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    Clinical Trial Results:
    A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ

    Summary
    EudraCT number
    		 2020-005054-19
    Trial protocol
    		 CZ   BG   DE   BE   ES  
    Global end of trial date
    06 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 May 2025
    First version publication date
    22 May 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MOR202C206
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05065970
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biogen
    Sponsor organisation address
    225 Binney Street, Cambridge, Massachusetts, United States, 02142
    Public contact
    Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
    Scientific contact
    Biogen Study Medical Director, Biogen, clinicaltrials@biogen.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
    06 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the efficacy of Felzartamab compared to placebo in participants with IgAN based on the change in urine protein to creatinine ratio (UPCR) at 9 months.
    Protection of trial subjects
    Written informed consent was obtained from each subject’s parent or legal guardian prior to evaluations being performed for eligibility. Adequate time to review the information in the informed consent and ask questions concerning all portions of the conduct of the study was provided. Through the informed consent process, awareness of the purpose of the study, the procedures, the benefits and risks of the study, the discomforts and the precautions taken was made. Any side effects or other health issues occurring during the study were followed up by the study doctor. Subjects were able to stop taking part in the study at any time without giving any reason.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Czechia: 8
    Country: Number of subjects enrolled
    Georgia: 3
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Japan: 8
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Malaysia: 1
    Country: Number of subjects enrolled
    Philippines: 2
    Country: Number of subjects enrolled
    Serbia: 4
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Ukraine: 3
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    54
    EEA total number of subjects
    24
    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)
    52
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at the investigative sites in Belgium, Bulgaria, Czechia, Georgia, Germany, Japan, Republic of Korea, Malaysia, Philippines, Serbia, Spain, Taiwan, Ukraine, and the United States from 31 August 2021 to 06 May 2024.

    Pre-assignment
    Screening details
    		 A total of 54 participants diagnosed with Immunoglobulin A Nephropathy (IgAN) were enrolled in the study, of which 48 participants completed the study. The study had 2 parts - Part 1 (Global Cohort) and Part 2 (Japanese Cohort).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The Global Study (Part I) was double-blind and the Japanese Cohort (Part II) was open-label.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Part 1: Placebo
    Arm description
    		 Participants were administered felzartamab matching placebo as an intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Arm title
    		 Part 1: Felzartamab Dosing Arm M1
    Arm description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Felzartamab
    Investigational medicinal product code
    MOR202
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Arm title
    		 Part 1: Felzartamab Dosing Arm M2
    Arm description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Felzartamab
    Investigational medicinal product code
    MOR202
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Arm title
    		 Part 1: Felzartamab Dosing Arm M3
    Arm description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Felzartamab
    Investigational medicinal product code
    MOR202
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Arm title
    		 Part 2: Japan Cohort
    Arm description
    		 Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Felzartamab
    Investigational medicinal product code
    MOR202
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Number of subjects in period 1
    		Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3 Part 2: Japan Cohort
    Started
    12
    12
    11
    13
    6
    Completed
    10
    11
    9
    12
    6
    Not completed
    2
    1
    2
    1
    0
         Withdrawal of Consent
    1
    1
    1
    -
    -
         Requires Prohibited Medication
    -
    -
    1
    1
    -
         Investigator Decision
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 Participants were administered felzartamab matching placebo as an intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.

    Reporting group title
    Part 1: Felzartamab Dosing Arm M1
    Reporting group description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.

    Reporting group title
    Part 1: Felzartamab Dosing Arm M2
    Reporting group description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.

    Reporting group title
    Part 1: Felzartamab Dosing Arm M3
    Reporting group description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.

    Reporting group title
    Part 2: Japan Cohort
    Reporting group description
    		 Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.

    Reporting group values
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3 Part 2: Japan Cohort Total
    Number of subjects
    		 12 12 11 13 6
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.6 ( 11.84 ) 47.4 ( 10.41 ) 35.1 ( 14.31 ) 39.2 ( 7.20 ) 51.7 ( 14.19 ) -
    Gender categorical
    Units: Subjects
        Male
    		 9 6 8 10 3 36
        Female
    		 3 6 3 3 3 18
    Race
    Units: Subjects
        White
    		 9 6 9 9 0 33
        American Indian or Alaska Native
    		 0 1 0 0 0 1
        Asian
    		 3 5 2 4 6 20
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 1 0 2 0 4
        Not Hispanic or Latino
    		 11 8 8 8 6 41
        Not Reported
    		 0 2 3 3 0 8
        Unknown
    		 0 1 0 0 0 1
    Urine Protein to Creatinine Ratio (UPCR)
    Units: gram per gram (g/g)
        arithmetic mean (standard deviation)
    		 2.04 ( 1.158 ) 1.57 ( 0.742 ) 1.76 ( 0.828 ) 1.69 ( 1.301 ) 1.02 ( 0.324 ) -
    Subject analysis sets

    Subject analysis set title
    All Felzartamab and Placebo-Treated Participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who received felzartamab or placebo during the study with evaluable IgA data and evaluable felzartamab serum concentrations (in felzartamab-treated participants only) divided into exposure quartiles.

    Subject analysis set title
    All Felzartamab-Treated Participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who received felzartamab during the study and had evaluable maximum felzartamab serum concentrations after the first dose.

    Subject analysis sets values
    		 All Felzartamab and Placebo-Treated Participants All Felzartamab-Treated Participants
    Number of subjects
    45
    39
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    0 ( 0 )
    0 ( 0 )
    Gender categorical
    Units: Subjects
        Male
    0
    0
        Female
    0
    0
    Race
    Units: Subjects
        White
    0
    0
        American Indian or Alaska Native
    0
    0
        Asian
    0
    0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0
    0
        Not Hispanic or Latino
    0
    0
        Not Reported
    0
    0
        Unknown
    0
    0
    Urine Protein to Creatinine Ratio (UPCR)
    Units: gram per gram (g/g)
        arithmetic mean (standard deviation)
    0 ( 0 )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 Participants were administered felzartamab matching placebo as an intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.

    Reporting group title
    Part 1: Felzartamab Dosing Arm M1
    Reporting group description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.

    Reporting group title
    Part 1: Felzartamab Dosing Arm M2
    Reporting group description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.

    Reporting group title
    Part 1: Felzartamab Dosing Arm M3
    Reporting group description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.

    Reporting group title
    Part 2: Japan Cohort
    Reporting group description
    		 Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.

    Subject analysis set title
    All Felzartamab and Placebo-Treated Participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who received felzartamab or placebo during the study with evaluable IgA data and evaluable felzartamab serum concentrations (in felzartamab-treated participants only) divided into exposure quartiles.

    Subject analysis set title
    All Felzartamab-Treated Participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who received felzartamab during the study and had evaluable maximum felzartamab serum concentrations after the first dose.

    Primary: Relative Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) in 24-hour Urine at Month 9

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    End point title
    		 Relative Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) in 24-hour Urine at Month 9 [1]
    End point description
    Proteinuria is high levels of protein in the urine and is measured by UPCR. Relative change in UPCR was estimated based on a mixed effects model for repeated measure (MMRM) model. Least squares (LS) mean and standard error (SE) were reported. The reference proteinuria value before start of treatment is defined as the mean of the values determined at screening and prior to baseline (visit 2) predose (UPCR from 24h urine). Negative change from baseline indicates less proteinuria. The full analysis set (FAS) included all participants randomized to Part 1 of the study. ‘Overall number of participants analyzed’ signifies number of participants with data available for outcome measure analysis.
    End point type
    Primary
    End point timeframe
    Baseline, Month 9
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo and Felzartamab dosing arms were planned to be analysed for this end point.
    End point values
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3
    Number of subjects analysed
    11
    11
    9
    12
    Units: gram per gram (g/g)
        least squares mean (standard error)
    -24.7 ( 19.43 )
    -16.5 ( 19.41 )
    -30.6 ( 21.72 )
    -38.5 ( 16.60 )
    Statistical analysis title
    		 Part 1: Placebo, Part 1: Felzartamab M2
    Statistical analysis description
    In the MMRM model, the ratio of post baseline UPCR over baseline UPCR at month 9 in log scale was response variable, while baseline UPCR in log scale, treatment, visit, treatment by visit interaction were fixed effect covariates.
    Comparison groups
    Part 1: Placebo v Part 1: Felzartamab Dosing Arm M2
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7599 [2]
    Method
    		 MMRM
    Parameter type
    		 Geometric LS Mean Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.57
    Notes
    [2] - Geometric mean ratio of UPCR at post baseline over baseline between Part 1: Felzartamab M2 to Part 1: Placebo.
    Statistical analysis title
    		 Part 1: Placebo, Part 1: Felzartamab M1
    Statistical analysis description
    In the MMRM model, the ratio of post baseline UPCR over baseline UPCR at month 9 in log scale was response variable, while baseline UPCR in log scale, treatment, visit, treatment by visit interaction were fixed effect covariates.
    Comparison groups
    Part 1: Placebo v Part 1: Felzartamab Dosing Arm M1
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6837 [3]
    Method
    		 MMRM
    Parameter type
    		 Geometric LS Mean Ratio
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.84
    Notes
    [3] - Geometric mean ratio of UPCR at post baseline over baseline between Part 1: Felzartamab M1 to Part 1: Placebo.
    Statistical analysis title
    		 Part 1: Placebo, Part 1: Felzartamab M3
    Statistical analysis description
    In the MMRM model, the ratio of post baseline UPCR over baseline UPCR at month 9 in log scale was response variable, while baseline UPCR in log scale, treatment, visit, treatment by visit interaction were fixed effect covariates.
    Comparison groups
    Part 1: Placebo v Part 1: Felzartamab Dosing Arm M3
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4165
    Method
    		 MMRM
    Parameter type
    		 Geometric LS Mean Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.35

    Secondary: Integrative Analysis of Several Endpoints: Percent Change From Baseline in Immunoglobulin A (IgA) Concentration by Predose Serum Concentration (Ctrough) Group

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    End point title
    		 Integrative Analysis of Several Endpoints: Percent Change From Baseline in Immunoglobulin A (IgA) Concentration by Predose Serum Concentration (Ctrough) Group
    End point description
    All felzartamab and placebo-treated participants with evaluable IgA data and felzartamab serum concentrations (in felzartamab-treated participants only) were divided into exposure quartiles using the sum of measurable felzartamab Ctrough values up to 9 months after the first dose. Percent change from baseline in IgA concentration in these participants was summarized as per each serum concentration quartile. ll participants who received felzartamab or placebo during the study with evaluable IgA data and evaluable felzartamab serum concentrations (in felzartamab-treated participants only). 'Overall number of participants analyzed’ signifies the number of participants with evaluable IgA data and felzartamab serum concentrations (in felzartamab-treated participants only).
    End point type
    Secondary
    End point timeframe
    Up to 9 months
    End point values
    		 All Felzartamab and Placebo-Treated Participants
    Number of subjects analysed
    45
    Units: percent change
    arithmetic mean (standard deviation)
        Serum Concentration 0-180 µg/mL
    -6.12 ( 15.0 )
        Serum Concentration 180-370 µg/mL
    -14.1 ( 15.6 )
        Serum Concentration 370-850 µg/mL
    -19.7 ( 22.7 )
        Serum Concentration >850 µg/mL
    -26.1 ( 10.1 )
    No statistical analyses for this end point

    Secondary: Integrative Analysis of Several Endpoints: Maximum Serum Concentrations (Cmax) as per the Infusion-Related Reactions (IRRs) After the First Dose

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    End point title
    		 Integrative Analysis of Several Endpoints: Maximum Serum Concentrations (Cmax) as per the Infusion-Related Reactions (IRRs) After the First Dose
    End point description
    All participants with evaluable maximum felzartamab concentrations after the first dose were included in the analysis. Cmax values were assessed by infusion-related reaction status after the first dose. PK analysis set included all participants with any available quantifiable felzartamab serum concentration data. Overall number of participants analyzed’ signifies the number of participants with data available for outcome measure analysis.
    End point type
    Secondary
    End point timeframe
    Up to 1 week
    End point values
    		 All Felzartamab-Treated Participants
    Number of subjects analysed
    39
    Units: µg/mL
    arithmetic mean (standard deviation)
        Cmax in Participants With IRR
    445 ( 198 )
        Cmax in Participants Without IRR
    367 ( 131 )
    No statistical analyses for this end point

    Secondary: Relative Change From Baseline in UPCR in 24-hour Urine at Months 3, 6, 12, 18 and 24

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    End point title
    		 Relative Change From Baseline in UPCR in 24-hour Urine at Months 3, 6, 12, 18 and 24 [4]
    End point description
    Proteinuria is high levels of protein in the urine and is measured by UPCR. Relative change in UPCR will be estimated based on an MMRM model. The reference proteinuria value before start of treatment is defined as the mean of the values determined at screening and prior to baseline (visit 2) predose (UPCR from 24h urine). Negative change from baseline indicates less proteinuria. The FAS included all participants randomized to Part 1 of the study. Number analysed (n) signifies number of participants analysed for the specified measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Months 3,6,12,18 and 24
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo and Felzartamab dosing arms were planned to be analysed for this end point.
    End point values
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3
    Number of subjects analysed
    12
    12
    11
    13
    Units: g/g
    least squares mean (standard error)
        Change at Month 3 (n=12,11,6,9)
    -18.0 ( 13.09 )
    -7.5 ( 13.47 )
    -35.1 ( 17.06 )
    -35.5 ( 14.57 )
        Change at Month 6 (n=10,11,8,9)
    -12.8 ( 20.85 )
    -29.3 ( 20.07 )
    -44.5 ( 23.32 )
    -43.9 ( 21.29 )
        Change at Month 12 (n=11,11,9,11)
    -3.9 ( 19.52 )
    1.1 ( 19.49 )
    -44.4 ( 21.81 )
    -38.2 ( 19.02 )
        Change at Month 18 (n=10,10,9,12)
    -11.0 ( 23.40 )
    -24.9 ( 23.03 )
    -39.3 ( 25.54 )
    -48.3 ( 21.81 )
        Change at Month 24 (n=10,9,8,10)
    -38.1 ( 33.67 )
    -15.3 ( 34.24 )
    -30.9 ( 38.03 )
    -48.6 ( 32.19 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24

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    End point title
    		 Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24 [5]
    End point description
    CR was defined as the reduction of proteinuria to less than 0.3 g/g UPCR, serum albumin within the reference range of the central laboratory and stable estimated glomerular filtration rate (eGFR) (at least 80% of value at baseline visit). The FAS included all participants randomized to Part 1 of the study. Number analysed (n) signifies number of participants analysed for the specified measurement.
    End point type
    Secondary
    End point timeframe
    Months 3,6,9,12,18 and 24
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo and Felzartamab dosing arms were planned to be analysed for this end point.
    End point values
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3
    Number of subjects analysed
    12
    12
    11
    13
    Units: participants
        Month 3 (n=12,11,6,9)
    0
    0
    0
    1
        Month 6 (n=10,11,8,9)
    0
    1
    0
    1
        Month 9 (n=11,11,9,12)
    0
    0
    0
    4
        Month 12 (n=11,11,9,11)
    0
    0
    0
    3
        Month 18 (n=10,10,9,12)
    0
    0
    0
    4
        Month 24 (n=10,9,8,10)
    1
    0
    0
    4
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24

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    End point title
    		 Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24 [6]
    End point description
    Response was defined as reduction of proteinuria to below 0.6 g/g (UPCR) and stable eGFR (at least 80% of value at baseline visit), but not CR. The FAS included all participants randomized to Part 1 of the study. Number analysed (n) signifies number of participants analysed for the specified measurement.
    End point type
    Secondary
    End point timeframe
    Months 3,6,9,12,18 and 24
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo and Felzartamab dosing arms were planned to be analysed for this end point.
    End point values
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3
    Number of subjects analysed
    12
    12
    11
    13
    Units: percentage of participants
    number (not applicable)
        Month 3 (n=12,11,6,9)
    8.3
    9.1
    0
    44.4
        Month 6 (n=10,11,8,9)
    0
    9.1
    0
    55.6
        Month 9 (n=11,11,9,12)
    9.1
    0
    11.1
    8.3
        Month 12 (n=11,11,9,11)
    9.1
    0
    22.2
    27.3
        Month 18 (n=10,10,9,12)
    0
    0
    22.2
    16.7
        Month 24 (n=10,9,8,10)
    0
    11.1
    12.5
    20.0
    No statistical analyses for this end point

    Secondary: Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24

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    End point title
    		 Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24 [7]
    End point description
    The FAS included all participants randomized to Part 1 of the study. Number analysed (n) signifies number of participants analysed for the specified measurement.
    End point type
    Secondary
    End point timeframe
    Months 6, 9,12,18 and 24
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo and Felzartamab dosing arms were planned to be analysed for this end point.
    End point values
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3
    Number of subjects analysed
    12
    12
    11
    13
    Units: milligrams per gram (mg/g)
    arithmetic mean (standard deviation)
        Month 6 (n=10,11,8,9)
    1.278 ( 0.8101 )
    0.802 ( 0.4633 )
    0.841 ( 0.7925 )
    0.723 ( 1.0052 )
        Month 9 (n=11,11,9,12)
    1.053 ( 0.717 )
    0.830 ( 0.3378 )
    0.834 ( 0.4391 )
    0.948 ( 1.1494 )
        Month 12 (n=11,11,9,11)
    1.324 ( 0.7726 )
    1.062 ( 0.5072 )
    0.702 ( 0.4307 )
    1.013 ( 1.5322 )
        Month 18 (n=10,10,9,12)
    1.305 ( 0.9155 )
    0.729 ( 0.3501 )
    0.822 ( 0.6515 )
    0.827 ( 0.9789 )
        Month 24 (n=10,9,8,10)
    1.102 ( 0.8979 )
    0.903 ( 0.5079 )
    0.913 ( 0.6047 )
    0.622 ( 0.9405 )
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response [8]
    End point description
    Duration of response was defined as date of 1st observation of progressive disease minus date of 1st observation of response+1 day. The FAS included all participants randomized to Part 1 of the study. ‘Overall number of participants analysed’ signifies number of participants evaluable for this outcome measure. '99.999, 999, and 99999' signifies confidence interval was not estimable due to low number of participants.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo and Felzartamab dosing arms were planned to be analysed for this end point.
    End point values
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3
    Number of subjects analysed
    2
    2
    1
    7
    Units: days
        median (confidence interval 95%)
    250 (78 to 99999)
    140 (92 to 99999)
    451 (99.999 to 999)
    188 (83 to 99999)
    No statistical analyses for this end point

    Secondary: Time to Response

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    End point title
    		 Time to Response [9]
    End point description
    Time to response was defined as date of 1st observation of response minus date of randomization+1 day. The FAS included all participants randomized to Part 1 of the study. ‘Overall number of participants analysed’ signifies number of participants evaluable for this outcome measure. '99.999, 999, and 99999' signifies that median and confidence interval were not estimable due to low number of participants.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo and Felzartamab dosing arms were planned to be analysed for this end point.
    End point values
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3
    Number of subjects analysed
    1
    1
    0 [10]
    6
    Units: days
        median (confidence interval 95%)
    767 (99.999 to 999)
    99999 (99999 to 99999)
    ( to )
    720 (260.0 to 99999)
    Notes
    [10] - None of the participants had a response.
    No statistical analyses for this end point

    Secondary: Change From Baseline in eGFR Over Time

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    End point title
    		 Change From Baseline in eGFR Over Time
    End point description
    eGFR was calculated as per the chronic kidney disease epidemiology collaboration (CKD-EPI) equation. eGFR =141×min(Scr/κ, 1)α×max(Scr κ,1)-1.209×0.993Age ×1.018[if female]×1.159 [if black] where: Scr is serum creatinine in μmol/L, κ is 61.9 for females and 79.6 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1 eGFR as a measure of kidney function. eGFR was calculated in terms of milliliter per minute per 1.73 meter square (mL/min/1.73 m^2). A numerically smaller negative change in eGFR indicates a slowing in kidney disease progression. All enrolled participants included all randomized participants from the FAS plus all Japanese participants who were enrolled in Part 2. Number analysed (n) signifies number of participants analysed for the specified measurement. '99999' mean and standard deviation were not estimable due to low number of participants.
    End point type
    Secondary
    End point timeframe
    Baseline, Months 3,6,9,12,15,18, and 24
    End point values
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3 Part 2: Japan Cohort
    Number of subjects analysed
    12
    12
    11
    13
    6
    Units: mL/min/1.73 m^2
    arithmetic mean (standard deviation)
        Change at Month 3 (n=12,11,6,9,6)
    -1.985 ( 7.5920 )
    2.058 ( 4.9858 )
    8.100 ( 18.1222 )
    4.224 ( 8.3131 )
    1.011 ( 6.3803 )
        Change at Month 6 (n=11,11,7,10,6)
    -8.163 ( 12.4166 )
    -2.560 ( 6.6112 )
    3.914 ( 12.4652 )
    0.033 ( 12.7546 )
    0.296 ( 7.1089 )
        Change at Month 9 (n=10,10,9,12,6)
    -10.006 ( 9.3866 )
    -5.792 ( 7.3286 )
    3.619 ( 11.2770 )
    -4.199 ( 15.8864 )
    -1.890 ( 2.9519 )
        Change at Month 12 (n=10,11,9,11,6)
    -8.299 ( 11.1636 )
    -4.618 ( 7.9684 )
    -0.747 ( 15.3308 )
    -4.198 ( 9.1530 )
    -8.959 ( 5.6681 )
        Change at Month 18 (n=9,10,9,12,0)
    -11.131 ( 9.7842 )
    -6.707 ( 8.4971 )
    2.167 ( 11.0455 )
    -4.778 ( 11.7583 )
    99999 ( 99999 )
        Change at Month 24 (n=10,10,8,10,0)
    -9.550 ( 18.1470 )
    -7.394 ( 6.0913 )
    -3.342 ( 17.0161 )
    -6.210 ( 9.9485 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
    End point description
    TEAEs were defined as any AEs reported after the start of trial treatment until 28 days after the last trial treatment, defined as the treatment-emergent period. TESAEs were TEAEs that met the following criteria: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition.
    End point type
    Secondary
    End point timeframe
    From the first dose until 28 days after last dose of study drug (up to 191 days)
    End point values
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3 Part 2: Japan Cohort
    Number of subjects analysed
    12
    12
    11
    13
    6
    Units: participants
        TEAE
    6
    10
    9
    11
    3
        TESAE
    0
    1
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Felzartamab Over Time

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    End point title
    		 Serum Concentrations of Felzartamab Over Time [11]
    End point description
    Pharmacokinetic (PK) analysis set included all participants with any available quantifiable felzartamab serum concentration data. Number analysed (n) signifies number of participants analysed for the specified measurement.
    End point type
    Secondary
    End point timeframe
    Predose and 30 minutes post-dose on Days 1, 15, 29; predose on Days 8, 57, 85, 113, 141; Post Treatment Days 169 and 267
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Felzartamab dosing arms were planned to be analysed for this end point.
    End point values
    		 Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3 Part 2: Japan Cohort
    Number of subjects analysed
    12
    11
    13
    6
    Units: nanograms per milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Day 1: Predose (n=12,10,13,6)
    67.9 ( 143.5 )
    54.6 ( 28.2 )
    50.0 ( 0.0 )
    50.0 ( 0.0 )
        Day 1: 30 mins postdose (n=12,9,11,6)
    204326.5 ( 3176.6 )
    320616.0 ( 56.2 )
    424347.7 ( 42.9 )
    355517.2 ( 21.9 )
        Day 8: Predose (n=12,11,11,6)
    123890.6 ( 34.3 )
    111734.3 ( 17.7 )
    119475.8 ( 29.9 )
    119280.5 ( 35.6 )
        Day 15: Predose (n=12,8,9,6)
    58680.3 ( 39.6 )
    73299.3 ( 136.9 )
    242622.8 ( 14.9 )
    217362.3 ( 21.7 )
        Day 15: 30 mins postdose (n=11,7,9,6)
    479855.1 ( 27.8 )
    564030.0 ( 14.5 )
    726082.1 ( 18.0 )
    579946.2 ( 19.9 )
        Day 29: Predose (n=10,7,10,6)
    93782.5 ( 40.0 )
    142190.5 ( 28.3 )
    156053.1 ( 777.0 )
    339770.3 ( 39.1 )
        Day 29: 30 mins postdose (n=10,8,10,6)
    94110.3 ( 42.2 )
    471802.8 ( 29.7 )
    868596.5 ( 30.2 )
    696420.5 ( 22.7 )
        Day 57: Predose (n=11,6,10,6)
    5243.4 ( 1663.5 )
    70569.7 ( 68.4 )
    126530.5 ( 40.1 )
    132181.4 ( 69.6 )
        Day 85: Predose (n=11,7,9,6)
    69.6 ( 153.0 )
    21010.4 ( 3668.4 )
    55920.7 ( 89.4 )
    69524.7 ( 96.5 )
        Day 113: Predose (n=10,8,10,6)
    74.6 ( 199.2 )
    849.3 ( 2399.8 )
    28697.5 ( 209.5 )
    63543.2 ( 95.0 )
        Day 141: Predose (n=10,8,10,6)
    74.6 ( 194.4 )
    50.0 ( 0.0 )
    59744.8 ( 50.9 )
    18172.1 ( 9900.0 )
        Post Treatment Day 169 (n=11,8,10,6)
    64.8 ( 104.8 )
    50.0 ( 0.0 )
    48355.6 ( 109.3 )
    35243.0 ( 194.3 )
        Post Treatment Day 267 (n=10,8,10,6)
    72.8 ( 176.5 )
    50.0 ( 0.0 )
    50.0 ( 0.0 )
    50.0 ( 0.0 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Anti- Felzartamab Antibodies

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    End point title
    		 Percentage of Participants With Anti- Felzartamab Antibodies
    End point description
    Blood samples were collected for measurement of anti-felzartamab antibodies in the serum. Number of participants with Anti-drug antibody (ADA) status positive/negative was summarized. The Immunogenicity analysis set included all participants with at least one ADA sample. Number analysed (n) signifies number of participants analysed for the specified measurement.
    End point type
    Secondary
    End point timeframe
    From the first dose up to the end of the study (up to 2 years)
    End point values
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 1: Felzartamab Dosing Arm M2 Part 1: Felzartamab Dosing Arm M3 Part 2: Japan Cohort
    Number of subjects analysed
    12
    12
    11
    13
    6
    Units: percentage of participants
    number (not applicable)
        Positive (Any Postbaseline Visit) n=12,12,10,13,6
    1
    6
    3
    3
    1
        Negative (All Postbaseline Visit) n=12,12,10,13,6
    11
    6
    7
    10
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing of informed consent up to the end of the study (up to 24 months)
    Adverse event reporting additional description
    Safety analysis set included all participants who received at least one dose of trial treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141.

    Reporting group title
    Part 1: Felzartamab Dosing Arm M1
    Reporting group description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.

    Reporting group title
    Part 2: Japan Cohort
    Reporting group description
    		 Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.

    Reporting group title
    Part 1: Felzartamab Dosing Arm M3
    Reporting group description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.

    Reporting group title
    Part 1: Felzartamab Dosing Arm M2
    Reporting group description
    		 Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.

    Serious adverse events
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 2: Japan Cohort Part 1: Felzartamab Dosing Arm M3 Part 1: Felzartamab Dosing Arm M2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Dedifferentiated liposarcoma
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Part 1: Placebo Part 1: Felzartamab Dosing Arm M1 Part 2: Japan Cohort Part 1: Felzartamab Dosing Arm M3 Part 1: Felzartamab Dosing Arm M2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 12 (50.00%)
    10 / 12 (83.33%)
    3 / 6 (50.00%)
    11 / 13 (84.62%)
    8 / 11 (72.73%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Fatigue
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    1 / 11 (9.09%)
         occurrences all number
    2
    11
    0
    9
    9
    Oedema peripheral
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Malaise
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    Vessel puncture site haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Non-cardiac chest pain
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    0
    1
    1
    Hypogammaglobulinaemia
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Device allergy
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Reproductive system and breast disorders
    Penile pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    7
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Hyperventilation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rhinorrhoea
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oropharyngeal discomfort
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Bronchitis chronic
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Bronchial disorder
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Asthma
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rhinitis allergic
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    3
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 6 (16.67%)
    1 / 13 (7.69%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    1
    1
    1
    Adjustment disorder with anxiety
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Depression
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Amylase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    5
    0
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Digestive enzyme abnormal
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Lipase abnormal
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    4
    0
    Liver function test increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Blood bilirubin increased
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    SARS-CoV-2 test positive
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 6 (16.67%)
    2 / 13 (15.38%)
    2 / 11 (18.18%)
         occurrences all number
    0
    1
    1
    2
    3
    Eye injury
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hand fracture
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Joint injury
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin laceration
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Muscle contusion
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Contusion
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cardiac disorders
    Coronary artery stenosis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Sinus arrhythmia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Angina pectoris
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Palpitations
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Coronary artery occlusion
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    1 / 11 (9.09%)
         occurrences all number
    3
    6
    0
    1
    4
    Somnolence
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    3
    0
    0
    0
    3
    Migraine
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    1
    Eosinophilia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Leukopenia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Lymphopenia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Anaemia
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    2
    0
    0
    0
    1
    Polycythaemia
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Motion sickness
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Eye disorders
    Swelling of eyelid
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    9
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Presbyopia
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
    0 / 11 (0.00%)
         occurrences all number
    1
    2
    0
    3
    0
    Nausea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    0
    1
    1
    Toothache
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    0
    0
    3
    Abdominal discomfort
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    2
    0
    0
    0
    1
    Gastritis
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Abdominal pain upper
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Nail ridging
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Neurodermatitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Night sweats
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Dermatitis atopic
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Dermal cyst
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Haematuria
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
    1 / 11 (9.09%)
         occurrences all number
    2
    0
    0
    2
    1
    Acute kidney injury
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Nocturia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Azotaemia
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Glycosuria
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Renal impairment
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Urine flow decreased
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Back pain
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Articular calcification
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Joint stiffness
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Intervertebral disc protrusion
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Muscle spasms
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Muscle tightness
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rheumatic disorder
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 12 (25.00%)
    4 / 12 (33.33%)
    2 / 6 (33.33%)
    6 / 13 (46.15%)
    2 / 11 (18.18%)
         occurrences all number
    3
    4
    2
    7
    3
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 6 (16.67%)
    2 / 13 (15.38%)
    3 / 11 (27.27%)
         occurrences all number
    1
    4
    1
    3
    5
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    2 / 11 (18.18%)
         occurrences all number
    0
    4
    0
    1
    2
    Bronchitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    1 / 11 (9.09%)
         occurrences all number
    0
    3
    0
    1
    1
    Cellulitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Urethritis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    0
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Otitis externa
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Keratitis bacterial
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Paronychia
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hordeolum
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    0
    1
    Laryngitis
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Bacterial infection
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Influenza
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gastrointestinal bacterial infection
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Conjunctivitis bacterial
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Candida infection
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Respiratory tract infection
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Subcutaneous abscess
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Sinusitis
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperphosphataemia
    alternative dictionary used: MedDRA 27
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Sep 2021
    - Trial design section updated to include country specific (Japanese) open-label cohort to enroll 4 additional participants in M3 dosing arm (part II). - Revised exclusion criterion no. 9 (i.e. minimum hemoglobin limit at screening changed from 80 to 90 gram per liter (g/L)). - Implemented post infusion monitoring requirements, added additional pre-medication for prevention of IRRs, and recommendation of post infusion medication for participants with a history of asthma and chronic obstructive pulmonary disease. - Revised the total volume to 250 milliliter (ml) in the table providing an example of infusion speeds - Added stratification information for the 4 Japanese participants enrolling in global study (part I). - Revised treatment discontinuation criterion to ensure that participants with grade 3 infusion related reaction (IRR)/allergic reaction or grade 2 cytokine release syndrome (CRS) cannot continue receiving felzartamab. - Added criteria of grade 4 hematological abnormalities related to investigational medicinal product (IMP) and clinically significant elevated liver enzymes to the list of reasons for discontinuation from treatment. - Removed criteria of “use of prohibited treatment” to clarify that participants using prohibited treatment will be discontinued from the trial - Clarified that a participants can be withdrawn from the study due to lack of efficacy. - Clarified timing of analysis; primary analysis will be conducted after all participants in global study (part I) complete their 9-month visit or discontinued early. Final analysis will be conducted after all randomized participants in global Study (part I) and Japanese cohort (part II) have completed their last visit, or discontinued the trial earlier. - Added Japan population to facilitate further analysis on Japanese participants safety and PK profile. - Updated analysis method for primary endpoint. - Added description of eGFR under the statistical consideration section.
    01 Dec 2021
    - An overview of procedures related to interim analysis (IA) including unblinding procedures was included. - Timing of the 3-months pharmacokinetic (PK) IA was included. - IA section was added to describe timing, scope, and procedures related to 3-months PK biomarkers IA with no changes to the planned study design or conduct. - A summary of statistical analysis and protocol title was added to section 1. - Reporting of treatment error, misuse or abuse section was added. - Council for International Organizations of Medical Sciences (CIOMS) international ethical guidelines was added under regulatory and ethical consideration. - Text on quality tolerance limits (QTLs) was added.
    17 Feb 2022
    - Section 1.1 and 5 trial design, section 1.3 dosing, section 1.4 trial population were updated to enable flexible enrollment in Japan across part I and part II. - Treatment assignment section was updated to clarify stratification in Part I based on country (Japan vs ex-Japan). - Section 10.1 Sample size determination and section 10.2 integrative analysis of dose and dosing regimens were updated to include the number of participants in Japan. - Section 7.1 Treatments administered were updated to recommend the Investigator to consult medical monitor and sponsor for an alternative premedication(s) in case of unavailability of any of the prespecified premedication.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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