0.01 ± 0.04
    0.00 ± 0.02
        Week 8 (42, 41, 43, 43)
    0.01 ± 0.04
    0.01 ± 0.04
    0.01 ± 0.03
    0.00 ± 0.02
        Week 12 (44, 40, 44, 42)
    0.01 ± 0.03
    0.01 ± 0.04
    0.00 ± 0.03
    0.00 ± 0.03
        Week 16 (43, 42, 43, 44)
    0.01 ± 0.04
    0.00 ± 0.03
    0.01 ± 0.03
    0.00 ± 0.03
        Week 20 (42, 40, 40, 42)
    0.00 ± 0.03
    0.01 ± 0.03
    0.00 ± 0.03
    0.00 ± 0.03
        Week 24 (41, 40, 44, 44)
    0.00 ± 0.03
    0.02 ± 0.04
    0.00 ± 0.03
    0.00 ± 0.03
        Week 28 (44, 39, 40, 44)
    0.02 ± 0.05
    0.01 ± 0.04
    0.00 ± 0.02
    0.00 ± 0.03
        Week 32 (41, 40, 43, 42)
    0.00 ± 0.03
    0.00 ± 0.02
    0.01 ± 0.03
    0.00 ± 0.03
        Week 40 (41, 42, 40, 43)
    0.00 ± 0.02
    0.00 ± 0.02
    0.01 ± 0.03
    0.00 ± 0.03
        Week 48 (37, 41, 39, 41)
    0.00 ± 0.03
    0.00 ± 0.02
    0.00 ± 0.03
    0.01 ± 0.03
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Basophils/Leukocytes

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    End point title
    Mean change from baseline in Basophils/Leukocytes
    End point description
    Basophils/Leukocytes was measured in percentages (%). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: % of Basophils per Leukocytes
    arithmetic mean (standard deviation)
        Week 2 (42, 39, 44, 41)
    -0.05 ± 0.23
    0.02 ± 0.20
    -0.05 ± 0.31
    -0.03 ± 0.27
        Week 4 (43, 43, 41, 46)
    0.03 ± 0.27
    -0.06 ± 0.26
    -0.01 ± 0.43
    -0.07 ± 0.26
        Week 8 (42, 41, 43, 43)
    0.08 ± 0.42
    0.03 ± 0.32
    0.00 ± 0.33
    -0.06 ± 0.23
        Week 12 (44, 40, 44, 42)
    0.04 ± 0.30
    0.09 ± 0.48
    0.00 ± 0.25
    -0.07 ± 0.28
        Week 16 (43, 42, 43, 44)
    0.01 ± 0.25
    0.00 ± 0.28
    -0.02 ± 0.31
    -0.05 ± 0.30
        Week 20 (42, 40, 40, 42)
    -0.02 ± 0.26
    0.00 ± 0.27
    -0.07 ± 0.29
    -0.04 ± 0.32
        Week 24 (41, 40, 44, 44)
    -0.04 ± 0.31
    0.15 ± 0.44
    -0.03 ± 0.24
    -0.03 ± 0.21
        Week 28 (44, 39, 40, 44)
    0.08 ± 0.54
    0.03 ± 0.29
    0.00 ± 0.24
    0.07 ± 0.32
        Week 32 (41, 40, 43, 42)
    -0.03 ± 0.29
    0.00 ± 0.23
    0.01 ± 0.25
    0.01 ± 0.25
        Week 40 (41, 42, 40, 43)
    -0.08 ± 0.24
    -0.03 ± 0.25
    0.07 ± 0.29
    0.01 ± 0.29
        Week 48 (37, 41, 39, 41)
    -0.01 ± 0.29
    -0.08 ± 0.21
    0.02 ± 0.25
    0.06 ± 0.28
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Eosinophils

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    End point title
    Mean change from baseline in Eosinophils
    End point description
    Eosinophils was measured in number of eosinophils per liter (10^9/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: 10^9 eosinophils per liter
    arithmetic mean (standard deviation)
        Week 2 (42, 39, 44, 41)
    -0.01 ± 0.04
    0.01 ± 0.06
    0.00 ± 0.09
    -0.01 ± 0.05
        Week 4 (43, 43, 41, 46)
    -0.01 ± 0.04
    -0.01 ± 0.06
    0.00 ± 0.04
    -0.01 ± 0.04
        Week 8 (42, 41, 43, 43)
    -0.01 ± 0.04
    0.03 ± 0.16
    0.00 ± 0.04
    0.01 ± 0.07
        Week 12 (44, 40, 44, 42)
    0.00 ± 0.04
    0.04 ± 0.20
    0.02 ± 0.10
    0.02 ± 0.17
        Week 16 (43, 42, 43, 44)
    0.00 ± 0.05
    0.02 ± 0.11
    0.01 ± 0.05
    0.00 ± 0.06
        Week 20 (42, 40, 40, 42)
    0.00 ± 0.05
    0.04 ± 0.24
    0.01 ± 0.05
    -0.01 ± 0.05
        Week 24 (41, 40, 44, 44)
    -0.01 ± 0.05
    0.04 ± 0.15
    0.02 ± 0.07
    -0.02 ± 0.06
        Week 28 (44, 39, 40, 44)
    -0.01 ± 0.04
    0.01 ± 0.07
    0.01 ± 0.05
    0.00 ± 0.06
        Week 32 (41, 40, 43, 42)
    -0.01 ± 0.06
    0.01 ± 0.10
    0.01 ± 0.05
    -0.02 ± 0.04
        Week 40 (41, 42, 40, 43)
    0.00 ± 0.05
    0.01 ± 0.06
    0.02 ± 0.06
    0.00 ± 0.07
        Week 48 (37, 41, 39, 41)
    0.00 ± 0.04
    -0.01 ± 0.05
    0.00 ± 0.06
    0.00 ± 0.06
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Eosinophils/Leukocytes

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    End point title
    Mean change from baseline in Eosinophils/Leukocytes
    End point description
    Eosinophils/Leukocytes was measured in percentages (%). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: % of Eosinophils per Leukocytes
    arithmetic mean (standard deviation)
        Week 2 (42, 39, 44, 41)
    -0.19 ± 1.07
    0.07 ± 0.86
    -0.18 ± 1.13
    -0.29 ± 1.22
        Week 4 (43, 43, 41, 46)
    -0.32 ± 0.96
    -0.05 ± 1.26
    -0.12 ± 1.01
    -0.26 ± 0.94
        Week 8 (42, 41, 43, 43)
    -0.05 ± 1.09
    0.54 ± 2.13
    0.10 ± 1.11
    0.22 ± 1.89
        Week 12 (44, 40, 44, 42)
    0.18 ± 1.03
    0.70 ± 3.12
    0.33 ± 1.68
    0.05 ± 1.83
        Week 16 (43, 42, 43, 44)
    0.06 ± 1.05
    0.36 ± 1.24
    0.20 ± 1.40
    -0.11 ± 1.33
        Week 20 (42, 40, 40, 42)
    0.04 ± 1.11
    0.83 ± 3.58
    0.11 ± 1.24
    -0.39 ± 1.29
        Week 24 (41, 40, 44, 44)
    0.11 ± 1.16
    0.82 ± 2.89
    -0.01 ± 1.22
    0.06 ± 1.63
        Week 28 (44, 39, 40, 44)
    0.06 ± 1.00
    0.21 ± 1.33
    0.18 ± 1.02
    -0.03 ± 1.35
        Week 32 (41, 40, 43, 42)
    0.02 ± 1.09
    0.28 ± 1.60
    0.16 ± 1.13
    -0.20 ± 1.03
        Week 40 (41, 42, 40, 43)
    -0.10 ± 0.85
    0.05 ± 1.09
    0.40 ± 1.23
    -0.09 ± 1.47
        Week 48 (37, 41, 39, 41)
    0.09 ± 1.02
    -0.17 ± 1.08
    0.06 ± 0.90
    0.24 ± 1.03
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Lymphocytes

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    End point title
    Mean change from baseline in Lymphocytes
    End point description
    Lymphocytes was measured in number of lymphocytes per liter (10^9/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: 10^9 lymphocytes per liter
    arithmetic mean (standard deviation)
        Week 2 (42, 39, 44, 41)
    -0.03 ± 0.39
    0.05 ± 0.36
    0.16 ± 0.29
    0.24 ± 0.37
        Week 4 (43, 43, 41, 46)
    -0.04 ± 0.36
    -0.01 ± 0.47
    -0.01 ± 0.41
    0.23 ± 0.42
        Week 8 (42, 41, 43, 43)
    -0.15 ± 0.48
    -0.03 ± 0.39
    0.06 ± 0.46
    0.14 ± 0.50
        Week 12 (44, 40, 44, 42)
    -0.06 ± 0.43
    0.02 ± 0.59
    0.01 ± 0.42
    0.21 ± 0.51
        Week 16 (43, 42, 43, 44)
    -0.09 ± 0.52
    -0.11 ± 0.51
    -0.02 ± 0.47
    0.04 ± 0.40
        Week 20 (42, 40, 40, 42)
    -0.14 ± 0.56
    -0.13 ± 0.54
    0.02 ± 0.39
    0.13 ± 0.55
        Week 24 (41, 40, 44, 44)
    -0.11 ± 0.51
    -0.08 ± 0.60
    -0.03 ± 0.45
    0.05 ± 0.52
        Week 28 (44, 39, 40, 44)
    -0.04 ± 0.57
    -0.02 ± 0.59
    0.01 ± 0.53
    0.03 ± 0.56
        Week 32 (41, 40, 43, 42)
    -0.11 ± 0.57
    -0.16 ± 0.59
    0.05 ± 0.45
    -0.02 ± 0.44
        Week 40 (41, 42, 40, 43)
    -0.11 ± 0.54
    -0.11 ± 0.52
    -0.11 ± 0.43
    -0.03 ± 0.48
        Week 48 (37, 41, 39, 41)
    -0.19 ± 0.68
    -0.19 ± 0.60
    -0.10 ± 0.44
    -0.02 ± 0.49
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Lymphocytes/Leukocytes

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    End point title
    Mean change from baseline in Lymphocytes/Leukocytes
    End point description
    Lymphocytes/Leukocytes was measured in percentages (%). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: % of Lymphocytes per Leukocytes
    arithmetic mean (standard deviation)
        Week 2 (42, 39, 44, 41)
    -1.88 ± 9.01
    0.19 ± 6.55
    1.18 ± 6.09
    2.61 ± 6.11
        Week 4 (43, 43, 41, 46)
    -0.88 ± 7.09
    -1.02 ± 6.34
    -1.18 ± 9.93
    0.97 ± 8.00
        Week 8 (42, 41, 43, 43)
    -1.98 ± 10.59
    -1.40 ± 7.13
    0.56 ± 10.20
    1.97 ± 8.51
        Week 12 (44, 40, 44, 42)
    0.21 ± 7.87
    0.56 ± 10.58
    -0.44 ± 9.90
    2.46 ± 10.18
        Week 16 (43, 42, 43, 44)
    -0.91 ± 8.33
    -1.49 ± 7.50
    -1.18 ± 9.65
    0.12 ± 9.34
        Week 20 (42, 40, 40, 42)
    -1.97 ± 10.37
    -0.66 ± 6.58
    0.88 ± 10.69
    0.71 ± 10.32
        Week 24 (41, 40, 44, 44)
    -0.75 ± 8.69
    -0.56 ± 7.35
    -0.52 ± 10.55
    1.85 ± 9.67
        Week 28 (44, 39, 40, 44)
    -1.18 ± 8.27
    -0.05 ± 8.51
    -0.05 ± 9.97
    1.61 ± 10.55
        Week 32 (41, 40, 43, 42)
    -1.59 ± 7.69
    -2.56 ± 6.51
    -0.16 ± 7.70
    0.70 ± 8.74
        Week 40 (41, 42, 40, 43)
    -2.60 ± 9.18
    -2.02 ± 5.99
    -1.36 ± 10.12
    0.33 ± 8.41
        Week 48 (37, 41, 39, 41)
    -1.46 ± 11.29
    -3.71 ± 7.41
    -0.84 ± 9.42
    1.69 ± 10.05
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Monocytes

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    End point title
    Mean change from baseline in Monocytes
    End point description
    Monocytes was measured in number of monocytes per liter (10^9/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: 10^9 monocytes per liter
    arithmetic mean (standard deviation)
        Week 2 (42, 39, 44, 41)
    -0.01 ± 0.17
    0.01 ± 0.18
    0.05 ± 0.14
    0.01 ± 0.13
        Week 4 (43, 43, 41, 46)
    0.01 ± 0.18
    0.04 ± 0.18
    0.01 ± 0.14
    0.06 ± 0.19
        Week 8 (42, 41, 43, 43)
    -0.03 ± 0.18
    0.04 ± 0.18
    0.03 ± 0.16
    0.02 ± 0.17
        Week 12 (44, 40, 44, 42)
    -0.01 ± 0.19
    0.00 ± 0.14
    0.04 ± 0.18
    0.06 ± 0.15
        Week 16 (43, 42, 43, 44)
    -0.01 ± 0.17
    0.01 ± 0.17
    0.05 ± 0.18
    0.03 ± 0.14
        Week 20 (42, 40, 40, 42)
    -0.03 ± 0.19
    0.00 ± 0.16
    0.00 ± 0.13
    0.05 ± 0.19
        Week 24 (41, 40, 44, 44)
    0.00 ± 0.19
    0.04 ± 0.19
    0.03 ± 0.17
    0.00 ± 0.17
        Week 28 (44, 39, 40, 44)
    0.00 ± 0.20
    0.04 ± 0.21
    0.08 ± 0.19
    0.02 ± 0.17
        Week 32 (41, 40, 43, 42)
    -0.01 ± 0.18
    0.02 ± 0.19
    0.05 ± 0.23
    -0.01 ± 0.19
        Week 40 (41, 42, 40, 43)
    0.03 ± 0.17
    0.05 ± 0.16
    0.04 ± 0.16
    -0.01 ± 0.18
        Week 48 (37, 41, 39, 41)
    -0.02 ± 0.20
    -0.01 ± 0.13
    0.03 ± 0.15
    -0.02 ± 0.18
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Monocytes/Leukocytes

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    End point title
    Mean change from baseline in Monocytes/Leukocytes
    End point description
    Monocytes/Leukocytes was measured in percentages (%). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: % of Monocytes per Leukocytes
    arithmetic mean (standard deviation)
        Week 2 (42, 39, 44, 41)
    -0.87 ± 2.50
    -0.07 ± 2.46
    0.23 ± 3.03
    -0.37 ± 2.25
        Week 4 (43, 43, 41, 46)
    0.26 ± 3.30
    0.27 ± 2.41
    -0.16 ± 3.11
    -0.24 ± 2.82
        Week 8 (42, 41, 43, 43)
    -0.21 ± 3.47
    0.07 ± 3.61
    0.51 ± 3.83
    0.08 ± 3.12
        Week 12 (44, 40, 44, 42)
    0.07 ± 2.79
    -0.11 ± 2.38
    0.22 ± 3.37
    0.45 ± 2.74
        Week 16 (43, 42, 43, 44)
    0.06 ± 3.30
    0.59 ± 2.85
    0.43 ± 3.31
    0.28 ± 3.13
        Week 20 (42, 40, 40, 42)
    -0.27 ± 3.84
    0.56 ± 3.08
    0.33 ± 3.81
    0.43 ± 3.39
        Week 24 (41, 40, 44, 44)
    0.06 ± 3.45
    0.84 ± 2.97
    0.46 ± 3.00
    0.41 ± 3.24
        Week 28 (44, 39, 40, 44)
    -0.24 ± 3.54
    0.69 ± 3.24
    0.64 ± 3.67
    0.94 ± 3.78
        Week 32 (41, 40, 43, 42)
    -0.08 ± 3.11
    0.13 ± 2.62
    0.46 ± 3.91
    -0.03 ± 3.76
        Week 40 (41, 42, 40, 43)
    0.49 ± 3.55
    0.64 ± 2.92
    0.83 ± 3.69
    0.59 ± 3.07
        Week 48 (37, 41, 39, 41)
    -0.04 ± 3.79
    -0.13 ± 2.41
    0.47 ± 3.82
    0.29 ± 3.30
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Neutrophils

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    End point title
    Mean change from baseline in Neutrophils
    End point description
    Neutrophils was measured in number of neutrophils per liter (10^9/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: 10^9 neutrophils per liter
    arithmetic mean (standard deviation)
        Week 2 (43, 39, 44, 41)
    0.28 ± 2.43
    0.26 ± 1.17
    0.17 ± 1.33
    -0.01 ± 1.46
        Week 4 (43, 43, 41, 46)
    0.07 ± 1.82
    0.27 ± 1.40
    0.21 ± 1.64
    0.23 ± 1.96
        Week 8 (42, 41, 43, 43)
    -0.13 ± 2.20
    0.41 ± 1.32
    -0.07 ± 1.53
    -0.20 ± 1.49
        Week 12 (44, 41, 44, 42)
    -0.24 ± 1.56
    0.20 ± 1.65
    0.10 ± 1.94
    -0.01 ± 2.03
        Week 16 (43, 42, 43, 44)
    -0.22 ± 2.13
    0.20 ± 1.41
    0.15 ± 1.61
    -0.20 ± 2.14
        Week 20 (42, 41, 40, 42)
    -0.07 ± 2.21
    0.01 ± 1.22
    -0.39 ± 1.69
    0.09 ± 2.51
        Week 24 (41, 40, 44, 44)
    -0.12 ± 2.24
    -0.06 ± 1.54
    -0.16 ± 1.77
    -0.38 ± 1.92
        Week 28 (44, 39, 40, 44)
    0.04 ± 1.81
    0.13 ± 1.64
    0.10 ± 1.91
    -0.62 ± 1.78
        Week 32 (41, 40, 43, 42)
    -0.07 ± 1.87
    0.33 ± 1.27
    0.07 ± 1.54
    -0.40 ± 1.67
        Week 40 (41, 42, 40, 43)
    0.16 ± 2.37
    0.16 ± 1.31
    -0.32 ± 1.57
    -0.41 ± 1.88
        Week 48 (37, 41, 39, 41)
    -0.29 ± 1.58
    0.55 ± 1.15
    -0.09 ± 2.02
    -0.54 ± 1.78
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Neutrophils/Leukocytes

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    End point title
    Mean change from baseline in Neutrophils/Leukocytes
    End point description
    Neutrophils/Leukocytes was measured in percentages (%). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: % of Neutrophils per Leukocytes
    arithmetic mean (standard deviation)
        Week 2 (42, 39, 44, 41)
    2.99 ± 10.73
    -0.21 ± 7.94
    -1.20 ± 8.40
    -1.93 ± 8.18
        Week 4 (43, 43, 41, 46)
    0.91 ± 9.37
    0.89 ± 7.82
    1.47 ± 12.70
    -0.37 ± 10.27
        Week 8 (42, 41, 43, 43)
    2.15 ± 12.95
    0.79 ± 8.80
    -1.17 ± 13.28
    -2.23 ± 10.92
        Week 12 (44, 40, 44, 42)
    -0.52 ± 9.44
    -1.25 ± 11.78
    -0.12 ± 13.18
    -2.90 ± 12.85
        Week 16 (43, 42, 43, 44)
    0.77 ± 11.02
    0.54 ± 8.50
    0.56 ± 12.48
    -0.24 ± 12.23
        Week 20 (42, 40, 40, 42)
    2.22 ± 13.21
    -0.73 ± 8.42
    -1.25 ± 14.29
    -0.71 ± 13.91
        Week 24 (41, 40, 44, 44)
    0.65 ± 11.48
    -1.25 ± 8.74
    0.10 ± 13.20
    -2.30 ± 12.41
        Week 28 (44, 39, 40, 44)
    1.28 ± 10.38
    -0.88 ± 10.56
    -0.77 ± 13.27
    -2.60 ± 13.79
        Week 32 (41, 40, 43, 42)
    1.67 ± 9.93
    2.15 ± 7.42
    -0.47 ± 9.80
    -0.48 ± 12.08
        Week 40 (41, 42, 40, 43)
    2.29 ± 11.66
    1.36 ± 6.95
    0.07 ± 13.23
    -0.93 ± 11.50
        Week 48 (37, 41, 39, 41)
    1.41 ± 13.58
    4.09 ± 8.40
    0.30 ± 12.47
    -2.28 ± 12.38
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Platelets

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    End point title
    Mean change from baseline in Platelets
    End point description
    Platelets was measured in number of platelets per liter (10^9/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: 10^9 platelets per liter
    arithmetic mean (standard deviation)
        Week 2 (41, 42, 45, 42)
    5.9 ± 33.2
    10.0 ± 40.0
    1.4 ± 47.5
    -1.0 ± 52.0
        Week 4 (43, 44, 43, 46)
    -5.2 ± 51.3
    0.0 ± 32.4
    4.9 ± 43.8
    8.1 ± 42.6
        Week 8 (42, 44, 44, 44)
    0.2 ± 45.3
    -0.3 ± 40.3
    3.9 ± 52.0
    -6.4 ± 40.5
        Week 12 (43, 43, 43, 44)
    -4.3 ± 50.6
    -1.7 ± 38.8
    -2.7 ± 49.0
    1.8 ± 49.4
        Week 16 (44, 43, 43, 45)
    0.7 ± 57.7
    -0.7 ± 40.5
    -1.5 ± 66.7
    -2.3 ± 68.1
        Week 20 (42, 43, 41, 42)
    9.2 ± 57.1
    -3.3 ± 43.0
    0.5 ± 44.6
    0.8 ± 64.4
        Week 24 (42, 41, 44, 43)
    0.2 ± 60.2
    -5.2 ± 43.8
    2.4 ± 68.6
    1.7 ± 67.0
        Week 28 (42, 41, 41, 44)
    3.6 ± 64.6
    1.8 ± 52.6
    -5.8 ± 71.9
    1.5 ± 64.4
        Week 32 (42, 42, 42, 40)
    4.0 ± 71.8
    -1.9 ± 55.4
    -4.6 ± 57.5
    9.9 ± 93.8
        Week 40 (42, 43, 41, 43)
    10.3 ± 74.9
    14.2 ± 52.7
    -8.8 ± 63.2
    -1.5 ± 67.4
        Week 48 (37, 42, 39, 42)
    7.1 ± 67.4
    3.5 ± 58.2
    -9.5 ± 70.9
    -8.8 ± 66.5
    No statistical analyses for this end point

    Secondary: Mean change from baseline in cluster of differentiation 3 (CD3)

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    End point title
    Mean change from baseline in cluster of differentiation 3 (CD3)
    End point description
    Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: cells/µL
    arithmetic mean (standard deviation)
        Week 2 (38, 40, 42, 40)
    33.0 ± 313.6
    77.7 ± 383.6
    106.6 ± 283.1
    126.9 ± 338.9
        Week 4 (39, 40, 40, 39)
    -30.6 ± 293.5
    -47.7 ± 504.3
    24.0 ± 394.9
    227.2 ± 412.1
        Week 8 (38, 40, 39, 40)
    -64.7 ± 405.7
    -58.6 ± 422.8
    -20.5 ± 403.2
    78.3 ± 560.0
        Week 12 (41, 41, 40, 40)
    -44.2 ± 283.2
    -48.8 ± 452.1
    -57.8 ± 385.1
    43.7 ± 599.3
        Week 16 (38, 42, 38, 42)
    -81.9 ± 479.4
    -141.2 ± 516.1
    -4.5 ± 383.2
    -45.4 ± 520.8
        Week 20 (40, 40, 39, 42)
    -92.7 ± 391.1
    -173.4 ± 490.9
    5.9 ± 352.9
    -89.9 ± 577.7
        Week 24 (39, 39, 42, 43)
    -85.8 ± 472.5
    -128.9 ± 569.4
    -88.5 ± 462.1
    -78.3 ± 570.7
        Week 28 (41, 40, 39, 38)
    -27.6 ± 507.3
    -81.2 ± 652.7
    46.1 ± 482.2
    7.4 ± 561.2
        Week 32 (41, 41, 41, 41)
    -70.9 ± 428.4
    -173.6 ± 565.8
    18.0 ± 415.0
    -90.5 ± 504.0
        Week 40 (40, 41, 39, 43)
    -110.5 ± 526.4
    -166.9 ± 542.2
    -1.8 ± 410.7
    31.7 ± 528.8
        Week 48 (35, 40, 35, 41)
    -115.6 ± 581.1
    -253.1 ± 637.0
    36.1 ± 492.3
    22.3 ± 558.0
    No statistical analyses for this end point

    Secondary: Mean change from baseline in CD3/Lymphocytes

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    End point title
    Mean change from baseline in CD3/Lymphocytes
    End point description
    CD3/Lymphocytes was measured in percentages (%). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: % of CD3 per Leukocytes
    arithmetic mean (standard deviation)
        Week 2 (38, 40, 42, 40)
    -0.7 ± 6.1
    -0.9 ± 4.6
    -2.0 ± 5.7
    -0.2 ± 7.8
        Week 4 (39, 40, 40, 39)
    -2.1 ± 7.3
    -0.5 ± 6.0
    -1.9 ± 5.0
    -0.5 ± 6.8
        Week 8 (38, 40, 39, 40)
    -0.9 ± 6.1
    -1.2 ± 4.8
    -2.6 ± 5.9
    0.6 ± 9.5
        Week 12 (41, 41, 40, 40)
    -0.4 ± 5.6
    -1.1 ± 8.2
    -2.4 ± 6.0
    -0.1 ± 9.2
        Week 16 (38, 42, 38, 42)
    -1.9 ± 5.8
    -1.6 ± 7.8
    -1.9 ± 7.6
    -1.4 ± 7.9
        Week 20 (40, 40, 39, 42)
    -0.8 ± 5.0
    0.0 ± 8.6
    -2.3 ± 6.9
    0.6 ± 9.2
        Week 24 (39, 39, 42, 43)
    0.0 ± 6.5
    -0.1 ± 8.8
    -1.8 ± 6.6
    18.7 ± 114.3
        Week 28 (41, 40, 39, 38)
    -0.2 ± 6.9
    0.2 ± 8.3
    -2.9 ± 7.2
    0.9 ± 10.2
        Week 32 (41, 41, 41, 41)
    -1.3 ± 7.0
    0.2 ± 7.9
    -1.8 ± 6.8
    1.4 ± 8.5
        Week 40 (40, 41, 39, 43)
    0.2 ± 6.7
    1.4 ± 6.9
    0.5 ± 6.5
    3.3 ± 7.9
        Week 48 (35, 40, 35, 41)
    1.3 ± 8.0
    0.3 ± 7.6
    0.1 ± 6.2
    4.5 ± 7.3
    No statistical analyses for this end point

    Secondary: Mean change from baseline in cluster of differentiation 19 (CD19)

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    End point title
    Mean change from baseline in cluster of differentiation 19 (CD19)
    End point description
    Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: cells/µL
    arithmetic mean (standard deviation)
        Week 2 (38, 40, 42, 40)
    9.6 ± 56.7
    12.3 ± 76.2
    24.8 ± 71.0
    63.4 ± 133.5
        Week 4 (39, 40, 40, 39)
    -2.8 ± 46.3
    -31.2 ± 177.0
    9.2 ± 60.5
    82.8 ± 154.5
        Week 8 (38, 40, 39, 40)
    -13.3 ± 72.9
    -29.4 ± 183.5
    8.7 ± 70.8
    19.4 ± 146.4
        Week 12 (41, 41, 40, 40)
    -2.6 ± 83.4
    -48.1 ± 207.1
    -17.9 ± 77.8
    53.2 ± 203.6
        Week 16 (38, 42, 38, 42)
    -12.5 ± 84.3
    -50.1 ± 201.5
    -10.0 ± 92.4
    13.2 ± 147.8
        Week 20 (40, 40, 39, 42)
    -15.1 ± 86.0
    -75.4 ± 216.6
    -2.5 ± 57.1
    2.7 ± 132.6
        Week 24 (39, 39, 42, 43)
    -15.0 ± 89.3
    -77.2 ± 231.9
    -20.3 ± 72.0
    -1.1 ± 135.0
        Week 28 (41, 40, 39, 38)
    -20.6 ± 106.7
    -69.6 ± 206.7
    -13.1 ± 84.5
    -13.0 ± 123.2
        Week 32 (41, 41, 41, 41)
    -14.3 ± 106.3
    -75.8 ± 225.7
    -10.4 ± 93.0
    -20.9 ± 168.1
        Week 40 (40, 41, 39, 43)
    -24.8 ± 103.3
    -68.6 ± 211.0
    -26.9 ± 83.0
    -46.9 ± 138.0
        Week 48 (35, 40, 35, 41)
    -37.0 ± 132.7
    -82.4 ± 243.7
    -15.5 ± 83.2
    -41.2 ± 120.0
    No statistical analyses for this end point

    Secondary: Mean change from baseline in CD19/Lymphocytes

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    End point title
    Mean change from baseline in CD19/Lymphocytes
    End point description
    CD19/Lymphocytes was measured in percentages (%). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: % of CD19 per Leukocytes
    arithmetic mean (standard deviation)
        Week 2 (38, 40, 42, 40)
    -0.3 ± 2.1
    -0.1 ± 3.0
    1.0 ± 3.5
    1.5 ± 5.9
        Week 4 (39, 40, 40, 39)
    0.0 ± 2.9
    -0.5 ± 3.7
    0.7 ± 3.3
    2.8 ± 5.7
        Week 8 (38, 40, 39, 40)
    0.1 ± 2.8
    -0.5 ± 4.2
    0.7 ± 2.5
    0.4 ± 6.4
        Week 12 (41, 41, 40, 40)
    -0.2 ± 3.2
    -1.0 ± 3.9
    -0.4 ± 3.1
    1.7 ± 7.9
        Week 16 (38, 42, 38, 42)
    0.0 ± 4.7
    -1.2 ± 5.0
    -0.4 ± 3.3
    0.7 ± 5.9
        Week 20 (40, 40, 39, 42)
    -0.4 ± 3.8
    -2.1 ± 6.2
    -0.3 ± 3.0
    -0.2 ± 6.9
        Week 24 (39, 39, 42, 43)
    -0.9 ± 4.5
    -2.0 ± 6.5
    -0.6 ± 3.3
    -0.3 ± 7.3
        Week 28 (41, 40, 39, 38)
    -1.2 ± 5.4
    -2.5 ± 5.9
    -1.1 ± 3.3
    -1.0 ± 6.6
        Week 32 (41, 41, 41, 41)
    -0.4 ± 4.7
    -2.4 ± 5.5
    -0.6 ± 4.4
    -1.6 ± 6.3
        Week 40 (40, 41, 39, 43)
    -1.2 ± 4.7
    -2.6 ± 5.4
    -1.9 ± 4.2
    -3.4 ± 6.7
        Week 48 (35, 40, 35, 41)
    -1.2 ± 6.8
    -2.6 ± 7.2
    -1.6 ± 4.9
    -3.3 ± 6.2
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Aspartate Aminotransferase

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    End point title
    Mean change from baseline in Aspartate Aminotransferase
    End point description
    Aspartate Aminotransferase was measured in units per liter (U/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: U/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 43)
    -0.5 ± 8.8
    0.2 ± 8.0
    4.3 ± 43.1
    0.0 ± 7.2
        Week 4 (44, 44, 43, 46)
    -0.1 ± 11.2
    0.2 ± 7.4
    -1.1 ± 7.6
    -1.9 ± 8.0
        Week 8 (44, 43, 44, 44)
    -0.1 ± 8.7
    -1.5 ± 6.2
    0.5 ± 13.0
    -1.1 ± 8.1
        Week 12 (44, 44, 45, 44)
    5.1 ± 27.0
    0.9 ± 6.2
    -1.8 ± 10.0
    -2.9 ± 7.1
        Week 16 (44, 44, 43, 45)
    0.4 ± 7.7
    0.0 ± 6.3
    -2.3 ± 11.6
    -2.8 ± 8.4
        Week 20 (43, 43, 41, 44)
    4.1 ± 24.1
    1.0 ± 11.5
    -0.7 ± 13.8
    -3.8 ± 8.1
        Week 24 (42, 43, 44, 44)
    0.6 ± 11.8
    1.6 ± 10.4
    -1.8 ± 11.5
    -3.8 ± 8.4
        Week 28 (43, 42, 40, 42)
    0.0 ± 12.3
    0.0 ± 10.2
    -1.5 ± 11.1
    -3.4 ± 9.1
        Week 32 (44, 44, 43, 44)
    -0.3 ± 11.0
    0.3 ± 6.8
    -0.7 ± 12.9
    -3.4 ± 9.2
        Week 40 (42, 42, 41, 44)
    -0.6 ± 10.2
    0.1 ± 9.1
    -0.3 ± 11.5
    -1.5 ± 9.8
        Week 48 (38, 42, 40, 43)
    1.1 ± 10.8
    0.1 ± 13.1
    1.4 ± 13.4
    -2.1 ± 8.6
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Alanine Aminotransferase

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    End point title
    Mean change from baseline in Alanine Aminotransferase
    End point description
    Alanine Aminotransferase was measured in units per liter (U/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: U/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 43)
    2.4 ± 14.1
    2.6 ± 10.6
    0.5 ± 11.1
    -0.1 ± 8.6
        Week 4 (44, 44, 43, 46)
    0.8 ± 9.9
    -0.5 ± 8.5
    0.9 ± 7.4
    0.3 ± 8.2
        Week 8 (44, 43, 44, 44)
    0.2 ± 10.2
    -0.8 ± 8.3
    5.3 ± 28.8
    -0.6 ± 9.6
        Week 12 (44, 44, 45, 44)
    7.0 ± 21.3
    0.8 ± 14.3
    -0.8 ± 8.1
    -0.1 ± 7.6
        Week 16 (44, 44, 43, 45)
    1.5 ± 13.3
    -0.4 ± 9.3
    0.0 ± 10.3
    -1.1 ± 7.8
        Week 20 (43, 43, 42, 44)
    5.3 ± 23.6
    -0.2 ± 10.2
    1.4 ± 10.8
    -3.7 ± 6.3
        Week 24 (42, 43, 44, 44)
    3.1 ± 20.9
    0.5 ± 14.1
    2.0 ± 12.0
    -2.8 ± 7.7
        Week 28 (43, 42, 40, 42)
    1.0 ± 13.9
    0.7 ± 10.5
    -0.4 ± 9.3
    -2.7 ± 7.2
        Week 32 (44, 44, 43, 44)
    1.2 ± 13.4
    -0.5 ± 10.3
    1.3 ± 10.8
    -3.2 ± 6.1
        Week 40 (42, 42, 41, 44)
    -0.5 ± 13.4
    2.6 ± 12.8
    3.0 ± 12.9
    -0.7 ± 8.3
        Week 48 (38, 42, 40, 43)
    0.4 ± 11.5
    -1.2 ± 10.4
    3.5 ± 17.0
    -1.1 ± 7.8
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Alkaline Phosphatase

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    End point title
    Mean change from baseline in Alkaline Phosphatase
    End point description
    Alkaline Phosphatase was measured in units per liter (U/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: U/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 44)
    1.8 ± 10.7
    2.4 ± 10.6
    1.5 ± 8.0
    -3.6 ± 10.1
        Week 4 (44, 44, 43, 46)
    -1.7 ± 9.7
    0.7 ± 9.2
    -0.7 ± 8.4
    -4.7 ± 9.4
        Week 8 (44, 43, 44, 44)
    1.7 ± 12.9
    2.4 ± 12.7
    1.8 ± 15.6
    -6.1 ± 11.0
        Week 12 (44, 44, 45, 44)
    2.2 ± 11.6
    4.2 ± 16.4
    1.9 ± 12.9
    -4.4 ± 11.8
        Week 16 (44, 45, 43, 45)
    3.1 ± 10.7
    2.7 ± 13.0
    0.0 ± 10.4
    -6.7 ± 12.8
        Week 20 (43, 45, 42, 44)
    3.9 ± 14.0
    1.4 ± 11.8
    1.4 ± 11.8
    -7.4 ± 11.2
        Week 24 (42, 43, 44, 44)
    4.7 ± 15.0
    3.7 ± 14.0
    2.8 ± 11.6
    -2.7 ± 14.0
        Week 28 (43, 43, 40, 43)
    2.8 ± 14.0
    3.1 ± 14.2
    1.9 ± 9.5
    -2.1 ± 13.5
        Week 32 (44, 44, 43, 45)
    3.8 ± 14.6
    2.7 ± 16.0
    3.2 ± 12.1
    1.0 ± 15.9
        Week 40 (42, 42, 41, 44)
    2.4 ± 17.1
    1.3 ± 13.1
    2.7 ± 13.0
    -3.0 ± 18.0
        Week 48 (38, 42, 40, 43)
    2.6 ± 13.3
    4.0 ± 16.8
    5.5 ± 12.8
    -4.5 ± 18.8
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Gamma Glutamyl Transferase

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    End point title
    Mean change from baseline in Gamma Glutamyl Transferase
    End point description
    Gamma Glutamyl Transferase was measured in units per liter (U/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: U/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 43)
    0.3 ± 7.6
    2.0 ± 11.5
    8.8 ± 68.9
    -3.4 ± 24.3
        Week 4 (44, 44, 43, 46)
    2.1 ± 8.7
    -1.3 ± 8.8
    2.7 ± 28.5
    -6.5 ± 35.5
        Week 8 (44, 43, 44, 44)
    3.5 ± 23.0
    0.3 ± 10.5
    -2.8 ± 49.3
    -9.2 ± 43.3
        Week 12 (44, 44, 45, 44)
    4.1 ± 21.0
    0.5 ± 13.4
    -5.1 ± 29.3
    -8.3 ± 46.1
        Week 16 (44, 45, 43, 45)
    6.5 ± 20.2
    2.1 ± 12.5
    -6.1 ± 45.0
    -10.6 ± 47.7
        Week 20 (43, 44, 42, 44)
    3.5 ± 14.1
    0.2 ± 13.4
    -3.7 ± 50.3
    -8.5 ± 50.5
        Week 24 (42, 43, 44, 44)
    7.1 ± 22.0
    4.0 ± 18.7
    -0.4 ± 53.1
    -9.5 ± 47.2
        Week 28 (43, 43, 40, 43)
    4.6 ± 25.7
    2.2 ± 18.3
    -7.0 ± 46.8
    0.0 ± 23.1
        Week 32 (44, 44, 43, 45)
    4.4 ± 28.6
    1.5 ± 16.7
    -5.9 ± 44.5
    -8.2 ± 37.4
        Week 40 (42, 42, 41, 44)
    3.4 ± 41.3
    5.7 ± 32.4
    0.4 ± 10.1
    -9.1 ± 45.3
        Week 48 (38, 42, 40,43 )
    1.8 ± 11.4
    5.3 ± 23.9
    4.7 ± 21.6
    -9.8 ± 44.5
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Bilirubin

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    End point title
    Mean change from baseline in Bilirubin
    End point description
    Bilirubin was measured in micromols per liter (µmol/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: μmol/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 43)
    0.35 ± 2.72
    -0.48 ± 2.71
    0.28 ± 2.38
    -0.78 ± 3.13
        Week 4 (44, 44, 43, 46)
    0.07 ± 2.50
    -0.18 ± 2.09
    -0.05 ± 2.14
    -0.79 ± 2.80
        Week 8 (44, 43, 44, 44)
    -0.09 ± 2.66
    -0.69 ± 2.22
    -0.19 ± 2.13
    -0.23 ± 2.80
        Week 12 (44, 44, 45, 44)
    -0.04 ± 2.60
    -0.70 ± 2.74
    0.37 ± 2.17
    -0.33 ± 3.28
        Week 16 (44, 45, 43, 45)
    0.06 ± 2.41
    -0.45 ± 2.43
    -0.20 ± 2.71
    -0.51 ± 3.64
        Week 20 (43, 43, 42, 44)
    -0.54 ± 2.89
    -0.38 ± 2.51
    0.51 ± 2.81
    -0.30 ± 3.03
        Week 24 (42, 43, 44, 44)
    0.08 ± 2.75
    -0.14 ± 2.86
    0.54 ± 2.18
    -0.38 ± 3.57
        Week 28 (43, 42, 40, 42)
    -0.10 ± 2.98
    -0.26 ± 3.23
    0.79 ± 2.71
    -0.82 ± 2.61
        Week 32 (44, 44, 43, 44)
    0.09 ± 2.75
    -0.38 ± 2.61
    0.93 ± 3.18
    -0.38 ± 3.61
        Week 40 (42, 42, 41, 44)
    -0.26 ± 3.70
    0.07 ± 3.18
    1.03 ± 2.35
    -0.15 ± 2.64
        Week 48 (38, 42, 40, 43)
    0.69 ± 3.57
    -0.50 ± 3.12
    0.79 ± 3.04
    -0.20 ± 2.52
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Direct Bilirubin

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    End point title
    Mean change from baseline in Direct Bilirubin
    End point description
    Direct Bilirubin was measured in micromols per liter (µmol/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: μmol/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 43)
    0.03 ± 0.92
    -0.06 ± 0.92
    0.09 ± 1.12
    -0.24 ± 1.10
        Week 4 (44, 44, 43, 46)
    0.10 ± 1.03
    0.03 ± 0.75
    -0.04 ± 0.82
    -0.10 ± 0.93
        Week 8 (44, 43, 44, 44)
    0.03 ± 0.91
    -0.18 ± 0.55
    -0.17 ± 0.86
    0.03 ± 1.10
        Week 12 (44, 44, 45, 44)
    0.15 ± 0.99
    -0.07 ± 0.95
    -0.01 ± 1.06
    -0.05 ± 1.30
        Week 16 (44, 45, 43, 45)
    0.18 ± 0.81
    -0.01 ± 0.66
    -0.07 ± 1.04
    -0.01 ± 1.40
        Week 20 (43, 43, 42, 44)
    -0.04 ± 0.95
    0.07 ± 0.91
    0.02 ± 0.94
    0.00 ± 1.19
        Week 24 (42, 43, 44, 44)
    0.05 ± 1.10
    0.14 ± 0.95
    0.08 ± 1.02
    -0.08 ± 1.25
        Week 28 (43, 42, 40, 42)
    0.06 ± 1.06
    -0.06 ± 1.00
    0.11 ± 0.80
    -0.06 ± 1.15
        Week 32 (44, 44, 43, 44)
    0.12 ± 1.16
    0.05 ± 0.90
    0.21 ± 1.21
    -0.04 ± 1.36
        Week 40 (42, 42, 41, 44)
    0.07 ± 1.31
    0.03 ± 0.76
    0.23 ± 1.00
    0.07 ± 1.05
        Week 48 (38, 42, 40, 43)
    0.31 ± 1.34
    -0.05 ± 1.01
    0.20 ± 1.25
    0.08 ± 0.98
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Lactate Dehydrogenase

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    End point title
    Mean change from baseline in Lactate Dehydrogenase
    End point description
    Lactate Dehydrogenase was measured in units per liter (U/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: U/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 44)
    -3.3 ± 27.8
    -7.8 ± 21.2
    -5.9 ± 35.2
    -12.8 ± 24.8
        Week 4 (44, 44, 43, 46)
    -3.0 ± 23.4
    -3.7 ± 37.0
    -5.6 ± 35.6
    -18.5 ± 34.1
        Week 8 (44, 43, 44, 44)
    -5.7 ± 27.4
    -11.8 ± 31.5
    -9.2 ± 39.0
    -20.4 ± 37.4
        Week 12 (44, 44, 45, 44)
    3.0 ± 28.7
    -7.4 ± 34.6
    -11.1 ± 45.1
    -24.4 ± 39.0
        Week 16 (44, 44, 43, 45)
    -2.2 ± 25.5
    -11.1 ± 29.9
    -10.6 ± 48.6
    -22.4 ± 43.3
        Week 20 (43, 45, 41, 44)
    -0.7 ± 33.9
    -10.8 ± 37.0
    -9.9 ± 47.8
    -28.5 ± 32.1
        Week 24 (42, 43, 44, 44)
    -4.5 ± 31.3
    -14.3 ± 31.5
    -14.6 ± 34.4
    -29.3 ± 32.2
        Week 28 (43, 43, 40, 43)
    0.0 ± 40.8
    -16.0 ± 40.9
    -13.2 ± 35.0
    -34.8 ± 36.9
        Week 32 (44, 44, 43, 45)
    5.0 ± 55.0
    -9.9 ± 43.4
    -8.1 ± 33.5
    -22.9 ± 40.6
        Week 40 (42, 42, 41, 44)
    -1.6 ± 38.1
    -2.9 ± 41.1
    -8.0 ± 28.4
    -20.5 ± 40.1
        Week 48 (38, 42, 40, 43)
    -8.8 ± 35.2
    -4.2 ± 54.3
    -1.5 ± 32.7
    -16.0 ± 36.3
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Creatinine

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    End point title
    Mean change from baseline in Creatinine
    End point description
    Creatinine was measured in micromols per liter (µmol/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: μmol/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 44)
    0.9 ± 9.1
    -0.1 ± 8.0
    1.5 ± 5.8
    0.6 ± 7.2
        Week 4 (44, 44, 43, 46)
    -0.8 ± 8.9
    -0.2 ± 9.3
    -0.6 ± 7.3
    -1.4 ± 8.2
        Week 8 (44, 43, 44, 44)
    0.5 ± 7.0
    0.3 ± 7.6
    -0.5 ± 6.9
    0.1 ± 8.4
        Week 12 (44, 44, 45, 44)
    -0.3 ± 7.0
    1.4 ± 7.5
    -0.4 ± 6.4
    -0.7 ± 8.2
        Week 16 (44, 45, 43, 45)
    -0.1 ± 9.8
    1.0 ± 8.2
    0.7 ± 6.8
    -1.1 ± 9.4
        Week 20 (43, 45, 42, 44)
    0.7 ± 8.6
    1.4 ± 10.2
    0.8 ± 6.9
    -0.3 ± 7.7
        Week 24 (42, 43, 44, 44)
    0.0 ± 8.8
    0.8 ± 8.8
    0.3 ± 6.6
    0.9 ± 9.7
        Week 28 (43, 43, 40, 43)
    2.5 ± 10.0
    2.7 ± 10.0
    1.0 ± 7.8
    -0.9 ± 7.8
        Week 32 (44, 44, 43, 45)
    5.5 ± 35.7
    0.5 ± 8.1
    3.6 ± 7.8
    1.6 ± 11.2
        Week 40 (42, 42, 41, 44)
    2.3 ± 9.5
    2.2 ± 8.5
    3.9 ± 6.0
    3.0 ± 8.4
        Week 48 (38, 42, 40, 43)
    1.9 ± 10.6
    0.7 ± 7.6
    2.5 ± 5.2
    2.9 ± 9.8
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Urea Nitrogen

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    End point title
    Mean change from baseline in Urea Nitrogen
    End point description
    Urea Nitrogen was measured in millimoles per liter (mmol/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: mmol/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 43)
    0.28 ± 1.55
    -0.09 ± 1.23
    -0.05 ± 1.32
    -0.02 ± 1.31
        Week 4 (44, 44, 43, 46)
    -0.07 ± 1.21
    -0.33 ± 1.52
    -0.14 ± 1.20
    0.04 ± 1.19
        Week 8 (44, 43, 44, 44)
    0.06 ± 1.25
    -0.26 ± 1.22
    -0.19 ± 1.07
    0.17 ± 1.59
        Week 12 (44, 44, 45, 44)
    0.03 ± 1.13
    -0.39 ± 1.31
    -0.29 ± 1.17
    -0.22 ± 1.15
        Week 16 (44, 45, 43, 45)
    0.19 ± 1.35
    -0.18 ± 1.40
    0.19 ± 1.49
    -0.03 ± 1.41
        Week 20 (43, 44, 42, 44)
    -0.18 ± 1.29
    -0.20 ± 1.33
    -0.25 ± 1.22
    -0.16 ± 1.08
        Week 24 (42, 43, 44, 44)
    0.08 ± 1.69
    -0.44 ± 1.38
    -0.13 ± 1.18
    -0.09 ± 1.50
        Week 28 (43, 43, 40, 43)
    0.13 ± 1.38
    0.03 ± 1.61
    -0.23 ± 1.26
    -0.22 ± 1.14
        Week 32 (44, 44, 43, 45)
    0.40 ± 2.37
    -0.30 ± 1.65
    0.21 ± 1.17
    0.10 ± 1.43
        Week 40 (42, 42, 41, 44)
    0.29 ± 1.54
    0.10 ± 1.73
    0.21 ± 1.20
    0.14 ± 1.43
        Week 48 (38, 42, 40, 43)
    0.05 ± 1.22
    -0.31 ± 1.54
    0.23 ± 1.38
    -0.02 ± 1.56
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Sodium

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    End point title
    Mean change from baseline in Sodium
    End point description
    Sodium was measured in millimoles per liter (mmol/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: mmol/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 44)
    -0.1 ± 1.9
    -0.4 ± 2.4
    0.1 ± 1.6
    0.0 ± 2.2
        Week 4 (44, 44, 43, 46)
    -0.3 ± 2.0
    -0.6 ± 2.1
    0.3 ± 2.1
    -0.1 ± 2.4
        Week 8 (44, 43, 44, 44)
    0.1 ± 2.2
    -0.4 ± 2.4
    0.3 ± 2.2
    0.1 ± 2.3
        Week 12 (44, 44, 45, 44)
    -0.3 ± 2.0
    -0.5 ± 2.0
    0.2 ± 2.0
    0.1 ± 2.3
        Week 16 (44, 45, 43, 45)
    -0.4 ± 2.3
    -0.2 ± 1.9
    0.0 ± 2.0
    -0.2 ± 2.3
        Week 20 (43, 45, 42, 44)
    0.3 ± 2.2
    -0.8 ± 2.2
    -0.1 ± 2.0
    -0.5 ± 2.4
        Week 24 (42, 43, 44, 44)
    -0.1 ± 2.5
    -0.4 ± 2.2
    0.0 ± 2.2
    -0.3 ± 2.1
        Week 28 (43, 43, 40, 43)
    0.0 ± 1.9
    -0.4 ± 2.4
    0.2 ± 1.9
    0.1 ± 2.3
        Week 32 (44, 44, 43, 45)
    0.0 ± 2.3
    -0.8 ± 3.2
    0.1 ± 2.1
    0.2 ± 2.2
        Week 40 (42, 42, 41, 44)
    -0.1 ± 2.2
    -1.2 ± 2.2
    -0.1 ± 1.6
    -0.3 ± 2.4
        Week 48 (38, 42, 40, 43)
    -0.4 ± 2.0
    -1.1 ± 2.6
    -0.5 ± 1.7
    0.2 ± 2.3
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Potassium

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    End point title
    Mean change from baseline in Potassium
    End point description
    Potassium was measured in millimoles per liter (mmol/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: mmol/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 44, 44)
    0.04 ± 0.45
    0.15 ± 0.40
    0.00 ± 0.36
    -0.03 ± 0.37
        Week 4 (44, 44, 43, 46)
    0.06 ± 0.44
    0.08 ± 0.35
    -0.07 ± 0.41
    -0.12 ± 0.40
        Week 8 (44, 43, 44, 44)
    -0.04 ± 0.40
    0.11 ± 0.38
    0.00 ± 0.35
    -0.07 ± 0.40
        Week 12 (44, 44, 44, 44)
    -0.01 ± 0.33
    0.02 ± 0.31
    -0.07 ± 0.41
    -0.12 ± 0.34
        Week 16 (44, 44, 43, 45)
    -0.01 ± 0.34
    0.16 ± 0.33
    -0.09 ± 0.42
    -0.05 ± 0.33
        Week 20 (43, 45, 40, 43)
    0.04 ± 0.38
    0.14 ± 0.33
    -0.04 ± 0.46
    -0.08 ± 0.37
        Week 24 (42, 43, 43, 43)
    0.06 ± 0.43
    0.07 ± 0.39
    0.03 ± 0.33
    -0.11 ± 0.37
        Week 28 (41, 43, 40, 43)
    0.09 ± 0.43
    0.12 ± 0.47
    0.06 ± 0.42
    0.03 ± 0.45
        Week 32 (44, 44, 43, 45)
    0.03 ± 0.44
    0.07 ± 0.44
    0.10 ± 0.46
    -0.05 ± 0.38
        Week 40 (42, 41, 41, 44)
    0.06 ± 0.33
    0.16 ± 0.51
    0.16 ± 0.39
    -0.06 ± 0.37
        Week 48 (38, 42, 40, 43)
    -0.01 ± 0.30
    0.00 ± 0.30
    -0.02 ± 0.39
    -0.07 ± 0.40
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Calcium

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    End point title
    Mean change from baseline in Calcium
    End point description
    Calcium was measured in millimoles per liter (mmol/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: mmol/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 44)
    0.008 ± 0.104
    -0.001 ± 0.103
    0.004 ± 0.088
    -0.008 ± 0.092
        Week 4 (44, 44, 43, 46)
    0.007 ± 0.108
    -0.018 ± 0.099
    -0.018 ± 0.090
    -0.001 ± 0.086
        Week 8 (44, 43, 44, 44)
    -0.006 ± 0.093
    -0.033 ± 0.117
    -0.014 ± 0.106
    -0.003 ± 0.089
        Week 12 (44, 44, 45, 44)
    0.006 ± 0.108
    -0.011 ± 0.121
    -0.013 ± 0.097
    -0.004 ± 0.111
        Week 16 (44, 45, 43, 45)
    -0.025 ± 0.106
    -0.004 ± 0.088
    -0.013 ± 0.095
    -0.024 ± 0.119
        Week 20 (43, 45, 42, 44)
    -0.036 ± 0.116
    -0.020 ± 0.084
    -0.015 ± 0.108
    0.005 ± 0.080
        Week 24 (42, 43, 44, 44)
    -0.027 ± 0.106
    -0.026 ± 0.094
    -0.012 ± 0.095
    0.007 ± 0.100
        Week 28 (43, 43, 40, 43)
    -0.031 ± 0.121
    -0.039 ± 0.091
    -0.016 ± 0.113
    -0.014 ± 0.092
        Week 32 (44, 44, 43, 45)
    0.003 ± 0.098
    -0.043 ± 0.099
    0.019 ± 0.107
    -0.001 ± 0.105
        Week 40 (42, 42, 41, 44)
    -0.027 ± 0.114
    -0.022 ± 0.115
    0.006 ± 0.115
    -0.012 ± 0.105
        Week 48 (38, 42, 40, 43)
    -0.013 ± 0.096
    -0.037 ± 0.119
    -0.004 ± 0.104
    -0.017 ± 0.110
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Phosphate

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    End point title
    Mean change from baseline in Phosphate
    End point description
    Phosphate was measured in millimoles per liter (mmol/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: mmol/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 44, 43)
    0.044 ± 0.163
    0.032 ± 0.192
    -0.047 ± 0.230
    0.033 ± 0.168
        Week 4 (44, 44, 43, 46)
    -0.004 ± 0.162
    -0.029 ± 0.185
    -0.070 ± 0.187
    0.020 ± 0.163
        Week 8 (44, 43, 44, 44)
    0.006 ± 0.178
    -0.063 ± 0.225
    -0.028 ± 0.207
    0.051 ± 0.187
        Week 12 (44, 44, 44, 44)
    0.029 ± 0.159
    -0.004 ± 0.149
    -0.015 ± 0.236
    0.045 ± 0.183
        Week 16 (44, 44, 43, 45)
    -0.010 ± 0.186
    0.012 ± 0.182
    -0.025 ± 0.195
    0.005 ± 0.178
        Week 20 (43, 43, 41, 43)
    -0.030 ± 0.208
    -0.037 ± 0.244
    -0.031 ± 0.177
    0.013 ± 0.187
        Week 24 (42, 43, 43, 43)
    -0.013 ± 0.181
    -0.042 ± 0.160
    -0.040 ± 0.229
    0.035 ± 0.200
        Week 28 (41, 42, 40, 42)
    -0.024 ± 0.189
    0.008 ± 0.238
    -0.031 ± 0.232
    0.037 ± 0.184
        Week 32 (44, 44, 43, 44)
    -0.002 ± 0.217
    -0.056 ± 0.223
    0.015 ± 0.220
    0.030 ± 0.190
        Week 40 (42, 41, 41, 44)
    0.018 ± 0.207
    0.009 ± 0.196
    -0.022 ± 0.208
    0.034 ± 0.224
        Week 48 (38, 41, 40, 43)
    0.032 ± 0.183
    -0.012 ± 0.167
    -0.044 ± 0.214
    0.035 ± 0.190
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Cholesterol

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    End point title
    Mean change from baseline in Cholesterol
    End point description
    Cholesterol was measured in millimoles per liter (mmol/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: mmol/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 43)
    0.00 ± 0.49
    -0.07 ± 0.46
    -0.06 ± 0.51
    -0.19 ± 0.47
        Week 4 (44, 44, 43, 46)
    -0.08 ± 0.49
    -0.03 ± 0.46
    -0.07 ± 0.68
    -0.07 ± 0.57
        Week 8 (44, 43, 44, 44)
    -0.09 ± 0.57
    -0.07 ± 0.46
    -0.15 ± 0.81
    -0.17 ± 0.59
        Week 12 (44, 44, 45, 44)
    -0.14 ± 0.72
    -0.16 ± 0.61
    -0.23 ± 0.68
    -0.10 ± 0.75
        Week 16 (44, 45, 43, 45)
    -0.16 ± 0.80
    -0.16 ± 0.66
    -0.35 ± 0.80
    -0.27 ± 0.72
        Week 20 (43, 44, 42, 44)
    -0.27 ± 0.77
    -0.22 ± 0.60
    -0.42 ± 0.81
    -0.23 ± 0.85
        Week 24 (42, 43, 44, 44)
    -0.12 ± 0.87
    -0.17 ± 0.66
    -0.28 ± 0.96
    -0.16 ± 0.78
        Week 28 (43, 43, 40, 43)
    -0.17 ± 0.89
    -0.37 ± 0.63
    -0.35 ± 0.97
    -0.29 ± 0.80
        Week 32 (44, 44, 43, 45)
    -0.13 ± 0.86
    -0.22 ± 0.63
    -0.16 ± 0.83
    -0.15 ± 0.81
        Week 40 (42, 42, 41, 44)
    -0.34 ± 0.87
    -0.25 ± 0.80
    -0.19 ± 0.77
    -0.13 ± 1.15
        Week 48 (38, 42, 40, 43)
    -0.40 ± 0.80
    -0.36 ± 0.74
    -0.23 ± 0.97
    -0.18 ± 1.09
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Triglycerides

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    End point title
    Mean change from baseline in Triglycerides
    End point description
    Triglycerides was measured in millimoles per liter (mmol/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: mmol/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 44)
    -0.176 ± 1.593
    0.046 ± 0.683
    0.110 ± 0.855
    0.183 ± 0.751
        Week 4 (44, 44, 43, 46)
    -0.189 ± 1.212
    -0.004 ± 0.510
    -0.030 ± 0.471
    0.084 ± 0.529
        Week 8 (44, 43, 44, 44)
    -0.182 ± 1.554
    0.076 ± 0.582
    -0.084 ± 0.498
    0.046 ± 0.585
        Week 12 (44, 44, 45, 44)
    -0.265 ± 1.445
    0.088 ± 0.713
    0.063 ± 0.578
    0.009 ± 0.514
        Week 16 (44, 45, 43, 45)
    -0.164 ± 1.345
    0.099 ± 1.488
    0.142 ± 0.580
    0.112 ± 1.035
        Week 20 (43, 45, 42, 44)
    -0.233 ± 1.391
    -0.104 ± 0.837
    0.008 ± 0.622
    -0.060 ± 0.707
        Week 24 (42, 43, 44, 44)
    -0.263 ± 1.515
    -0.045 ± 0.774
    -0.013 ± 0.608
    -0.030 ± 0.707
        Week 28 (43, 43, 40, 43)
    -0.013 ± 1.559
    -0.125 ± 0.782
    -0.043 ± 0.423
    -0.036 ± 0.663
        Week 32 (44, 44, 43, 45)
    -0.260 ± 1.418
    0.045 ± 0.717
    0.057 ± 0.532
    0.112 ± 0.718
        Week 40 (42, 42, 41, 44)
    -0.134 ± 1.175
    -0.159 ± 0.765
    0.177 ± 0.821
    0.022 ± 0.644
        Week 48 (38, 42, 40, 43)
    -0.242 ± 1.516
    -0.149 ± 0.758
    0.114 ± 0.507
    0.054 ± 0.752
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Protein

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    End point title
    Mean change from baseline in Protein
    End point description
    Protein was measured in grams per liter (g/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.Protein
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: g/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 44)
    -0.2 ± 3.7
    -1.2 ± 4.0
    -1.0 ± 4.2
    -1.1 ± 3.8
        Week 4 (44, 44, 43, 46)
    -1.5 ± 4.4
    -1.6 ± 4.2
    -1.5 ± 4.7
    -1.7 ± 4.4
        Week 8 (44, 43, 44, 44)
    -1.1 ± 4.4
    -2.1 ± 4.1
    -1.8 ± 5.7
    -2.0 ± 3.9
        Week 12 (44, 44, 45, 44)
    -0.8 ± 3.8
    -1.3 ± 4.7
    -1.4 ± 5.2
    -1.2 ± 5.8
        Week 16 (44, 45, 43, 45)
    -1.2 ± 5.2
    -0.3 ± 4.1
    -2.3 ± 5.6
    -3.8 ± 5.0
        Week 20 (43, 45, 42, 44)
    -2.7 ± 6.0
    -1.6 ± 4.6
    -2.6 ± 4.7
    -3.1 ± 5.4
        Week 24 (42, 43, 44, 44)
    -2.2 ± 7.5
    -1.8 ± 4.6
    -1.8 ± 5.5
    -2.0 ± 4.7
        Week 28 (43, 43, 40, 43)
    -3.1 ± 7.4
    -2.4 ± 4.6
    -2.5 ± 5.7
    -3.6 ± 6.4
        Week 32 (44, 44, 43, 45)
    -1.4 ± 6.9
    -1.5 ± 5.7
    -0.8 ± 5.0
    -1.9 ± 6.4
        Week 40 (42, 42, 41, 44)
    -2.2 ± 6.5
    -0.9 ± 5.0
    -1.8 ± 5.3
    -2.6 ± 6.1
        Week 48 (38, 42, 40, 43)
    -2.3 ± 6.2
    -2.4 ± 5.9
    -0.9 ± 5.1
    -3.4 ± 6.4
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Albumin

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    End point title
    Mean change from baseline in Albumin
    End point description
    Albumin was measured in grams per liter (g/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.Protein
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: g/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 44)
    0.1 ± 2.1
    -0.4 ± 2.4
    -0.5 ± 2.4
    -0.5 ± 1.9
        Week 4 (44, 44, 43, 46)
    -0.5 ± 2.4
    -0.4 ± 2.3
    -0.2 ± 2.4
    -0.3 ± 1.9
        Week 8 (44, 43, 44, 44)
    -0.3 ± 2.3
    -0.3 ± 2.5
    -0.3 ± 3.0
    0.1 ± 2.2
        Week 12 (44, 44, 45, 44)
    -0.1 ± 2.2
    0.2 ± 2.7
    0.2 ± 2.7
    0.7 ± 3.0
        Week 16 (44, 45, 43, 45)
    0.0 ± 2.5
    1.0 ± 2.5
    0.1 ± 2.9
    -0.2 ± 2.9
        Week 20 (43, 45, 42, 44)
    -0.7 ± 2.7
    0.1 ± 2.7
    0.4 ± 2.4
    0.4 ± 2.2
        Week 24 (42, 43, 44, 44)
    -0.1 ± 2.9
    0.0 ± 2.1
    0.4 ± 2.4
    1.2 ± 2.7
        Week 28 (43, 43, 40, 43)
    -0.7 ± 3.0
    -0.4 ± 2.3
    0.1 ± 2.9
    0.1 ± 2.6
        Week 32 (44, 44, 43, 45)
    0.6 ± 2.8
    -0.1 ± 3.0
    0.9 ± 3.2
    0.7 ± 2.8
        Week 40 (42, 42, 41, 44)
    0.1 ± 2.8
    -0.1 ± 2.9
    0.2 ± 2.6
    0.3 ± 3.0
        Week 48 (38, 42, 40, 43)
    0.1 ± 2.8
    -0.7 ± 3.0
    0.2 ± 3.0
    -0.8 ± 3.5
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Glucose

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    End point title
    Mean change from baseline in Glucose
    End point description
    Glucose was measured in millimoles per liter (mmol/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: mmol/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 44, 43)
    0.18 ± 0.75
    0.26 ± 0.70
    0.09 ± 0.78
    0.13 ± 1.28
        Week 4 (44, 44, 43, 46)
    0.04 ± 0.71
    0.03 ± 0.70
    -0.04 ± 0.90
    0.11 ± 1.10
        Week 8 (44, 43, 44, 44)
    0.17 ± 0.66
    0.12 ± 0.90
    0.23 ± 0.95
    0.12 ± 1.16
        Week 12 (44, 44, 43, 44)
    -0.08 ± 0.69
    0.08 ± 0.66
    -0.13 ± 0.79
    -0.15 ± 0.99
        Week 16 (44, 45, 43, 45)
    0.11 ± 0.77
    0.06 ± 0.63
    0.16 ± 0.92
    -0.18 ± 1.47
        Week 20 (43, 44, 42, 43)
    0.16 ± 0.85
    0.20 ± 0.84
    0.13 ± 0.83
    -0.08 ± 1.01
        Week 24 (42, 43, 43, 43)
    -0.07 ± 0.85
    0.05 ± 0.49
    -0.09 ± 0.73
    -0.22 ± 1.06
        Week 28 (39, 43, 40, 43)
    0.22 ± 1.01
    0.09 ± 0.76
    -0.01 ± 0.74
    0.07 ± 1.22
        Week 32 (44, 44, 42, 45)
    -0.04 ± 0.72
    -0.07 ± 0.63
    -0.08 ± 0.65
    0.06 ± 1.10
        Week 40 (41, 41, 41, 44)
    -0.05 ± 0.62
    0.08 ± 0.71
    -0.09 ± 0.68
    -0.08 ± 1.07
        Week 48 (38, 42, 40, 43)
    -0.14 ± 0.78
    -0.11 ± 0.61
    -0.06 ± 0.64
    -0.14 ± 1.25
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Lipase, Pancreatic

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    End point title
    Mean change from baseline in Lipase, Pancreatic
    End point description
    Lipase, Pancreatic was measured in units per liter (U/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: U/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 44)
    -1.1 ± 10.5
    2.2 ± 11.9
    0.1 ± 9.2
    -0.2 ± 7.5
        Week 4 (44, 44, 43, 46)
    -2.1 ± 9.8
    0.9 ± 9.1
    0.1 ± 10.6
    -1.2 ± 10.0
        Week 8 (44, 43, 44, 44)
    -3.1 ± 9.2
    3.7 ± 11.8
    2.0 ± 20.0
    -1.8 ± 10.3
        Week 12 (44, 44, 45, 44)
    -0.5 ± 8.7
    1.0 ± 11.1
    -0.7 ± 13.4
    -0.6 ± 9.6
        Week 16 (44, 45, 43, 45)
    0.4 ± 7.4
    2.7 ± 8.4
    0.5 ± 11.3
    -0.2 ± 11.8
        Week 20 (43, 45, 42, 44)
    -0.6 ± 10.4
    2.1 ± 8.0
    -0.9 ± 9.0
    -1.7 ± 9.3
        Week 24 (42, 43, 44, 44)
    -0.5 ± 11.0
    -0.1 ± 9.1
    -0.1 ± 8.1
    1.2 ± 11.8
        Week 28 (43, 43, 40, 43)
    1.6 ± 13.1
    1.7 ± 10.5
    0.5 ± 11.9
    1.7 ± 14.1
        Week 32 (44, 44, 43, 45)
    1.1 ± 15.1
    1.0 ± 11.0
    1.2 ± 10.6
    3.8 ± 21.6
        Week 40 (42, 42, 41, 44)
    1.2 ± 11.0
    1.3 ± 7.0
    -0.3 ± 8.9
    2.5 ± 8.9
        Week 48 (38, 42, 40, 43)
    1.4 ± 10.1
    2.2 ± 10.0
    0.3 ± 10.7
    3.7 ± 10.2
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Creatine Kinase

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    End point title
    Mean change from baseline in Creatine Kinase
    End point description
    Creatine Kinase was measured in units per liter (U/L). Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: U/L
    arithmetic mean (standard deviation)
        Week 2 (42, 45, 45, 43)
    -3.0 ± 67.1
    -2.2 ± 55.6
    -2.2 ± 18.2
    0.1 ± 46.5
        Week 4 (44, 44, 43, 46)
    29.6 ± 218.4
    -6.2 ± 54.8
    3.2 ± 22.0
    -16.9 ± 56.5
        Week 8 (44, 43, 44, 44)
    -4.9 ± 56.9
    -8.5 ± 52.7
    -1.5 ± 23.6
    -4.6 ± 122.1
        Week 12 (44, 44, 45, 44)
    -6.3 ± 57.5
    -8.4 ± 85.8
    -3.0 ± 22.4
    -29.4 ± 80.7
        Week 16 (44, 45, 43, 45)
    0.9 ± 59.4
    -11.5 ± 105.1
    -7.5 ± 22.2
    -23.2 ± 106.3
        Week 20 (43, 43, 42, 44)
    -8.2 ± 60.0
    5.9 ± 149.1
    -3.5 ± 22.2
    -33.4 ± 95.3
        Week 24 (42, 43, 44, 44)
    -6.4 ± 48.6
    -5.4 ± 123.7
    -2.6 ± 27.4
    -27.7 ± 98.9
        Week 28 (43, 42, 40, 43)
    -1.5 ± 67.3
    -19.1 ± 131.5
    -0.7 ± 25.4
    -36.7 ± 103.8
        Week 32 (44, 44, 43, 45)
    2.0 ± 67.0
    -10.0 ± 167.0
    34.0 ± 222.1
    -24.2 ± 91.2
        Week 40 (42, 42, 41, 44)
    9.9 ± 109.1
    -20.4 ± 131.4
    -2.7 ± 25.4
    -16.3 ± 106.4
        Week 48 (38, 42, 40, 43)
    7.8 ± 67.3
    -20.4 ± 138.3
    -3.6 ± 25.5
    -33.4 ± 106.5
    No statistical analyses for this end point

    Secondary: Mean change from baseline in pH

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    End point title
    Mean change from baseline in pH
    End point description
    Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: pH
    arithmetic mean (standard deviation)
        Week 2 (43, 43, 44, 43)
    -0.01 ± 0.66
    0.03 ± 0.62
    -0.07 ± 0.67
    0.15 ± 0.78
        Week 4 (43, 43, 43, 43)
    0.10 ± 0.77
    0.15 ± 0.52
    0.06 ± 0.72
    0.16 ± 0.74
        Week 8 (42, 44, 44, 42)
    -0.12 ± 0.79
    0.00 ± 0.62
    -0.08 ± 0.56
    -0.04 ± 0.65
        Week 12 (44, 43, 43, 42)
    0.00 ± 0.81
    0.15 ± 0.69
    0.03 ± 0.79
    0.20 ± 0.83
        Week 16 (44, 45, 39, 45)
    -0.02 ± 0.61
    0.00 ± 0.51
    -0.09 ± 0.81
    0.11 ± 0.69
        Week 20 (42, 43, 41, 43)
    -0.11 ± 0.75
    -0.01 ± 0.59
    0.06 ± 0.58
    0.07 ± 0.88
        Week 24 (43, 42, 44, 42)
    0.03 ± 0.85
    -0.01 ± 0.46
    -0.11 ± 0.81
    0.02 ± 0.81
        Week 28 (44, 42, 42, 41)
    -0.13 ± 0.84
    -0.06 ± 0.57
    -0.05 ± 0.73
    -0.01 ± 0.69
        Week 32 (44, 44, 42, 43)
    -0.02 ± 0.75
    -0.03 ± 0.55
    -0.18 ± 0.66
    0.09 ± 0.86
        Week 40 (42, 43, 41, 44)
    -0.14 ± 0.81
    0.19 ± 0.66
    -0.21 ± 0.81
    -0.07 ± 0.62
        Week 48 (38, 42, 40, 43)
    -0.11 ± 0.66
    0.06 ± 0.73
    -0.11 ± 0.74
    -0.08 ± 0.72
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Erythrocytes (/HPF)

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    End point title
    Mean change from baseline in Erythrocytes (/HPF)
    End point description
    Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: % of Erythrocytes per HPF
    arithmetic mean (standard deviation)
        Week 2 (43, 43, 44, 43)
    -6.8 ± 53.7
    0.1 ± 8.4
    0.2 ± 2.4
    0.9 ± 7.9
        Week 4 (43, 43, 43, 43)
    -8.7 ± 52.6
    -0.8 ± 4.1
    1.4 ± 10.5
    -0.6 ± 3.2
        Week 8 (42, 44, 44, 42)
    -8.7 ± 53.5
    -0.3 ± 6.9
    0.4 ± 6.1
    0.0 ± 6.8
        Week 12 (44, 43, 43, 42)
    -8.6 ± 52.6
    1.3 ± 17.4
    -0.4 ± 2.4
    17.4 ± 118.5
        Week 16 (43, 45, 39, 45)
    -5.7 ± 48.0
    -1.3 ± 4.1
    -0.6 ± 2.6
    -0.5 ± 5.5
        Week 20 (42, 43, 41, 43)
    -7.7 ± 53.7
    -1.0 ± 3.5
    -0.1 ± 3.9
    -0.6 ± 4.4
        Week 24 (43, 42, 44, 42)
    -7.2 ± 53.5
    -1.2 ± 3.9
    -0.3 ± 2.3
    -0.9 ± 4.6
        Week 28 (44, 42, 42, 41)
    -7.6 ± 51.3
    -1.3 ± 4.2
    -0.7 ± 2.9
    3.0 ± 16.9
        Week 32 (44, 44, 42, 43)
    -8.5 ± 52.5
    4.9 ± 41.8
    0.0 ± 3.9
    0.1 ± 4.5
        Week 40 (42, 43, 41, 44)
    -9.1 ± 53.2
    3.5 ± 18.8
    -0.5 ± 3.5
    0.4 ± 5.4
        Week 48 (38, 42, 40, 43)
    -9.7 ± 56.3
    -0.4 ± 5.4
    1.9 ± 15.5
    0.1 ± 4.0
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Leukocytes (/HPF)

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    End point title
    Mean change from baseline in Leukocytes (/HPF)
    End point description
    Note: The number of participants analyzed in each Week are presented in parentheses following this model (n1, n2, n3, n4) where: n1 = number of participants analyzed in the SOC + Placebo iv Q4W (SS) group; n2 = number of participants analyzed in the SOC + DZP dose 1 iv Q4W (SS) group; n3 = number of participants analyzed in the SOC + DZP dose 2 iv Q4W (SS) group; n4 = number of participants analyzed in the SOC + DZP dose 3 iv Q4W (SS) group.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 1) to Week 48
    End point values
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Number of subjects analysed
    45
    45
    45
    47
    Units: % of Leukocytes per HPF
    arithmetic mean (standard deviation)
        Week 2 (43, 43, 44, 43)
    -0.1 ± 11.4
    -1.4 ± 8.1
    -0.8 ± 2.9
    2.9 ± 13.7
        Week 4 (43, 43, 43, 43)
    -0.2 ± 9.0
    -0.6 ± 8.5
    -0.7 ± 4.5
    3.0 ± 12.6
        Week 8 (42, 44, 44, 42)
    -1.2 ± 10.4
    4.8 ± 29.3
    -0.3 ± 6.8
    3.0 ± 14.4
        Week 12 (44, 43, 43, 42)
    -1.1 ± 11.3
    4.4 ± 42.2
    -1.3 ± 4.2
    2.7 ± 13.9
        Week 16 (43, 45, 39, 45)
    0.1 ± 9.6
    -1.6 ± 12.5
    -0.2 ± 9.6
    1.8 ± 12.9
        Week 20 (42, 43, 41, 43)
    -0.1 ± 10.1
    3.7 ± 13.3
    0.4 ± 9.8
    1.7 ± 4.0
        Week 24 (43, 42, 44, 42)
    -1.0 ± 10.9
    10.7 ± 52.1
    -0.7 ± 4.5
    0.4 ± 4.5
        Week 28 (44, 42, 42, 41)
    -0.2 ± 9.6
    2.4 ± 9.7
    -1.1 ± 4.4
    2.0 ± 10.1
        Week 32 (44, 44, 42, 43)
    -0.6 ± 10.8
    -0.5 ± 13.5
    -1.0 ± 5.4
    4.1 ± 15.7
        Week 40 (42, 43, 41, 44)
    -1.6 ± 10.4
    2.2 ± 19.8
    1.4 ± 7.7
    6.8 ± 30.9
        Week 48 (38, 42, 40, 43)
    -0.3 ± 8.9
    10.8 ± 71.9
    -1.0 ± 4.0
    0.8 ± 5.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from Baseline (Week 1) until 12 weeks after the last dose of study drug.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    SOC + Placebo iv Q4W (SS)
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).

    Reporting group title
    SOC + DZP dose 1 iv Q4W (SS)
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 1 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.

    Reporting group title
    SOC + DZP dose 2 iv Q4W (SS)
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 2 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.

    Reporting group title
    SOC + DZP dose 3 iv Q4W (SS)
    Reporting group description
    This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) dose 3 intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.

    Serious adverse events
    SOC + Placebo iv Q4W (SS) SOC + DZP dose 1 iv Q4W (SS) SOC + DZP dose 2 iv Q4W (SS) SOC + DZP dose 3 iv Q4W (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 45 (11.11%)
    2 / 45 (4.44%)
    4 / 45 (8.89%)
    5 / 47 (10.64%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Pneumothorax
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    1 / 45 (2.22%)
    0 / 47 (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
    Pulmonary embolism
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all