Trial Outcomes & Findings for Efficacy and Safety of Atacicept in IgA Nephropathy (NCT NCT02808429)
NCT ID: NCT02808429
Last Updated: 2021-02-25
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline up to 96 weeks
Results posted on
2021-02-25
Participant Flow
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.
Participant milestones
| Measure |
Placebo
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
5
|
|
Overall Study
COMPLETED
|
2
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Premature study termination by sponsor
|
2
|
0
|
1
|
|
Overall Study
Relocation
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Atacicept in IgA Nephropathy
Baseline characteristics by cohort
| Measure |
Placebo
n=5 Participants
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=6 Participants
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=5 Participants
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
41 years
STANDARD_DEVIATION 16.9 • n=7 Participants
|
43 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
43 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 96 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=6 Participants
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=5 Participants
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
|---|---|---|---|
|
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
|
83.3 percentage of participants
|
60 percentage of participants
|
|
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
|
100 percentage of participants
|
60 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
66.67 percentage of participants
|
20 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
|
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
|
83.33 percentage of participants
|
20 percentage of participants
|
|
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
|
50 percentage of participants
|
0 percentage of participants
|
|
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
|
16.66 percentage of participants
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
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 24Population: As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.
Serum Atacicept Concentrations was to be performed; however; as per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
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 24Population: 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.
The change in serum levels of IgA from baseline was reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=6 Participants
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=5 Participants
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
|---|---|---|---|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 1
|
-0.194 gram per liter
Standard Deviation 0.3012
|
-0.203 gram per liter
Standard Deviation 0.1325
|
-0.278 gram per liter
Standard Deviation 0.1561
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 2
|
-0.114 gram per liter
Standard Deviation 0.2825
|
-0.280 gram per liter
Standard Deviation 0.1108
|
-0.486 gram per liter
Standard Deviation 0.2289
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 4
|
-0.014 gram per liter
Standard Deviation 0.3570
|
-0.197 gram per liter
Standard Deviation 0.1952
|
-0.828 gram per liter
Standard Deviation 0.2319
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 8
|
0.008 gram per liter
Standard Deviation 0.5340
|
-0.572 gram per liter
Standard Deviation 0.2838
|
-1.144 gram per liter
Standard Deviation 0.4997
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 12
|
-0.030 gram per liter
Standard Deviation 0.4011
|
-0.476 gram per liter
Standard Deviation 0.3879
|
-1.146 gram per liter
Standard Deviation 0.4226
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 16
|
0.044 gram per liter
Standard Deviation 0.4869
|
-0.692 gram per liter
Standard Deviation 0.3608
|
-1.296 gram per liter
Standard Deviation 0.4237
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 20
|
0.218 gram per liter
Standard Deviation 0.6157
|
-0.616 gram per liter
Standard Deviation 0.2880
|
-1.430 gram per liter
Standard Deviation 0.4635
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 24
|
0.212 gram per liter
Standard Deviation 0.3140
|
-0.514 gram per liter
Standard Deviation 0.4552
|
-1.424 gram per liter
Standard Deviation 0.5226
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 32
|
0.180 gram per liter
Standard Deviation 0.4924
|
-0.920 gram per liter
Standard Deviation 0.2950
|
-1.468 gram per liter
Standard Deviation 0.3851
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 40
|
0.112 gram per liter
Standard Deviation 0.7745
|
-0.963 gram per liter
Standard Deviation 0.2815
|
-1.388 gram per liter
Standard Deviation 0.3212
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 48
|
0.526 gram per liter
Standard Deviation 1.2935
|
-0.710 gram per liter
Standard Deviation 0.3804
|
-1.375 gram per liter
Standard Deviation 0.4680
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 60
|
0.233 gram per liter
Standard Deviation 0.3676
|
-0.733 gram per liter
Standard Deviation 0.3057
|
-1.283 gram per liter
Standard Deviation 0.4308
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Week 72
|
0.307 gram per liter
Standard Deviation 0.3650
|
-0.957 gram per liter
Standard Deviation 0.2157
|
-1.240 gram per liter
Standard Deviation 0.4491
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at Early termination
|
0.420 gram per liter
Standard Deviation 0.0849
|
-0.493 gram per liter
Standard Deviation 0.2173
|
-1.835 gram per liter
Standard Deviation 0.1344
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at PT FU Week 4
|
0.300 gram per liter
Standard Deviation 0.4757
|
-0.452 gram per liter
Standard Deviation 0.3529
|
-1.223 gram per liter
Standard Deviation 0.2515
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at PT FU Week 12
|
0.622 gram per liter
Standard Deviation 0.7436
|
-0.440 gram per liter
Standard Deviation 0.6335
|
-0.668 gram per liter
Standard Deviation 0.2843
|
|
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change at PT FU Week 24
|
0.563 gram per liter
Standard Deviation 0.6716
|
-0.420 gram per liter
Standard Deviation 0.6503
|
-0.370 gram per liter
Standard Deviation 0.1160
|
SECONDARY outcome
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 24Population: 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.
The change in serum levels of IgG from baseline was reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=6 Participants
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=5 Participants
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
|---|---|---|---|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 16
|
-0.608 gram per liter
Standard Deviation 1.1858
|
-1.480 gram per liter
Standard Deviation 0.4687
|
-3.360 gram per liter
Standard Deviation 0.8546
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 1
|
-0.630 gram per liter
Standard Deviation 0.5524
|
-0.480 gram per liter
Standard Deviation 0.4289
|
-0.444 gram per liter
Standard Deviation 0.4372
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 2
|
-0.362 gram per liter
Standard Deviation 0.7146
|
-0.650 gram per liter
Standard Deviation 0.5764
|
-0.898 gram per liter
Standard Deviation 0.5507
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 4
|
-0.354 gram per liter
Standard Deviation 0.7073
|
-0.415 gram per liter
Standard Deviation 0.4965
|
-1.792 gram per liter
Standard Deviation 0.8182
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 8
|
-0.562 gram per liter
Standard Deviation 1.0023
|
-1.128 gram per liter
Standard Deviation 0.3574
|
-2.812 gram per liter
Standard Deviation 1.2085
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 12
|
-0.472 gram per liter
Standard Deviation 0.9304
|
-0.930 gram per liter
Standard Deviation 0.7748
|
-3.126 gram per liter
Standard Deviation 0.9324
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 20
|
0.016 gram per liter
Standard Deviation 1.0781
|
-1.024 gram per liter
Standard Deviation 0.3893
|
-3.684 gram per liter
Standard Deviation 0.7597
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 24
|
-0.748 gram per liter
Standard Deviation 1.0059
|
-0.926 gram per liter
Standard Deviation 0.8289
|
-3.776 gram per liter
Standard Deviation 1.0876
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 32
|
-0.296 gram per liter
Standard Deviation 1.1195
|
-1.055 gram per liter
Standard Deviation 0.5701
|
-3.962 gram per liter
Standard Deviation 0.8830
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 40
|
0.218 gram per liter
Standard Deviation 0.8904
|
-1.363 gram per liter
Standard Deviation 0.4895
|
-3.623 gram per liter
Standard Deviation 0.2993
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 48
|
0.256 gram per liter
Standard Deviation 1.5731
|
-0.600 gram per liter
Standard Deviation 0.7654
|
-3.745 gram per liter
Standard Deviation 0.4608
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 60
|
0.305 gram per liter
Standard Deviation 1.2881
|
-0.743 gram per liter
Standard Deviation 1.5627
|
-3.368 gram per liter
Standard Deviation 0.5721
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Week 72
|
-0.203 gram per liter
Standard Deviation 1.3606
|
-0.867 gram per liter
Standard Deviation 0.7772
|
-3.477 gram per liter
Standard Deviation 0.8618
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at Early Termination
|
0.655 gram per liter
Standard Deviation 0.5445
|
-1.547 gram per liter
Standard Deviation 0.5353
|
-3.995 gram per liter
Standard Deviation 0.0636
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at PT FU Week 4
|
0.360 gram per liter
Standard Deviation 1.7711
|
-0.736 gram per liter
Standard Deviation 0.7900
|
-2.553 gram per liter
Standard Deviation 0.7160
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at PT FU Week 12
|
0.922 gram per liter
Standard Deviation 1.2793
|
-0.800 gram per liter
Standard Deviation 1.4692
|
-1.300 gram per liter
Standard Deviation 0.5610
|
|
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Change at PT FU Week 24
|
0.273 gram per liter
Standard Deviation 0.9758
|
-0.878 gram per liter
Standard Deviation 1.0395
|
0.020 gram per liter
Standard Deviation 1.2498
|
SECONDARY outcome
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 24Population: 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.
The change in serum levels of IgM from baseline was reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=6 Participants
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=5 Participants
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
|---|---|---|---|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 1
|
-0.082 gram per liter
Standard Deviation 0.0835
|
-0.072 gram per liter
Standard Deviation 0.0736
|
-0.096 gram per liter
Standard Deviation 0.0924
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 2
|
-0.054 gram per liter
Standard Deviation 0.1026
|
-0.140 gram per liter
Standard Deviation 0.1906
|
-0.102 gram per liter
Standard Deviation 0.1625
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 4
|
-0.002 gram per liter
Standard Deviation 0.1190
|
-0.197 gram per liter
Standard Deviation 0.2655
|
-0.410 gram per liter
Standard Deviation 0.1637
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 8
|
0.006 gram per liter
Standard Deviation 0.1710
|
-0.302 gram per liter
Standard Deviation 0.3114
|
-0.558 gram per liter
Standard Deviation 0.1859
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 12
|
0.022 gram per liter
Standard Deviation 0.0955
|
-0.360 gram per liter
Standard Deviation 0.3169
|
-0.638 gram per liter
Standard Deviation 0.2497
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 16
|
0.024 gram per liter
Standard Deviation 0.1412
|
-0.408 gram per liter
Standard Deviation 0.3531
|
-0.710 gram per liter
Standard Deviation 0.2463
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 20
|
0.082 gram per liter
Standard Deviation 0.2288
|
-0.444 gram per liter
Standard Deviation 0.3965
|
-0.748 gram per liter
Standard Deviation 0.2500
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 24
|
-0.016 gram per liter
Standard Deviation 0.1390
|
-0.364 gram per liter
Standard Deviation 0.3377
|
-0.774 gram per liter
Standard Deviation 0.2517
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 32
|
-0.016 gram per liter
Standard Deviation 0.1566
|
-0.510 gram per liter
Standard Deviation 0.4498
|
-0.796 gram per liter
Standard Deviation 0.2773
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 40
|
0.036 gram per liter
Standard Deviation 0.1464
|
-0.247 gram per liter
Standard Deviation 0.1553
|
-0.848 gram per liter
Standard Deviation 0.2668
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 48
|
0.012 gram per liter
Standard Deviation 0.1951
|
-0.227 gram per liter
Standard Deviation 0.1250
|
-0.848 gram per liter
Standard Deviation 0.2557
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 60
|
-0.033 gram per liter
Standard Deviation 0.0907
|
-0.297 gram per liter
Standard Deviation 0.2495
|
-0.843 gram per liter
Standard Deviation 0.2573
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Week 72
|
-0.027 gram per liter
Standard Deviation 0.0153
|
-0.337 gram per liter
Standard Deviation 0.2914
|
-0.900 gram per liter
Standard Deviation 0.3081
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at Early Termination
|
0.115 gram per liter
Standard Deviation 0.0354
|
-0.463 gram per liter
Standard Deviation 0.1626
|
-0.670 gram per liter
Standard Deviation 0.1414
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at PT FU Week 4
|
-0.048 gram per liter
Standard Deviation 0.1941
|
-0.328 gram per liter
Standard Deviation 0.1906
|
-0.667 gram per liter
Standard Deviation 0.2259
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at PT FU Week 12
|
0.058 gram per liter
Standard Deviation 0.2281
|
-0.214 gram per liter
Standard Deviation 0.1739
|
-0.465 gram per liter
Standard Deviation 0.2319
|
|
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
Change at PT FU Week 24
|
0.020 gram per liter
Standard Deviation 0.1687
|
-0.178 gram per liter
Standard Deviation 0.1504
|
-0.340 gram per liter
Standard Deviation 0.1896
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24Population: 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.
The change in serum Gd-IgA1 from baseline was reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=6 Participants
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=5 Participants
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
|---|---|---|---|
|
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
|
-2383 nanogram per milliliter (ng/mL)
Standard Deviation 2551.1
|
-2680 nanogram per milliliter (ng/mL)
Standard Deviation 1258.7
|
|
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
|
-772 nanogram per milliliter (ng/mL)
Standard Deviation 2050.2
|
-818 nanogram per milliliter (ng/mL)
Standard Deviation 1277.9
|
|
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
|
-1262 nanogram per milliliter (ng/mL)
Standard Deviation 2444.1
|
-1090 nanogram per milliliter (ng/mL)
Standard Deviation 70.7
|
|
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
|
-620 nanogram per milliliter (ng/mL)
Standard Deviation 1580.4
|
-2288 nanogram per milliliter (ng/mL)
Standard Deviation 730.5
|
|
Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels
Change at Week 12
|
-380 nanogram per milliliter (ng/mL)
Standard Deviation 1505.0
|
-1672 nanogram per milliliter (ng/mL)
Standard Deviation 1459.2
|
-2778 nanogram per milliliter (ng/mL)
Standard Deviation 1345.8
|
|
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
|
-1912 nanogram per milliliter (ng/mL)
Standard Deviation 1835.0
|
-3660 nanogram per milliliter (ng/mL)
Standard Deviation 1940.9
|
|
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
|
-423 nanogram per milliliter (ng/mL)
Standard Deviation 795.1
|
-2938 nanogram per milliliter (ng/mL)
Standard Deviation 1756.9
|
|
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
|
-1327 nanogram per milliliter (ng/mL)
Standard Deviation 1181.4
|
-3202 nanogram per milliliter (ng/mL)
Standard Deviation 1594.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24Population: 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.
The change in serum component C3 and C4 from baseline were reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=5 Participants
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=5 Participants
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
|---|---|---|---|
|
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
|
-18.2 milligram per liter
Standard Deviation 30.34
|
19.5 milligram per liter
Standard Deviation 18.30
|
|
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
|
80.0 milligram per liter
Standard Deviation 125.10
|
122.0 milligram per liter
Standard Deviation 114.76
|
|
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
|
-6.0 milligram per liter
Standard Deviation 220.64
|
70.0 milligram per liter
Standard Deviation 104.24
|
|
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
|
63.3 milligram per liter
Standard Deviation 110.15
|
162.5 milligram per liter
Standard Deviation 219.91
|
|
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
|
43.3 milligram per liter
Standard Deviation 212.21
|
196.7 milligram per liter
Standard Deviation 196.55
|
|
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
|
-60.0 milligram per liter
Standard Deviation 284.78
|
180.0 milligram per liter
|
|
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
|
-96.0 milligram per liter
Standard Deviation 196.67
|
170.0 milligram per liter
Standard Deviation 390.00
|
|
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
|
-144.0 milligram per liter
Standard Deviation 93.97
|
164.0 milligram per liter
Standard Deviation 205.45
|
|
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
|
13.4 milligram per liter
Standard Deviation 9.24
|
33.8 milligram per liter
Standard Deviation 44.81
|
|
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
|
8.8 milligram per liter
Standard Deviation 29.66
|
34.3 milligram per liter
Standard Deviation 40.20
|
|
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
|
33.3 milligram per liter
Standard Deviation 18.90
|
16.0 milligram per liter
Standard Deviation 27.89
|
|
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
|
12.0 milligram per liter
Standard Deviation 17.35
|
49.7 milligram per liter
Standard Deviation 30.02
|
|
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
|
-8.0 milligram per liter
Standard Deviation 38.57
|
125.0 milligram per liter
|
|
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 32.00
|
-4.2 milligram per liter
Standard Deviation 9.07
|
-1.3 milligram per liter
Standard Deviation 44.52
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=2 Participants
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=3 Participants
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
|---|---|---|---|
|
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
|
—
|
38.0 cells per microliter
Standard Deviation 42.43
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Plasma Cells: Change at Week 12
|
-0.10 cells per microliter
|
—
|
0.15 cells per microliter
Standard Deviation 0.212
|
|
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
|
-0.10 cells per microliter
|
0.00 cells per microliter
Standard Deviation 0.000
|
|
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
|
—
|
0.00 cells per microliter
Standard Deviation 0.000
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Plasma Cells: Change at Week 72
|
0.00 cells per microliter
|
—
|
0.20 cells per microliter
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Plasma Cells: Change at Early Termination
|
0.20 cells per microliter
|
—
|
—
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Plasma Cells: Change at PT FU Week 24
|
0.10 cells per microliter
|
—
|
—
|
|
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
|
37.3 cells per microliter
Standard Deviation 64.39
|
|
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
|
-105.0 cells per microliter
|
108.7 cells per microliter
Standard Deviation 88.90
|
|
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
|
-78.0 cells per microliter
Standard Deviation 131.52
|
-32.5 cells per microliter
Standard Deviation 116.67
|
|
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
|
—
|
-27.5 cells per microliter
Standard Deviation 115.26
|
|
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
|
—
|
2.0 cells per microliter
|
|
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
|
—
|
71.0 cells per microliter
|
|
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
|
—
|
—
|
|
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
|
41.0 cells per microliter
Standard Deviation 40.60
|
|
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
|
-137.0 cells per microliter
|
52.0 cells per microliter
Standard Deviation 65.09
|
|
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
|
-96.5 cells per microliter
Standard Deviation 135.06
|
-40.5 cells per microliter
Standard Deviation 88.39
|
|
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
|
—
|
-52.5 cells per microliter
Standard Deviation 81.32
|
|
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
|
—
|
-78.0 cells per microliter
|
|
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
|
—
|
48.0 cells per microliter
|
|
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
|
—
|
—
|
|
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
|
169.0 cells per microliter
Standard Deviation 189.71
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Total T Cells: Change at Week 12
|
861.0 cells per microliter
|
-165.0 cells per microliter
|
314.7 cells per microliter
Standard Deviation 50.54
|
|
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
|
111.0 cells per microliter
Standard Deviation 260.22
|
130.0 cells per microliter
Standard Deviation 2.83
|
|
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
|
—
|
113.5 cells per microliter
Standard Deviation 140.71
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Total T Cells: Change at Week 72
|
-227.0 cells per microliter
|
—
|
-529.5 cells per microliter
Standard Deviation 767.21
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Total T Cells: Change at Early Termination
|
350.0 cells per microliter
|
—
|
393.0 cells per microliter
|
|
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
|
—
|
—
|
|
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
|
46.7 cells per microliter
Standard Deviation 72.57
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Cytotoxic T Cells: Change at Week 12
|
713.0 cells per microliter
|
-114.0 cells per microliter
|
75.0 cells per microliter
Standard Deviation 33.41
|
|
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
|
-30.5 cells per microliter
Standard Deviation 125.16
|
37.0 cells per microliter
Standard Deviation 39.60
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Cytotoxic T Cells: Change at Week 72
|
-60.0 cells per microliter
|
—
|
-186.0 cells per microliter
Standard Deviation 289.91
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Cytotoxic T Cells: Change at Early Termination
|
282.0 cells per microliter
|
—
|
45.0 cells per microliter
|
|
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
|
—
|
—
|
|
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
|
114.7 cells per microliter
Standard Deviation 117.05
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Helper T Cells: Change at Week 12
|
124.0 cells per microliter
|
-51.0 cells per microliter
|
221.3 cells per microliter
Standard Deviation 85.33
|
|
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
|
134.0 cells per microliter
Standard Deviation 124.45
|
85.0 cells per microliter
Standard Deviation 45.25
|
|
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 338.70
|
—
|
72.5 cells per microliter
Standard Deviation 86.97
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Helper T Cells: Change at Week 72
|
-170.0 cells per microliter
|
—
|
-312.5 cells per microliter
Standard Deviation 427.80
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Helper T Cells: Change at Early Termination
|
81.0 cells per microliter
|
—
|
348.0 cells per microliter
|
|
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
|
—
|
—
|
|
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
|
-17.0 cells per microliter
Standard Deviation 78.31
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Mature naive B Cells: Change at Week 12
|
137.0 cells per microliter
|
-106.0 cells per microliter
|
-14.7 cells per microliter
Standard Deviation 94.07
|
|
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
|
-117.5 cells per microliter
Standard Deviation 51.62
|
-87.5 cells per microliter
Standard Deviation 109.60
|
|
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
|
—
|
-91.0 cells per microliter
Standard Deviation 107.48
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Mature naive B Cells: Change at Week 72
|
-24.0 cells per microliter
|
—
|
-32.0 cells per microliter
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Mature naive B Cells: Change at Early Termination
|
36.0 cells per microliter
|
—
|
-1.0 cells per microliter
|
|
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
|
—
|
—
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Memory B Cells: Change at Week 4
|
—
|
8.0 cells per microliter
|
14.5 cells per microliter
Standard Deviation 2.12
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Memory B Cells: Change at Week 12
|
5.0 cells per microliter
|
—
|
34.0 cells per microliter
Standard Deviation 0.00
|
|
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
|
13.0 cells per microliter
|
5.5 cells per microliter
Standard Deviation 21.92
|
|
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
|
—
|
5.0 cells per microliter
Standard Deviation 16.97
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Memory B Cells: Change at Week 72
|
-6.0 cells per microliter
|
—
|
8.0 cells per microliter
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Memory B Cells: Change at Early Termination
|
-3.0 cells per microliter
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
88.3 cells per microliter
Standard Deviation 30.62
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
NK Cells: Change at Week 12
|
43.0 cells per microliter
|
-105.0 cells per microliter
|
74.0 cells per microliter
Standard Deviation 89.94
|
|
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
|
-34.5 cells per microliter
Standard Deviation 112.43
|
37.5 cells per microliter
Standard Deviation 58.69
|
|
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
|
—
|
39.0 cells per microliter
Standard Deviation 48.08
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
NK Cells: Change at Week 72
|
130.0 cells per microliter
|
—
|
104.0 cells per microliter
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
NK Cells: Change at Early Termination
|
54.0 cells per microliter
|
—
|
12.0 cells per microliter
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
NK Cells:Change at PT FU Week 24
|
81.0 cells per microliter
|
—
|
—
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Plasma Blasts: Change at Week 4
|
—
|
0.10 cells per microliter
|
-0.05 cells per microliter
Standard Deviation 0.071
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Plasma Blasts: Change at Week 12
|
-0.10 cells per microliter
|
—
|
0.55 cells per microliter
Standard Deviation 0.212
|
|
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
|
-0.30 cells per microliter
|
0.10 cells per microliter
Standard Deviation 0.283
|
|
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
|
—
|
0.15 cells per microliter
Standard Deviation 0.212
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Plasma Blasts: Change at Week 72
|
-0.10 cells per microliter
|
—
|
0.40 cells per microliter
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Plasma Blasts: Change at Early Termination
|
0.80 cells per microliter
|
—
|
—
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Plasma Blasts: Change at PT FU Week 24
|
3.40 cells per microliter
|
—
|
—
|
|
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Plasma Cells: Change at Week 4
|
—
|
0.10 cells per microliter
|
0.00 cells per microliter
Standard Deviation 0.141
|
SECONDARY outcome
Timeframe: 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.
Urinary IgG, IgA and IgM levels to be measured by Immuno-Electrophoresis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Percentage of participants with positive ADA were reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=6 Participants
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=5 Participants
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Positive Anti-Drug Antibody (ADA)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
Laboratory investigation included hematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=6 Participants
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=5 Participants
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Atacicept 25 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Atacicept 75 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=5 participants at risk
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=6 participants at risk
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=5 participants at risk
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
Other adverse events
| Measure |
Placebo
n=5 participants at risk
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
|
Atacicept 25 mg
n=6 participants at risk
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
|
Atacicept 75 mg
n=5 participants at risk
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
|
|---|---|---|---|
|
General disorders
Injection site erythema
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
66.7%
4/6 • Baseline up to safety follow up period (96 weeks)
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
|
General disorders
Injection site bruising
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
50.0%
3/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
General disorders
Injection site pruritus
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
50.0%
3/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
General disorders
Injection site reaction
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
40.0%
2/5 • Baseline up to safety follow up period (96 weeks)
|
|
General disorders
Fatigue
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
General disorders
Injection site induration
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
General disorders
Injection site inflammation
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
|
General disorders
Injection site pain
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
General disorders
Pain
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
50.0%
3/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
33.3%
2/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Infections and infestations
Influenza
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
33.3%
2/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
|
Infections and infestations
Herpes simplex
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Infections and infestations
Viral infection
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Metabolism and nutrition disorders
Gout
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
33.3%
2/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Blood and lymphatic system disorders
Paratracheal lymphadenopathy
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Nervous system disorders
Migraine
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Immune system disorders
Allergy to chemicals
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Investigations
Blood glucose increased
|
20.0%
1/5 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
16.7%
1/6 • Baseline up to safety follow up period (96 weeks)
|
0.00%
0/5 • Baseline up to safety follow up period (96 weeks)
|
Additional Information
Communication Center
Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place