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    Clinical Trial Results:
    A Dose-Blinded, 2-Dose Level, Parallel-Group, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Efficacy, and Immunogenicity of BIIB023 in Subjects with Lupus Nephritis

    Summary
    EudraCT number
    		 2013-000594-69
    Trial protocol
    		 BE   ES   IT   HU   PL   DE  
    Global end of trial date
    15 Jan 2016

    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

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    211LE202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01930890
    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
    15 Jan 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the long-term safety and tolerability of BIIB023 in subjects with lupus nephritis (LN). This was an extension study for all subjects who completed study 211LE201 (2011-002159-32) through Week 52 and did not discontinue BIIB023 or placebo. Eligible subjects from Study 211LE201 were followed for up to 108 weeks. Subjects who received BIIB023 low dose or high dose in 211LE201 continued to receive the same dosing in this study (211LE202; 2013-000594-69) in addition to background therapy. Subjects who received placebo in 211LE201 were randomized to receive either BIIB023 low dose or high dose in addition to background therapy.
    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
    		 Open-label mycophenolate mofetil (MMF) and oral corticosteroids were used at the Investigator’s discretion. MMF could be increased to a maximum of 3 g/day or reduced/discontinued in response to peripheral neutrophil counts and/or serious infection. Corticosteriod therapy was specified as prednisone doses, but equivalent doses of other corticosteroids were permitted. The subjects were to obtain corticosteroid therapy by prescription.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Nov 2013
    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: 21
    Country: Number of subjects enrolled
    Philippines: 14
    Country: Number of subjects enrolled
    Malaysia: 8
    Country: Number of subjects enrolled
    Colombia: 7
    Country: Number of subjects enrolled
    Peru: 7
    Country: Number of subjects enrolled
    United States: 7
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Thailand: 3
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Hong Kong: 1
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    Spain: 1
    Worldwide total number of subjects
    87
    EEA total number of subjects
    10
    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)
    87
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects who completed Week 52 of Study 211LE201 and did not discontinue BIIB023 or placebo study treatment were eligible for this study.

    Pre-assignment
    Screening details
    		 A total of 87 subjects were randomized.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer
    Blinding implementation details
    BIIB023 was prepared and dispensed by an unblinded Pharmacist or an unblinded medically qualified designee (other than the Investigator or co-Investigator). All subjects enrolled in Study 211LE202 were blinded to their dose level.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)
    Arm description
    		 Subjects who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BIIB023
    Investigational medicinal product code
    BIIB023
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    BIIB023 was administered by IV infusion over 1 hour, followed by a minimum of 1-hour observation period.

    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
    MMF was taken orally morning and evening, before meals, and with a glass of water. Subjects who experienced tolerability issues (e.g., nausea or diarrhea) were allowed to receive MMF 3 times daily. MMF could be increased to a maximum of 3 g/day or reduced/discontinued in response to peripheral neutrophil counts and/or serious infection.

    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
    Use of oral corticosteroids was at the Investigator’s discretion.

    Arm title
    		 BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
    Arm description
    		 Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BIIB023
    Investigational medicinal product code
    BIIB023
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    BIIB023 was administered by IV infusion over 1 hour, followed by a minimum of 1-hour observation period.

    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
    MMF was taken orally morning and evening, before meals, and with a glass of water. Subjects who experienced tolerability issues (e.g., nausea or diarrhea) were allowed to receive MMF 3 times daily. MMF could be increased to a maximum of 3 g/day or reduced/discontinued in response to peripheral neutrophil counts and/or serious infection.

    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
    Use of oral corticosteroids was at the Investigator’s discretion.

    Arm title
    		 Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
    Arm description
    		 Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BIIB023
    Investigational medicinal product code
    BIIB023
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    BIIB023 was administered by IV infusion over 1 hour, followed by a minimum of 1-hour observation period.

    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
    MMF was taken orally morning and evening, before meals, and with a glass of water. Subjects who experienced tolerability issues (e.g., nausea or diarrhea) were allowed to receive MMF 3 times daily. MMF could be increased to a maximum of 3 g/day or reduced/discontinued in response to peripheral neutrophil counts and/or serious infection.

    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
    Use of oral corticosteroids was at the Investigator’s discretion.

    Arm title
    		 BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
    Arm description
    		 Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BIIB023
    Investigational medicinal product code
    BIIB023
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    BIIB023 was administered by IV infusion over 1 hour, followed by a minimum of 1-hour observation period.

    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
    MMF was taken orally morning and evening, before meals, and with a glass of water. Subjects who experienced tolerability issues (e.g., nausea or diarrhea) were allowed to receive MMF 3 times daily. MMF could be increased to a maximum of 3 g/day or reduced/discontinued in response to peripheral neutrophil counts and/or serious infection.

    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
    Use of oral corticosteroids was at the Investigator’s discretion.

    Number of subjects in period 1
    		Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
    Started
    14
    33
    13
    27
    Completed
    0
    0
    0
    0
    Not completed
    14
    33
    13
    27
         Adverse event, serious fatal
    -
    -
    -
    1
         Study Termination
    14
    28
    13
    25
         Adverse event, non-fatal
    -
    1
    -
    -
         Investigator Decision
    -
    1
    -
    -
         Consent Withdrawn
    -
    3
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)
    Reporting group description
    		 Subjects who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Reporting group title
    BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
    Reporting group description
    		 Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Reporting group title
    Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
    Reporting group description
    		 Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Reporting group title
    BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
    Reporting group description
    		 Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Reporting group values
    		 Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) Total
    Number of subjects
    		 14 33 13 27 87
    Age, Customized
    Units: participants
        18 to 19 years
    		 0 0 1 1 2
        20 to 29 years
    		 6 15 6 9 36
        30 to 39 years
    		 6 11 3 14 34
        40 to 49 years
    		 2 6 2 1 11
        50 to 55 years
    		 0 0 1 2 3
        > 55 years
    		 0 1 0 0 1
    Gender, Male/Female
    Units:
        Female
    		 11 29 10 25 75
        Male
    		 3 4 3 2 12

    End points

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    End points reporting groups
    Reporting group title
    Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)
    Reporting group description
    		 Subjects who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Reporting group title
    BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
    Reporting group description
    		 Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Reporting group title
    Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
    Reporting group description
    		 Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Reporting group title
    BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
    Reporting group description
    		 Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Primary: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    AEs with a start date on or after the first dose date in study 211LE202. 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
    Primary
    End point timeframe
    Up to Week 108
    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
    		 Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
    Number of subjects analysed
    14
    33
    13
    27
    Units: participants
    number (not applicable)
        Any event
    4
    23
    7
    19
        Moderate or severe event
    2
    12
    3
    6
        Severe event
    0
    4
    1
    3
        Event related to dose-blinded treatment
    1
    5
    1
    4
        Event related to MMF
    2
    8
    2
    9
        Serious event
    1
    7
    4
    3
        Serious event related to dose-blinded treatment
    0
    2
    1
    1
        Serious event related to MMF
    0
    3
    1
    2
        Fatal event
    0
    0
    0
    1
    No statistical analyses for this end point

    Primary: Number of Subjects Who Discontinued Study Treatment or Withdrew From Study Due to an AE

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    End point title
    		 Number of Subjects Who Discontinued Study Treatment or Withdrew From Study Due to an AE [2]
    End point description
    AEs with a start date on or after the first dose date in study 211LE202. 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
    Primary
    End point timeframe
    Up to week 108
    Notes
    [2] - 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
    		 Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
    Number of subjects analysed
    14
    33
    13
    27
    Units: subjects
        Discontinued treatment due to an AE
    0
    0
    0
    0
        Withdrew from study due to an AE
    0
    2
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 108
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Placebo (211LE201) to BIIB023 3 mg/ kg (211LE202)
    Reporting group description
    		 Subjects who received placebo Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Reporting group title
    BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)
    Reporting group description
    		 Subjects who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Reporting group title
    Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)
    Reporting group description
    		 Subjects who received placebo Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Reporting group title
    BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
    Reporting group description
    		 Subjects who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.

    Serious adverse events
    		 Placebo (211LE201) to BIIB023 3 mg/ kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 14 (7.14%)
    7 / 33 (21.21%)
    4 / 13 (30.77%)
    3 / 27 (11.11%)
         number of deaths (all causes)
    0
    0
    0
    1
         number of deaths resulting from adverse events
    Investigations
    Hepatic enzyme abnormal
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    1 / 27 (3.70%)
         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
    Nervous system disorders
    Tension headache
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (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
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (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
    General disorders and administration site conditions
    Multi-organ failure
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    1 / 27 (3.70%)
         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 / 1
    Eye disorders
    Aphakia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (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
    Cataract
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (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
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    1 / 27 (3.70%)
         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
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    0 / 27 (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
    Skin and subcutaneous tissue disorders
    Stevens-johnson syndrome
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    0 / 27 (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
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 33 (3.03%)
    0 / 13 (0.00%)
    0 / 27 (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
    Renal and urinary disorders
    Lupus nephritis
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 33 (9.09%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 33 (3.03%)
    0 / 13 (0.00%)
    0 / 27 (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
    Gastroenteritis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    1 / 27 (3.70%)
         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 / 1
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (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
    Pneumonia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 33 (3.03%)
    0 / 13 (0.00%)
    0 / 27 (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
    Septic shock
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    1 / 27 (3.70%)
         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 / 1
    Tuberculosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 33 (3.03%)
    0 / 13 (0.00%)
    0 / 27 (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
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 33 (3.03%)
    0 / 13 (0.00%)
    0 / 27 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo (211LE201) to BIIB023 3 mg/ kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 14 (28.57%)
    19 / 33 (57.58%)
    7 / 13 (53.85%)
    13 / 27 (48.15%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 33 (6.06%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    3
    0
    0
    General disorders and administration site conditions
    Face oedema
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Oedema
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 33 (3.03%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 33 (6.06%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Reproductive system and breast disorders
    Menopausal symptoms
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 33 (3.03%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 33 (9.09%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 33 (3.03%)
    0 / 13 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    0
    2
    Haemoglobin decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 33 (9.09%)
    0 / 13 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    3
    0
    2
    Red blood cell count decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Spleen palpable
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Transaminases increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    2
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    1
    Foot fracture
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 33 (3.03%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Road traffic accident
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 33 (3.03%)
    4 / 13 (30.77%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    4
    3
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Tension headache
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 33 (3.03%)
    2 / 13 (15.38%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    2
    1
    Constipation
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 33 (3.03%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 33 (6.06%)
    0 / 13 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    2
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 33 (6.06%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    5
    0
    Nausea
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Granulomatous liver disease
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Butterfly rash
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Livedo reticularis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 33 (3.03%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Rash pruritic
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Systemic lupus erythematosus rash
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dysuria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    2
    2
    Renal impairment
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 33 (9.09%)
    0 / 13 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    3
    0
    4
    Arthritis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 33 (3.03%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Back pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    1
    Muscle spasms
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    2 / 13 (15.38%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Osteoporosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    1
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 14 (7.14%)
    5 / 33 (15.15%)
    0 / 13 (0.00%)
    5 / 27 (18.52%)
         occurrences all number
    1
    5
    0
    7
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Herpes zoster
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 33 (3.03%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 33 (6.06%)
    1 / 13 (7.69%)
    1 / 27 (3.70%)
         occurrences all number
    0
    2
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 33 (3.03%)
    0 / 13 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    1
    0
    2
    Onychomycosis
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 33 (6.06%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 33 (6.06%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    6
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    5 / 33 (15.15%)
    0 / 13 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    8
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 33 (6.06%)
    4 / 13 (30.77%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    5
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 33 (6.06%)
    0 / 13 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    3
    0
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 33 (0.00%)
    1 / 13 (7.69%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperlipidaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 33 (0.00%)
    0 / 13 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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 a pre-specified, blinded futility analysis of Study 211LE201 (2011-002159-32), which didn't demonstrate sufficient efficacy to warrant continuation of the studies. Study was not terminated based on safety considerations.
    For support, Contact us.
    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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