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    Clinical Trial Results:
    An exploratory maintenance trial evaluating the effect of BI 655064 in Lupus Nephritis patients who have achieved a meaningful response either at the end of 1293.10 or after an induction treatment outside of 1293.10

    Summary
    EudraCT number
    		 2017-003101-17
    Trial protocol
    		 CZ   GR   DE   PT   PL   GB   ES   FR   IT  
    Global end of trial date
    27 Jul 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Jul 2022
    First version publication date
    28 May 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1293-0013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03385564
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    Boehringer Ingelheim Call Center, Boehringer Ingelheim, +1 18002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    Boehringer Ingelheim Call Center, Boehringer Ingelheim, +1 18002430127, clintriage.rdg@boehringer-ingelheim.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 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives of this trial were to evaluate long-term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to standard of care during maintenance treatment for lupus nephritis. The further objective of the trial was to study the effect of steroid tapering and steroid withdrawal during maintenance treatment.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jan 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Hong Kong: 2
    Country: Number of subjects enrolled
    Japan: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Malaysia: 1
    Country: Number of subjects enrolled
    Mexico: 13
    Country: Number of subjects enrolled
    Philippines: 4
    Country: Number of subjects enrolled
    Thailand: 13
    Country: Number of subjects enrolled
    United States: 5
    Country: Number of subjects enrolled
    Czechia: 3
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Greece: 5
    Country: Number of subjects enrolled
    Portugal: 3
    Country: Number of subjects enrolled
    United Kingdom: 3
    Worldwide total number of subjects
    69
    EEA total number of subjects
    19
    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)
    69
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was to evaluate long-term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to standard of care during maintenance treatment for lupus nephritis.

    Pre-assignment
    Screening details
    		 This is an extension trial with the requirement to entry that subjects responded to treatment in 1293.10 (NCT02770170) and had the desire to continue participation in a clinical trial. Subjects were screened for eligibility prior to participation in trial 1293.10 (NCT02770170).

    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, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BI 655064 120 mg
    Arm description
    		 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 655064 120 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Arm title
    		 BI 655064 180 mg
    Arm description
    		 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 655064 180 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Arm title
    		 BI 655064 240 mg
    Arm description
    		 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 655064 240 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Number of subjects in period 1
    		BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Started
    7
    15
    21
    26
    Intent to treat set
    7
    15
    21
    26
    Completed
    7
    14
    16
    17
    Not completed
    0
    1
    5
    9
         Adverse event, serious fatal
    -
    -
    1
    -
         Consent withdrawn by subject
    -
    1
    1
    -
         Adverse event, non-fatal
    -
    -
    3
    3
         Other than listed
    -
    -
    -
    5
         Lack of efficacy
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BI 655064 120 mg
    Reporting group description
    		 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Reporting group title
    BI 655064 180 mg
    Reporting group description
    		 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Reporting group title
    BI 655064 240 mg
    Reporting group description
    		 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Reporting group values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo Total
    Number of subjects
    		 7 15 21 26 69
    Age categorical
    Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 7 15 21 26 69
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
    Units: years
        arithmetic mean (standard deviation)
    		 31.9 ( 6.5 ) 36.5 ( 8.7 ) 35.4 ( 10.5 ) 34.8 ( 10.9 ) -
    Sex: Female, Male
    Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
    Units: Participants
        Female
    		 5 13 19 24 61
        Male
    		 2 2 2 2 8
    Race (NIH/OMB)
    Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 2 6 9 11 28
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 1 0 1
        White
    		 3 9 11 15 38
        More than one race
    		 1 0 0 0 1
        Unknown or Not Reported
    		 1 0 0 0 1
    Ethnicity (NIH/OMB)
    Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
    Units: Subjects
        Hispanic or Latino
    		 3 4 6 6 19
        Not Hispanic or Latino
    		 4 11 15 20 50
        Unknown or Not Reported
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    BI 655064 120 mg
    Reporting group description
    		 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Reporting group title
    BI 655064 180 mg
    Reporting group description
    		 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Reporting group title
    BI 655064 240 mg
    Reporting group description
    		 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Primary: Percentage of patients with complete renal response (CRR) and without any renal flares

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    End point title
    		 Percentage of patients with complete renal response (CRR) and without any renal flares
    End point description
    The adjusted (model-based, adjusted for race and proteinuria at screening) percentage of patients with CRR and without any renal flares is reported. A logistic regression model was used including treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria <3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) <3 vs. UP/UC ≥3) at screening. CRR was defined as urine protein (UP) < 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR < 20% from baseline if eGFR was below normal range (below lower limit of normal [LLN], where LLN = 90 mL/min. Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis.
    End point type
    Primary
    End point timeframe
    At Week 52
    End point values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Number of subjects analysed
    7
    14
    20
    25
    Units: Percentage of participants
        number (not applicable)
    51.83
    48.15
    59.49
    57.51
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    BI 655064 120 mg v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.7957
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference
    Point estimate
    -5.68
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -34.192
         upper limit
    		 22.825
    Notes
    [1] - Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria <3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) <3 vs. UP/UC ≥3) at screening. The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    BI 655064 180 mg v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 = 0.5811
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference
    Point estimate
    -9.37
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -31.178
         upper limit
    		 12.44
    Notes
    [2] - Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria <3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) <3 vs. UP/UC ≥3) at screening. The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    BI 655064 240 mg v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    P-value
    		 = 0.8972
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference
    Point estimate
    1.97
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -17.534
         upper limit
    		 21.48
    Notes
    [3] - Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria <3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) <3 vs. UP/UC ≥3) at screening. The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.

    Secondary: Percentage of patients with confirmed complete renal response (CRR) and without any renal flares

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    End point title
    		 Percentage of patients with confirmed complete renal response (CRR) and without any renal flares
    End point description
    The percentage of patients with confirmed complete renal response (CRR) (defined as CRR at both Week 42 and Week 52 using urine protein (UP)/urine creatine (UC) ratio [UP/UC] from the spot urines) and without any renal flares is reported. Complete renal response (CRR) was defined as urine protein (UP) < 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR < 20% from baseline if eGFR was below normal range (below lower limit of normal [LLN], where LLN = 90 mL/min). Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Number of subjects analysed
    7
    13
    20
    25
    Units: Percentage of participants
        number (not applicable)
    42.9
    30.8
    50.0
    52.0
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    BI 655064 120 mg v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    P-value
    		 = 0.825
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    -9.14
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -32.83
         upper limit
    		 17.02
    Notes
    [4] - The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.
    Statistical analysis title
    		 Statistical Analysis 6
    Comparison groups
    BI 655064 240 mg v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    P-value
    		 = 0.9632
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    -2
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -20.45
         upper limit
    		 16.62
    Notes
    [5] - The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.
    Statistical analysis title
    		 Statistical Analysis 5
    Comparison groups
    BI 655064 180 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    P-value
    		 = 0.2562
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    -21.23
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -39.44
         upper limit
    		 0.51
    Notes
    [6] - The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.

    Secondary: Percentage of patients with proteinuria <0.8 grams (g)/day (d) and without any renal flares at week 52

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    End point title
    		 Percentage of patients with proteinuria <0.8 grams (g)/day (d) and without any renal flares at week 52
    End point description
    The percentage of patients with proteinuria <0.8 grams (g)/day (d) and without any renal flares at week 52 is reported. Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Number of subjects analysed
    7
    14
    20
    25
    Units: Percentage of participants
        number (not applicable)
    57.1
    50.0
    60.0
    60.0
    Statistical analysis title
    		 Statistical Analysis 7
    Comparison groups
    BI 655064 120 mg v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    P-value
    		 = 0.9275
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    -2.86
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -28.58
         upper limit
    		 21.1
    Notes
    [7] - The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.
    Statistical analysis title
    		 Statistical Analysis 9
    Comparison groups
    BI 655064 240 mg v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -18.37
         upper limit
    		 18.07
    Notes
    [8] - The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.
    Statistical analysis title
    		 Statistical Analysis 8
    Comparison groups
    BI 655064 180 mg v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    P-value
    		 = 0.6064
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    -10
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -29.9
         upper limit
    		 10.64
    Notes
    [9] - The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.

    Secondary: Percentage of patients with complete renal response (CRR) at week 52 and sustained steroid reduction to ≤5 milligrams (mg)/day (d) from Week 26 to Week 52

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    End point title
    		 Percentage of patients with complete renal response (CRR) at week 52 and sustained steroid reduction to ≤5 milligrams (mg)/day (d) from Week 26 to Week 52
    End point description
    The percentage of patients with complete renal response (CRR) at Week 52 and sustained steroid reduction to ≤5 milligrams (mg)/day (d) from Week 26 to Week 52 is reported. Complete renal response (CRR) was defined as urine protein (UP) < 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR < 20% from baseline if eGFR was below normal range (below lower limit of normal [LLN], where LLN = 90 mL/min. Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Week 52 (Sustained Steroid Reduction to ≤5 mg/d was evaluated from Week 26 to Week 52).
    End point values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Number of subjects analysed
    7
    14
    18
    23
    Units: Percentage of participants
        number (not applicable)
    42.9
    42.9
    55.6
    39.1
    Statistical analysis title
    		 Statistical Analysis 10
    Comparison groups
    BI 655064 120 mg v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    P-value
    		 = 0.9119
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    3.73
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -20.53
         upper limit
    		 29.6
    Notes
    [10] - The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.
    Statistical analysis title
    		 Statistical Analysis 11
    Comparison groups
    BI 655064 180 mg v Placebo
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 [11]
    P-value
    		 = 0.851
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    3.73
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -16.58
         upper limit
    		 24.31
    Notes
    [11] - The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.
    Statistical analysis title
    		 Statistical Analysis 12
    Comparison groups
    BI 655064 240 mg v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 [12]
    P-value
    		 = 0.3498
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    16.43
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -3.53
         upper limit
    		 34.73
    Notes
    [12] - The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.

    Secondary: Percentage of patients experiencing at least one renal flare during 52 weeks

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    End point title
    		 Percentage of patients experiencing at least one renal flare during 52 weeks
    End point description
    The percentage of patients experiencing at least one renal flare during 52 weeks is reported. Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Number of subjects analysed
    7
    14
    21
    25
    Units: Percentage of participants
        number (not applicable)
    0
    21.4
    0
    16.0
    Statistical analysis title
    		 Statistical Analysis 13
    Comparison groups
    BI 655064 180 mg v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 [13]
    P-value
    		 = 0.7921
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    5.43
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -10.19
         upper limit
    		 23.57
    Notes
    [13] - The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.

    Secondary: Time to first renal flare over the course of 52 weeks

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    End point title
    		 Time to first renal flare over the course of 52 weeks
    End point description
    The time to first renal flare over the course of 52 weeks is reported. Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subject with non-missing results were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks.
    End point values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Number of subjects analysed
    0 [14]
    3
    0 [15]
    4
    Units: Weeks
        median (full range (min-max))
    ( to )
    36.0 (26 to 52)
    ( to )
    37.5 (6 to 52)
    Notes
    [14] - Only subject with non-missing results were included in the analysis.
    [15] - Only subject with non-missing results were included in the analysis.
    No statistical analyses for this end point

    Secondary: Percentage of patients with partial renal response (PRR) and without any renal flares derived from urine protein (UP) 24 hours (h) collection at Week 52

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    End point title
    		 Percentage of patients with partial renal response (PRR) and without any renal flares derived from urine protein (UP) 24 hours (h) collection at Week 52
    End point description
    The percentage of patients with partial renal response (PRR) and without any renal flares derived from urine protein (UP) 24 hours (h) collection at Week 52 is reported. Partial renal response (PRR) was defined as at least 50% reduction of proteinuria from baseline if estimated glomerular filtration rate (eGFR) was within normal range at time of assessment or decrease of eGFR <20% from baseline if eGFR was below normal range at time of assessment. Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Number of subjects analysed
    7
    14
    20
    25
    Units: Percentage of participants
        number (not applicable)
    100.0
    64.3
    75.0
    68.0
    Statistical analysis title
    		 Statistical Analysis 14
    Comparison groups
    BI 655064 120 mg v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 [16]
    P-value
    		 = 0.1016
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    32
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 10.28
         upper limit
    		 44.74
    Notes
    [16] - The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.
    Statistical analysis title
    		 Statistical Analysis 16
    Comparison groups
    BI 655064 240 mg v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 [17]
    P-value
    		 = 0.6247
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    7
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -10.5
         upper limit
    		 23.31
    Notes
    [17] - The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.
    Statistical analysis title
    		 Statistical Analysis 15
    Comparison groups
    BI 655064 180 mg v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 [18]
    P-value
    		 = 0.8323
    Method
    		 Barnard test
    Parameter type
    		 Difference
    Point estimate
    -3.71
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -23.79
         upper limit
    		 15.29
    Notes
    [18] - The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.

    Secondary: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 12

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    End point title
    		 Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 12
    End point description
    Change from baseline in SLEDAI total score at Week 12 is calculated as: value at Week 12 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health). Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At baseline and at Week 12
    End point values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Number of subjects analysed
    7
    13
    18
    25
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -8.4 ( 5.8 )
    -7.5 ( 4.3 )
    -9.3 ( 4.9 )
    -7.7 ( 6.1 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 26

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    End point title
    		 Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 26
    End point description
    Change from baseline in SLEDAI total score at Week 26 is calculated as: value at Week 26 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health). Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At baseline and at Week 26
    End point values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Number of subjects analysed
    7
    14
    16
    21
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -8.7 ( 5.7 )
    -7.9 ( 3.5 )
    -11.3 ( 4.8 )
    -5.9 ( 5.2 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 42

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    End point title
    		 Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 42
    End point description
    Change from baseline in SLEDAI total score at Week 42 is calculated as: value at Week 42 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health). Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At baseline and at Week 42
    End point values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Number of subjects analysed
    5
    7
    9
    13
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -6.6 ( 3.4 )
    -6.3 ( 2.4 )
    -11.1 ( 5.1 )
    -6.5 ( 6.7 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 52

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    End point title
    		 Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score at Week 52
    End point description
    Change from baseline in SLEDAI total score at Week 52 is calculated as: value at Week 52 - value at baseline. SLEDAI assessment consists of 24 items capturing non-renal and renal symptoms. The total score captures non-renal and renal symptoms. Each of the 24 items has a score ranging from 1 to 8. A participant will get the score if the event of the item presents, while 0 if not. 8 items have the score 8, 6 items have the score 4, 7 items have the score 2, and 3 items have the score 1. The SLEDAI Total score is the sum of the scores of the 24 items, ranging from 0 (better health) to 105 (worse health). Intent to treat (ITT) set: this patient set included all patients from the treated set (TS) who had a baseline proteinuria (spot urine could be a used if the patient did not have 24 hours urine collections) and a baseline Estimated glomerular filtration rate (eGFR) value. Only subjects with non-missing results were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At baseline and at Week 52
    End point values
    		 BI 655064 120 mg BI 655064 180 mg BI 655064 240 mg Placebo
    Number of subjects analysed
    7
    14
    16
    17
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -8.9 ( 6.1 )
    -7.2 ( 4.0 )
    -10.6 ( 4.9 )
    -5.3 ( 8.0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For serious and non-serious adverse events: From first dose of trial medication until last dose + 50 days of residual effect period, up to 52 weeks + 50 days. For all-cause mortality: From first dose of trial medication until end of study, up to 64 weeks.
    Adverse event reporting additional description
    Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    BI 655064 120 mg
    Reporting group description
    		 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Reporting group title
    BI 655064 240 mg
    Reporting group description
    		 120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Reporting group title
    BI 655064 180 mg
    Reporting group description
    		 180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.

    Serious adverse events
    		 BI 655064 120 mg Placebo BI 655064 240 mg BI 655064 180 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
    4 / 26 (15.38%)
    6 / 21 (28.57%)
    2 / 15 (13.33%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ocular lymphoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    1 / 1
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    8 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    0 / 15 (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
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    0 / 15 (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
    Pulmonary hypertension
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    0 / 15 (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
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         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
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (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
    Nervous system disorders
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Ascites
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Ileus
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Nausea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Hepatobiliary disorders
    Haemobilia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    0 / 15 (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
    Skin and subcutaneous tissue disorders
    Panniculitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    0 / 15 (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
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Musculoskeletal and connective tissue disorders
    Crystal arthropathy
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Myalgia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    0 / 15 (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
    Infections and infestations
    Clostridium difficile infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Meningitis enterococcal
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Nocardiosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Pelvic abscess
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Pyelonephritis acute
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         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
    Tuberculosis of central nervous system
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BI 655064 120 mg Placebo BI 655064 240 mg BI 655064 180 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
    15 / 26 (57.69%)
    15 / 21 (71.43%)
    11 / 15 (73.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    3
    Hypotension
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Asthenia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Chills
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oedema
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Reproductive system and breast disorders
    Menometrorrhagia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Adenomyosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 26 (7.69%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    2 / 21 (9.52%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Blood lactate dehydrogenase decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urine protein/creatinine ratio increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    1
    0
    2
    Weight increased
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 26 (7.69%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Injury, poisoning and procedural complications
    Chillblains
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 26 (3.85%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Syncope
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 26 (7.69%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vertigo
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Photopsia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Visual field defect
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 26 (7.69%)
    1 / 21 (4.76%)
    3 / 15 (20.00%)
         occurrences all number
    1
    2
    1
    4
    Dyspepsia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 26 (7.69%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 26 (11.54%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
         occurrences all number
    0
    3
    1
    0
    Butterfly rash
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    1
    1
    Onychoclasis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 26 (7.69%)
    4 / 21 (19.05%)
    0 / 15 (0.00%)
         occurrences all number
    0
    3
    5
    0
    Subacute cutaneous lupus erythematosus
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 26 (11.54%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    6
    0
    1
    Lupus nephritis
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 26 (7.69%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    2 / 21 (9.52%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Arthritis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    0
    1
    Oligoarthritis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Coronavirus infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Herpes simplex
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Periodontitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 26 (3.85%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 26 (11.54%)
    5 / 21 (23.81%)
    3 / 15 (20.00%)
         occurrences all number
    1
    3
    6
    4
    Urinary tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 26 (11.54%)
    3 / 21 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    0
    3
    4
    2
    Vaginal infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 26 (3.85%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    2
    1
    Iron deficiency
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 26 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 May 2018
    - Plasma concentrations of BI 655064 and anti-BI 655064 antibody response were added as further endpoints to align with the objectives of the trial - In inclusion criterion 1, contraception instructions for patients on AZA were added following inclusion of Azathioprine (AZA) as background medication allowed in any case in the trial - A statement was included that Mycophenolate mofetil (MMF) and AZA were considered auxiliary medicinal products in the trial - A statement was added that the patients who did not follow glucocorticoid tapering scheme due to medical reasons would not be excluded from the trial - AZA was allowed as background medication in any case - The version of SLEDAI-2K assessment was corrected to SELENA-SLEDAI to align with the predecessor trial (1293-0010) in which SELENA-SLEDAI was used - A statement was added that genotyping of patients rolling over from trial 1293-0010 was already performed and was not to be repeated - The time window between End of treatment (EOT) of trial 1293-0010 and Visit 1 of trial 1293-0013 was reduced from 7 to 3 days to avoid treatment interruption - The time window for follow-up visits for early discontinued patients was changed from 8 to 12 weeks to align with the follow-up period of 12 weeks for patients who completed the treatment.
    21 Dec 2020
    - The start of Group 2 (constituting patients recruited outside of trial 1293-0010) was cancelled based on the outcome of trial 1293-0010, and all references to Group 2 were removed from the CTP accordingly - Immunology tests (C3/C4 complement, anti-dsDNA) were added to Visit 8 (Week 42) to be consistent with the requirements of the SLEDAI questionnaire - New safety and efficacy data from the final analysis of 1293-0010 were included to better describe drug profile - An infection risk-assessment and stopping rules in the COVID-19 pandemic were added to account for the COVID-19 pandemic situation - Baseline values were redefined in Section 2.1.1 ‘Main Objectives’ to enable analysis of outcomes in the full 2-year treatment period in trials 1293-0010 and 1293-0013 - A primary endpoint from 1293-0010 (‘Proportion of patients with CRR at Week 52’) and ‘Proportion of patients with confirmed CRR’ endpoint from 1293-0010 were added as secondary endpoints. However, the former was not analysed according to changes introduced by the TSAP - The following further endpoints were added: ‘Proportion of patients with CRR and without any renal flares at Week 26’ (to allow comparison of outcomes after the 1.5-year treatment period to competitor trials), ‘Proportion of patients with CRR based on spot urine and without any renal flares at Week 52’ (based on learnings from the final analysis of trial 1293-0010), ‘Average daily steroid dose in 1293-0013 and average daily steroid dose from Week 13 of trial 1293-0010 to end of treatment in 1293-0013’ (to allow comparison of daily steroid dose over the whole treatment period), ‘Change from baseline in each renal, non-renal and clinical part of the SLEDAI at Weeks 12, 26, 42,and 52’, ‘Change from baseline in SLEDAI domains at Weeks 12, 26, 42, and 52’ (to allow a more detailed analysis of changes in the SLEDAI).

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

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