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    Clinical Trial Results:
    A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of voclosporin (23.7 mg Twice Daily) with Placebo in Subjects with Lupus Nephritis

    Summary
    EudraCT number
    		 2016-004046-28
    Trial protocol
    		 ES   BG   HR  
    Global end of trial date
    07 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2022
    First version publication date
    25 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AUR-VCS-2016-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03597464
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aurinia Pharmaceuticals Inc.
    Sponsor organisation address
    1203-4464 Markham Street, Victoria, Canada,
    Public contact
    Clinical Trials Information, Aurinia Pharmaceuticals Inc., clinicaltrials@auriniapharma.com
    Scientific contact
    Clinical Trials Information, Aurinia Pharmaceuticals Inc., clinicaltrials@auriniapharma.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
    03 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this Phase 3 continuation study is to assess the long-term safety and tolerability of voclosporin compared with placebo, when added to the standard of care treatment in lupus nephritis (LN), for an additional 24 months, following a treatment period of 52 weeks in the AURORA 1 (AUR-VCS-2016-01). All subjects will continue to receive background therapy of mycophenolate mofetil (MMF) and/or corticosteroids starting at the same dose as at the end of the AURORA 1 study. Subjects with LN, who have completed 52 weeks of treatment with study drug in the AURORA 1 study, will be eligible to enter AURORA 2. The long-term safety and tolerability of the drug combination will be assessed from its safety profile while demonstrating the continued ability to achieve and maintain long-term renal response.
    Protection of trial subjects
    Dose of voclosporin could be reduced in subjects with controlled urine protein creatine ratio (UPCR) if considered appropriate at the discretion of the investigator and in consultation with the Medical Monitor When clinically indicated, dose of oral corticosteroid could be adjusted or discontinued in consultation with the Medical Monitor.
    Background therapy
    		 mycophenolate mofetil (MMF) + oral corticosteroids
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Sep 2019
    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
    Japan: 6
    Country: Number of subjects enrolled
    Malaysia: 3
    Country: Number of subjects enrolled
    Philippines: 13
    Country: Number of subjects enrolled
    Thailand: 19
    Country: Number of subjects enrolled
    Taiwan: 7
    Country: Number of subjects enrolled
    Viet Nam: 8
    Country: Number of subjects enrolled
    Belarus: 9
    Country: Number of subjects enrolled
    Russian Federation: 31
    Country: Number of subjects enrolled
    Serbia: 9
    Country: Number of subjects enrolled
    Turkey: 2
    Country: Number of subjects enrolled
    Ukraine: 11
    Country: Number of subjects enrolled
    South Africa: 6
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Croatia: 1
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    Chile: 3
    Country: Number of subjects enrolled
    Colombia: 14
    Country: Number of subjects enrolled
    Dominican Republic: 9
    Country: Number of subjects enrolled
    Guatemala: 9
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    Peru: 16
    Country: Number of subjects enrolled
    United States: 24
    Worldwide total number of subjects
    216
    EEA total number of subjects
    7
    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)
    215
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited in 100 centers in 24 countries in North America, Latin America, Europe, South Africa, and Asia. The first subject was enrolled on 29 September 2019 and the last subject, last visit date was 07 October 2021.

    Pre-assignment
    Screening details
    		 Eligible subjects included male or female subjects who: 1. Had completed 52 weeks of treatment with study drug in the AURORA 1 study 2. Provided prior written informed consent 3. In the opinion of the Investigator, required continued immunosuppressive therapy 4. Were willing to continue taking oral MMF for the study duration

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Subjects continued to receive the blinded treatments that were assigned at the start of AURORA 1. Background therapies (MMF + corticosteroids) were administered at the same doses as at the end of AURORA 1.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Voclosporin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    voclosporin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    three 7.9 mg capsules (23.7 mg total), administered twice daily

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    placebo, oral, three capsules administered twice daily

    Number of subjects in period 1
    		Voclosporin Placebo
    Started
    116
    100
    Completed
    101
    85
    Not completed
    15
    15
         Consent withdrawn by subject
    4
    5
         Physician decision
    2
    2
         Adverse event, non-fatal
    -
    2
         Death
    -
    3
         Pregnancy
    3
    1
         Non-compliance
    1
    1
         Lost to follow-up
    3
    1
         Lack of efficacy
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Voclosporin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Voclosporin Placebo Total
    Number of subjects
    		 116 100 216
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.3 ± 10.31 35.4 ± 11.64 -
    Gender categorical
    Units: Subjects
        Female
    		 105 88 193
        Male
    		 11 12 23
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 39 33 72
        Not Hispanic or Latino
    		 77 67 144
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 30 30 60
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 18 7 25
        White
    		 44 40 84
        Not Reported
    		 24 23 47
    Region of Enrollment
    Southeast Asia ("Asia Pacific") includes Japan, Malaysia, Philippines, Thailand, Taiwan & Vietnam Europe ("Europe") includes Belarus, Croatia, Netherlands, Russia, Serbia, Spain, Turkey, Ukraine as well as South Africa South America ("Latin America") includes Argentina, Brazil, Chile, Colombia, Dominican Republic, Guatemala, Mexico & Peru
    Units: Subjects
        United States
    		 15 9 24
        Southeast Asia
    		 29 27 56
        Europe
    		 38 37 75
        South America
    		 34 27 61
    Lupus Nephritis History - Years since diagnosis of systemic lupus erythematosus (SLE)
    Units: Years
        arithmetic mean (standard deviation)
    		 6.6 ± 6.66 7.3 ± 6.85 -
    Lupus Nephritis History - Years since diagnosis of lupus nephritis (LN)
    Units: Years
        arithmetic mean (standard deviation)
    		 4.8 ± 5.27 5.0 ± 5.23 -
    Lupus Nephritis History - Years since first instance of significant proteinuria (> 500 mg/day)
    Units: Years
        arithmetic mean (standard deviation)
    		 5.0 ± 5.15 4.7 ± 4.49 -
    Baseline Urine Protein Creatinine Ratio (UPCR)
    Average pre-randomisation values
    Units: mg/mg
        arithmetic mean (standard deviation)
    		 3.941 ± 2.5766 3.868 ± 2.4764 -
    Baseline Estimated Glomerular Filtration Rate (eGFR)
    Baseline estimated Glomerular Filtration Rate Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi formula) (lowest pre-randomisation value)
    Units: mL/min/1.73 m2
        arithmetic mean (standard deviation)
    		 94.1 ± 31.36 92.0 ± 28.04 -

    End points

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    End points reporting groups
    Reporting group title
    Voclosporin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Adverse events, routine biochemical and hematological assessments

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    End point title
    		 Adverse events, routine biochemical and hematological assessments [1]
    End point description
    This study evaluated the safety of continued treatment with voclosporin for up to three years. Voclosporin was well tolerated in the study with no new or unexpected safety signals observed. The overall profile of adverse events seen in Years 2 and 3 of treatment was similar to that seen in the first year of treatment (in AURORA 1); however, the frequency of adverse events reduced each year.
    End point type
    Primary
    End point timeframe
    36 Months
    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: Estimand for AEs is the proportion of subjects reporting AEs in the Safety Population when comparing voclosporin and placebo. Estimands for biochemical and hematological assessments are the mean absolute values and mean changes from AURORA 1 baseline in the Safety Population when comparing voclosporin and placebo.
    End point values
    		 Voclosporin Placebo
    Number of subjects analysed
    116
    100
    Units: Number of subjects
        Any treatment-emergent adverse event (TEAE)
    100
    80
        Treatment-related TEAE
    28
    21
        Serious TEAE
    21
    23
        TEAE leading to study drug discontinuation
    11
    17
        TEAE leading to death
    0
    3
        Treatment-related TEAE leading to death
    0
    0
        Disease-related TEAE
    50
    34
        Disease-related serious TEAE
    7
    11
    No statistical analyses for this end point

    Secondary: Proportion of subjects in renal response

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    End point title
    		 Proportion of subjects in renal response
    End point description
    Proportion of subjects in renal response defined as: o Urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg, and o Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%, and o Received no rescue medication for LN, and o Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during the 8 weeks prior to the renal response assessment. Subjects who withdrew from the study prior to the response assessment were defined as non-responders.
    End point type
    Secondary
    End point timeframe
    Months 12 (AURORA 2 Baseline) , 18, 24, 30 and 36
    End point values
    		 Voclosporin Placebo
    Number of subjects analysed
    116
    100
    Units: Number of participants
        Renal Response - 12 Months
    61
    34
        Renal Response - 18 Months
    74
    46
        Renal Response - 24 Months
    65
    43
        Renal Response - 30 Months
    69
    42
        Renal Response - 36 Months
    59
    39
    Statistical analysis title
    		 Renal Response - 12 Months (AURORA 2 Baseline)
    Statistical analysis description
    The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders.
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 4.05
    Statistical analysis title
    		 Renal Response - 18 Months
    Statistical analysis description
    The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders.
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.006
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 3.83
    Statistical analysis title
    		 Renal Response - 24 Months
    Statistical analysis description
    The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders.
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.035
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 3.16
    Statistical analysis title
    		 Renal Response - 30 Months
    Statistical analysis description
    The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders.
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.005
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.28
         upper limit
    		 3.92
    Statistical analysis title
    		 Renal Response - 36 Months
    Statistical analysis description
    The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders.
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.051
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 3.03

    Secondary: Proportion of subjects in partial renal response

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    End point title
    		 Proportion of subjects in partial renal response
    End point description
    Partial renal response defined as 50% reduction from AURORA 1 baseline in UPCR. The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders.
    End point type
    Secondary
    End point timeframe
    Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36
    End point values
    		 Voclosporin Placebo
    Number of subjects analysed
    116
    100
    Units: Number of Subjects
        Partial Renal Response - Month 12
    104
    70
        Partial Renal Response - Month 18
    96
    68
        Partial Renal Response - Month 24
    90
    58
        Partial Renal Response - Month 30
    85
    61
        Partial Renal Response - Month 36
    86
    69
    Statistical analysis title
    		 Partial Renal Response - 12 Months
    Statistical analysis description
    The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders.
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.88
         upper limit
    		 8.46
    Statistical analysis title
    		 Partial Renal Response - 18 Months
    Statistical analysis description
    The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders.
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.008
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.28
         upper limit
    		 4.88
    Statistical analysis title
    		 Partial Renal Response - 24 Months
    Statistical analysis description
    The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders.
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 4.91
    Statistical analysis title
    		 Partial Renal Response - 30 Months
    Statistical analysis description
    The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders.
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.04
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 3.34
    Statistical analysis title
    		 Partial Renal Response - 36 Months
    Statistical analysis description
    The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders.
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.29
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 2.58

    Secondary: Renal flare as adjudicated by the Clinical Endpoints Committee (CEC)

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    End point title
    		 Renal flare as adjudicated by the Clinical Endpoints Committee (CEC)
    End point description
    A patient could experience a flare from the point they achieved a response (or recovery). Renal flares were judged according to the following criteria: • A reproducible increase to UPCR >1 mg/mg from a post-response baseline of <0.2 mg/mg or • an increase to UPCR >2 mg/mg from a post-response baseline between 0.2 to 1.0 mg/mg or • a doubling of UPCR for baseline values of UPCR >1 mg/mg
    End point type
    Secondary
    End point timeframe
    up to 36 months
    End point values
    		 Voclosporin Placebo
    Number of subjects analysed
    116
    100
    Units: Number of Subjects (%)
    number (not applicable)
        Subjects without Adequate Response or with Flares
    39
    46
        Subjects with Adequate Response & without Flares
    77
    54
    Statistical analysis title
    		 Number of Subjects with Adequate Renal Response
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.045
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 0.99
    Notes
    [2] - The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and Region. An odds ration < unity indicates benefit of voclosporin

    Secondary: Change from AURORA 1 baseline in urine protein creatinine ratio (UPCR)

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    End point title
    		 Change from AURORA 1 baseline in urine protein creatinine ratio (UPCR)
    End point description
    Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Reductions in UPCR are indicative of better renal outcomes. The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits.
    End point type
    Secondary
    End point timeframe
    Months 12 (AURORA 2 baseline), 18, 24, 30 and 36
    End point values
    		 Voclosporin Placebo
    Number of subjects analysed
    116 [3]
    100 [4]
    Units: mg/mg
    least squares mean (standard error)
        Month 12 (AURORA 2 Baseline)
    -3.17 ± 0.164
    -2.52 ± 0.175
        Month 18
    -3.05 ± 0.216
    -2.42 ± 0.232
        Month 24
    -3.18 ± 0.188
    -2.41 ± 0.202
        Month 30
    -3.12 ± 0.219
    -2.21 ± 0.235
        Month 36
    -3.00 ± 0.222
    -2.52 ± 0.236
    Notes
    [3] - # participants: 116 (Month 12) 113 (Month 18) 105 (Month 24) 100 (Month 30) 99 (Month 36)
    [4] - # participants: 100 (Month 12) 96 (Month 18) 81 (Month 24) 87 (Month 30) 87 (Month 36)
    Statistical analysis title
    		 UPCR change from baseline at Month 12
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 -0.26
    Statistical analysis title
    		 UPCR change from baseline at Month 18
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.029
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.07
    Statistical analysis title
    		 UPCR change from baseline at Month 24
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.24
         upper limit
    		 -0.29
    Statistical analysis title
    		 UPCR change from baseline at Month 30
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.49
         upper limit
    		 -0.33
    Statistical analysis title
    		 UPCR change from baseline at Month 36
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.106
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 -0.1

    Secondary: Change from AURORA 1 baseline in urine protein

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    End point title
    		 Change from AURORA 1 baseline in urine protein
    End point description
    Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Reductions in Urine Protein levels are indicative of better renal outcomes. The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits.
    End point type
    Secondary
    End point timeframe
    Months 12 (AURORA 2 baseline), 18, 24, 30 and 36
    End point values
    		 Voclosporin Placebo
    Number of subjects analysed
    116 [5]
    100 [6]
    Units: mg/dL
    least squares mean (standard error)
        Month 12
    -302.4 ± 16.91
    -234.6 ± 18.05
        Month 18
    -297.8 ± 23.41
    -210.1 ± 25.15
        Month 24
    -295.8 ± 17.10
    -248.8 ± 18.51
        Month 30
    -304.7 ± 19.23
    -231.6 ± 20.67
        Month 36
    -280.7 ± 22.66
    -261.7 ± 24.01
    Notes
    [5] - # participants: 116 (Month 12) 112 (Month 18) 104 (Month 24) 99 (Month 30) 99 (Month 36)
    [6] - # participants: 100 (Month 12) 95 (Month 18) 81 (Month 24) 87 (Month 30) 86 (Month 36)
    Statistical analysis title
    		 Urine protein change from baseline at Month 12
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -67.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -110.4
         upper limit
    		 -25.1
    Statistical analysis title
    		 Urine protein change from baseline at Month 18
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -87.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -151.2
         upper limit
    		 -24.2
    Statistical analysis title
    		 Urine protein change from baseline at Month 24
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.035
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -90.8
         upper limit
    		 -3.3
    Statistical analysis title
    		 Urine protein change from baseline at Month 30
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -73.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -123.5
         upper limit
    		 -22.6
    Statistical analysis title
    		 Urine protein change from baseline at Month 36
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.537
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -79.7
         upper limit
    		 41.7

    Secondary: Change from AURORA 1 baseline in serum creatinine (SCr)

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    End point title
    		 Change from AURORA 1 baseline in serum creatinine (SCr)
    End point description
    Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Decreases in SCr levels can be indicative of better renal outcomes. The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits.
    End point type
    Secondary
    End point timeframe
    Months 12 (AURORA 2 baseline), 18, 24, 30 and 36
    End point values
    		 Voclosporin Placebo
    Number of subjects analysed
    116 [7]
    100 [8]
    Units: mg/dL
    least squares mean (standard error)
        Month 12
    0.051 ± 0.0207
    -0.034 ± 0.0221
        Month 18
    0.078 ± 0.0300
    0.027 ± 0.0323
        Month 24
    0.117 ± 0.0429
    0.060 ± 0.0466
        Month 30
    0.094 ± 0.0494
    0.129 ± 0.0534
        Month 36
    0.119 ± 0.0597
    0.197 ± 0.0644
    Notes
    [7] - # participants: 116 (Month 12) 114 (Month 18) 103 (Month 24) 99 (Month 30) 100 (Month 36)
    [8] - # participants: 100 (Month 12) 96 (Month 18) 81 (Month 24) 85 (Month 30) 87 (Month 36)
    Statistical analysis title
    		 Serum creatinine change from baseline at Month 12
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    0.084
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.035
         upper limit
    		 0.134
    Statistical analysis title
    		 Serum creatinine change from baseline at Month 18
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.209
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    0.051
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.029
         upper limit
    		 0.131
    Statistical analysis title
    		 Serum creatinine change from baseline at Month 24
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.353
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    0.057
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.064
         upper limit
    		 0.178
    Statistical analysis title
    		 Serum creatinine change from baseline at Month 30
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.616
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -0.036
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.176
         upper limit
    		 0.105
    Statistical analysis title
    		 Serum creatinine change from baseline at Month 36
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.372
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -0.077
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.248
         upper limit
    		 0.094

    Secondary: Change from AURORA 1 baseline in estimated glomerular filtration rate (eGFR)

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    End point title
    		 Change from AURORA 1 baseline in estimated glomerular filtration rate (eGFR)
    End point description
    Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. This endpoint incorporated Corrected eGFR values with a ceiling set to 90 mL/min/1.73 m2. Increases in eGFR levels are indicative of better renal outcomes. The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits. The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits.
    End point type
    Secondary
    End point timeframe
    Months 12 (AURORA 2 baseline), 18, 24, 30 and 36
    End point values
    		 Voclosporin Placebo
    Number of subjects analysed
    116 [9]
    100 [10]
    Units: mL/min/1.73 m2
    least squares mean (standard error)
        Month 12
    1.8 ± 1.08
    4.4 ± 1.15
        Month 18
    -0.2 ± 1.31
    1.6 ± 1.40
        Month 24
    -1.3 ± 1.48
    0.9 ± 1.60
        Month 30
    0.2 ± 1.56
    -0.8 ± 1.67
        Month 36
    -0.2 ± 1.69
    -2.0 ± 1.81
    Notes
    [9] - # participants: 116 (Month 12) 114 (Month 18) 103 (Month 24) 99 (Month 30) 100 (Month 36)
    [10] - # participants: 100 (Month 12) 96 (Month 18) 81 (Month 24) 85 (Month 30) 87 (Month 36)
    Statistical analysis title
    		 eGFR change from baseline at Month 12
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.041
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 -0.1
    Statistical analysis title
    		 eGFR change from baseline at Month 18
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.292
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 1.6
    Statistical analysis title
    		 eGFR change from baseline at Month 24
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.282
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 1.8
    Statistical analysis title
    		 eGFR change from baseline at Month 30
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.659
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 5.1
    Statistical analysis title
    		 eGFR change from baseline at Month 36
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.438
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 6.4

    Secondary: Change from AURORA 1 baseline in Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score

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    End point title
    		 Change from AURORA 1 baseline in Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score
    End point description
    Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Assessment of Systemic Lupus Erythematosus (SLE) Disease Activity within the last 10 days. It scores 24 disease descriptors across 9 organ systems which are summed to a minimum of <2 (considered indicative of no activity) and maximum of 105 points. Scores are weighted and a score of 6 is considered clinically significant. Higher scores indicate worse disease activity. The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits.
    End point type
    Secondary
    End point timeframe
    Months 18, 24 and 36
    End point values
    		 Voclosporin Placebo
    Number of subjects analysed
    116 [11]
    100 [12]
    Units: SELENA-SLEDAI Score
    least squares mean (confidence interval 95%)
        Month 18
    -6.4 (-7.4 to -5.4)
    -5.6 (-6.6 to -4.5)
        Month 24
    -6.8 (-7.7 to -5.9)
    -6.1 (-7.0 to -5.1)
        Month 36
    -6.8 (-7.7 to -5.9)
    -6.1 (-7.1 to -5.2)
    Notes
    [11] - 112 participants (Month 18) 100 participants (Month 24) 97 participants (Month 36)
    [12] - 96 participants (Month 18) 84 participants (Month 24) 85 participants (Month 36)
    Statistical analysis title
    		 SELENA-SLEDAI change from baseline at Month 18
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.238
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 0.5
    Statistical analysis title
    		 SELENA-SLEDAI change from baseline at Month 24
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.215
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 0.4
    Statistical analysis title
    		 SELENA-SLEDAI change from baseline at Month 36
    Comparison groups
    Voclosporin v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.246
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 0.5

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) are events starting in AURORA 2 up to 30 days after study treatment end.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Voclosporin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Voclosporin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 116 (18.10%)
    23 / 100 (23.00%)
         number of deaths (all causes)
    0
    3
         number of deaths resulting from adverse events
    0
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometriosis
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Pericarditis lupus
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 116 (0.86%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant glaucoma
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis toxic
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Lupus nephritis
         subjects affected / exposed
    2 / 116 (1.72%)
    3 / 100 (3.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 116 (0.86%)
    3 / 100 (3.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 116 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Corona virus infection
         subjects affected / exposed
    2 / 116 (1.72%)
    5 / 100 (5.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Urinary tract infection
         subjects affected / exposed
    2 / 116 (1.72%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 116 (0.00%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 116 (0.86%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 116 (0.86%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Voclosporin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    84 / 116 (72.41%)
    60 / 100 (60.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    10 / 116 (8.62%)
    6 / 100 (6.00%)
         occurrences all number
    10
    6
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    4 / 116 (3.45%)
    8 / 100 (8.00%)
         occurrences all number
    4
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 116 (2.59%)
    4 / 100 (4.00%)
         occurrences all number
    3
    5
    Investigations
    Glomerular filtration rate decreased
         subjects affected / exposed
    11 / 116 (9.48%)
    5 / 100 (5.00%)
         occurrences all number
    14
    5
    Neutrophil count decreased
         subjects affected / exposed
    2 / 116 (1.72%)
    3 / 100 (3.00%)
         occurrences all number
    2
    3
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    4 / 116 (3.45%)
    1 / 100 (1.00%)
         occurrences all number
    5
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 116 (6.90%)
    5 / 100 (5.00%)
         occurrences all number
    12
    6
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 116 (6.03%)
    0 / 100 (0.00%)
         occurrences all number
    7
    0
    Neutropenia
         subjects affected / exposed
    6 / 116 (5.17%)
    5 / 100 (5.00%)
         occurrences all number
    8
    5
    Eye disorders
    Dry eye
         subjects affected / exposed
    4 / 116 (3.45%)
    1 / 100 (1.00%)
         occurrences all number
    4
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 116 (8.62%)
    5 / 100 (5.00%)
         occurrences all number
    15
    5
    Nausea
         subjects affected / exposed
    3 / 116 (2.59%)
    5 / 100 (5.00%)
         occurrences all number
    3
    6
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    5 / 116 (4.31%)
    2 / 100 (2.00%)
         occurrences all number
    5
    2
    Rash
         subjects affected / exposed
    3 / 116 (2.59%)
    2 / 100 (2.00%)
         occurrences all number
    3
    2
    Renal and urinary disorders
    Lupus nephritis
         subjects affected / exposed
    8 / 116 (6.90%)
    1 / 100 (1.00%)
         occurrences all number
    9
    1
    Renal impairment
         subjects affected / exposed
    4 / 116 (3.45%)
    2 / 100 (2.00%)
         occurrences all number
    4
    2
    Proteinuria
         subjects affected / exposed
    4 / 116 (3.45%)
    1 / 100 (1.00%)
         occurrences all number
    6
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 116 (6.03%)
    3 / 100 (3.00%)
         occurrences all number
    7
    4
    Systemic lupus erythematosus
         subjects affected / exposed
    5 / 116 (4.31%)
    7 / 100 (7.00%)
         occurrences all number
    5
    9
    Arthritis
         subjects affected / exposed
    4 / 116 (3.45%)
    2 / 100 (2.00%)
         occurrences all number
    5
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    14 / 116 (12.07%)
    8 / 100 (8.00%)
         occurrences all number
    22
    10
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 116 (8.62%)
    3 / 100 (3.00%)
         occurrences all number
    11
    6
    Viral upper respiratory tract infection
         subjects affected / exposed
    10 / 116 (8.62%)
    4 / 100 (4.00%)
         occurrences all number
    10
    6
    Bronchitis
         subjects affected / exposed
    5 / 116 (4.31%)
    4 / 100 (4.00%)
         occurrences all number
    5
    4
    Corona virus infection
         subjects affected / exposed
    5 / 116 (4.31%)
    8 / 100 (8.00%)
         occurrences all number
    6
    9
    Gastroenteritis
         subjects affected / exposed
    5 / 116 (4.31%)
    2 / 100 (2.00%)
         occurrences all number
    5
    2
    Herpes zoster
         subjects affected / exposed
    4 / 116 (3.45%)
    7 / 100 (7.00%)
         occurrences all number
    4
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Oct 2018
    Editorial changes for clarification and changes to correct errors.
    21 Dec 2018
    Editorial changes for clarification and changes to correct errors.

    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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