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    Clinical Trial Results:
    A randomized, placebo-controlled, patient and investigator blinded, study investigating the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple doses of CFZ533 in patients with moderately active proliferative lupus nephritis

    Summary
    EudraCT number
    		 2017-003230-93
    Trial protocol
    		 HU   DE  
    Global end of trial date
    29 Jun 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Nov 2024
    First version publication date
    30 Jun 2024
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    CCFZ533X2202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03610516
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.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
    29 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objectives: • To evaluate the safety and tolerability of 24 weeks of treatment with multiple intravenous (IV) doses of 10 mg/kg CFZ533 as an add-on therapy of CFZ533 to standard of care in moderately active lupus nephritis (LN) patients • To assess the effect of CFZ533 on renal proteinuria using urinary protein creatinine ratio (UPCR) in moderately active LN patients after 24 weeks of treatment as an add-on therapy to standard of care as compared to placebo
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Sep 2018
    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
    Argentina: 14
    Country: Number of subjects enrolled
    China: 15
    Country: Number of subjects enrolled
    Hong Kong: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Taiwan: 12
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Russian Federation: 4
    Country: Number of subjects enrolled
    Tunisia: 2
    Country: Number of subjects enrolled
    Türkiye: 1
    Worldwide total number of subjects
    57
    EEA total number of subjects
    3
    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)
    57
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in 21 investigative sites in 10 countries.

    Pre-assignment
    Screening details
    		 There was a screening period within 29 days to assess participants eligibility.

    Period 1
    Period 1 title
    Treatment Epoch (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CFZ533 10 mg/kg i.v.
    Arm description
    		 CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
    Arm type
    		 Experimental

    Investigational medicinal product name
    CFZ533
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141

    Arm title
    		 Placebo i.v.
    Arm description
    		 Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
    Arm type
    		 Placebo

    Investigational medicinal product name
    CFZ533
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141

    Number of subjects in period 1
    		CFZ533 10 mg/kg i.v. Placebo i.v.
    Started
    39
    18
    Completed
    21
    10
    Not completed
    18
    8
         Physician decision
    8
    5
         Consent withdrawn by subject
    3
    1
         Protocol Deviation
    1
    -
         Death
    1
    -
         Adverse event
    3
    1
         No longer requires treatment
    1
    -
         Non-Compliance with study treatment
    1
    -
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CFZ533 10 mg/kg i.v.
    Reporting group description
    		 CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141

    Reporting group title
    Placebo i.v.
    Reporting group description
    		 Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141

    Reporting group values
    		 CFZ533 10 mg/kg i.v. Placebo i.v. Total
    Number of subjects
    		 39 18 57
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 39 18 57
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.1 ( 9.20 ) 36.4 ( 9.15 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 30 17 47
        Male
    		 9 1 10
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 16 7 23
        Asian
    		 23 11 34

    End points

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    End points reporting groups
    Reporting group title
    CFZ533 10 mg/kg i.v.
    Reporting group description
    		 CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141

    Reporting group title
    Placebo i.v.
    Reporting group description
    		 Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141

    Primary: Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    		 Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs) [1]
    End point description
    Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation.
    End point type
    Primary
    End point timeframe
    Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only analyzed descriptively.
    End point values
    		 CFZ533 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    39
    18
    Units: participants
        Adverse Events
    33
    18
        Serious Adverse Events
    6
    3
        AEs leading to discontinuation of study treatment
    3
    1
        SAEs leading to discontinuation of study treatment
    0
    0
    No statistical analyses for this end point

    Primary: Ratio to Baseline in Urinary protein creatinine ratio (UPCR)

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    End point title
    		 Ratio to Baseline in Urinary protein creatinine ratio (UPCR)
    End point description
    A urine protein creatinine ratio (UPCR) test is a urine test. It measures the levels of protein and creatinine in urine. UPCR was assessed using the first morning void if available at a visit otherwise using the clinic spot sample, and was expressed as protein/creatinine (mg/mmol). High UPCR values can be a sign of kidney disease. An UPCR ratio to baseline <1 indicates improvement from baseline.
    End point type
    Primary
    End point timeframe
    Baseline, Day 169
    End point values
    		 CFZ533 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    20
    10
    Units: ratio to baseline in UPCR
        geometric mean (confidence interval 95%)
    0.369 (0.234 to 0.582)
    0.637 (0.338 to 1.202)
    Statistical analysis title
    		 Ratio to Baseline in UPCR
    Comparison groups
    CFZ533 10 mg/kg i.v. v Placebo i.v.
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 = 0.0788 [3]
    Method
    		 Repeated measures Mixed Model
    Parameter type
    		 Ratio of geometric means CFZ533/placebo
    Point estimate
    0.579
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.267
         upper limit
    		 1.256
    Notes
    [2] - A repeated measures mixed model was fitted with factors for treatment group (CFZ533 or placebo) and visit.
    [3] - one-sided p-value

    Secondary: Ratio to baseline for urine protein creatinine ratio (UPCR)

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    End point title
    		 Ratio to baseline for urine protein creatinine ratio (UPCR)
    End point description
    A urine protein creatinine ratio (UPCR) test is a urine test. It measures the levels of protein and creatinine in urine. UPCR was assessed using the first morning void if available at a visit otherwise using the clinic spot sample, and was expressed as protein/creatinine (mg/mmol). High UPCR values can be a sign of kidney disease. An UPCR ratio to baseline <1 indicates improvement from baseline. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 (End of Study)
    End point values
    		 CFZ533 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    35
    16
    Units: ratio to baseline in UPCR
    arithmetic mean (standard deviation)
        Day 197 (n=35,16)
    0.532 ( 0.4160 )
    0.985 ( 0.9045 )
        Day 225 (n=32,16)
    0.456 ( 0.3876 )
    1.153 ( 1.2178 )
        Day 253 (n=33,14)
    0.648 ( 1.3314 )
    0.667 ( 0.3612 )
        Day 281 (n=27,13)
    0.526 ( 0.5440 )
    0.701 ( 0.7690 )
        Day 309 (n=26,12)
    0.580 ( 0.7175 )
    1.101 ( 1.1337 )
        Day 337 (n=20,10)
    0.640 ( 0.7446 )
    0.735 ( 0.5323 )
    No statistical analyses for this end point

    Secondary: Area under plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) of CFZ533

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    End point title
    		 Area under plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) of CFZ533 [4]
    End point description
    Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of free CFZ533.
    End point type
    Secondary
    End point timeframe
    Day 141: pre dose and 1 hour post dose
    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: PK Endpoint not analyzed for participants on placebo
    End point values
    		 CFZ533 10 mg/kg i.v.
    Number of subjects analysed
    11
    Units: day*ug/mL
        arithmetic mean (standard deviation)
    7250 ( 1800 )
    No statistical analyses for this end point

    Secondary: Pre-dose trough concentration (Ctrough) of CFZ533

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    End point title
    		 Pre-dose trough concentration (Ctrough) of CFZ533 [5]
    End point description
    Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. Ctrough is the observed plasma concentration that is just prior to the beginning of, or at the end of a dosing interval. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Pre-dose at: Day 1, Day 15, Day 29, Day 57, Day 85, Day 113 and Day 141
    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: PK Endpoint not analyzed for participants on placebo
    End point values
    		 CFZ533 10 mg/kg i.v.
    Number of subjects analysed
    33
    Units: ug/mL
    arithmetic mean (standard deviation)
        Day 1 (n=33)
    0 ( 0 )
        Day 15 (n=14)
    49.8 ( 37.0 )
        Day 29 (n=30)
    64.1 ( 31.6 )
        Day 57 (n=15)
    34.5 ( 21.7 )
        Day 85 (n=25)
    33.2 ( 25.0 )
        Day 113 (n=26)
    32.7 ( 26.3 )
        Day 141 (n=21)
    34.1 ( 26.6 )
    No statistical analyses for this end point

    Secondary: The observed maximum plasma concentration following CFZ533 administration at steady state (Cmax,ss)

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    End point title
    		 The observed maximum plasma concentration following CFZ533 administration at steady state (Cmax,ss) [6]
    End point description
    Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. Cmax,ss is the observed maximum plasma concentration following CFZ533 administration at steady state [mass/volume].
    End point type
    Secondary
    End point timeframe
    Day 141: pre dose and 1 hour post dose
    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: PK Endpoint not analyzed for participants on placebo
    End point values
    		 CFZ533 10 mg/kg i.v.
    Number of subjects analysed
    20
    Units: ug/mL
        arithmetic mean (standard deviation)
    263 ( 81.8 )
    No statistical analyses for this end point

    Secondary: Total soluble CD40 plasma concentrations

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    End point title
    		 Total soluble CD40 plasma concentrations [7]
    End point description
    Total soluble CD40 concentrations in plasma. An increase in soluble CD40 concentrations is considered a marker for CFZ533 target engagement. This endpoint is only applicable to the CFZ533 arm. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 15, Day 29, Day 57, Day 113, Day 169, Day 225, Day 281, Day 337 (End of Study)
    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: Endpoint not analyzed for participants on placebo
    End point values
    		 CFZ533 10 mg/kg i.v.
    Number of subjects analysed
    30
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 1 (n=30)
    0.2723 ( 0.22222 )
        Day 15 (n=16)
    78.7375 ( 20.58802 )
        Day 29 (n=28)
    90.4286 ( 23.86165 )
        Day 57 (n=14)
    127.6214 ( 26.11617 )
        Day 113 (n=24)
    109.2672 ( 50.19834 )
        Day 169 (n=7)
    158.5714 ( 22.24753 )
        Day 225 (n=16)
    8.3406 ( 17.77703 )
        Day 281 (n=15)
    0.7981 ( 0.32464 )
        Day 337 (End of Study) (n=13)
    0.5331 ( 0.30080 )
    No statistical analyses for this end point

    Secondary: Number of participants with anti-CFZ533 antibodies

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    End point title
    		 Number of participants with anti-CFZ533 antibodies
    End point description
    To evaluate the immunogenicity of CFZ533 via the quasi-quantitative analysis of anti-CFZ533 antibodies. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 15, Day 29, Day 57, Day 113, Day 169, Day 225, Day 281, Day 337 (End of study)
    End point values
    		 CFZ533 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    33
    16
    Units: Participants
        Day 1-Negative (n=33,13)
    32
    13
        Day 1-Positive (n=33,13)
    1
    0
        Day 15-Negative (n=17,8)
    17
    8
        Day 15-Positive (n=17,8)
    0
    0
        Day 29-Negative (n=33,16)
    33
    16
        Day 29-Positive (n=33,16)
    0
    0
        Day 57-Negative (n=17,8)
    17
    8
        Day 57-Positive (n=17,8)
    0
    0
        Day 113-Negative (n=32,15)
    32
    15
        Day 113-Positive (n=32,15)
    0
    0
        Day 169-Negative (n=14,8)
    14
    8
        Day 169-Positive (n=14,8)
    0
    0
        Day 225-Negative (n=26,13)
    25
    13
        Day 225-Positive (n=26,13)
    1
    0
        Day 281-Negative (n=24,13)
    23
    13
        Day 281-Positive (n=24,13)
    1
    0
        Day 337-Negative (EOS) (n=13,8)
    12
    8
        Day 337-Positive (EOS) (n=13,8)
    1
    0
    No statistical analyses for this end point

    Secondary: Hematuria casts- Urine white blood cell casts

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    End point title
    		 Hematuria casts- Urine white blood cell casts
    End point description
    Urine was tested using a dipstick. If the dipstick result was positive for protein, nitrite, leucocytes and/or blood, a microscopic analysis of white blood cells (WBC), red blood cells (RBC) and casts was performed. Hematuria is the presence of blood in the urine. Hematuria casts were assessed by microscopic urinalysis and classified as granular casts and WBC casts. Only in the event of a positive result, these samples were submitted to reflex testing microscopic analysis for counting of casts which resulted in a numeric value related to the number of respective casts presented in the urine.The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 (Pre dose), and Day 309
    End point values
    		 CFZ533 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    37
    18
    Units: number of casts per low power field
    arithmetic mean (standard deviation)
        Baseline (n=1,0)
    2 ( 999 )
    999 ( 999 )
        Day 1 (n=1,0)
    2 ( 999 )
    999 ( 999 )
        Day 309 (n=1,0)
    4 ( 999 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: Hematuria casts- Casts granular

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    End point title
    		 Hematuria casts- Casts granular
    End point description
    Urine was tested using a dipstick. If the dipstick result was positive for protein, nitrite, leucocytes and/or blood, a microscopic analysis of white blood cells (WBC), red blood cells (RBC) and casts was performed. Hematuria is the presence of blood in the urine. Hematuria casts were assessed by microscopic urinalysis and classified as granular casts and WBC casts. Only in the event of a positive result, these samples were submitted to reflex testing microscopic analysis for counting of casts which resulted in a numeric value related to the number of respective casts presented in the urine. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Day 1 (Pre dose), Day 15 (Pre dose), Day 29 (Pre dose), Day 253, and Day 337 (end of study)
    End point values
    		 CFZ533 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    37
    18
    Units: number of casts per low power field
    arithmetic mean (standard deviation)
        Day 1 (n=1,0)
    3 ( 999 )
    999 ( 999 )
        Day 15 (n=2,0)
    2.5 ( 0.71 )
    999 ( 999 )
        Day 29 (n=0,2)
    999 ( 999 )
    3 ( 1.41 )
        Day 253 (n=1,0)
    14.0 ( 999 )
    999 ( 999 )
        Day 337 (End of Study) (n=2,0)
    5 ( 2.83 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: Change from baseline in urine hyaline casts

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    End point title
    		 Change from baseline in urine hyaline casts
    End point description
    Urine was tested using a dipstick. If the dipstick result was positive for protein, nitrite, leucocytes and/or blood, a microscopic analysis of white blood cells (WBC), red blood cells (RBC) and casts was performed. Urine hyaline casts were assessed by microscopic urinalysis. Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 (Pre dose), Day 15 (Pre dose), Day 29 (Pre dose), Day 57 (Pre dose), Day 85 (Pre dose), Day 113 (Pre dose), Day 141 (Pre dose), Day 169, Day 197, Day 225, Day 253, Day 281, Day 309 and Day 337 (end of study)
    End point values
    		 CFZ533 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    37
    18
    Units: number of casts per low power field
    arithmetic mean (standard deviation)
        Day 1 (n=0,0)
    999 ( 999 )
    999 ( 999 )
        Day 15 (n=4,3)
    8.3 ( 15.88 )
    3.7 ( 3.51 )
        Day 29 (n=4,4)
    2.8 ( 4.99 )
    5.0 ( 2.16 )
        Day 57 (n=3,2)
    -5.0 ( 3.61 )
    1.0 ( 1.41 )
        Day 85 (n=2,1)
    0.5 ( 2.12 )
    -4.0 ( 999 )
        Day 113 (n=0,3)
    999 ( 999 )
    18.0 ( 28.58 )
        Day 141 (n=0,2)
    999 ( 999 )
    -4.5 ( 6.36 )
        Day 169 (n=1,1)
    0.0 ( 999 )
    0.0 ( 999 )
        Day 197 (n=3,3)
    -1.0 ( 2.65 )
    2.7 ( 9.02 )
        Day 225 (n=1,1)
    2.0 ( 999 )
    0.0 ( 999 )
        Day 253 (n=0,2)
    999 ( 999 )
    -0.5 ( 4.95 )
        Day 281 (n=1,2)
    0.0 ( 999 )
    -1.5 ( 4.95 )
        Day 309 (n=3,1)
    1.7 ( 1.15 )
    -4.0 ( 999 )
        Day 337 (EOS) (n=0,2)
    999 ( 999 )
    0.5 ( 0.71 )
    No statistical analyses for this end point

    Secondary: Number of participants who fulfil the criteria for complete renal remission (CRR)

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    End point title
    		 Number of participants who fulfil the criteria for complete renal remission (CRR)
    End point description
    The criteria for CRR were defined as: 1. Urinary protein creatinine ratio (UPCR) ≤ 0.2 mg/mg 2. Estimated glomerular filtration rate (eGFR) ≤ 25% of Baseline 3. Normal urine sediment. If the UPCR from the first morning void sample was not available, then the UPCR from the corresponding spot sample taken at the investigator site was used in the derivation of complete renal remission.
    End point type
    Secondary
    End point timeframe
    Baseline, up to Day 169
    End point values
    		 CFZ533 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    37
    18
    Units: participants
    13
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    CCFZ533 10mg/kg
    Reporting group description
    		 CCFZ533 10mg/kg

    Reporting group title
    All patients
    Reporting group description
    		 All patients

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 CCFZ533 10mg/kg All patients Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 39 (15.38%)
    9 / 57 (15.79%)
    3 / 18 (16.67%)
         number of deaths (all causes)
    2
    2
    0
         number of deaths resulting from adverse events
    1
    1
    0
    Immune system disorders
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal behaviour
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Lupus nephritis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 CCFZ533 10mg/kg All patients Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 39 (82.05%)
    50 / 57 (87.72%)
    18 / 18 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Hypertension
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 57 (3.51%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Accelerated hypertension
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 57 (5.26%)
    2 / 18 (11.11%)
         occurrences all number
    1
    3
    2
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Menstrual disorder
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Nasal congestion
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Cough
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 57 (3.51%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Insomnia
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 57 (3.51%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Investigations
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    4
    4
    0
    Blood immunoglobulin G decreased
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Blood immunoglobulin M decreased
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 57 (3.51%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Neutrophil count increased
         subjects affected / exposed
    3 / 39 (7.69%)
    3 / 57 (5.26%)
    0 / 18 (0.00%)
         occurrences all number
    8
    8
    0
    Protein urine present
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 57 (3.51%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    1
    Systemic lupus erythematosus disease activity index abnormal
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Urine albumin/creatinine ratio increased
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Urine protein/creatinine ratio increased
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    3
    3
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Limb injury
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Skin wound
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Tooth fracture
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 57 (3.51%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Upper limb fracture
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 57 (5.26%)
    2 / 18 (11.11%)
         occurrences all number
    1
    3
    2
    Occipital neuralgia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Anaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 57 (3.51%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Leukocytosis
         subjects affected / exposed
    3 / 39 (7.69%)
    3 / 57 (5.26%)
    0 / 18 (0.00%)
         occurrences all number
    6
    6
    0
    Leukopenia
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 57 (5.26%)
    1 / 18 (5.56%)
         occurrences all number
    3
    4
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Eyelid bleeding
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Corneal erosion
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Keratitis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Gastrointestinal disorders
    Chronic gastritis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Oesophagitis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 57 (3.51%)
    1 / 18 (5.56%)
         occurrences all number
    2
    3
    1
    Gingival swelling
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Gingival pain
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 57 (3.51%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Gastritis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 57 (3.51%)
    0 / 18 (0.00%)
         occurrences all number
    3
    3
    0
    Cholelithiasis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Cholecystitis
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 57 (3.51%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    1
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 57 (3.51%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Butterfly rash
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Alopecia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Acne
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 57 (5.26%)
    1 / 18 (5.56%)
         occurrences all number
    2
    3
    1
    Rash
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 57 (3.51%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    1
    Pruritus
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Ecchymosis
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 57 (3.51%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    1
    Urticaria
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Renal and urinary disorders
    Lupus nephritis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Haematuria
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Acute kidney injury
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Proteinuria
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 57 (3.51%)
    1 / 18 (5.56%)
         occurrences all number
    3
    4
    1
    Back pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Bursitis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Periarthritis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Tendonitis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 57 (3.51%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    1
    COVID-19
         subjects affected / exposed
    5 / 39 (12.82%)
    8 / 57 (14.04%)
    3 / 18 (16.67%)
         occurrences all number
    5
    8
    3
    Gastroenteritis
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 57 (3.51%)
    0 / 18 (0.00%)
         occurrences all number
    3
    3
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Folliculitis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 57 (3.51%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    1
    Gastrointestinal infection
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Herpes zoster
         subjects affected / exposed
    3 / 39 (7.69%)
    4 / 57 (7.02%)
    1 / 18 (5.56%)
         occurrences all number
    3
    4
    1
    Influenza
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 39 (10.26%)
    4 / 57 (7.02%)
    0 / 18 (0.00%)
         occurrences all number
    7
    7
    0
    Peri-implantitis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 57 (3.51%)
    1 / 18 (5.56%)
         occurrences all number
    2
    3
    1
    Pneumonia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Pulpitis dental
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Pyuria
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 57 (1.75%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Soft tissue infection
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 39 (5.13%)
    5 / 57 (8.77%)
    3 / 18 (16.67%)
         occurrences all number
    3
    7
    4
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 39 (17.95%)
    9 / 57 (15.79%)
    2 / 18 (11.11%)
         occurrences all number
    9
    12
    3
    Tuberculosis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Tinea cruris
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Herpes simplex
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 57 (3.51%)
    2 / 18 (11.11%)
         occurrences all number
    0
    3
    3
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Decreased appetite
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 57 (3.51%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Hyperlipidaemia
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 57 (3.51%)
    1 / 18 (5.56%)
         occurrences all number
    2
    3
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Hypoproteinaemia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    Diabetes mellitus
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 57 (1.75%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Aug 2018
    The key purpose of this amendment was to: i) To address the comments received from Health Authorities in response to the Sponsors clinical trial application (CTA) submission. ii) To adapt the protocol to allow enrollment of patients with a histologic diagnosis of class III/IV lupus nephritis within 5 years (instead of 2 years). iii) To correct inconsistencies, errors or typos and to improve clarity.
    22 May 2019
    The key purposes of this amendment was: i) To adjust hepatitis B screening and monitoring procedures in accordance with the current international guidelines, including the guidance of the American Association for the Study of Liver Diseases (Terrault et al 2018) and the European Association For The Study Of The Liver (EASL 2017). ii) To add the collection and assessment of a first morning void urine sample on visit days when urine collection is foreseen in the assessment schedule and to use the urine protein creatinine ratio (UPCR) from this sample as the UPCR for the primary endpoint. iii) To update relevant sections as per the latest version of the IB. iv) To address the comment received in response to the Sponsor’s clinical trial application (CTA) submission from Health Authority in Tunisia with regards to Section 9.7 Pregnancy reporting. v) To incorporate the local Protocol Amendment 1
    09 Jul 2020
    The key purpose of this amendment is to mitigate the risk of human cytomegalovirus (CMV) infection. In addition, guidance related to COVID19 as well as clarifications in the protocol are also proposed.
    26 Jul 2021
    The key purpose of this amendment was to introduce updated guidance to investigators regarding vaccinations against SARS-CoV-2 during the study, previously communicated via Letter to investigators. Further, we introduced changes regarding inclusion/exclusion criteria.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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