IgA Nephropathy
Conditions
Keywords
Atacicept, IgA Nephropathy, Berger´s disease, Glomerulonephritis, Proteinuria
Brief summary
This main purpose of this study was to evaluate the safety, tolerability, dose response and efficacy of Atacicept in participants with IgA nephropathy and persistent proteinuria. The study hypothesis was that treatment with Atacicept would reduce proteinuria compared to placebo.
Interventions
DRUGPlacebo
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
DRUGAtacicept 25 mg
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
DRUGAtacicept 75 mg
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
Sponsors
Merck KGaA, Darmstadt, Germany
EMD Serono Research & Development Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than or equal to (\>=)18 years of age * Biopsy-proven Immunoglobulin (IgA) nephropathy * Urine Protein to Creatinine Ratio (UPCR) \>= 0.75 and \<= 6 milligram per milligram (mg/mg) during screening * Stable and optimal dose of Angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blockers (ARB) at least 8 weeks prior to screening
Exclusion criteria
* Concomitant significant renal disease other than IgA nephropathy * IgA nephropathy with significant glomerulosclerosis or cortical scarring * Diagnosis of Henoch-Schonlein purpura * Failure to meet estimated glomerular filtration rate (eGFR) and biopsy requirement criteria * Serum IgG below 6 grams per liter (g/L) * Use of cyclophosphamide ever or use of other immunosuppressants or systemic corticosteroids within 4 months * Active infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks * History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB infection * History of or positive HIV and/or positive for hepatitis B or Hepatitis C at screening * History of malignancy * Nursing or pregnancy * Any condition, including any uncontrolled disease state other than IgA nephropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Baseline up to 96 weeks | Adverse Event (AE): any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE: 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, hypersensitivity reaction (including anaphylactic/anaphylactoid shock conditions, asthma/bronchospasm, and angioedema), injection site reactions (ISRs) and demyelinating disorders. Investigator or his /her designee assessed ISRs as local reactions (redness, bruising, swelling, induration and itching). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Atacicept Concentrations | 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 | Serum Atacicept Concentrations was to be performed; however; as per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed. |
| Change From Baseline Levels in Serum Immunoglobulin A (IgA) | 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 | The change in serum levels of IgA from baseline was reported. |
| Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | 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 | The change in serum levels of IgG from baseline was reported. |
| Change From Baseline Levels in Serum Immunoglobulin M (IgM) | 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 | The change in serum levels of IgM from baseline was reported. |
| Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24 | The change in serum Gd-IgA1 from baseline was reported. |
| Change From Baseline in Serum Complement C3 and C4 Levels | Baseline, Week 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24 | The change in serum component C3 and C4 from baseline were reported. |
| Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24 | 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. |
| Change From Baseline in Urinary IgG, IgA, and IgM Levels | Baseline (Day1), Weeks 24, 48 and Early Termination (up to earlier than Week 72) | Urinary IgG, IgA and IgM levels to be measured by Immuno-Electrophoresis. |
| Percentage of Participants With Positive Anti-Drug Antibody (ADA) | Baseline up to safety follow-up (96 weeks) | Percentage of participants with positive ADA were reported. |
| Percentage of Participants With Clinical Significant Abnormalities in Laboratory Assessments | Baseline up to safety follow-up (96 weeks) | Laboratory investigation included hematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator. |
| Percentage of Participants With Clinical Significant Abnormalities in Vital Signs | Baseline up to safety follow-up (96 weeks) | 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 participants have in a rested at least 3 minutes in seated position. Clinical significance was to be decided by the investigator. |
| Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs) | Baseline up to safety follow-up (96 weeks) | 12-lead ECG were recorded after the participants have rested for at least 15 minutes in supine position. Clinically significance was decided by the investigator. The number of participants with clinically significant abnormalities in 12-lead ECG were reported. |
Countries
Japan, United Kingdom, United States
Participant flow
Pre-assignment 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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks. | 5 |
| Atacicept 25 mg Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks. | 6 |
| Atacicept 75 mg Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks. | 5 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Premature study termination by sponsor | 2 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Relocation | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo | Atacicept 25 mg | Atacicept 75 mg |
|---|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 11.1 | 46 years STANDARD_DEVIATION 3.1 | 41 years STANDARD_DEVIATION 16.9 | 43 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 0 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 5 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 11 Participants | 4 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Female | 8 Participants | 1 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 8 Participants | 4 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 5 / 5 | 6 / 6 | 3 / 5 |
| serious Total, serious adverse events | 1 / 5 | 3 / 6 | 0 / 5 |
Outcome results
Primary
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
Adverse Event (AE): any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE: 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, hypersensitivity reaction (including anaphylactic/anaphylactoid shock conditions, asthma/bronchospasm, and angioedema), injection site reactions (ISRs) and demyelinating disorders. Investigator or his /her designee assessed ISRs as local reactions (redness, bruising, swelling, induration and itching).
Time frame: Baseline up to 96 weeks
Population: The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with TEAE | 100 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Infections | 40 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with AESI: Cardiac arrhythmia | 0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Injection site reactions | 0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Demyalinating disorders | 0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Hypersensitivity reactions | 20 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with TEAEs leading to discontinuation | 0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with AESI: Cardiac failure | 0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with TEAEs leading to death | 0 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with serious TEAEs | 20 percentage of participants |
| Placebo | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with AESI: Ischaemic heart disease | 0 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Demyalinating disorders | 0 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Injection site reactions | 83.3 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with TEAE | 100 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with AESI: Cardiac failure | 0 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with AESI: Ischaemic heart disease | 0 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with AESI: Cardiac arrhythmia | 0 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Hypersensitivity reactions | 66.67 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Infections | 83.33 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with serious TEAEs | 50 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with TEAEs leading to discontinuation | 16.66 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with TEAEs leading to death | 0 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with TEAEs leading to discontinuation | 0 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Infections | 20 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with AESI: Cardiac failure | 0 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Demyalinating disorders | 0 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with serious TEAEs | 0 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with TEAE | 60 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with TEAEs leading to death | 0 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Hypersensitivity reactions | 20 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with AESI: Cardiac arrhythmia | 0 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Partcipants with AESI: Injection site reactions | 60 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Participants with AESI: Ischaemic heart disease | 0 percentage of participants |
Secondary
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
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.
Time frame: Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24
Population: Flow Cytometry (FC) Set: all participants in SAF set who were part of the selected sites for FC analysis and who had at least 1 sample taken for FC analysis. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure. and number analyzed signifies those participants who were evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 72 | -60.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at PT FU Week 24 | 3.40 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 12 | 43.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 12 | 861.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Early Termination | 0.80 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 24 | 44.5 cells per microliter | Standard Deviation 20.51 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Early Termination | 282.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Week 72 | -0.10 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 48 | 20.5 cells per microliter | Standard Deviation 16.26 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Week 48 | 1.40 cells per microliter | Standard Deviation 1.414 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 72 | 130.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Week 24 | 0.05 cells per microliter | Standard Deviation 0.071 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Early Termination | 54.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Week 12 | -0.10 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells:Change at PT FU Week 24 | 81.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at PT FU Week 24 | -36.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at PT FU Week 24 | 132.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 12 | 713.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week Early Termination | 23.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 12 | 124.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 48 | -116.5 cells per microliter | Standard Deviation 564.98 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 72 | -38.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 24 | -79.0 cells per microliter | Standard Deviation 190.92 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Early Termination | 350.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 48 | 9.0 cells per microliter | Standard Deviation 113.14 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 48 | -129.5 cells per microliter | Standard Deviation 338.7 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 24 | -11.0 cells per microliter | Standard Deviation 53.74 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 72 | -170.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 12 | 16.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Early Termination | 81.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at PT FU Week 24 | 27.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at PT FU Week 24 | 90.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 24 | 101.5 cells per microliter | Standard Deviation 243.95 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Early Termination | 43.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 12 | 137.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at PT FU Week 24 | 220.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Week 72 | -31.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 24 | 1.0 cells per microliter | Standard Deviation 42.43 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 72 | -227.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWh CD45): Change at Week 48 | 20.0 cells per microliter | Standard Deviation 91.92 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 48 | 21.5 cells per microliter | Standard Deviation 74.25 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Week 24 | -0.5 cells per microliter | Standard Deviation 57.28 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 72 | -24.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Week 12 | 154.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Early Termination | 36.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at PT FU Week 24 | 0.10 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at PT FU Week 24 | 8.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 48 | 9.0 cells per microliter | Standard Deviation 224.86 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Early Termination | 0.20 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Week 12 | 5.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Week 72 | 0.00 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Week 24 | -1.5 cells per microliter | Standard Deviation 7.78 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 24 | 18.5 cells per microliter | Standard Deviation 419.31 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Week 48 | 0.30 cells per microliter | Standard Deviation 0.283 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Week 48 | -1.0 cells per microliter | Standard Deviation 4.24 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Week 24 | 0.05 cells per microliter | Standard Deviation 0.071 |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Week 72 | -6.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Week 12 | -0.10 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Early Termination | -3.0 cells per microliter | — |
| Placebo | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at PT FU Week 24 | 6.0 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Week 24 | -78.0 cells per microliter | Standard Deviation 131.52 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 4 | -22.5 cells per microliter | Standard Deviation 215.67 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 12 | -114.0 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 24 | -30.5 cells per microliter | Standard Deviation 125.16 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 4 | 59.0 cells per microliter | Standard Deviation 240.42 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 12 | -51.0 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 24 | 134.0 cells per microliter | Standard Deviation 124.45 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 4 | -76.5 cells per microliter | Standard Deviation 12.02 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 12 | -106.0 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 24 | -117.5 cells per microliter | Standard Deviation 51.62 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Week 4 | 8.0 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Week 24 | 13.0 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 4 | 19.0 cells per microliter | Standard Deviation 227.69 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 12 | -105.0 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 24 | -34.5 cells per microliter | Standard Deviation 112.43 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Week 4 | 0.10 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Week 24 | -0.30 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Week 4 | 0.10 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Week 24 | -0.10 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Week 4 | -50.0 cells per microliter | Standard Deviation 36.77 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Week 12 | -105.0 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 4 | -33.0 cells per microliter | Standard Deviation 104.65 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 12 | -137.0 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 24 | -96.5 cells per microliter | Standard Deviation 135.06 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 4 | 40.0 cells per microliter | Standard Deviation 466.69 |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 12 | -165.0 cells per microliter | — |
| Atacicept 25 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 24 | 111.0 cells per microliter | Standard Deviation 260.22 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 4 | 88.3 cells per microliter | Standard Deviation 30.62 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Early Termination | 393.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Week 4 | 0.00 cells per microliter | Standard Deviation 0.141 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Week 72 | 8.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Week 12 | 0.15 cells per microliter | Standard Deviation 0.212 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Week 48 | 5.0 cells per microliter | Standard Deviation 16.97 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 12 | 314.7 cells per microliter | Standard Deviation 50.54 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Week 24 | 0.00 cells per microliter | Standard Deviation 0 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Week 24 | 5.5 cells per microliter | Standard Deviation 21.92 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Week 48 | 0.00 cells per microliter | Standard Deviation 0 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Week 12 | 34.0 cells per microliter | Standard Deviation 0 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Cells: Change at Week 72 | 0.20 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Memory B Cells: Change at Week 4 | 14.5 cells per microliter | Standard Deviation 2.12 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Early Termination | -1.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 48 | 38.0 cells per microliter | Standard Deviation 42.43 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Week 4 | 37.3 cells per microliter | Standard Deviation 64.39 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 72 | -32.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 4 | 46.7 cells per microliter | Standard Deviation 72.57 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Week 12 | 108.7 cells per microliter | Standard Deviation 88.9 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 48 | -91.0 cells per microliter | Standard Deviation 107.48 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 24 | 130.0 cells per microliter | Standard Deviation 2.83 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Week 24 | -32.5 cells per microliter | Standard Deviation 116.67 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 24 | -87.5 cells per microliter | Standard Deviation 109.6 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWh CD45): Change at Week 48 | -27.5 cells per microliter | Standard Deviation 115.26 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 12 | -14.7 cells per microliter | Standard Deviation 94.07 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Week 72 | 2.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Mature naive B Cells: Change at Week 4 | -17.0 cells per microliter | Standard Deviation 78.31 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AW CD45): Change at Early Termination | 71.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Early Termination | 348.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 48 | 113.5 cells per microliter | Standard Deviation 140.71 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 4 | 41.0 cells per microliter | Standard Deviation 40.6 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 72 | -312.5 cells per microliter | Standard Deviation 427.8 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 24 | 37.0 cells per microliter | Standard Deviation 39.6 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 12 | 52.0 cells per microliter | Standard Deviation 65.09 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 48 | 72.5 cells per microliter | Standard Deviation 86.97 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 72 | -529.5 cells per microliter | Standard Deviation 767.21 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 24 | -40.5 cells per microliter | Standard Deviation 88.39 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 24 | 85.0 cells per microliter | Standard Deviation 45.25 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 48 | -52.5 cells per microliter | Standard Deviation 81.32 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 12 | 221.3 cells per microliter | Standard Deviation 85.33 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week 72 | -78.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Helper T Cells: Change at Week 4 | 114.7 cells per microliter | Standard Deviation 117.05 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total B cells (AWO CD45): Change at Week Early Termination | 48.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Early Termination | 45.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 12 | 75.0 cells per microliter | Standard Deviation 33.41 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Total T Cells: Change at Week 4 | 169.0 cells per microliter | Standard Deviation 189.71 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Week 4 | -0.05 cells per microliter | Standard Deviation 0.071 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Early Termination | 12.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Week 12 | 0.55 cells per microliter | Standard Deviation 0.212 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 72 | 104.0 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Cytotoxic T Cells: Change at Week 72 | -186.0 cells per microliter | Standard Deviation 289.91 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Week 24 | 0.10 cells per microliter | Standard Deviation 0.283 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 48 | 39.0 cells per microliter | Standard Deviation 48.08 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Week 48 | 0.15 cells per microliter | Standard Deviation 0.212 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 24 | 37.5 cells per microliter | Standard Deviation 58.69 |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Plasma Blasts: Change at Week 72 | 0.40 cells per microliter | — |
| Atacicept 75 mg | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | NK Cells: Change at Week 12 | 74.0 cells per microliter | Standard Deviation 89.94 |
Secondary
Change From Baseline in Serum Complement C3 and C4 Levels
The change in serum component C3 and C4 from baseline were reported.
Time frame: Baseline, Week 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24
Population: The safety population set (SAF) consisted of all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Number of participants analyzed signifies participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 72 | -43.0 milligram per liter | Standard Deviation 82.46 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at PT FU Week 12 | -12.0 milligram per liter | Standard Deviation 106.16 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 48 | 82.0 milligram per liter | Standard Deviation 215.57 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 48 | -0.4 milligram per liter | Standard Deviation 20.74 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at PT FU Week 24 | -85.0 milligram per liter | Standard Deviation 183.76 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 24 | -38.0 milligram per liter | Standard Deviation 100.85 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 24 | -27.0 milligram per liter | Standard Deviation 32.26 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 12 | -26.8 milligram per liter | Standard Deviation 25.35 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Early Termination | -22.0 milligram per liter | Standard Deviation 32.53 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 72 | -56.7 milligram per liter | Standard Deviation 127.41 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at PT FU Week 24 | -37.0 milligram per liter | Standard Deviation 64.97 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 12 | -60.0 milligram per liter | Standard Deviation 88.32 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Early Termination | -145.0 milligram per liter | Standard Deviation 190.92 |
| Placebo | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at PT FU Week 12 | -12.6 milligram per liter | Standard Deviation 32 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 72 | 12.0 milligram per liter | Standard Deviation 17.35 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 12 | 80.0 milligram per liter | Standard Deviation 125.1 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 24 | -6.0 milligram per liter | Standard Deviation 220.64 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 48 | 63.3 milligram per liter | Standard Deviation 110.15 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 72 | 43.3 milligram per liter | Standard Deviation 212.21 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Early Termination | -60.0 milligram per liter | Standard Deviation 284.78 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at PT FU Week 12 | -96.0 milligram per liter | Standard Deviation 196.67 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at PT FU Week 24 | -144.0 milligram per liter | Standard Deviation 93.97 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 12 | 13.4 milligram per liter | Standard Deviation 9.24 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 24 | 8.8 milligram per liter | Standard Deviation 29.66 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 48 | 33.3 milligram per liter | Standard Deviation 18.9 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Early Termination | -8.0 milligram per liter | Standard Deviation 38.57 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at PT FU Week 12 | -4.2 milligram per liter | Standard Deviation 9.07 |
| Atacicept 25 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at PT FU Week 24 | -18.2 milligram per liter | Standard Deviation 30.34 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at PT FU Week 12 | -1.3 milligram per liter | Standard Deviation 44.52 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 48 | 16.0 milligram per liter | Standard Deviation 27.89 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Early Termination | 180.0 milligram per liter | — |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 72 | 196.7 milligram per liter | Standard Deviation 196.55 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 72 | 49.7 milligram per liter | Standard Deviation 30.02 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 48 | 162.5 milligram per liter | Standard Deviation 219.91 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 12 | 122.0 milligram per liter | Standard Deviation 114.76 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Early Termination | 125.0 milligram per liter | — |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at Week 24 | 70.0 milligram per liter | Standard Deviation 104.24 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 12 | 33.8 milligram per liter | Standard Deviation 44.81 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at PT FU Week 24 | 164.0 milligram per liter | Standard Deviation 205.45 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at PT FU Week 24 | 19.5 milligram per liter | Standard Deviation 18.3 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C4: Change at Week 24 | 34.3 milligram per liter | Standard Deviation 40.2 |
| Atacicept 75 mg | Change From Baseline in Serum Complement C3 and C4 Levels | Complement C3: Change at PT FU Week 12 | 170.0 milligram per liter | Standard Deviation 390 |
Secondary
Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels
The change in serum Gd-IgA1 from baseline was reported.
Time frame: Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24
Population: The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 4 | -1438 nanogram per milliliter (ng/mL) | Standard Deviation 598.2 |
| Placebo | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 12 | -380 nanogram per milliliter (ng/mL) | Standard Deviation 1505 |
| Placebo | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 24 | 160 nanogram per milliliter (ng/mL) | Standard Deviation 848.8 |
| Placebo | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 48 | 1140 nanogram per milliliter (ng/mL) | Standard Deviation 4339.5 |
| Placebo | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 72 | 580 nanogram per milliliter (ng/mL) | Standard Deviation 2594.8 |
| Placebo | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Early Termination | 3520 nanogram per milliliter (ng/mL) | Standard Deviation 4638.6 |
| Placebo | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at PT FU Week 12 | 1926 nanogram per milliliter (ng/mL) | Standard Deviation 3523.3 |
| Placebo | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at PT FU Week 24 | 1673 nanogram per milliliter (ng/mL) | Standard Deviation 5072.9 |
| Atacicept 25 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 24 | -1912 nanogram per milliliter (ng/mL) | Standard Deviation 1835 |
| Atacicept 25 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at PT FU Week 12 | -772 nanogram per milliliter (ng/mL) | Standard Deviation 2050.2 |
| Atacicept 25 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 48 | -423 nanogram per milliliter (ng/mL) | Standard Deviation 795.1 |
| Atacicept 25 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 72 | -1327 nanogram per milliliter (ng/mL) | Standard Deviation 1181.4 |
| Atacicept 25 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Early Termination | -2383 nanogram per milliliter (ng/mL) | Standard Deviation 2551.1 |
| Atacicept 25 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 4 | -620 nanogram per milliliter (ng/mL) | Standard Deviation 1580.4 |
| Atacicept 25 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 12 | -1672 nanogram per milliliter (ng/mL) | Standard Deviation 1459.2 |
| Atacicept 25 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at PT FU Week 24 | -1262 nanogram per milliliter (ng/mL) | Standard Deviation 2444.1 |
| Atacicept 75 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 24 | -3660 nanogram per milliliter (ng/mL) | Standard Deviation 1940.9 |
| Atacicept 75 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 12 | -2778 nanogram per milliliter (ng/mL) | Standard Deviation 1345.8 |
| Atacicept 75 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 4 | -2288 nanogram per milliliter (ng/mL) | Standard Deviation 730.5 |
| Atacicept 75 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 48 | -2938 nanogram per milliliter (ng/mL) | Standard Deviation 1756.9 |
| Atacicept 75 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at PT FU Week 12 | -818 nanogram per milliliter (ng/mL) | Standard Deviation 1277.9 |
| Atacicept 75 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Early Termination | -2680 nanogram per milliliter (ng/mL) | Standard Deviation 1258.7 |
| Atacicept 75 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at Week 72 | -3202 nanogram per milliliter (ng/mL) | Standard Deviation 1594.9 |
| Atacicept 75 mg | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Change at PT FU Week 24 | -1090 nanogram per milliliter (ng/mL) | Standard Deviation 70.7 |
Secondary
Change From Baseline in Urinary IgG, IgA, and IgM Levels
Urinary IgG, IgA and IgM levels to be measured by Immuno-Electrophoresis.
Time frame: Baseline (Day1), Weeks 24, 48 and Early Termination (up to earlier than Week 72)
Population: As per changed in planned analysis the outcome measure related to Urinary Immunoglobulins was not assessed.
Secondary
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
The change in serum levels of IgG from baseline was reported.
Time frame: 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
Population: The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 60 | 0.305 gram per liter | Standard Deviation 1.2881 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 20 | 0.016 gram per liter | Standard Deviation 1.0781 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 2 | -0.362 gram per liter | Standard Deviation 0.7146 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 1 | -0.630 gram per liter | Standard Deviation 0.5524 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 24 | -0.748 gram per liter | Standard Deviation 1.0059 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at PT FU Week 4 | 0.360 gram per liter | Standard Deviation 1.7711 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 48 | 0.256 gram per liter | Standard Deviation 1.5731 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 32 | -0.296 gram per liter | Standard Deviation 1.1195 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 8 | -0.562 gram per liter | Standard Deviation 1.0023 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 40 | 0.218 gram per liter | Standard Deviation 0.8904 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at PT FU Week 24 | 0.273 gram per liter | Standard Deviation 0.9758 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Early Termination | 0.655 gram per liter | Standard Deviation 0.5445 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 12 | -0.472 gram per liter | Standard Deviation 0.9304 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at PT FU Week 12 | 0.922 gram per liter | Standard Deviation 1.2793 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 72 | -0.203 gram per liter | Standard Deviation 1.3606 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 16 | -0.608 gram per liter | Standard Deviation 1.1858 |
| Placebo | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 4 | -0.354 gram per liter | Standard Deviation 0.7073 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 48 | -0.600 gram per liter | Standard Deviation 0.7654 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 1 | -0.480 gram per liter | Standard Deviation 0.4289 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 2 | -0.650 gram per liter | Standard Deviation 0.5764 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 4 | -0.415 gram per liter | Standard Deviation 0.4965 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 8 | -1.128 gram per liter | Standard Deviation 0.3574 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 12 | -0.930 gram per liter | Standard Deviation 0.7748 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 16 | -1.480 gram per liter | Standard Deviation 0.4687 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 20 | -1.024 gram per liter | Standard Deviation 0.3893 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 24 | -0.926 gram per liter | Standard Deviation 0.8289 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 32 | -1.055 gram per liter | Standard Deviation 0.5701 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 40 | -1.363 gram per liter | Standard Deviation 0.4895 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 60 | -0.743 gram per liter | Standard Deviation 1.5627 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 72 | -0.867 gram per liter | Standard Deviation 0.7772 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Early Termination | -1.547 gram per liter | Standard Deviation 0.5353 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at PT FU Week 4 | -0.736 gram per liter | Standard Deviation 0.79 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at PT FU Week 12 | -0.800 gram per liter | Standard Deviation 1.4692 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at PT FU Week 24 | -0.878 gram per liter | Standard Deviation 1.0395 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 2 | -0.898 gram per liter | Standard Deviation 0.5507 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 60 | -3.368 gram per liter | Standard Deviation 0.5721 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 12 | -3.126 gram per liter | Standard Deviation 0.9324 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at PT FU Week 24 | 0.020 gram per liter | Standard Deviation 1.2498 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 72 | -3.477 gram per liter | Standard Deviation 0.8618 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 8 | -2.812 gram per liter | Standard Deviation 1.2085 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at PT FU Week 12 | -1.300 gram per liter | Standard Deviation 0.561 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Early Termination | -3.995 gram per liter | Standard Deviation 0.0636 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 4 | -1.792 gram per liter | Standard Deviation 0.8182 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 1 | -0.444 gram per liter | Standard Deviation 0.4372 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 32 | -3.962 gram per liter | Standard Deviation 0.883 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at PT FU Week 4 | -2.553 gram per liter | Standard Deviation 0.716 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 40 | -3.623 gram per liter | Standard Deviation 0.2993 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 24 | -3.776 gram per liter | Standard Deviation 1.0876 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 20 | -3.684 gram per liter | Standard Deviation 0.7597 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 48 | -3.745 gram per liter | Standard Deviation 0.4608 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Change at Week 16 | -3.360 gram per liter | Standard Deviation 0.8546 |
Secondary
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
The change in serum levels of IgA from baseline was reported.
Time frame: 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
Population: The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Early termination | 0.420 gram per liter | Standard Deviation 0.0849 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 20 | 0.218 gram per liter | Standard Deviation 0.6157 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 2 | -0.114 gram per liter | Standard Deviation 0.2825 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at PT FU Week 12 | 0.622 gram per liter | Standard Deviation 0.7436 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 24 | 0.212 gram per liter | Standard Deviation 0.314 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 72 | 0.307 gram per liter | Standard Deviation 0.365 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 4 | -0.014 gram per liter | Standard Deviation 0.357 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 32 | 0.180 gram per liter | Standard Deviation 0.4924 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 16 | 0.044 gram per liter | Standard Deviation 0.4869 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at PT FU Week 24 | 0.563 gram per liter | Standard Deviation 0.6716 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 40 | 0.112 gram per liter | Standard Deviation 0.7745 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 12 | -0.030 gram per liter | Standard Deviation 0.4011 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 1 | -0.194 gram per liter | Standard Deviation 0.3012 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 48 | 0.526 gram per liter | Standard Deviation 1.2935 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at PT FU Week 4 | 0.300 gram per liter | Standard Deviation 0.4757 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 8 | 0.008 gram per liter | Standard Deviation 0.534 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 60 | 0.233 gram per liter | Standard Deviation 0.3676 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 2 | -0.280 gram per liter | Standard Deviation 0.1108 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 8 | -0.572 gram per liter | Standard Deviation 0.2838 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 72 | -0.957 gram per liter | Standard Deviation 0.2157 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Early termination | -0.493 gram per liter | Standard Deviation 0.2173 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 12 | -0.476 gram per liter | Standard Deviation 0.3879 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at PT FU Week 4 | -0.452 gram per liter | Standard Deviation 0.3529 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at PT FU Week 12 | -0.440 gram per liter | Standard Deviation 0.6335 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at PT FU Week 24 | -0.420 gram per liter | Standard Deviation 0.6503 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 16 | -0.692 gram per liter | Standard Deviation 0.3608 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 60 | -0.733 gram per liter | Standard Deviation 0.3057 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 20 | -0.616 gram per liter | Standard Deviation 0.288 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 1 | -0.203 gram per liter | Standard Deviation 0.1325 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 24 | -0.514 gram per liter | Standard Deviation 0.4552 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 32 | -0.920 gram per liter | Standard Deviation 0.295 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 4 | -0.197 gram per liter | Standard Deviation 0.1952 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 40 | -0.963 gram per liter | Standard Deviation 0.2815 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 48 | -0.710 gram per liter | Standard Deviation 0.3804 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at PT FU Week 24 | -0.370 gram per liter | Standard Deviation 0.116 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 1 | -0.278 gram per liter | Standard Deviation 0.1561 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 2 | -0.486 gram per liter | Standard Deviation 0.2289 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 4 | -0.828 gram per liter | Standard Deviation 0.2319 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 12 | -1.146 gram per liter | Standard Deviation 0.4226 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 16 | -1.296 gram per liter | Standard Deviation 0.4237 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 20 | -1.430 gram per liter | Standard Deviation 0.4635 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 24 | -1.424 gram per liter | Standard Deviation 0.5226 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 32 | -1.468 gram per liter | Standard Deviation 0.3851 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 40 | -1.388 gram per liter | Standard Deviation 0.3212 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 48 | -1.375 gram per liter | Standard Deviation 0.468 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 60 | -1.283 gram per liter | Standard Deviation 0.4308 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 72 | -1.240 gram per liter | Standard Deviation 0.4491 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Early termination | -1.835 gram per liter | Standard Deviation 0.1344 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at PT FU Week 4 | -1.223 gram per liter | Standard Deviation 0.2515 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at PT FU Week 12 | -0.668 gram per liter | Standard Deviation 0.2843 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Change at Week 8 | -1.144 gram per liter | Standard Deviation 0.4997 |
Secondary
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
The change in serum levels of IgM from baseline was reported.
Time frame: 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
Population: The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 60 | -0.033 gram per liter | Standard Deviation 0.0907 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 20 | 0.082 gram per liter | Standard Deviation 0.2288 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 2 | -0.054 gram per liter | Standard Deviation 0.1026 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 1 | -0.082 gram per liter | Standard Deviation 0.0835 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 24 | -0.016 gram per liter | Standard Deviation 0.139 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at PT FU Week 4 | -0.048 gram per liter | Standard Deviation 0.1941 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 48 | 0.012 gram per liter | Standard Deviation 0.1951 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 32 | -0.016 gram per liter | Standard Deviation 0.1566 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 8 | 0.006 gram per liter | Standard Deviation 0.171 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 40 | 0.036 gram per liter | Standard Deviation 0.1464 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at PT FU Week 24 | 0.020 gram per liter | Standard Deviation 0.1687 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Early Termination | 0.115 gram per liter | Standard Deviation 0.0354 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 12 | 0.022 gram per liter | Standard Deviation 0.0955 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at PT FU Week 12 | 0.058 gram per liter | Standard Deviation 0.2281 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 72 | -0.027 gram per liter | Standard Deviation 0.0153 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 16 | 0.024 gram per liter | Standard Deviation 0.1412 |
| Placebo | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 4 | -0.002 gram per liter | Standard Deviation 0.119 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 48 | -0.227 gram per liter | Standard Deviation 0.125 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 1 | -0.072 gram per liter | Standard Deviation 0.0736 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 2 | -0.140 gram per liter | Standard Deviation 0.1906 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 4 | -0.197 gram per liter | Standard Deviation 0.2655 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 8 | -0.302 gram per liter | Standard Deviation 0.3114 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 12 | -0.360 gram per liter | Standard Deviation 0.3169 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 16 | -0.408 gram per liter | Standard Deviation 0.3531 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 20 | -0.444 gram per liter | Standard Deviation 0.3965 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 24 | -0.364 gram per liter | Standard Deviation 0.3377 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 32 | -0.510 gram per liter | Standard Deviation 0.4498 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 40 | -0.247 gram per liter | Standard Deviation 0.1553 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 60 | -0.297 gram per liter | Standard Deviation 0.2495 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 72 | -0.337 gram per liter | Standard Deviation 0.2914 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Early Termination | -0.463 gram per liter | Standard Deviation 0.1626 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at PT FU Week 4 | -0.328 gram per liter | Standard Deviation 0.1906 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at PT FU Week 12 | -0.214 gram per liter | Standard Deviation 0.1739 |
| Atacicept 25 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at PT FU Week 24 | -0.178 gram per liter | Standard Deviation 0.1504 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 2 | -0.102 gram per liter | Standard Deviation 0.1625 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 60 | -0.843 gram per liter | Standard Deviation 0.2573 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 12 | -0.638 gram per liter | Standard Deviation 0.2497 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at PT FU Week 24 | -0.340 gram per liter | Standard Deviation 0.1896 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 72 | -0.900 gram per liter | Standard Deviation 0.3081 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 8 | -0.558 gram per liter | Standard Deviation 0.1859 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at PT FU Week 12 | -0.465 gram per liter | Standard Deviation 0.2319 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Early Termination | -0.670 gram per liter | Standard Deviation 0.1414 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 4 | -0.410 gram per liter | Standard Deviation 0.1637 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 1 | -0.096 gram per liter | Standard Deviation 0.0924 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 32 | -0.796 gram per liter | Standard Deviation 0.2773 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at PT FU Week 4 | -0.667 gram per liter | Standard Deviation 0.2259 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 40 | -0.848 gram per liter | Standard Deviation 0.2668 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 24 | -0.774 gram per liter | Standard Deviation 0.2517 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 20 | -0.748 gram per liter | Standard Deviation 0.25 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 48 | -0.848 gram per liter | Standard Deviation 0.2557 |
| Atacicept 75 mg | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Change at Week 16 | -0.710 gram per liter | Standard Deviation 0.2463 |
Secondary
Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs)
12-lead ECG were recorded after the participants have rested for at least 15 minutes in supine position. Clinically significance was decided by the investigator. The number of participants with clinically significant abnormalities in 12-lead ECG were reported.
Time frame: Baseline up to safety follow-up (96 weeks)
Population: The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs) | 0 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs) | 0 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs) | 0 percentage of participants |
Secondary
Percentage of Participants With Clinical Significant Abnormalities in Laboratory Assessments
Laboratory investigation included hematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator.
Time frame: Baseline up to safety follow-up (96 weeks)
Population: As per changed in planned analysis the outcome measure related to clinically significant abnormalities in laboratory assessments was not assessed.
Secondary
Percentage of Participants With Clinical Significant Abnormalities in Vital Signs
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 participants have in a rested at least 3 minutes in seated position. Clinical significance was to be decided by the investigator.
Time frame: Baseline up to safety follow-up (96 weeks)
Population: As per changed in planned analysis the outcome measure related to clinically significant abnormalities in vital signs was not assessed.
Secondary
Percentage of Participants With Positive Anti-Drug Antibody (ADA)
Percentage of participants with positive ADA were reported.
Time frame: Baseline up to safety follow-up (96 weeks)
Population: The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Positive Anti-Drug Antibody (ADA) | 0 percentage of participants |
| Atacicept 25 mg | Percentage of Participants With Positive Anti-Drug Antibody (ADA) | 0 percentage of participants |
| Atacicept 75 mg | Percentage of Participants With Positive Anti-Drug Antibody (ADA) | 0 percentage of participants |
Secondary
Serum Atacicept Concentrations
Serum Atacicept Concentrations was to be performed; however; as per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.
Time frame: 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
Population: As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.