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    Clinical Trial Results:
    A Phase II, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy

    Summary
    EudraCT number
    2016-002262-31
    Trial protocol
    GB  
    Global end of trial date
    07 Feb 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Feb 2021
    First version publication date
    22 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MS700461-0035
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02808429
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck KGaA, Darmstadt, Germany
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Communication Centre, Merck KGaA, Darmstadt, Germany, +49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Center, Merck KGaA, Darmstadt, Germany, +49 6151725200, service@merckgroup.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
    07 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main purpose of this study was to evaluate the safety, tolerability, dose response and efficacy of Atacicept in subjects with Immunoglobulin A (IgA) nephropathy and persistent proteinuria. The study hypothesis was that treatment with Atacicept would reduce proteinuria compared to placebo.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    31 Jan 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 1
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    16
    EEA total number of subjects
    0
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    This study was to be conducted in 2 parts; Part A and Part B. However, study was terminated early as per sponsor decision due to unexpectedly slow enrollment and Part B was not initiated.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo matched to Atacicept once weekly as subcutaneous (SC) injection for 72 weeks.

    Arm title
    Atacicept 25 mg
    Arm description
    Subjects received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Atacicept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 25 milligarms (mg) of Atacicept once weekly as SC injection for 72 weeks.

    Arm title
    Atacicept 75 mg
    Arm description
    Subjects received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Atacicept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 75 mg of Atacicept once weekly as SC injection for 72 weeks.

    Number of subjects in period 1
    Placebo Atacicept 25 mg Atacicept 75 mg
    Started
    5
    6
    5
    Completed
    2
    5
    3
    Not completed
    3
    1
    2
         Protocol deviation
    -
    1
    -
         Premature Study termination by Sponsor
    2
    -
    1
         Relocation
    -
    -
    1
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.

    Reporting group title
    Atacicept 25 mg
    Reporting group description
    Subjects received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.

    Reporting group title
    Atacicept 75 mg
    Reporting group description
    Subjects received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.

    Reporting group values
    Placebo Atacicept 25 mg Atacicept 75 mg Total
    Number of subjects
    5 6 5 16
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    46 ± 3.1 41 ± 16.9 43 ± 8.7 -
    Sex: Female, Male
    Units: Subjects
        Female
    1 5 2 8
        Male
    4 1 3 8
    Race (NIH/OMB)
    Units: Subjects
        Asian
    1 1 1 3
        White
    4 5 2 11
        Unknown or Not Reported
    0 0 2 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0 1 3 4
        Not Hispanic or Latino
    5 5 2 12
        Unknown or Not Reported
    0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.

    Reporting group title
    Atacicept 25 mg
    Reporting group description
    Subjects received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.

    Reporting group title
    Atacicept 75 mg
    Reporting group description
    Subjects received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.

    Primary: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death

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    End point title
    Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death [1]
    End point description
    Adverse Event (AE) any untoward medical occurrence in subject administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: AEs that developed or worsened/became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 96]). TEAEs included serious AEs and non-serous AEs. AESIs included infections, cardiac failure, cardiomyopathy/ ischemic heart disease (IHD), hypersensitivity reaction (HR), injection site reactions (ISRs) and demyelinating disorders (DD). Investigator or his /her designee assessed ISRs as local reactions. Safety population set (SAF) included all randomized subjects who received at least 1 dose of IMP and had at least one post-dose assessment.
    End point type
    Primary
    End point timeframe
    Baseline up to 96 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive summary statistics was planned for this endpoint.
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    5
    6
    5
    Units: percentage of subjects
        Subjects with TEAE
    100
    100
    60
        Subjects with AESI: Cardiac failure
    0
    0
    0
        Subjects with AESI: Ischemic heart disease
    0
    0
    0
        Subjects with AESI: Cardiac arrhythmia
    0
    0
    0
        Subjects with AESI: Hypersensitivity reactions
    20
    67
    20
        Subjects with AESI: demyelinating disorders
    0
    0
    0
        Subjects with AESI: injection site reactions
    0
    83
    20
        Subjects with AESI: Infections
    40
    83
    20
        Subjects with serious TEAEs
    20
    50
    0
        Subjects with TEAEs Leading to discontinuation
    0
    17
    0
        Subjects with TEAEs leading to death
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Serum Atacicept Concentrations

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    End point title
    Serum Atacicept Concentrations
    End point description
    Serum Atacicept Concentrations was to be performed; however; as per changed in planned analysis the endpoint related to pharmacokinetic (PK) parameters was not assessed.
    End point type
    Secondary
    End point timeframe
    Week 0 Day 1 (pre-dose), Weeks 1, 2, 4, 8, 12, 16, 24, 40, 48, 72, Early Termination (up to Week 72) and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: gram per liter
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [2] - No subject was analyzed because as per change in planned analysis PK endpoints were not assessed.
    [3] - No subject was analyzed because as per change in planned analysis PK endpoints were not assessed.
    [4] - No subject was analyzed because as per change in planned analysis PK endpoints were not assessed.
    No statistical analyses for this end point

    Secondary: Change from Baseline Levels in Serum Immunoglobulin A (IgA)

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    End point title
    Change from Baseline Levels in Serum Immunoglobulin A (IgA)
    End point description
    The change in serum levels of IgA from baseline was reported. The safety population set (SAF) included all randomized subjects who received at least 1 dose of IMP and had at least one post-dose assessment. Here "n" = subjects who were evaluable for this endpoint at given time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and and PT FU Weeks 4, 12 and 24
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    5
    6
    5
    Units: gram per liter
    arithmetic mean (standard deviation)
        Change at Week 1 (n=5,6,5)
    -0.194 ± 0.3012
    -0.203 ± 0.1325
    -0.278 ± 0.1561
        Change at Week 2 (n=5,6,5)
    -0.114 ± 0.2825
    -0.280 ± 0.1108
    -0.486 ± 0.2289
        Change at Week 4 (n=5,6,5)
    -0.014 ± 0.3570
    -0.197 ± 0.1952
    -0.828 ± 0.2319
        Change at Week 8 (n=5,5,5)
    0.008 ± 0.5340
    -0.572 ± 0.2838
    -1.144 ± 0.4997
        Change at Week 12 (n=5,5,5)
    -0.030 ± 0.4011
    -0.476 ± 0.3879
    -1.146 ± 0.4226
        Change at Week 16 (n=5,5,5)
    0.044 ± 0.4869
    -0.692 ± 0.3608
    -1.296 ± 0.4237
        Change at Week 20 (n=5,5,5)
    0.218 ± 0.6157
    -0.616 ± 0.2880
    -1.430 ± 0.4635
        Change at Week 24 (n=5,5,5)
    0.212 ± 0.3140
    -0.514 ± 0.4552
    -1.424 ± 0.5226
        Change at Week 32 (n=5,4,5)
    0.180 ± 0.4924
    -0.920 ± 0.2950
    -1.468 ± 0.3851
        Change at Week 40 (n=5,3,4)
    0.112 ± 0.7745
    -0.963 ± 0.2815
    -1.388 ± 0.3212
        Change at Week 48 (n=5,3,4)
    0.526 ± 1.2935
    -0.710 ± 0.3804
    -1.375 ± 0.4680
        Change at Week 60 (n=4,3,4)
    0.233 ± 0.3676
    -0.733 ± 0.3057
    -1.283 ± 0.4308
        Change at Week 72 (n=3,3,3)
    0.307 ± 0.3650
    -0.957 ± 0.2157
    -1.240 ± 0.4491
        Change at Early Termination (n=2,3,2)
    0.420 ± 0.0849
    -0.493 ± 0.2173
    -1.835 ± 0.1344
        Change at PT FU Week 4 (n=5,5,3)
    0.300 ± 0.4757
    -0.452 ± 0.3529
    -1.223 ± 0.2515
        Change at PT FU Week 12 (n=5,5,4)
    0.622 ± 0.7436
    -0.440 ± 0.6335
    -0.668 ± 0.2843
        Change at PT FU Week 24 (n=4,5,4)
    0.563 ± 0.6716
    -0.420 ± 0.6503
    -0.370 ± 0.1160
    No statistical analyses for this end point

    Secondary: Change from Baseline Levels in Serum Iimmunoglobulin G (IgG)

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    End point title
    Change from Baseline Levels in Serum Iimmunoglobulin G (IgG)
    End point description
    The change in serum levels of IgG from baseline was reported. The safety population set (SAF) included all randomized subjects who received at least 1 dose of IMP and had at least one post-dose assessment. Here "n" = subjects who were evaluable for this endpoint at given time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    5
    6
    5
    Units: gram per liter
    arithmetic mean (standard deviation)
        Change at Week 1 (n=5,6,5)
    -0.630 ± 0.5524
    -0.480 ± 0.4289
    -0.444 ± 0.4372
        Change at Week 2 (n=5,6,5)
    -0.362 ± 0.7146
    -0.650 ± 0.5764
    -0.898 ± 0.5507
        Change at Week 4 (n=5,6,5)
    -0.354 ± 0.7073
    -0.415 ± 0.4965
    -1.792 ± 0.8182
        Change at Week 8 (n=5,5,5)
    -0.562 ± 1.0023
    -1.128 ± 0.3574
    -2.812 ± 1.2085
        Change at Week 12 (n=5,5,5)
    -0.472 ± 0.9304
    -0.930 ± 0.7748
    -3.126 ± 0.9324
        Change at Week 16 (n=5,5,5)
    -0.608 ± 1.1858
    -1.480 ± 0.4687
    -3.360 ± 0.8546
        Change at Week 20 (n=5,5,5)
    0.016 ± 1.0781
    -1.024 ± 0.3893
    -3.684 ± 0.7597
        Change at Week 24 (n=5,5,5)
    -0.748 ± 1.0059
    -0.926 ± 0.8289
    -3.776 ± 1.0876
        Change at Week 32 (n=5,4,5)
    -0.296 ± 1.1195
    -1.055 ± 0.5701
    -3.962 ± 0.8830
        Change at Week 40 (n=5,3,4)
    0.218 ± 0.8904
    -1.363 ± 0.4895
    -3.623 ± 0.2993
        Change at Week 48 (n=5,3,4)
    0.256 ± 1.5731
    -0.600 ± 0.7654
    -3.745 ± 0.4608
        Change at Week 60 (n=4,3,4)
    0.305 ± 1.2881
    -0.743 ± 1.5627
    -3.368 ± 0.5721
        Change at Week 72 (n=3,3,3)
    -0.203 ± 1.3606
    -0.867 ± 0.7772
    -3.477 ± 0.8618
        Change at Early Termination (n=2,3,2)
    0.655 ± 0.5445
    -1.547 ± 0.5353
    -3.995 ± 0.0636
        Change at PT FU Week 4 (n=5,5,3)
    0.360 ± 1.7711
    -0.736 ± 0.7900
    -2.553 ± 0.7160
        Change at PT FU Week 12 (n=5,5,4)
    0.922 ± 1.2793
    -0.800 ± 1.4692
    -1.300 ± 0.5610
        Change at PT FU Week 24 (n=4,5,4)
    0.273 ± 0.9758
    -0.878 ± 1.0395
    0.020 ± 1.2498
    No statistical analyses for this end point

    Secondary: Change from Baseline Levels in Serum Immunoglobulin M (IgM)

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    End point title
    Change from Baseline Levels in Serum Immunoglobulin M (IgM)
    End point description
    The change in serum levels of IgM from baseline was reported. The safety population set (SAF) included all randomized subjects who received at least 1 dose of IMP and had at least one post-dose assessment. Here "n" = subjects who were evaluable for this endpoint at given time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and at PT FU Weeks 4, 12 and 24
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    5
    6
    5
    Units: gram per liter
    arithmetic mean (standard deviation)
        Change at Week 1 (n=5,6,5)
    -0.082 ± 0.0835
    -0.072 ± 0.0736
    -0.096 ± 0.0924
        Change at Week 2 (n=5,6,5)
    -0.054 ± 0.1026
    -0.140 ± 0.1906
    -0.102 ± 0.1625
        Change at Week 4 (n=5,6,5)
    -0.002 ± 0.1190
    -0.197 ± 0.2655
    -0.410 ± 0.1637
        Change at Week 8 (n=5,5,5)
    0.006 ± 0.1710
    -0.302 ± 0.3114
    -0.558 ± 0.1859
        Change at Week 12 (n=5,5,5)
    0.022 ± 0.0955
    -0.360 ± 0.3169
    -0.638 ± 0.2497
        Change at Week 16 (n=5,5,5)
    0.024 ± 0.1412
    -0.408 ± 0.3531
    -0.710 ± 0.2463
        Change at Week 20 (n=5,5,5)
    0.082 ± 0.2288
    -0.444 ± 0.3965
    -0.748 ± 0.2500
        Change at Week 24 (n=5,5,5)
    -0.016 ± 0.1390
    -0.364 ± 0.3377
    -0.774 ± 0.2517
        Change at Week 32 (n=5,4,5)
    -0.016 ± 0.1566
    -0.510 ± 0.4498
    -0.796 ± 0.2773
        Change at Week 40 (n=5,3,4)
    0.036 ± 0.1464
    -0.247 ± 0.1553
    -0.848 ± 0.2668
        Change at Week 48 (n=5,3,4)
    0.012 ± 0.1951
    -0.227 ± 0.1250
    -0.848 ± 0.2557
        Change at Week 60 (n=4,3,4)
    -0.033 ± 0.0907
    -0.297 ± 0.2495
    -0.843 ± 0.2573
        Change at Week 72 (n=3,3,3)
    -0.027 ± 0.0153
    -0.337 ± 0.2914
    -0.900 ± 0.3081
        Change at Early Termination (n=2,3,2)
    0.115 ± 0.0354
    -0.463 ± 0.1626
    -0.670 ± 0.1414
        Change at PT FU Week 4 (n=5,5,3)
    -0.048 ± 0.1941
    -0.328 ± 0.1906
    -0.667 ± 0.2259
        Change at PT FU Week 12 (n=5,5,4)
    0.058 ± 0.2281
    -0.214 ± 0.1739
    -0.465 ± 0.2319
        Change at PT FU Week 24 (n=4,5,4)
    0.020 ± 0.1687
    -0.178 ± 0.1504
    -0.340 ± 0.1896
    No statistical analyses for this end point

    Secondary: Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels

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    End point title
    Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels
    End point description
    The change in serum Gd-IgA1 from baseline was reported. The safety population set (SAF) included all randomized subjects who received at least 1 dose of IMP and had at least one post-dose assessment. Here "n" = subjects who were evaluable for this endpoint at given time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    5
    6
    5
    Units: nanogram per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Change at Week 4 (n=5,6,5)
    -1438 ± 598.2
    -620 ± 1580.4
    -2288 ± 730.5
        Change at Week 12 (n=5,5,5)
    -380 ± 1505.0
    -1672 ± 1459.2
    -2778 ± 1345.8
        Change at Week 24 (n=5,5,4)
    160 ± 848.8
    -1912 ± 1835.0
    -3660 ± 1940.9
        Change at Week 48 (n=5,3,4)
    1140 ± 4339.5
    -423 ± 795.1
    -2938 ± 1756.9
        Change at Week 72 (n=3,3,3)
    580 ± 2594.8
    -1327 ± 1181.4
    -3202 ± 1594.9
        Change at Early Termination (n=2,3,2)
    3520 ± 4638.6
    -2383 ± 2551.1
    -2680 ± 1258.7
        Change at PT FU Week 12 (n=5,5,3)
    1926 ± 3523.3
    -772 ± 2050.2
    -818 ± 1277.9
        Change at PT FU Week 24 (n=3,5,2)
    1673 ± 5072.9
    -1262 ± 2444.1
    -1090 ± 70.7
    No statistical analyses for this end point

    Secondary: Change From Baseline in Serum Complement C3 and C4 Levels

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    End point title
    Change From Baseline in Serum Complement C3 and C4 Levels
    End point description
    The change in serum component C3 and C4 from baseline were reported. The safety population set (SAF) consisted of all randomized subjects who received at least 1 dose of IMP and had at least one post-dose assessment. "Number of subjects analyzed" signifies subjects who were evaluable for this endpoint and "n" signifies those subjects who were evaluable for specified category. Here, '99999' signifies that standard deviation could not be calculated as only 1 subject was analyzed for this category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 48, 72, Early Termination (ET) (up to Week 72) and at PT FU Weeks 12 and 24
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    5
    5
    5
    Units: milligram per liter
    arithmetic mean (standard deviation)
        Complement C3: Change at Week 12 (n=5,5,5)
    -60.0 ± 88.32
    80.0 ± 125.10
    122.0 ± 114.76
        Complement C3: Change at Week 24 (n=5,5,4)
    -38.0 ± 100.85
    -6.0 ± 220.64
    70.0 ± 104.24
        Complement C3: Change at Week 48 (n=5,3,4)
    82.0 ± 215.57
    63.3 ± 110.15
    162.5 ± 219.91
        Complement C3: Change at Week 72 (n=3,3,3)
    -56.7 ± 127.41
    43.3 ± 212.21
    196.7 ± 196.55
        Complement C3: Change at ET (n=2,3,1)
    -145.0 ± 190.92
    -60.0 ± 284.78
    180.0 ± 99999
        Complement C3: Change at PT FU Week 12 (n=5,5,3)
    -12.0 ± 106.16
    -96.0 ± 196.67
    170.0 ± 390.00
        Complement C3: Change at PT FU Week 24 (n=4,5,4)
    -85.0 ± 183.76
    -144.0 ± 93.97
    164.0 ± 205.45
        Complement C4: Change at Week 12 (n=5,5,5)
    -26.8 ± 25.35
    13.4 ± 9.24
    33.8 ± 44.81
        Complement C4: Change at Week 24 (n=5,5,4)
    -27.0 ± 32.26
    8.8 ± 29.66
    34.3 ± 40.20
        Complement C4: Change at Week 48 (n=5,3,4)
    -0.4 ± 20.74
    33.3 ± 18.90
    16.0 ± 27.89
        Complement C4: Change at Week 72 (n=3,3,3)
    -43.0 ± 82.46
    12.0 ± 17.35
    49.7 ± 30.02
        Complement C4: Change at ET (n=2,3,1)
    -22.0 ± 32.53
    -8.0 ± 38.57
    125.0 ± 99999
        Complement C4: Change at PT FU Week 12 (n=5,5,3)
    -12.6 ± 32.00
    -4.2 ± 9.07
    -1.3 ± 44.52
        Complement C4: Change at PT FU Week 24 (n=4,5,4)
    -37.0 ± 64.97
    -18.2 ± 30.34
    19.5 ± 18.30
    No statistical analyses for this end point

    Secondary: Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis

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    End point title
    Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
    End point description
    Change from baseline in immune cell subsets included total T cells, helper T cells, cytotoxic T cells, total B cells (assay with [AW] CD45 or assay without [AWO] CD45), mature naïve B cells, memory B cells, plasma cells, plasma blasts, and natural killer (NK) cells and were reported. Analysis was performed by flow cytometry analysis. Flow Cytometry (FC) Set: all subjects in SAF set who were part of the selected sites for FC analysis and who had at least 1 sample taken for FC analysis. "Number of subjects analyzed" signifies subjects who were evaluable for this endpoint and "n" signifies those subjects who were evaluable for specified category. Here, '99999' signifies that standard deviation could not be calculated as only 1 subject was analyzed and "9999" standard deviation could not be calculated as 0 subjects was analyzed for this category.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    2
    2
    3
    Units: cells per microliter
    arithmetic mean (standard deviation)
        Cytotoxic T Cells:Change at Week 4(n=0,2,3)
    9999 ± 99999
    -22.5 ± 215.67
    46.7 ± 72.57
        Cytotoxic T Cells:Change at Week 12(n=1,1,3)
    713.0 ± 99999
    -114.0 ± 99999
    75.0 ± 33.41
        Cytotoxic T Cells:Change at Week 24(n=2,2,2)
    101.5 ± 243.95
    -30.5 ± 125.16
    37.0 ± 39.60
        CytotoxicT Cells:Change Week 48(n=2,0,2)
    9.0 ± 224.86
    9999 ± 9999
    38.0 ± 42.43
        Cytotoxic T Cells:Change Week 72(n=1,0,2)
    -60.0 ± 99999
    9999 ± 9999
    -186.0 ± 289.91
        Cytotoxic T Cells:Change at ET(n=1,0,1)
    282.0 ± 99999
    9999 ± 9999
    45.0 ± 99999
        Cytotoxic T Cells:Change at PT FU Week 24(n=1,0,0)
    132.0 ± 99999
    9999 ± 9999
    99999 ± 99999
        Helper T Cells:Change at Week 4 (n=0,2,3)
    9999 ± 9999
    59.0 ± 240.42
    114.7 ± 117.05
        Helper T Cells:Change at Week 12 (n=1,1,3)
    124.0 ± 99999
    -51.0 ± 99999
    221.3 ± 85.33
        Helper T Cells:Change at Week 24(n=2,2,2)
    -79.0 ± 190.92
    134.0 ± 124.45
    85.0 ± 45.25
        Helper T Cells:Change at Week 48(n=2,0,2)
    -129.5 ± 338.70
    9999 ± 9999
    72.5 ± 86.97
        Helper T Cells:Change at Week 72 (n=1,0,2)
    -170.0 ± 99999
    9999 ± 9999
    -312.5 ± 427.80
        Helper T Cells:Change at ET(n=1,0,1)
    81.0 ± 99999
    9999 ± 9999
    348.0 ± 99999
        Helper T Cells:Change at PT FU Week 24(n=1, 0,0)
    90.0 ± 99999
    9999 ± 9999
    9999 ± 9999
        Mature naive B Cells:Change at Week 4(n=0,2,3)
    9999 ± 9999
    -76.5 ± 12.02
    -17.0 ± 78.31
        Mature B Cells: Change Week 12(n=1,1,3)
    137.0 ± 99999
    -106.0 ± 99999
    -14.7 ± 94.07
        Mature B Cells: Change Week 24(n=2,2,2)
    1.0 ± 42.43
    -117.5 ± 51.62
    -87.5 ± 109.60
        Mature B Cells: Change Week 48(n=2,0,2)
    21.5 ± 74.25
    9999 ± 9999
    -91.0 ± 107.48
        Mature B Cells: Change Week 72(n=1,0,1)
    -24.0 ± 99999
    9999 ± 9999
    -32.0 ± 99999
        Mature B Cells: Change at ET (n=1,0,1)
    36.0 ± 99999
    9999 ± 9999
    -1.0 ± 99999
        Mature BCells ChangePTFU Week24(n=1,0,0)
    8.0 ± 99999
    9999 ± 9999
    9999 ± 9999
        Memory B Cells:Change at Week 4(n=0,1,2)
    9999 ± 9999
    8.0 ± 99999
    14.5 ± 2.12
        Memory B Cells:Change at Week 12(n=1,0,2)
    5.0 ± 99999
    9999 ± 9999
    34.0 ± 0.00
        Memory B Cells: Change at Week 24(n=2,1,2)
    -1.5 ± 7.78
    13.0 ± 99999
    5.5 ± 21.92
        Memory B Cells: Change at Week 48(n=2,0,2)
    -1.0 ± 4.24
    9999 ± 9999
    5.0 ± 16.97
        Memory B Cells: Change at Week 72(n=1,0,1)
    -6.0 ± 99999
    9999 ± 9999
    8.0 ± 99999
        Memory B Cells:Change at ET(n=1,0,0)
    -3.0 ± 99999
    9999 ± 9999
    9999 ± 9999
        MemoryBCells:Change PTFU Week24(n=1,0,0)
    6.0 ± 99999
    9999 ± 9999
    9999 ± 9999
        NK Cells: Change at Week 4(n=0,2,3)
    9999 ± 9999
    19.0 ± 227.69
    88.3 ± 30.62
        NK Cells:Change at Week 12(n=1,1,3)
    43.0 ± 99999
    -105.0 ± 99999
    74.0 ± 89.94
        NK Cells:Change at Week 24(n=2,2,2)
    44.5 ± 20.51
    -34.5 ± 112.43
    37.5 ± 58.69
        NK Cells: Change at Week 48 (n=2,0,2)
    20.5 ± 16.26
    9999 ± 9999
    39.0 ± 48.08
        NK Cells: Change at Week 72 (n=1,0,1)
    130.0 ± 99999
    9999 ± 9999
    104.0 ± 99999
        NK Cells: Change at ET (n=1,0,1)
    54.0 ± 99999
    9999 ± 9999
    12.0 ± 99999
        NKCells:Change at PT FU Week 24(n=1,0,0)
    81.0 ± 99999
    9999 ± 9999
    9999 ± 9999
        Plasma Blasts:Change at Week 4 (n=0,1,2)
    9999 ± 9999
    0.10 ± 99999
    -0.05 ± 0.071
        Plasma Blasts:Change at Week12 (n=1,0,2)
    -0.10 ± 99999
    9999 ± 9999
    0.55 ± 0.212
        Plasma Blasts:Change at Week24 (n=2,1,2)
    0.05 ± 0.071
    -0.30 ± 99999
    0.10 ± 0.283
        Plasma Blasts:Change at Week48 (n=2,0,2)
    1.40 ± 1.414
    9999 ± 9999
    0.15 ± 0.212
        Plasma Blasts:Change at Week72 (n=1,0,1)
    -0.10 ± 99999
    9999 ± 9999
    0.40 ± 99999
        Plasma Blasts:Change at ET (n= 1,0,0)
    0.80 ± 99999
    9999 ± 9999
    9999 ± 9999
        Plasma Blasts:Change PTFUWeek24(n=1,0,0)
    3.40 ± 99999
    9999 ± 9999
    9999 ± 9999
        Plasma Cells: Change at Week 4 (n=0,1,2)
    9999 ± 9999
    0.10 ± 99999
    0.00 ± 0.141
        Plasma Cells: Change at Week 12 (n= 1,0,2)
    -0.10 ± 99999
    9999 ± 9999
    0.15 ± 0.212
        Plasma Cells: Change at Week 24 (n=2,1,2)
    0.05 ± 0.071
    -0.10 ± 99999
    0.00 ± 0.000
        Plasma Cells: Change at Week 48 (n=2,0,2)
    0.30 ± 0.283
    9999 ± 9999
    0.00 ± 0.000
        Plasma Cells: Change at Week 72 (n=1,0,1)
    0.00 ± 99999
    9999 ± 9999
    0.20 ± 99999
        Plasma Cells: Change at ET (n=1,0,0)
    0.20 ± 99999
    9999 ± 9999
    9999 ± 9999
        Plasma Cells Change PTFU Week24(n=1,0,0)
    0.10 ± 99999
    9999 ± 9999
    9999 ± 9999
        AWCD45: Change at Week 4 (n=0,2,3)
    9999 ± 9999
    -50.0 ± 36.77
    37.3 ± 64.39
        AWCD45:Change at Week 12 (n=1,1,3)
    154.0 ± 99999
    -105.0 ± 99999
    108.7 ± 88.90
        AWCD45:Change at Week 24 (n=2,2,2)
    -0.5 ± 57.28
    -78.0 ± 131.52
    -32.5 ± 116.67
        AWCD45:Change at Week 48 (n=2,0,2)
    20.0 ± 91.92
    9999 ± 9999
    -27.5 ± 115.26
        AWCD45::Change at Week 72 (n=1,0,1)
    -31.0 ± 99999
    9999 ± 9999
    2.0 ± 99999
        AWCD45:Change at ET (n=1,0,1)
    43.0 ± 99999
    9999 ± 9999
    71.0 ± 99999
        AWCD45:Change at PT FU Week 24 (n=1,0,0)
    27.0 ± 99999
    9999 ± 9999
    9999 ± 9999
        AWOCD45: Change at Week 4 (n=0,2,3)
    9999 ± 9999
    -33.0 ± 104.65
    41.0 ± 40.60
        AWOCD45: Change at Week 12 (n=1,1,3)
    16.0 ± 99999
    -137.0 ± 99999
    52.0 ± 65.09
        AWOCD45:Change at Week 24 (n=2,2,2)
    -11.0 ± 53.74
    -96.5 ± 135.06
    -40.5 ± 88.39
        AWOCD45:Change at Week 48 (n= 2,0,2)
    9.0 ± 113.14
    9999 ± 9999
    -52.5 ± 81.32
        AWOCD45: Change at Week 72 (n=1,0,1)
    -38.0 ± 99999
    9999 ± 9999
    -78.0 ± 99999
        AWOCD45:Change at Week ET (n=1,0,1)
    23.0 ± 99999
    9999 ± 9999
    48.0 ± 99999
        AWOCD45: Change at PTFU Week24(n=1,0,0)
    -36.0 ± 99999
    9999 ± 9999
    9999 ± 9999
        Total T Cells: Change at Week 4 (n=0,2,3)
    9999 ± 9999
    40.0 ± 466.69
    169.0 ± 189.71
        Total T Cells: Change at Week 12 (n=1,1,3)
    861.0 ± 99999
    -165.0 ± 99999
    314.7 ± 50.54
        Total T Cells: Change at Week 24 (n=2,2,2)
    18.5 ± 419.31
    111.0 ± 260.22
    130.0 ± 2.83
        Total T Cells: Change at Week 48 (n=2,0,2)
    -116.5 ± 564.98
    9999 ± 9999
    113.5 ± 140.71
        Total T Cells: Change at Week 72 (n=1,0,2)
    -227.0 ± 99999
    9999 ± 9999
    -529.5 ± 767.21
        Total T Cells: Change at Week ET (n=1,0,1)
    350.0 ± 99999
    9999 ± 9999
    393.0 ± 99999
        Total T Cells:Change PT FU Week 24 (n=1,0,0)
    220.0 ± 99999
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Secondary: Change From Baseline in Urinary IgG, IgA, and IgM levels

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    End point title
    Change From Baseline in Urinary IgG, IgA, and IgM levels
    End point description
    Urinary IgG, IgA and IgM levels to be measured by Immuno-Electrophoresis. As per changed in planned analysis the outcome measure related to Urinary Immunoglobulins was not assessed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day1), Weeks 24, 48 and Early Termination (up to Week 72)
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: gram per liter
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [5] - As per changes in planned analysis the endpoint related to Urinary Immunoglobulins was not assessed.
    [6] - As per changes in planned analysis the endpoint related to Urinary Immunoglobulins was not assessed.
    [7] - As per changes in planned analysis the endpoint related to Urinary Immunoglobulins was not assessed.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Positive Anti-Drug Antibody (ADA)

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    End point title
    Percentage of Subjects With Positive Anti-Drug Antibody (ADA)
    End point description
    Percentage of subjects with positive ADA were reported. The safety population set (SAF) included all randomized subjects who received at least 1 dose of IMP and had at least one post-dose assessment.
    End point type
    Secondary
    End point timeframe
    Baseline up to safety follow-up (96 weeks)
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    5
    6
    5
    Units: percentage of subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinical Significant Abnormalities in Laboratory Assessments

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    End point title
    Percentage of Subjects with Clinical Significant Abnormalities in Laboratory Assessments
    End point description
    Laboratory investigation included hematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator. As per changed in planned analysis the endpoint related to clinically significant abnormalities laboratory assessments was not assessed.
    End point type
    Secondary
    End point timeframe
    Baseline up to safety follow-up (96 weeks)
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    Units: Percentage of Subjects
        number (not applicable)
    Notes
    [8] - As per changes in planned analysis the endpoint laboratory assessments was not assessed.
    [9] - As per changes in planned analysis the endpoint laboratory assessments was not assessed.
    [10] - As per changes in planned analysis the endpoint laboratory assessments was not assessed.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinical Significant Abnormalities in Vital Signs

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    End point title
    Percentage of Subjects with Clinical Significant Abnormalities in Vital Signs
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, weight and height. The systolic and diastolic blood pressure and pulse rate was measured after the subjects have in a rested at least 3 minutes in seated position. Clinical significance was to be decided by the investigator. As per changed in planned analysis the endpoint related to clinically significant abnormalities vital signs was not assessed.
    End point type
    Secondary
    End point timeframe
    Baseline up to safety follow-up (96 weeks)
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [11] - As per changes in planned analysis the endpoint related to vital signs was not assessed.
    [12] - As per changes in planned analysis the endpoint related to vital signs was not assessed.
    [13] - As per changes in planned analysis the endpoint related to vital signs was not assessed.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs)

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    End point title
    Percentage of Subjects With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs)
    End point description
    12-lead ECG were recorded after the subjects have rested for at least 15 minutes in supine position. Clinically significance was decided by the investigator. The percentages of subjects with clinically significant abnormalities in 12-lead ECG were reported. The safety population set (SAF) included all randomized subjects who received at least 1 dose of IMP and had at least one post-dose assessment.
    End point type
    Secondary
    End point timeframe
    Baselien up to safety follow-up (96 weeks)
    End point values
    Placebo Atacicept 25 mg Atacicept 75 mg
    Number of subjects analysed
    5
    6
    5
    Units: percentage of subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to safety follow up period (96 weeks)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matched to Atacicept once weekly as subcutaneous (SC) injection for 72 weeks.

    Reporting group title
    Atacicept 25 mg
    Reporting group description
    Subjects received 25 milligrams (mg) of Atacicept once weekly as SC injection for 72 weeks.

    Reporting group title
    Atacicept 75 mg
    Reporting group description
    Subjects received 75 mg of Atacicept once weekly as SC injection for 72 weeks.

    Serious adverse events
    Placebo Atacicept 25 mg Atacicept 75 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 6 (50.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian adenoma
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Atacicept 25 mg Atacicept 75 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    6 / 6 (100.00%)
    3 / 5 (60.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Allergy to chemicals
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 6 (66.67%)
    1 / 5 (20.00%)
         occurrences all number
    0
    4
    1
    Injection site bruising
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 6 (50.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    3
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 6 (50.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    3
    0
    Injection site reaction
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    2 / 5 (40.00%)
         occurrences all number
    0
    1
    2
    Fatigue
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site induration
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site inflammation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Injection site pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Dysphonia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Paratracheal lymphadenopathy
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Cervical radiculopathy
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Head discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Migraine
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Ear congestion
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal tenderness
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Haematochezia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Micturition urgency
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Erythema
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Rash erythematous
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Skin mass
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthropathy
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Synovial cyst
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Temporomandibular joint syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Dehydration
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Diabetes mellitus
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 6 (50.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    3
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Influenza
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    1
    Herpes simplex
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 May 2016
    A staggered enrollment design had been added so that the IDMC can review interim 12 week cumulative safety data in the placebo and lower dose atacicept arms. Upon approval and Sponsor review, subjects were enrolled into the high-dose (150 mg) atacicept arm; subjects were randomized to all 4 arms.
    20 Oct 2016
    Primary and Secondary objectives were updated. Exclusion criteria was updated.
    15 Sep 2017
    Reordered the objectives since they were not key secondary objectives. Adverse Events of the primary endpoint were not repeated as secondary endpoint.
    27 Nov 2018
    Removed mention of needle gauge. Included and provided a description of an interim analysis to inform the Sponsor decision with regards to Part A of the study.

    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.
    The study was prematurely terminated due to poor enrollment and Part B was not conducted as per Sponsor decision. This decision was not related to any safety or efficacy findings regarding Atacicept.
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