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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis

    Summary
    EudraCT number
    		 2011-002159-32
    Trial protocol
    		 PT   BE   DE   ES   HU   IT   PL  
    Global end of trial date
    09 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Dec 2016
    First version publication date
    08 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    211LE201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01499355
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biogen
    Sponsor organisation address
    225 Binney Street, Cambridge, Massachusetts, United States, 02142
    Public contact
    Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
    Scientific contact
    Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of subjects with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population. Subjects who completed this study through Week 52 were offered the option to enter an extension study under a separate protocol 211LE202 (2013-000594-69).
    Protection of trial subjects
    Written informed consent was obtained from each subject prior to evaluations being performed for eligibility. Subjects were given adequate time to review the information in the informed consent and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study. Through the informed consent process each subject was made aware of the purpose of the study, the procedures, the benefits and risks of the study, the discomforts and the precautions taken. Any side effects or other health issues occurring during the study were followed up by the study doctor. Subjects were able to stop taking part in the study at any time without giving any reason.
    Background therapy
    		 Oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day. Mycophenolate mofetil (MMF) titrated to a target dose of 2 g/day (1 g twice daily).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jul 2012
    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: 54
    Country: Number of subjects enrolled
    Malaysia: 29
    Country: Number of subjects enrolled
    United States: 27
    Country: Number of subjects enrolled
    Philippines: 24
    Country: Number of subjects enrolled
    Peru: 23
    Country: Number of subjects enrolled
    Mexico: 18
    Country: Number of subjects enrolled
    Thailand: 16
    Country: Number of subjects enrolled
    Colombia: 14
    Country: Number of subjects enrolled
    Brazil: 9
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Hong Kong: 8
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    Serbia: 2
    Country: Number of subjects enrolled
    Spain: 2
    Worldwide total number of subjects
    276
    EEA total number of subjects
    40
    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)
    276
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 276 subjects were enrolled and 203 completed the run-in period and qualified for randomization; of these, 15 subjects were not randomized.

    Period 1
    Period 1 title
    Run-In Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All Enrolled Subjects
    Arm description
    		 At Run-in Day 1, subjects entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
    Arm type
    		 run-in period (background therapy)

    Investigational medicinal product name
    oral corticosteroid (prednisone or equivalent)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At Run-in Day 1, subjects entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10.

    Investigational medicinal product name
    mycophenolate mofetil
    Investigational medicinal product code
    Other name
    MMF, Cellcept
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2. Subjects already receiving MMF prior to Screening, but at a dose of <2 g/day, were to have their dose titrated up to the target daily dose by Run-in Week 2. The MMF dose could be titrated up to a maximum dose of 3 g/day at the Investigator’s discretion.

    Number of subjects in period 1
    		All Enrolled Subjects
    Started
    276
    Completed
    245
    Not completed
    31
         Adverse Event
    8
         Study Termination
    15
         Death
    2
         Not Specified
    3
         Investigator Decision
    2
         Consent Withdrawn
    1
    Period 2
    Period 2 title
    Double-Blind Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    The subject and all study site staff will be blinded to the subject treatment assignments (BIIB023 20 mg/kg, BIIB023 3 mg/kg, or placebo) with the exception of the unblinded Pharmacist or designee who is responsible for preparing the study treatments and the unblinded Pharmacy Monitor.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
    Arm type
    		 Placebo

    Investigational medicinal product name
    oral corticosteroid (prednisone or equivalent)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg/day prednisone dose (or equivalent)

    Investigational medicinal product name
    mycophenolate mofetil
    Investigational medicinal product code
    Other name
    MMF, Cellcept
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Target dose of 2 g/day (could be titrated up to a maximum dose of 3 g/day at the Investigator’s discretion).

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    sterile normal saline (0.9% sodium chloride for injection)
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects will receive administration of placebo at 14 study visits (Day 1 [Baseline], Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48).

    Arm title
    		 BIIB023 3 mg/kg
    Arm description
    		 BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
    Arm type
    		 Experimental

    Investigational medicinal product name
    oral corticosteroid (prednisone or equivalent)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg/day prednisone dose (or equivalent)

    Investigational medicinal product name
    mycophenolate mofetil
    Investigational medicinal product code
    Other name
    MMF, Cellcept
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Target dose of 2 g/day (could be titrated up to a maximum dose of 3 g/day at the Investigator’s discretion).

    Investigational medicinal product name
    BIIB023
    Investigational medicinal product code
    BIIB023
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received administration of BIIB023 at 14 study visits (Day 1 [Baseline], Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48).

    Arm title
    		 BIIB023 20 mg/kg
    Arm description
    		 BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
    Arm type
    		 Experimental

    Investigational medicinal product name
    oral corticosteroid (prednisone or equivalent)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg/day prednisone dose (or equivalent)

    Investigational medicinal product name
    mycophenolate mofetil
    Investigational medicinal product code
    Other name
    MMF, Cellcept
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Target dose of 2 g/day (could be titrated up to a maximum dose of 3 g/day at the Investigator’s discretion).

    Investigational medicinal product name
    BIIB023
    Investigational medicinal product code
    BIIB023
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received administration of BIIB023 at 14 study visits (Day 1 [Baseline], Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48).

    Number of subjects in period 2 [1]
    		Placebo BIIB023 3 mg/kg BIIB023 20 mg/kg
    Started
    63
    63
    62
    Completed
    40
    38
    39
    Not completed
    23
    25
    23
         Adverse event, serious fatal
    1
    -
    -
         Study Termination
    18
    16
    14
         Adverse event, non-fatal
    2
    3
    2
         NotSpecified
    1
    2
    2
         Investigator Decision
    -
    3
    3
         Lost to follow-up
    1
    -
    -
         Consent Withdrawn
    -
    1
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: A total of 276 subjects were enrolled and 203 completed the run-in period and qualified for randomization; of these, 15 subjects were not randomized into Period 2.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All Enrolled Subjects
    Reporting group description
    		 At Run-in Day 1, subjects entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.

    Reporting group values
    		 All Enrolled Subjects Total
    Number of subjects
    		 276 276
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 276 276
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.3 ( 10.11 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 242 242
        Male
    		 34 34

    End points

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    End points reporting groups
    Reporting group title
    All Enrolled Subjects
    Reporting group description
    		 At Run-in Day 1, subjects entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.

    Reporting group title
    BIIB023 3 mg/kg
    Reporting group description
    		 BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.

    Reporting group title
    BIIB023 20 mg/kg
    Reporting group description
    		 BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.

    Subject analysis set title
    mITT: Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects in the Placebo arm in the mITT population (subjects in ITT population except for those who withdrew from study due to study early termination. (Includes subjects who completed Week 44 infusion and Visits at Week 52/early withdrawal and Week 56/End of Study but withdrew due to study early termination.)

    Subject analysis set title
    mITT: BIIB023 3 mg/kg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects in the BIIB023 3 mg/kg arm in the mITT population (subjects in ITT population except for those who withdrew from study due to study early termination. (Includes subjects who completed Week 44 infusion and Visits at Week 52/early withdrawal and Week 56/End of Study but withdrew due to study early termination.)

    Subject analysis set title
    mITT: BIIB023 20 mg/kg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects in the BIIB023 20 mg/kg arm in the mITT population (subjects in ITT population except for those who withdrew from study due to study early termination. (Includes subjects who completed Week 44 infusion and Visits at Week 52/early withdrawal and Week 56/End of Study but withdrew due to study early termination.)

    Subject analysis set title
    ITT: Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects in the Placebo arm who were randomized and received at least 1 dose of study treatment (placebo).

    Subject analysis set title
    ITT: BIIB023 3 mg/kg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects in the Placebo arm who were randomized and received at least 1 dose of study treatment (BIIB023).

    Subject analysis set title
    ITT: BIIB023 20 mg/kg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects in the BIIB023 20 mg/kg arm who were randomized and received at least 1 dose of study treatment (BIIB023).

    Primary: Percentage of Subjects Who Achieve a Complete or Partial Renal Response at Week 52

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    End point title
    		 Percentage of Subjects Who Achieve a Complete or Partial Renal Response at Week 52 [1]
    End point description
    Complete renal response is defined as: (1) urinary protein:creatinine ratio (uPCR) < 0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline; from a 24 hour urine collection); and (2) estimated glomerular filtration rate (eGFR) within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range).
    End point type
    Primary
    End point timeframe
    Week 52
    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: Descriptive statistics are presented, per protocol.
    End point values
    		 mITT: Placebo mITT: BIIB023 3 mg/kg mITT: BIIB023 20 mg/kg
    Number of subjects analysed
    48
    49
    48
    Units: percentage of subjects
        number (confidence interval 90%)
    25 (14.7 to 35.3)
    16 (7.6 to 25)
    31 (20.3 to 42.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieve Complete Renal Response at Week 52

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    End point title
    		 Percentage of Subjects Who Achieve Complete Renal Response at Week 52
    End point description
    Complete renal response is defined as uPCR < 0.5 mg/mg with ≥ 50% reduction of uPCR from Baseline (from a 24-hour urine collection) and eGFR within normal range.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 mITT: Placebo mITT: BIIB023 3 mg/kg mITT: BIIB023 20 mg/kg
    Number of subjects analysed
    48
    49
    48
    Units: percentage of subjects
        number (not applicable)
    6
    8
    8
    No statistical analyses for this end point

    Secondary: Time to Renal Response (Partial or Complete) in Subjects Who Achieve Renal Response at Week 52

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    End point title
    		 Time to Renal Response (Partial or Complete) in Subjects Who Achieve Renal Response at Week 52
    End point description
    Onset of renal response was calculated as weeks elapsed from baseline date to first visit where renal response was achieved. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 ITT: Placebo ITT: BIIB023 3 mg/kg ITT: BIIB023 20 mg/kg
    Number of subjects analysed
    12 [2]
    8 [3]
    15 [4]
    Units: weeks
        median (full range (min-max))
    10.6 (2 to 41)
    5.2 (2 to 28)
    4.1 (2 to 37)
    Notes
    [2] - Subjects who achieved a renal response at Week 52.
    [3] - Subjects who achieved a renal response at Week 52.
    [4] - Subjects who achieved a renal response at Week 52.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    ITT: Placebo v ITT: BIIB023 3 mg/kg
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.367 [5]
    Method
    		 Cox proportional hazard
    Confidence interval
    Notes
    [5] - P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, rest of world [ROW]) and renal response at Run-in Week 12 (partial and non-response).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    ITT: Placebo v ITT: BIIB023 20 mg/kg
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.283 [6]
    Method
    		 Cox proportional hazard
    Confidence interval
    Notes
    [6] - P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).

    Secondary: Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study

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    End point title
    		 Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study
    End point description
    Number of days between first visit with response to last consecutive visit with partial or complete response. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 ITT: Placebo ITT: BIIB023 3 mg/kg ITT: BIIB023 20 mg/kg
    Number of subjects analysed
    48
    39
    40
    Units: days
        arithmetic mean (standard deviation)
    48.3 ( 83.23 )
    45.6 ( 75.42 )
    52.1 ( 106.72 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    ITT: Placebo v ITT: BIIB023 3 mg/kg
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.863
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    ITT: Placebo v ITT: BIIB023 20 mg/kg
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.769
    Method
    		 Regression, Cox
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    ITT: Placebo v ITT: BIIB023 3 mg/kg
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.907
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    ITT: Placebo v ITT: BIIB023 20 mg/kg
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.996
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percentage of Subjects With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52

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    End point title
    		 Percentage of Subjects With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 52
    End point values
    		 mITT: Placebo mITT: BIIB023 3 mg/kg mITT: BIIB023 20 mg/kg
    Number of subjects analysed
    12 [7]
    18 [8]
    15 [9]
    Units: percentage of subjects
        number (not applicable)
    0
    22
    13
    Notes
    [7] - Subjects with a uPCR > 3.0 mg/mg at Baseline
    [8] - Subjects with a uPCR > 3.0 mg/mg at Baseline
    [9] - Subjects with a uPCR > 3.0 mg/mg at Baseline
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    mITT: BIIB023 3 mg/kg v mITT: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0486 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [10] - Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    mITT: Placebo v mITT: BIIB023 20 mg/kg
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0668 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [11] - Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).

    Secondary: Percentage of Subjects With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52

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    End point title
    		 Percentage of Subjects With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52
    End point description
    Active urinary sediment is defined by 1 of the following (in the absence of a urinary tract infection or menses): > 5 red blood cell/high power field (RBC/HPF) or above the reference range for the laboratory, and > 5 white blood cell/high power field (WBC/HPF) or above the reference range for the laboratory, and presence of cellular casts (RBC or WBC). Inactive urinary sediment is defined as: < 5 RBC/HPF and < 5 WBC/HPF, or within the laboratory reference range, and no cellular casts (no RBC or WBC casts).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 mITT: Placebo mITT: BIIB023 3 mg/kg mITT: BIIB023 20 mg/kg
    Number of subjects analysed
    16 [12]
    21 [13]
    14 [14]
    Units: percentage of subjects
        number (confidence interval 90%)
    38 (17.6 to 57.4)
    5 (0 to 12.4)
    21 (3.4 to 39.5)
    Notes
    [12] - Subjects with active urinary sediment at Day 1
    [13] - Subjects with active urinary sediment at Day 1
    [14] - Subjects with active urinary sediment at Day 1
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    mITT: Placebo v mITT: BIIB023 3 mg/kg
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0456 [15]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.0628
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.0081
         upper limit
    		 0.4843
    Notes
    [15] - Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    mITT: Placebo v mITT: BIIB023 20 mg/kg
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5455 [16]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.4344
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.0996
         upper limit
    		 1.8941
    Notes
    [16] - Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    mITT: Placebo v mITT: BIIB023 3 mg/kg
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0252
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    mITT: Placebo v mITT: BIIB023 20 mg/kg
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2876
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of Subjects with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period

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    End point title
    		 Number of Subjects with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period
    End point description
    AEs that had an onset on or after dosing of MMF on run-in Day 1 up to the first double-blind dose, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Day 1 to Week 12
    End point values
    		 All Enrolled Subjects
    Number of subjects analysed
    276
    Units: subjects
    number (not applicable)
        Any Event
    209
        Moderate or Severe Event
    94
        Severe Event
    18
        Related Event to MMF
    90
        Serious Event
    28
        Related Serious Event to MMF
    12
        Fatal Event
    2
        Discontinued Treatment Due to Event
    0
        Withdrew From Study Due to Event
    10
    No statistical analyses for this end point

    Secondary: Number of Subjects with AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period

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    End point title
    		 Number of Subjects with AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period
    End point description
    AEs that had an onset on or after dosing of BIIB023 or placebo, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Week 12 to Week 56
    End point values
    		 Placebo BIIB023 3 mg/kg BIIB023 20 mg/kg
    Number of subjects analysed
    63
    63
    62
    Units: subjects
    number (not applicable)
        Any event
    48
    60
    53
        Moderate or severe event
    26
    32
    22
        Severe event
    4
    6
    5
        Event related to double-blind treatment
    5
    15
    11
        Event related to MMF
    21
    24
    22
        Serious event
    7
    11
    10
        Serious event related to double-blind treatment
    3
    3
    2
        Serious event related to MMF
    6
    4
    3
        Fatal event
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Renal Response in Subjects Who Achieve Complete Renal Response at Week 52

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    End point title
    		 Duration of Renal Response in Subjects Who Achieve Complete Renal Response at Week 52
    End point description
    Duration of response was calculated as the days in between the date of Week 52 visit and the date when the participant last became complete renal responder on or before Week 52 visit. Complete renal response: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 mITT: Placebo mITT: BIIB023 3 mg/kg mITT: BIIB023 20 mg/kg
    Number of subjects analysed
    48
    49
    49
    Units: subjects
        1-day duration
    2
    3
    2
        27-day duration
    0
    0
    1
        78-day duration
    0
    1
    0
        141-day duration
    1
    0
    0
        169-day duration
    0
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs: Run-in Day 1 through Week 64 +/- 5 days. SAEs: Screening through Week 64 +/- 5 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Run-in period
    Reporting group description
    		 At Run-in Day 1, subjects entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.

    Reporting group title
    BIIB023 3mg/kg
    Reporting group description
    		 BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.

    Reporting group title
    BIIB023 20 mg/kg
    Reporting group description
    		 BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.

    Serious adverse events
    		 Run-in period Placebo BIIB023 3mg/kg BIIB023 20 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 276 (10.14%)
    7 / 63 (11.11%)
    11 / 63 (17.46%)
    10 / 62 (16.13%)
         number of deaths (all causes)
    2
    1
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Papilloma excision
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 276 (0.72%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 276 (0.72%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis rapidly progressive
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lupus nephritis
         subjects affected / exposed
    2 / 276 (0.72%)
    0 / 63 (0.00%)
    3 / 63 (4.76%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 276 (0.36%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Brain abscess
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysentery
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    3 / 63 (4.76%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    4 / 276 (1.45%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 276 (0.72%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 276 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 276 (0.36%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Run-in period Placebo BIIB023 3mg/kg BIIB023 20 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    134 / 276 (48.55%)
    33 / 63 (52.38%)
    46 / 63 (73.02%)
    43 / 62 (69.35%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    10 / 276 (3.62%)
    0 / 63 (0.00%)
    4 / 63 (6.35%)
    5 / 62 (8.06%)
         occurrences all number
    10
    0
    4
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 276 (1.09%)
    1 / 63 (1.59%)
    4 / 63 (6.35%)
    3 / 62 (4.84%)
         occurrences all number
    3
    1
    5
    4
    Headache
         subjects affected / exposed
    12 / 276 (4.35%)
    6 / 63 (9.52%)
    7 / 63 (11.11%)
    6 / 62 (9.68%)
         occurrences all number
    12
    10
    9
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 276 (2.54%)
    4 / 63 (6.35%)
    4 / 63 (6.35%)
    7 / 62 (11.29%)
         occurrences all number
    7
    4
    5
    7
    Leukopenia
         subjects affected / exposed
    10 / 276 (3.62%)
    7 / 63 (11.11%)
    5 / 63 (7.94%)
    2 / 62 (3.23%)
         occurrences all number
    10
    9
    5
    2
    Neutropenia
         subjects affected / exposed
    3 / 276 (1.09%)
    4 / 63 (6.35%)
    5 / 63 (7.94%)
    0 / 62 (0.00%)
         occurrences all number
    3
    7
    5
    0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    8 / 276 (2.90%)
    1 / 63 (1.59%)
    4 / 63 (6.35%)
    1 / 62 (1.61%)
         occurrences all number
    11
    1
    4
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    31 / 276 (11.23%)
    2 / 63 (3.17%)
    2 / 63 (3.17%)
    8 / 62 (12.90%)
         occurrences all number
    39
    2
    3
    8
    Nausea
         subjects affected / exposed
    14 / 276 (5.07%)
    3 / 63 (4.76%)
    5 / 63 (7.94%)
    2 / 62 (3.23%)
         occurrences all number
    14
    4
    5
    3
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    8 / 276 (2.90%)
    1 / 63 (1.59%)
    5 / 63 (7.94%)
    3 / 62 (4.84%)
         occurrences all number
    8
    1
    5
    3
    Rash
         subjects affected / exposed
    8 / 276 (2.90%)
    4 / 63 (6.35%)
    4 / 63 (6.35%)
    0 / 62 (0.00%)
         occurrences all number
    8
    4
    4
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 276 (0.36%)
    3 / 63 (4.76%)
    5 / 63 (7.94%)
    6 / 62 (9.68%)
         occurrences all number
    1
    3
    5
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    10 / 276 (3.62%)
    6 / 63 (9.52%)
    6 / 63 (9.52%)
    5 / 62 (8.06%)
         occurrences all number
    11
    7
    6
    5
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    10 / 276 (3.62%)
    1 / 63 (1.59%)
    3 / 63 (4.76%)
    7 / 62 (11.29%)
         occurrences all number
    12
    1
    3
    11
    Gastroenteritis
         subjects affected / exposed
    9 / 276 (3.26%)
    6 / 63 (9.52%)
    6 / 63 (9.52%)
    7 / 62 (11.29%)
         occurrences all number
    11
    6
    8
    9
    Influenza
         subjects affected / exposed
    4 / 276 (1.45%)
    2 / 63 (3.17%)
    1 / 63 (1.59%)
    4 / 62 (6.45%)
         occurrences all number
    4
    2
    1
    4
    Nasopharyngitis
         subjects affected / exposed
    13 / 276 (4.71%)
    3 / 63 (4.76%)
    5 / 63 (7.94%)
    5 / 62 (8.06%)
         occurrences all number
    13
    5
    5
    5
    Upper respiratory tract infection
         subjects affected / exposed
    21 / 276 (7.61%)
    7 / 63 (11.11%)
    13 / 63 (20.63%)
    6 / 62 (9.68%)
         occurrences all number
    24
    8
    18
    9
    Urinary tract infection
         subjects affected / exposed
    8 / 276 (2.90%)
    2 / 63 (3.17%)
    6 / 63 (9.52%)
    2 / 62 (3.23%)
         occurrences all number
    8
    2
    7
    2
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    11 / 276 (3.99%)
    1 / 63 (1.59%)
    6 / 63 (9.52%)
    3 / 62 (4.84%)
         occurrences all number
    11
    1
    13
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Oct 2011
    A global amendment was implemented to: - revise the reproductive toxicity (Segent 2, teratology) section - update Exclusion 3 to change “global fibrosis” to “diffuse fibrosis” - update contraception requirements to require at least 2 methods of birth control, including at least 1 barrier method
    18 Oct 2012
    A global amendment was implemented to: - update inclusion criteria to allow renal biopsies to be performed during the Screening Period if no renal biopsy from the last 3 months was available - simplify parameters of proteinuria at Screening (Inclusion Criteria 5) as uPCR > 1.0 mg/mg - increase the contraception requirement from 3 months to 6 months after last dose of study treatment - update tuberculosis exclusion criteria to allow local guidelines to be followed - remove the use of steroids from the exclusion criteria
    24 Jan 2014
    A global amendment was implemented to: - add an interim analysis for futility - change the number of subjects to be randomized into the Double-Blind Period from approximately 220 to approximately 210 - change the Screening window from 28 days to 35 days prior to Run-in Day 1, regardless of whether or not a subject had a renal biopsy performed during Screening - allow subjects who had a uPCR <0.5 mg/mg at Run-in (Week 12) and consequently did not meet the Randomization Inclusion Criteria to have the 24-hour uPCR repeated once within 4 weeks prior to Baseline at the Investigator’s discretion - revise Exclusion Criterion 18 to include any abnormal laboratory value at Screening considered by the Investigator to be clinically significant - revise Exclusion Criterion 28 to allow subjects taking cyclophosphamide, calcineurin, or a calcineurin inhibitor from within 12 months to within 6 months prior to Screening to be eligible for the study - revise the temporary dose reduction of MMF to <1.5 g/day for >14 days during the Double-Blind Period

    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.
    Study was terminated based on the review of results following the prespecified, blinded futility analysis, which did not demonstrate sufficient efficacy to warrant continuation of the study. Study was not terminated based on safety considerations.
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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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