Trial Outcomes & Findings for A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus (NCT NCT02804763)
NCT ID: NCT02804763
Last Updated: 2021-06-30
Results Overview
The primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using Multiple Comparison Procedure - Modelling (MCP-Mod). Four candidate dose-response models were evaluated: a linear model, a logistic model, and 2 Emax models, and the MCP-Mod methodology controlled for multiplicity. BICLA response was defined as meeting all of the following criteria: 1. BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. 2. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. 3. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as \< 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). 4. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
182 participants
Primary outcome timeframe
Week 24
Results posted on
2021-06-30
Participant Flow
The study started to enroll patients in June 2016 and concluded in November 2018.
The study included a 4-week Screening Period, a 24-week Double-Blind Treatment Period and a 24-week Observational Period. Participant Flow refers to the Randomized Set.
Participant milestones
| Measure |
SOC + Placebo iv Q4W
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
SOC + DZP 6mg/kg iv Q4W
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6 milligrams (mg)/kilogram (kg) intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
SOC + DZP 24mg/kg iv Q4W
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
SOC + DZP 45mg/kg iv Q4W
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
|---|---|---|---|---|
|
Double-Blind Period (Week 1 to Week 24)
STARTED
|
45
|
45
|
45
|
47
|
|
Double-Blind Period (Week 1 to Week 24)
Completed Week 24
|
44
|
45
|
44
|
45
|
|
Double-Blind Period (Week 1 to Week 24)
Finished Wk24 Began Observational Period
|
44
|
44
|
44
|
45
|
|
Double-Blind Period (Week 1 to Week 24)
COMPLETED
|
44
|
44
|
44
|
45
|
|
Double-Blind Period (Week 1 to Week 24)
NOT COMPLETED
|
1
|
1
|
1
|
2
|
|
Observational Period (Wk 24 to Wk 48)
STARTED
|
44
|
44
|
44
|
45
|
|
Observational Period (Wk 24 to Wk 48)
COMPLETED
|
38
|
43
|
41
|
42
|
|
Observational Period (Wk 24 to Wk 48)
NOT COMPLETED
|
6
|
1
|
3
|
3
|
Reasons for withdrawal
| Measure |
SOC + Placebo iv Q4W
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
SOC + DZP 6mg/kg iv Q4W
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6 milligrams (mg)/kilogram (kg) intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
SOC + DZP 24mg/kg iv Q4W
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
SOC + DZP 45mg/kg iv Q4W
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
|---|---|---|---|---|
|
Double-Blind Period (Week 1 to Week 24)
Adverse Event
|
1
|
0
|
0
|
0
|
|
Double-Blind Period (Week 1 to Week 24)
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
|
Double-Blind Period (Week 1 to Week 24)
Consent withdrawal after Week 24
|
0
|
1
|
0
|
0
|
|
Observational Period (Wk 24 to Wk 48)
Lost to Follow-up
|
2
|
0
|
1
|
1
|
|
Observational Period (Wk 24 to Wk 48)
Withdrawal by Subject
|
4
|
0
|
2
|
2
|
|
Observational Period (Wk 24 to Wk 48)
Patient moved out of state
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
SOC + Placebo iv Q4W
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
SOC + DZP 6mg/kg iv Q4W
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6 milligrams (mg)/kilogram (kg) intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
SOC + DZP 24mg/kg iv Q4W
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
SOC + DZP 45mg/kg iv Q4W
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period.
|
Total Title
n=182 Participants
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
178 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Age, Continuous
|
43.50 years
STANDARD_DEVIATION 12.79 • n=93 Participants
|
40.81 years
STANDARD_DEVIATION 11.55 • n=4 Participants
|
42.77 years
STANDARD_DEVIATION 10.42 • n=27 Participants
|
38.94 years
STANDARD_DEVIATION 12.92 • n=483 Participants
|
41.48 years
STANDARD_DEVIATION 12.01 • n=36 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
166 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
113 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
50 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The Full Analysis Set (FAS) consisted of all participants in the Randomized Set with the exception of 1 study participant who received less than 1 full dose during the study and 5 study participants who were randomized at Site 321. Missing values were imputed using a modified non-responder imputation (mNRI).
The primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using Multiple Comparison Procedure - Modelling (MCP-Mod). Four candidate dose-response models were evaluated: a linear model, a logistic model, and 2 Emax models, and the MCP-Mod methodology controlled for multiplicity. BICLA response was defined as meeting all of the following criteria: 1. BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. 2. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. 3. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as \< 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). 4. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=43 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=43 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=44 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=46 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Percentage of Participants With British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-Based Composite Lupus Assessment (BICLA) (mNRI) Response Across 3 Doses of Dapirolizumab Pegol (DZP) and Placebo (PBO) at Week 24
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: The Full Analysis Set (FAS) consisted of all participants in the Randomized Set with the exception of 1 study participant who received less than 1 full dose during the study and 5 study participants who were randomized at Site 321. Missing values were imputed using a modified non-responder imputation (mNRI).
BICLA response was defined as meeting all of the following criteria: 1. BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. 2. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. 3. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as \< 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). 4. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=43 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=43 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=44 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=46 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24
|
37.2 percentage of participants
|
48.8 percentage of participants
|
54.5 percentage of participants
|
52.2 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) until end of the study (Week 48)Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.
An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Events (AEs)
|
66.7 percentage of participants
|
66.7 percentage of participants
|
82.2 percentage of participants
|
74.5 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) until end of the study (Week 48)Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.
A Serious Adverse Event (SAE) must have met 1 or more of the following criteria: * Death * Life threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect (including that occurring in a fetus) * Important medical event that, based upon appropriate medical judgment, may have jeopardized the study participant, and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious * Initial inpatient hospitalization or prolongation of hospitalization.
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Percentage of Participants With a Serious Adverse Event (SAE)
|
13.3 percentage of participants
|
11.1 percentage of participants
|
13.3 percentage of participants
|
10.6 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) until end of the study (Week 48)Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.
Adverse events of interest (AEOI) were identified by the Investigator based on definitions per protocol, documented on the electronic Case Report Form (eCRF), adequately monitored, and source controlled. AEOI (regardless of seriousness): * Moderate to severe infections, including opportunistic infections and tuberculosis (TB) * Infusion reactions (including hypersensitivity and anaphylaxis) * Thromboembolic events (including but not limited to cardiovascular events, stroke, myocardial infarction, pulmonary embolism, and deep vein thrombosis) * Prespecified neurological events: severe and/or serious headache, positional headache, cranial nerve dysfunction, or signs and symptoms of meningitis (photophobia, neck stiffness) * Malignancies.
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Events (AEs) of Interest
|
24.4 percentage of participants
|
26.7 percentage of participants
|
28.9 percentage of participants
|
25.5 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) until end of the study (Week 48)Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.
An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)
|
8.9 percentage of participants
|
0 percentage of participants
|
4.4 percentage of participants
|
4.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Blood pressure was measured in millimetre of mercury (mmHg).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 8
|
0.5 mmHg
Standard Deviation 12.4
|
3.3 mmHg
Standard Deviation 12.6
|
-2.4 mmHg
Standard Deviation 9.9
|
-0.7 mmHg
Standard Deviation 11.9
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 12
|
-0.7 mmHg
Standard Deviation 10.1
|
3.2 mmHg
Standard Deviation 10.5
|
-3.0 mmHg
Standard Deviation 11.8
|
0.8 mmHg
Standard Deviation 9.2
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 2
|
3.3 mmHg
Standard Deviation 12.9
|
5.1 mmHg
Standard Deviation 10.5
|
0.7 mmHg
Standard Deviation 10.7
|
3.2 mmHg
Standard Deviation 9.9
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 4
|
0.6 mmHg
Standard Deviation 10.8
|
1.0 mmHg
Standard Deviation 7.9
|
-2.0 mmHg
Standard Deviation 8.9
|
0.6 mmHg
Standard Deviation 12.4
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 6
|
0.3 mmHg
Standard Deviation 11.5
|
4.0 mmHg
Standard Deviation 9.9
|
2.3 mmHg
Standard Deviation 11.0
|
2.4 mmHg
Standard Deviation 10.6
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 16
|
2.1 mmHg
Standard Deviation 12.3
|
2.1 mmHg
Standard Deviation 11.6
|
-2.8 mmHg
Standard Deviation 10.6
|
0.9 mmHg
Standard Deviation 11.1
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 20
|
1.6 mmHg
Standard Deviation 9.9
|
2.6 mmHg
Standard Deviation 9.8
|
-1.7 mmHg
Standard Deviation 12.3
|
1.5 mmHg
Standard Deviation 11.3
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 24
|
-0.7 mmHg
Standard Deviation 14.3
|
1.1 mmHg
Standard Deviation 13.1
|
0.3 mmHg
Standard Deviation 11.0
|
3.6 mmHg
Standard Deviation 9.3
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 28
|
1.8 mmHg
Standard Deviation 12.3
|
3.7 mmHg
Standard Deviation 13.1
|
0.9 mmHg
Standard Deviation 10.5
|
2.5 mmHg
Standard Deviation 11.8
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 32
|
2.2 mmHg
Standard Deviation 11.1
|
3.0 mmHg
Standard Deviation 13.2
|
0.4 mmHg
Standard Deviation 11.3
|
4.3 mmHg
Standard Deviation 13.7
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 36
|
2.1 mmHg
Standard Deviation 11.0
|
3.1 mmHg
Standard Deviation 12.6
|
0.2 mmHg
Standard Deviation 10.5
|
2.4 mmHg
Standard Deviation 12.9
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 40
|
-1.0 mmHg
Standard Deviation 14.1
|
6.2 mmHg
Standard Deviation 12.9
|
-2.0 mmHg
Standard Deviation 11.7
|
2.5 mmHg
Standard Deviation 11.3
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 44
|
0.1 mmHg
Standard Deviation 12.6
|
3.3 mmHg
Standard Deviation 14.1
|
1.3 mmHg
Standard Deviation 10.4
|
4.2 mmHg
Standard Deviation 11.8
|
|
Mean Change From Baseline in Systolic Blood Pressure
Week 48
|
-1.5 mmHg
Standard Deviation 11.5
|
4.9 mmHg
Standard Deviation 14.3
|
0.1 mmHg
Standard Deviation 10.2
|
4.4 mmHg
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Blood pressure was measured in millimetre of mercury (mmHg).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 16
|
-0.3 mmHg
Standard Deviation 8.9
|
-1.3 mmHg
Standard Deviation 7.6
|
-0.7 mmHg
Standard Deviation 9.5
|
-0.1 mmHg
Standard Deviation 7.0
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 20
|
1.5 mmHg
Standard Deviation 8.1
|
-1.1 mmHg
Standard Deviation 8.7
|
-0.7 mmHg
Standard Deviation 9.6
|
0.9 mmHg
Standard Deviation 8.8
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 28
|
1.5 mmHg
Standard Deviation 9.1
|
-0.2 mmHg
Standard Deviation 8.8
|
1.4 mmHg
Standard Deviation 8.4
|
2.5 mmHg
Standard Deviation 8.4
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 32
|
2.3 mmHg
Standard Deviation 10.1
|
2.8 mmHg
Standard Deviation 9.3
|
0.7 mmHg
Standard Deviation 10.2
|
2.3 mmHg
Standard Deviation 8.1
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 2
|
2.1 mmHg
Standard Deviation 10.5
|
1.4 mmHg
Standard Deviation 8.6
|
1.5 mmHg
Standard Deviation 9.3
|
2.4 mmHg
Standard Deviation 8.2
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 4
|
-0.7 mmHg
Standard Deviation 7.8
|
-1.5 mmHg
Standard Deviation 6.3
|
-1.7 mmHg
Standard Deviation 8.2
|
-0.1 mmHg
Standard Deviation 8.3
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 6
|
1.0 mmHg
Standard Deviation 10.0
|
1.5 mmHg
Standard Deviation 8.6
|
1.8 mmHg
Standard Deviation 10.0
|
1.9 mmHg
Standard Deviation 7.9
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 8
|
1.1 mmHg
Standard Deviation 9.2
|
0.4 mmHg
Standard Deviation 9.1
|
0.1 mmHg
Standard Deviation 8.6
|
1.0 mmHg
Standard Deviation 8.0
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 12
|
-0.9 mmHg
Standard Deviation 8.4
|
-0.3 mmHg
Standard Deviation 6.9
|
-2.2 mmHg
Standard Deviation 9.6
|
-0.3 mmHg
Standard Deviation 6.9
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 24
|
1.9 mmHg
Standard Deviation 11.2
|
1.6 mmHg
Standard Deviation 8.7
|
2.3 mmHg
Standard Deviation 10.7
|
0.6 mmHg
Standard Deviation 8.7
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 36
|
3.4 mmHg
Standard Deviation 9.8
|
1.4 mmHg
Standard Deviation 10.2
|
1.4 mmHg
Standard Deviation 8.4
|
2.2 mmHg
Standard Deviation 8.0
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 40
|
1.0 mmHg
Standard Deviation 9.2
|
2.6 mmHg
Standard Deviation 7.6
|
0.5 mmHg
Standard Deviation 9.9
|
3.6 mmHg
Standard Deviation 8.8
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 44
|
0.8 mmHg
Standard Deviation 10.2
|
1.5 mmHg
Standard Deviation 8.1
|
0.4 mmHg
Standard Deviation 9.4
|
2.2 mmHg
Standard Deviation 10.3
|
|
Mean Change From Baseline in Diastolic Blood Pressure
Week 48
|
1.4 mmHg
Standard Deviation 9.0
|
2.3 mmHg
Standard Deviation 8.8
|
1.1 mmHg
Standard Deviation 9.4
|
2.4 mmHg
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Pulse Rate was measured in beats per minute (beats/min).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Pulse Rate
Week 2
|
-0.2 beats/min
Standard Deviation 8.3
|
0.2 beats/min
Standard Deviation 10.4
|
2.3 beats/min
Standard Deviation 9.7
|
-0.9 beats/min
Standard Deviation 10.4
|
|
Mean Change From Baseline in Pulse Rate
Week 4
|
1.7 beats/min
Standard Deviation 9.6
|
1.5 beats/min
Standard Deviation 8.0
|
0.4 beats/min
Standard Deviation 8.4
|
-3.3 beats/min
Standard Deviation 9.7
|
|
Mean Change From Baseline in Pulse Rate
Week 6
|
-0.7 beats/min
Standard Deviation 10.2
|
0.1 beats/min
Standard Deviation 8.5
|
0.8 beats/min
Standard Deviation 8.9
|
-0.6 beats/min
Standard Deviation 8.8
|
|
Mean Change From Baseline in Pulse Rate
Week 8
|
1.3 beats/min
Standard Deviation 9.0
|
0.3 beats/min
Standard Deviation 9.2
|
1.4 beats/min
Standard Deviation 10.2
|
-2.6 beats/min
Standard Deviation 10.2
|
|
Mean Change From Baseline in Pulse Rate
Week 12
|
0.6 beats/min
Standard Deviation 10.3
|
1.1 beats/min
Standard Deviation 9.8
|
-0.3 beats/min
Standard Deviation 10.4
|
-1.5 beats/min
Standard Deviation 9.7
|
|
Mean Change From Baseline in Pulse Rate
Week 16
|
-0.8 beats/min
Standard Deviation 9.2
|
0.3 beats/min
Standard Deviation 8.9
|
0.9 beats/min
Standard Deviation 10.7
|
-1.6 beats/min
Standard Deviation 10.6
|
|
Mean Change From Baseline in Pulse Rate
Week 20
|
0.3 beats/min
Standard Deviation 10.6
|
1.1 beats/min
Standard Deviation 9.9
|
0.8 beats/min
Standard Deviation 9.5
|
0.4 beats/min
Standard Deviation 6.6
|
|
Mean Change From Baseline in Pulse Rate
Week 24
|
-1.5 beats/min
Standard Deviation 10.7
|
0.8 beats/min
Standard Deviation 10.9
|
-0.3 beats/min
Standard Deviation 10.2
|
-1.0 beats/min
Standard Deviation 8.7
|
|
Mean Change From Baseline in Pulse Rate
Week 28
|
0.6 beats/min
Standard Deviation 11.8
|
1.3 beats/min
Standard Deviation 10.9
|
0.0 beats/min
Standard Deviation 9.2
|
0.6 beats/min
Standard Deviation 8.8
|
|
Mean Change From Baseline in Pulse Rate
Week 32
|
0.4 beats/min
Standard Deviation 9.8
|
1.3 beats/min
Standard Deviation 10.9
|
0.8 beats/min
Standard Deviation 11.4
|
-2.1 beats/min
Standard Deviation 11.0
|
|
Mean Change From Baseline in Pulse Rate
Week 36
|
-0.7 beats/min
Standard Deviation 10.9
|
0.2 beats/min
Standard Deviation 8.3
|
0.7 beats/min
Standard Deviation 10.4
|
-0.2 beats/min
Standard Deviation 9.8
|
|
Mean Change From Baseline in Pulse Rate
Week 40
|
-0.1 beats/min
Standard Deviation 10.9
|
-0.1 beats/min
Standard Deviation 9.8
|
0.6 beats/min
Standard Deviation 10.2
|
-1.3 beats/min
Standard Deviation 9.6
|
|
Mean Change From Baseline in Pulse Rate
Week 44
|
-0.2 beats/min
Standard Deviation 10.2
|
-0.1 beats/min
Standard Deviation 9.8
|
0.3 beats/min
Standard Deviation 11.7
|
-0.6 beats/min
Standard Deviation 8.9
|
|
Mean Change From Baseline in Pulse Rate
Week 48
|
-0.2 beats/min
Standard Deviation 11.1
|
-0.7 beats/min
Standard Deviation 10.6
|
-0.9 beats/min
Standard Deviation 11.9
|
-2.0 beats/min
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Temperature was measured in Grad Celsius (°C).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Temperature
Week 2
|
-0.1 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.3
|
0.1 Temperature (C)
Standard Deviation 0.5
|
0.0 Temperature (C)
Standard Deviation 0.4
|
|
Mean Change From Baseline in Temperature
Week 4
|
-0.1 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.3
|
|
Mean Change From Baseline in Temperature
Week 6
|
-0.2 Temperature (C)
Standard Deviation 0.5
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.1 Temperature (C)
Standard Deviation 0.5
|
0.0 Temperature (C)
Standard Deviation 0.5
|
|
Mean Change From Baseline in Temperature
Week 8
|
-0.1 Temperature (C)
Standard Deviation 0.4
|
-0.1 Temperature (C)
Standard Deviation 0.3
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
|
Mean Change From Baseline in Temperature
Week 12
|
-0.1 Temperature (C)
Standard Deviation 0.4
|
-0.1 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.3
|
0.0 Temperature (C)
Standard Deviation 0.4
|
|
Mean Change From Baseline in Temperature
Week 16
|
-0.1 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.3
|
|
Mean Change From Baseline in Temperature
Week 20
|
-0.1 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.5
|
|
Mean Change From Baseline in Temperature
Week 24
|
-0.1 Temperature (C)
Standard Deviation 0.5
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.1 Temperature (C)
Standard Deviation 0.5
|
0.0 Temperature (C)
Standard Deviation 0.4
|
|
Mean Change From Baseline in Temperature
Week 28
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.1 Temperature (C)
Standard Deviation 0.5
|
0.1 Temperature (C)
Standard Deviation 0.5
|
|
Mean Change From Baseline in Temperature
Week 32
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.1 Temperature (C)
Standard Deviation 0.5
|
0.0 Temperature (C)
Standard Deviation 0.4
|
|
Mean Change From Baseline in Temperature
Week 36
|
-0.1 Temperature (C)
Standard Deviation 0.3
|
0.0 Temperature (C)
Standard Deviation 0.6
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.1 Temperature (C)
Standard Deviation 0.4
|
|
Mean Change From Baseline in Temperature
Week 40
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.5
|
0.1 Temperature (C)
Standard Deviation 0.3
|
|
Mean Change From Baseline in Temperature
Week 44
|
0.0 Temperature (C)
Standard Deviation 0.6
|
0.0 Temperature (C)
Standard Deviation 0.5
|
0.1 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
|
Mean Change From Baseline in Temperature
Week 48
|
-0.1 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.4
|
0.0 Temperature (C)
Standard Deviation 0.5
|
0.0 Temperature (C)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Weight was measured in kilograms (kg).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Weight
Week 20
|
0.3 kg
Standard Deviation 2.4
|
0.7 kg
Standard Deviation 2.6
|
1.0 kg
Standard Deviation 2.6
|
0.5 kg
Standard Deviation 2.8
|
|
Mean Change From Baseline in Weight
Week 4
|
0.0 kg
Standard Deviation 1.0
|
0.2 kg
Standard Deviation 1.0
|
0.4 kg
Standard Deviation 0.9
|
0.3 kg
Standard Deviation 1.2
|
|
Mean Change From Baseline in Weight
Week 8
|
0.3 kg
Standard Deviation 1.9
|
0.6 kg
Standard Deviation 1.4
|
0.6 kg
Standard Deviation 1.8
|
0.4 kg
Standard Deviation 1.8
|
|
Mean Change From Baseline in Weight
Week 12
|
0.4 kg
Standard Deviation 2.3
|
0.5 kg
Standard Deviation 1.6
|
0.5 kg
Standard Deviation 2.0
|
0.6 kg
Standard Deviation 2.3
|
|
Mean Change From Baseline in Weight
Week 16
|
0.3 kg
Standard Deviation 2.3
|
0.7 kg
Standard Deviation 2.3
|
0.8 kg
Standard Deviation 2.3
|
0.5 kg
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.
Height was measured in centimeters (cm).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Height
|
NA cm
Standard Deviation NA
Here, 'NA' signifies that height was only measured at Screening as per planned analysis. Therefore, data was not collected for this outcome measure.
|
NA cm
Standard Deviation NA
Here, 'NA' signifies that height was only measured at Screening as per planned analysis. Therefore, data was not collected for this outcome measure.
|
NA cm
Standard Deviation NA
Here, 'NA' signifies that height was only measured at Screening as per planned analysis. Therefore, data was not collected for this outcome measure.
|
NA cm
Standard Deviation NA
Here, 'NA' signifies that height was only measured at Screening as per planned analysis. Therefore, data was not collected for this outcome measure.
|
SECONDARY outcome
Timeframe: Screening, Week 4, Week 24, Week 28 and Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug.
Twelve-lead ECG assessments should have been performed prior to dosing (if applicable) and prior to obtaining pharmacokinetic (PK) or other laboratory samples. Electrocardiograms were recorded digitally and read by the Investigator for recording in the electronic Case Report Form (eCRF).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
Screening
|
8 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
Week 4
|
11 Participants
|
12 Participants
|
7 Participants
|
10 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
Week 24
|
9 Participants
|
7 Participants
|
6 Participants
|
10 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
Week 28
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
Week 48
|
8 Participants
|
7 Participants
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Hemoglobin was measured in grams per liter (g/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Hemoglobin
Week 2
|
0.4 g/L
Standard Deviation 6.4
|
-1.8 g/L
Standard Deviation 5.8
|
-0.7 g/L
Standard Deviation 6.9
|
-0.7 g/L
Standard Deviation 6.8
|
|
Mean Change From Baseline in Hemoglobin
Week 4
|
-1.0 g/L
Standard Deviation 7.2
|
-0.7 g/L
Standard Deviation 7.7
|
-1.4 g/L
Standard Deviation 8.6
|
-0.8 g/L
Standard Deviation 5.8
|
|
Mean Change From Baseline in Hemoglobin
Week 8
|
-0.3 g/L
Standard Deviation 7.3
|
-1.9 g/L
Standard Deviation 7.9
|
-1.9 g/L
Standard Deviation 8.6
|
-1.3 g/L
Standard Deviation 7.4
|
|
Mean Change From Baseline in Hemoglobin
Week 12
|
-0.5 g/L
Standard Deviation 9.5
|
-0.5 g/L
Standard Deviation 8.5
|
-0.5 g/L
Standard Deviation 10.1
|
0.2 g/L
Standard Deviation 8.3
|
|
Mean Change From Baseline in Hemoglobin
Week 16
|
0.3 g/L
Standard Deviation 10.4
|
-0.3 g/L
Standard Deviation 10.0
|
-0.8 g/L
Standard Deviation 10.6
|
-2.7 g/L
Standard Deviation 8.3
|
|
Mean Change From Baseline in Hemoglobin
Week 20
|
-0.7 g/L
Standard Deviation 11.5
|
0.3 g/L
Standard Deviation 9.9
|
-0.5 g/L
Standard Deviation 10.1
|
-2.4 g/L
Standard Deviation 7.2
|
|
Mean Change From Baseline in Hemoglobin
Week 24
|
-0.4 g/L
Standard Deviation 9.7
|
-0.7 g/L
Standard Deviation 11.2
|
-0.7 g/L
Standard Deviation 10.5
|
-2.9 g/L
Standard Deviation 8.1
|
|
Mean Change From Baseline in Hemoglobin
Week 28
|
0.7 g/L
Standard Deviation 10.6
|
-3.4 g/L
Standard Deviation 11.0
|
0.0 g/L
Standard Deviation 14.1
|
-3.1 g/L
Standard Deviation 9.5
|
|
Mean Change From Baseline in Hemoglobin
Week 32
|
1.6 g/L
Standard Deviation 12.5
|
-1.3 g/L
Standard Deviation 9.8
|
1.0 g/L
Standard Deviation 12.5
|
-1.3 g/L
Standard Deviation 9.6
|
|
Mean Change From Baseline in Hemoglobin
Week 40
|
0.7 g/L
Standard Deviation 13.5
|
-0.3 g/L
Standard Deviation 13.5
|
1.9 g/L
Standard Deviation 14.9
|
1.1 g/L
Standard Deviation 11.0
|
|
Mean Change From Baseline in Hemoglobin
Week 48
|
-0.5 g/L
Standard Deviation 14.3
|
-1.5 g/L
Standard Deviation 11.6
|
0.9 g/L
Standard Deviation 12.5
|
-0.7 g/L
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Hematocrit
Week 4
|
-0.46 volume % of red blood cells
Standard Deviation 2.29
|
-0.17 volume % of red blood cells
Standard Deviation 2.75
|
-0.79 volume % of red blood cells
Standard Deviation 2.92
|
-0.11 volume % of red blood cells
Standard Deviation 2.31
|
|
Mean Change From Baseline in Hematocrit
Week 8
|
-0.27 volume % of red blood cells
Standard Deviation 2.23
|
-0.12 volume % of red blood cells
Standard Deviation 2.94
|
-0.86 volume % of red blood cells
Standard Deviation 2.72
|
-0.42 volume % of red blood cells
Standard Deviation 2.31
|
|
Mean Change From Baseline in Hematocrit
Week 20
|
-0.41 volume % of red blood cells
Standard Deviation 3.20
|
0.13 volume % of red blood cells
Standard Deviation 2.99
|
-0.42 volume % of red blood cells
Standard Deviation 3.32
|
-0.80 volume % of red blood cells
Standard Deviation 2.83
|
|
Mean Change From Baseline in Hematocrit
Week 24
|
-0.09 volume % of red blood cells
Standard Deviation 2.61
|
-0.40 volume % of red blood cells
Standard Deviation 3.19
|
-0.29 volume % of red blood cells
Standard Deviation 3.14
|
-0.76 volume % of red blood cells
Standard Deviation 2.33
|
|
Mean Change From Baseline in Hematocrit
Week 28
|
0.03 volume % of red blood cells
Standard Deviation 2.98
|
-1.02 volume % of red blood cells
Standard Deviation 3.23
|
-0.22 volume % of red blood cells
Standard Deviation 3.99
|
-0.89 volume % of red blood cells
Standard Deviation 2.47
|
|
Mean Change From Baseline in Hematocrit
Week 32
|
0.29 volume % of red blood cells
Standard Deviation 2.89
|
-0.62 volume % of red blood cells
Standard Deviation 2.86
|
0.17 volume % of red blood cells
Standard Deviation 3.43
|
-0.21 volume % of red blood cells
Standard Deviation 2.82
|
|
Mean Change From Baseline in Hematocrit
Week 40
|
-0.20 volume % of red blood cells
Standard Deviation 3.32
|
-0.24 volume % of red blood cells
Standard Deviation 4.37
|
0.58 volume % of red blood cells
Standard Deviation 4.11
|
0.37 volume % of red blood cells
Standard Deviation 2.72
|
|
Mean Change From Baseline in Hematocrit
Week 48
|
-0.59 volume % of red blood cells
Standard Deviation 3.51
|
-0.37 volume % of red blood cells
Standard Deviation 3.58
|
-0.08 volume % of red blood cells
Standard Deviation 3.21
|
-0.11 volume % of red blood cells
Standard Deviation 2.54
|
|
Mean Change From Baseline in Hematocrit
Week 2
|
0.42 volume % of red blood cells
Standard Deviation 2.52
|
-0.25 volume % of red blood cells
Standard Deviation 2.26
|
-0.32 volume % of red blood cells
Standard Deviation 2.37
|
0.00 volume % of red blood cells
Standard Deviation 2.71
|
|
Mean Change From Baseline in Hematocrit
Week 12
|
-0.23 volume % of red blood cells
Standard Deviation 2.67
|
-0.13 volume % of red blood cells
Standard Deviation 2.72
|
-0.32 volume % of red blood cells
Standard Deviation 3.39
|
-0.02 volume % of red blood cells
Standard Deviation 2.54
|
|
Mean Change From Baseline in Hematocrit
Week 16
|
-0.12 volume % of red blood cells
Standard Deviation 2.86
|
0.05 volume % of red blood cells
Standard Deviation 3.25
|
-0.57 volume % of red blood cells
Standard Deviation 3.32
|
-0.84 volume % of red blood cells
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Erythrocytes was measured in number of erythrocytes per liter (10\^12/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Erythrocytes
Week 2
|
-0.004 10^12 erythrocytes per liter
Standard Deviation 0.246
|
-0.035 10^12 erythrocytes per liter
Standard Deviation 0.237
|
-0.032 10^12 erythrocytes per liter
Standard Deviation 0.223
|
-0.028 10^12 erythrocytes per liter
Standard Deviation 0.237
|
|
Mean Change From Baseline in Erythrocytes
Week 4
|
-0.080 10^12 erythrocytes per liter
Standard Deviation 0.243
|
-0.018 10^12 erythrocytes per liter
Standard Deviation 0.293
|
-0.052 10^12 erythrocytes per liter
Standard Deviation 0.273
|
-0.033 10^12 erythrocytes per liter
Standard Deviation 0.210
|
|
Mean Change From Baseline in Erythrocytes
Week 8
|
-0.039 10^12 erythrocytes per liter
Standard Deviation 0.224
|
-0.039 10^12 erythrocytes per liter
Standard Deviation 0.280
|
-0.069 10^12 erythrocytes per liter
Standard Deviation 0.262
|
-0.044 10^12 erythrocytes per liter
Standard Deviation 0.242
|
|
Mean Change From Baseline in Erythrocytes
Week 12
|
-0.024 10^12 erythrocytes per liter
Standard Deviation 0.271
|
0.014 10^12 erythrocytes per liter
Standard Deviation 0.292
|
-0.010 10^12 erythrocytes per liter
Standard Deviation 0.267
|
0.019 10^12 erythrocytes per liter
Standard Deviation 0.226
|
|
Mean Change From Baseline in Erythrocytes
Week 16
|
-0.002 10^12 erythrocytes per liter
Standard Deviation 0.312
|
0.041 10^12 erythrocytes per liter
Standard Deviation 0.360
|
0.000 10^12 erythrocytes per liter
Standard Deviation 0.302
|
-0.051 10^12 erythrocytes per liter
Standard Deviation 0.265
|
|
Mean Change From Baseline in Erythrocytes
Week 20
|
-0.029 10^12 erythrocytes per liter
Standard Deviation 0.333
|
0.062 10^12 erythrocytes per liter
Standard Deviation 0.309
|
-0.001 10^12 erythrocytes per liter
Standard Deviation 0.325
|
-0.047 10^12 erythrocytes per liter
Standard Deviation 0.302
|
|
Mean Change From Baseline in Erythrocytes
Week 24
|
0.005 10^12 erythrocytes per liter
Standard Deviation 0.308
|
0.036 10^12 erythrocytes per liter
Standard Deviation 0.312
|
0.013 10^12 erythrocytes per liter
Standard Deviation 0.319
|
-0.038 10^12 erythrocytes per liter
Standard Deviation 0.240
|
|
Mean Change From Baseline in Erythrocytes
Week 28
|
0.018 10^12 erythrocytes per liter
Standard Deviation 0.340
|
-0.040 10^12 erythrocytes per liter
Standard Deviation 0.304
|
0.019 10^12 erythrocytes per liter
Standard Deviation 0.346
|
-0.050 10^12 erythrocytes per liter
Standard Deviation 0.270
|
|
Mean Change From Baseline in Erythrocytes
Week 32
|
0.048 10^12 erythrocytes per liter
Standard Deviation 0.320
|
0.001 10^12 erythrocytes per liter
Standard Deviation 0.284
|
0.032 10^12 erythrocytes per liter
Standard Deviation 0.289
|
0.027 10^12 erythrocytes per liter
Standard Deviation 0.277
|
|
Mean Change From Baseline in Erythrocytes
Week 40
|
-0.005 10^12 erythrocytes per liter
Standard Deviation 0.343
|
0.042 10^12 erythrocytes per liter
Standard Deviation 0.382
|
0.054 10^12 erythrocytes per liter
Standard Deviation 0.368
|
0.060 10^12 erythrocytes per liter
Standard Deviation 0.256
|
|
Mean Change From Baseline in Erythrocytes
Week 48
|
-0.024 10^12 erythrocytes per liter
Standard Deviation 0.332
|
-0.018 10^12 erythrocytes per liter
Standard Deviation 0.295
|
0.017 10^12 erythrocytes per liter
Standard Deviation 0.299
|
-0.028 10^12 erythrocytes per liter
Standard Deviation 0.245
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Week 16
|
-0.25 Femtolitres (fL)
Standard Deviation 3.41
|
-0.65 Femtolitres (fL)
Standard Deviation 4.38
|
-1.38 Femtolitres (fL)
Standard Deviation 4.87
|
-0.97 Femtolitres (fL)
Standard Deviation 3.62
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Week 20
|
-0.37 Femtolitres (fL)
Standard Deviation 3.73
|
-0.92 Femtolitres (fL)
Standard Deviation 4.58
|
-1.00 Femtolitres (fL)
Standard Deviation 5.01
|
-0.97 Femtolitres (fL)
Standard Deviation 3.54
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Week 24
|
-0.23 Femtolitres (fL)
Standard Deviation 3.83
|
-1.63 Femtolitres (fL)
Standard Deviation 4.07
|
-0.92 Femtolitres (fL)
Standard Deviation 6.51
|
-1.05 Femtolitres (fL)
Standard Deviation 4.00
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Week 28
|
-0.33 Femtolitres (fL)
Standard Deviation 3.61
|
-1.40 Femtolitres (fL)
Standard Deviation 4.61
|
-0.96 Femtolitres (fL)
Standard Deviation 6.46
|
-1.21 Femtolitres (fL)
Standard Deviation 4.91
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Week 32
|
-0.27 Femtolitres (fL)
Standard Deviation 4.45
|
-1.33 Femtolitres (fL)
Standard Deviation 4.32
|
-0.45 Femtolitres (fL)
Standard Deviation 6.81
|
-1.06 Femtolitres (fL)
Standard Deviation 4.69
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Week 40
|
-0.36 Femtolitres (fL)
Standard Deviation 5.34
|
-1.46 Femtolitres (fL)
Standard Deviation 4.72
|
0.07 Femtolitres (fL)
Standard Deviation 6.27
|
-0.24 Femtolitres (fL)
Standard Deviation 4.85
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Week 48
|
-0.98 Femtolitres (fL)
Standard Deviation 5.34
|
-0.50 Femtolitres (fL)
Standard Deviation 4.97
|
-0.63 Femtolitres (fL)
Standard Deviation 6.92
|
0.34 Femtolitres (fL)
Standard Deviation 4.31
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Week 2
|
1.01 Femtolitres (fL)
Standard Deviation 2.28
|
0.24 Femtolitres (fL)
Standard Deviation 2.40
|
-0.09 Femtolitres (fL)
Standard Deviation 2.66
|
0.45 Femtolitres (fL)
Standard Deviation 2.96
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Week 4
|
0.60 Femtolitres (fL)
Standard Deviation 2.35
|
0.08 Femtolitres (fL)
Standard Deviation 2.66
|
-0.68 Femtolitres (fL)
Standard Deviation 2.10
|
0.40 Femtolitres (fL)
Standard Deviation 3.02
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Week 8
|
0.23 Femtolitres (fL)
Standard Deviation 3.48
|
-0.30 Femtolitres (fL)
Standard Deviation 5.36
|
-0.54 Femtolitres (fL)
Standard Deviation 2.85
|
-0.16 Femtolitres (fL)
Standard Deviation 2.79
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Week 12
|
0.06 Femtolitres (fL)
Standard Deviation 3.57
|
-0.52 Femtolitres (fL)
Standard Deviation 3.44
|
-0.55 Femtolitres (fL)
Standard Deviation 4.67
|
-0.57 Femtolitres (fL)
Standard Deviation 3.09
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Week 8
|
1.7 g/L
Standard Deviation 11.5
|
-3.8 g/L
Standard Deviation 13.4
|
2.1 g/L
Standard Deviation 8.2
|
-0.1 g/L
Standard Deviation 11.5
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Week 12
|
0.5 g/L
Standard Deviation 11.1
|
-0.6 g/L
Standard Deviation 10.7
|
0.6 g/L
Standard Deviation 12.3
|
0.5 g/L
Standard Deviation 12.7
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Week 16
|
1.6 g/L
Standard Deviation 13.8
|
-1.5 g/L
Standard Deviation 10.1
|
2.3 g/L
Standard Deviation 11.3
|
-0.2 g/L
Standard Deviation 14.1
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Week 20
|
1.6 g/L
Standard Deviation 12.9
|
-0.9 g/L
Standard Deviation 11.3
|
2.4 g/L
Standard Deviation 11.2
|
0.4 g/L
Standard Deviation 12.6
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Week 24
|
0.0 g/L
Standard Deviation 13.7
|
1.0 g/L
Standard Deviation 13.2
|
0.4 g/L
Standard Deviation 12.8
|
-1.2 g/L
Standard Deviation 13.1
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Week 28
|
1.6 g/L
Standard Deviation 13.4
|
-1.3 g/L
Standard Deviation 14.4
|
1.7 g/L
Standard Deviation 13.8
|
-0.6 g/L
Standard Deviation 16.5
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Week 32
|
1.7 g/L
Standard Deviation 18.9
|
1.1 g/L
Standard Deviation 13.8
|
1.2 g/L
Standard Deviation 15.0
|
-1.4 g/L
Standard Deviation 16.0
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Week 40
|
3.4 g/L
Standard Deviation 17.6
|
0.8 g/L
Standard Deviation 16.5
|
0.1 g/L
Standard Deviation 15.8
|
0.1 g/L
Standard Deviation 15.4
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Week 48
|
3.6 g/L
Standard Deviation 17.1
|
-0.6 g/L
Standard Deviation 16.2
|
2.9 g/L
Standard Deviation 14.5
|
0.0 g/L
Standard Deviation 13.5
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Week 2
|
-2.3 g/L
Standard Deviation 9.8
|
-2.6 g/L
Standard Deviation 10.9
|
0.7 g/L
Standard Deviation 9.8
|
-1.9 g/L
Standard Deviation 10.1
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Week 4
|
1.4 g/L
Standard Deviation 8.7
|
-0.9 g/L
Standard Deviation 10.1
|
2.7 g/L
Standard Deviation 8.6
|
-1.2 g/L
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Week 2
|
0.12 Picograms (pg)
Standard Deviation 0.71
|
-0.18 Picograms (pg)
Standard Deviation 0.65
|
0.04 Picograms (pg)
Standard Deviation 0.43
|
0.00 Picograms (pg)
Standard Deviation 0.47
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Week 4
|
0.31 Picograms (pg)
Standard Deviation 0.63
|
-0.06 Picograms (pg)
Standard Deviation 0.79
|
0.04 Picograms (pg)
Standard Deviation 0.64
|
0.02 Picograms (pg)
Standard Deviation 0.65
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Week 8
|
0.20 Picograms (pg)
Standard Deviation 0.87
|
-0.25 Picograms (pg)
Standard Deviation 0.87
|
0.04 Picograms (pg)
Standard Deviation 0.81
|
-0.04 Picograms (pg)
Standard Deviation 0.74
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Week 12
|
0.04 Picograms (pg)
Standard Deviation 1.08
|
-0.25 Picograms (pg)
Standard Deviation 1.03
|
-0.09 Picograms (pg)
Standard Deviation 1.25
|
-0.12 Picograms (pg)
Standard Deviation 0.90
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Week 16
|
0.03 Picograms (pg)
Standard Deviation 1.43
|
-0.36 Picograms (pg)
Standard Deviation 1.31
|
-0.20 Picograms (pg)
Standard Deviation 1.52
|
-0.31 Picograms (pg)
Standard Deviation 1.19
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Week 20
|
0.00 Picograms (pg)
Standard Deviation 1.49
|
-0.39 Picograms (pg)
Standard Deviation 1.40
|
-0.10 Picograms (pg)
Standard Deviation 1.63
|
-0.26 Picograms (pg)
Standard Deviation 1.24
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Week 24
|
-0.13 Picograms (pg)
Standard Deviation 1.57
|
-0.43 Picograms (pg)
Standard Deviation 1.39
|
-0.25 Picograms (pg)
Standard Deviation 1.96
|
-0.44 Picograms (pg)
Standard Deviation 1.42
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Week 28
|
0.01 Picograms (pg)
Standard Deviation 1.68
|
-0.55 Picograms (pg)
Standard Deviation 1.45
|
-0.15 Picograms (pg)
Standard Deviation 2.09
|
-0.44 Picograms (pg)
Standard Deviation 1.68
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Week 32
|
0.01 Picograms (pg)
Standard Deviation 2.12
|
-0.33 Picograms (pg)
Standard Deviation 1.28
|
-0.06 Picograms (pg)
Standard Deviation 2.39
|
-0.48 Picograms (pg)
Standard Deviation 1.63
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Week 40
|
0.17 Picograms (pg)
Standard Deviation 2.50
|
-0.40 Picograms (pg)
Standard Deviation 1.30
|
0.03 Picograms (pg)
Standard Deviation 2.32
|
-0.09 Picograms (pg)
Standard Deviation 2.00
|
|
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Week 48
|
0.02 Picograms (pg)
Standard Deviation 2.58
|
-0.21 Picograms (pg)
Standard Deviation 1.48
|
0.06 Picograms (pg)
Standard Deviation 2.55
|
0.10 Picograms (pg)
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Leukocytes was measured in number of leukocytes per liter (10\^9/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Leukocytes
Week 2
|
0.34 10^9 leukocytes per liter
Standard Deviation 2.45
|
0.27 10^9 leukocytes per liter
Standard Deviation 1.23
|
0.49 10^9 leukocytes per liter
Standard Deviation 1.46
|
0.20 10^9 leukocytes per liter
Standard Deviation 1.62
|
|
Mean Change From Baseline in Leukocytes
Week 4
|
0.10 10^9 leukocytes per liter
Standard Deviation 1.88
|
0.27 10^9 leukocytes per liter
Standard Deviation 1.63
|
0.25 10^9 leukocytes per liter
Standard Deviation 1.47
|
0.52 10^9 leukocytes per liter
Standard Deviation 2.11
|
|
Mean Change From Baseline in Leukocytes
Week 8
|
-0.25 10^9 leukocytes per liter
Standard Deviation 2.12
|
0.46 10^9 leukocytes per liter
Standard Deviation 1.41
|
-0.05 10^9 leukocytes per liter
Standard Deviation 1.50
|
-0.10 10^9 leukocytes per liter
Standard Deviation 1.65
|
|
Mean Change From Baseline in Leukocytes
Week 12
|
-0.27 10^9 leukocytes per liter
Standard Deviation 1.80
|
0.18 10^9 leukocytes per liter
Standard Deviation 1.73
|
0.17 10^9 leukocytes per liter
Standard Deviation 2.00
|
0.23 10^9 leukocytes per liter
Standard Deviation 2.01
|
|
Mean Change From Baseline in Leukocytes
Week 16
|
-0.31 10^9 leukocytes per liter
Standard Deviation 2.18
|
0.13 10^9 leukocytes per liter
Standard Deviation 1.55
|
0.21 10^9 leukocytes per liter
Standard Deviation 1.69
|
-0.20 10^9 leukocytes per liter
Standard Deviation 2.12
|
|
Mean Change From Baseline in Leukocytes
Week 20
|
-0.24 10^9 leukocytes per liter
Standard Deviation 2.27
|
-0.06 10^9 leukocytes per liter
Standard Deviation 1.59
|
-0.22 10^9 leukocytes per liter
Standard Deviation 1.74
|
0.30 10^9 leukocytes per liter
Standard Deviation 2.61
|
|
Mean Change From Baseline in Leukocytes
Week 24
|
-0.22 10^9 leukocytes per liter
Standard Deviation 2.41
|
-0.12 10^9 leukocytes per liter
Standard Deviation 1.83
|
-0.14 10^9 leukocytes per liter
Standard Deviation 1.75
|
-0.34 10^9 leukocytes per liter
Standard Deviation 1.97
|
|
Mean Change From Baseline in Leukocytes
Week 28
|
0.05 10^9 leukocytes per liter
Standard Deviation 2.04
|
0.06 10^9 leukocytes per liter
Standard Deviation 1.93
|
0.26 10^9 leukocytes per liter
Standard Deviation 2.04
|
-0.58 10^9 leukocytes per liter
Standard Deviation 1.70
|
|
Mean Change From Baseline in Leukocytes
Week 32
|
-0.14 10^9 leukocytes per liter
Standard Deviation 2.20
|
0.08 10^9 leukocytes per liter
Standard Deviation 1.64
|
0.19 10^9 leukocytes per liter
Standard Deviation 1.67
|
-0.44 10^9 leukocytes per liter
Standard Deviation 1.68
|
|
Mean Change From Baseline in Leukocytes
Week 40
|
0.17 10^9 leukocytes per liter
Standard Deviation 2.54
|
0.04 10^9 leukocytes per liter
Standard Deviation 1.60
|
-0.35 10^9 leukocytes per liter
Standard Deviation 1.49
|
-0.49 10^9 leukocytes per liter
Standard Deviation 1.96
|
|
Mean Change From Baseline in Leukocytes
Week 48
|
-0.49 10^9 leukocytes per liter
Standard Deviation 1.83
|
0.30 10^9 leukocytes per liter
Standard Deviation 1.53
|
-0.14 10^9 leukocytes per liter
Standard Deviation 2.06
|
-0.62 10^9 leukocytes per liter
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Basophils was measured in number of basophils per liter (10\^9/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Basophils
Week 2
|
0.01 10^9 basophils per liter
Standard Deviation 0.03
|
0.02 10^9 basophils per liter
Standard Deviation 0.04
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.02
|
|
Mean Change From Baseline in Basophils
Week 4
|
0.01 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
0.01 10^9 basophils per liter
Standard Deviation 0.04
|
0.00 10^9 basophils per liter
Standard Deviation 0.02
|
|
Mean Change From Baseline in Basophils
Week 8
|
0.01 10^9 basophils per liter
Standard Deviation 0.04
|
0.01 10^9 basophils per liter
Standard Deviation 0.04
|
0.01 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.02
|
|
Mean Change From Baseline in Basophils
Week 12
|
0.01 10^9 basophils per liter
Standard Deviation 0.03
|
0.01 10^9 basophils per liter
Standard Deviation 0.04
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
|
Mean Change From Baseline in Basophils
Week 16
|
0.01 10^9 basophils per liter
Standard Deviation 0.04
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
0.01 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
|
Mean Change From Baseline in Basophils
Week 20
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
0.01 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
|
Mean Change From Baseline in Basophils
Week 24
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
0.02 10^9 basophils per liter
Standard Deviation 0.04
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
|
Mean Change From Baseline in Basophils
Week 28
|
0.02 10^9 basophils per liter
Standard Deviation 0.05
|
0.01 10^9 basophils per liter
Standard Deviation 0.04
|
0.00 10^9 basophils per liter
Standard Deviation 0.02
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
|
Mean Change From Baseline in Basophils
Week 32
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.02
|
0.01 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
|
Mean Change From Baseline in Basophils
Week 40
|
0.00 10^9 basophils per liter
Standard Deviation 0.02
|
0.00 10^9 basophils per liter
Standard Deviation 0.02
|
0.01 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
|
Mean Change From Baseline in Basophils
Week 48
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
0.00 10^9 basophils per liter
Standard Deviation 0.02
|
0.00 10^9 basophils per liter
Standard Deviation 0.03
|
0.01 10^9 basophils per liter
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Basophils/Leukocytes was measured in percentages (%).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Basophils/Leukocytes
Week 2
|
-0.05 % of Basophils per Leukocytes
Standard Deviation 0.23
|
0.02 % of Basophils per Leukocytes
Standard Deviation 0.20
|
-0.05 % of Basophils per Leukocytes
Standard Deviation 0.31
|
-0.03 % of Basophils per Leukocytes
Standard Deviation 0.27
|
|
Mean Change From Baseline in Basophils/Leukocytes
Week 4
|
0.03 % of Basophils per Leukocytes
Standard Deviation 0.27
|
-0.06 % of Basophils per Leukocytes
Standard Deviation 0.26
|
-0.01 % of Basophils per Leukocytes
Standard Deviation 0.43
|
-0.07 % of Basophils per Leukocytes
Standard Deviation 0.26
|
|
Mean Change From Baseline in Basophils/Leukocytes
Week 8
|
0.08 % of Basophils per Leukocytes
Standard Deviation 0.42
|
0.03 % of Basophils per Leukocytes
Standard Deviation 0.32
|
0.00 % of Basophils per Leukocytes
Standard Deviation 0.33
|
-0.06 % of Basophils per Leukocytes
Standard Deviation 0.23
|
|
Mean Change From Baseline in Basophils/Leukocytes
Week 12
|
0.04 % of Basophils per Leukocytes
Standard Deviation 0.30
|
0.09 % of Basophils per Leukocytes
Standard Deviation 0.48
|
0.00 % of Basophils per Leukocytes
Standard Deviation 0.25
|
-0.07 % of Basophils per Leukocytes
Standard Deviation 0.28
|
|
Mean Change From Baseline in Basophils/Leukocytes
Week 16
|
0.01 % of Basophils per Leukocytes
Standard Deviation 0.25
|
0.00 % of Basophils per Leukocytes
Standard Deviation 0.28
|
-0.02 % of Basophils per Leukocytes
Standard Deviation 0.31
|
-0.05 % of Basophils per Leukocytes
Standard Deviation 0.30
|
|
Mean Change From Baseline in Basophils/Leukocytes
Week 20
|
-0.02 % of Basophils per Leukocytes
Standard Deviation 0.26
|
0.00 % of Basophils per Leukocytes
Standard Deviation 0.27
|
-0.07 % of Basophils per Leukocytes
Standard Deviation 0.29
|
-0.04 % of Basophils per Leukocytes
Standard Deviation 0.32
|
|
Mean Change From Baseline in Basophils/Leukocytes
Week 24
|
-0.04 % of Basophils per Leukocytes
Standard Deviation 0.31
|
0.15 % of Basophils per Leukocytes
Standard Deviation 0.44
|
-0.03 % of Basophils per Leukocytes
Standard Deviation 0.24
|
-0.03 % of Basophils per Leukocytes
Standard Deviation 0.21
|
|
Mean Change From Baseline in Basophils/Leukocytes
Week 28
|
0.08 % of Basophils per Leukocytes
Standard Deviation 0.54
|
0.03 % of Basophils per Leukocytes
Standard Deviation 0.29
|
0.00 % of Basophils per Leukocytes
Standard Deviation 0.24
|
0.07 % of Basophils per Leukocytes
Standard Deviation 0.32
|
|
Mean Change From Baseline in Basophils/Leukocytes
Week 32
|
-0.03 % of Basophils per Leukocytes
Standard Deviation 0.29
|
0.00 % of Basophils per Leukocytes
Standard Deviation 0.23
|
0.01 % of Basophils per Leukocytes
Standard Deviation 0.25
|
0.01 % of Basophils per Leukocytes
Standard Deviation 0.25
|
|
Mean Change From Baseline in Basophils/Leukocytes
Week 40
|
-0.08 % of Basophils per Leukocytes
Standard Deviation 0.24
|
-0.03 % of Basophils per Leukocytes
Standard Deviation 0.25
|
0.07 % of Basophils per Leukocytes
Standard Deviation 0.29
|
0.01 % of Basophils per Leukocytes
Standard Deviation 0.29
|
|
Mean Change From Baseline in Basophils/Leukocytes
Week 48
|
-0.01 % of Basophils per Leukocytes
Standard Deviation 0.29
|
-0.08 % of Basophils per Leukocytes
Standard Deviation 0.21
|
0.02 % of Basophils per Leukocytes
Standard Deviation 0.25
|
0.06 % of Basophils per Leukocytes
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Eosinophils was measured in number of eosinophils per liter (10\^9/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Eosinophils
Week 2
|
-0.01 10^9 eosinophils per liter
Standard Deviation 0.04
|
0.01 10^9 eosinophils per liter
Standard Deviation 0.06
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.09
|
-0.01 10^9 eosinophils per liter
Standard Deviation 0.05
|
|
Mean Change From Baseline in Eosinophils
Week 4
|
-0.01 10^9 eosinophils per liter
Standard Deviation 0.04
|
-0.01 10^9 eosinophils per liter
Standard Deviation 0.06
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.04
|
-0.01 10^9 eosinophils per liter
Standard Deviation 0.04
|
|
Mean Change From Baseline in Eosinophils
Week 8
|
-0.01 10^9 eosinophils per liter
Standard Deviation 0.04
|
0.03 10^9 eosinophils per liter
Standard Deviation 0.16
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.04
|
0.01 10^9 eosinophils per liter
Standard Deviation 0.07
|
|
Mean Change From Baseline in Eosinophils
Week 12
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.04
|
0.04 10^9 eosinophils per liter
Standard Deviation 0.20
|
0.02 10^9 eosinophils per liter
Standard Deviation 0.10
|
0.02 10^9 eosinophils per liter
Standard Deviation 0.17
|
|
Mean Change From Baseline in Eosinophils
Week 16
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.05
|
0.02 10^9 eosinophils per liter
Standard Deviation 0.11
|
0.01 10^9 eosinophils per liter
Standard Deviation 0.05
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.06
|
|
Mean Change From Baseline in Eosinophils
Week 20
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.05
|
0.04 10^9 eosinophils per liter
Standard Deviation 0.24
|
0.01 10^9 eosinophils per liter
Standard Deviation 0.05
|
-0.01 10^9 eosinophils per liter
Standard Deviation 0.05
|
|
Mean Change From Baseline in Eosinophils
Week 24
|
-0.01 10^9 eosinophils per liter
Standard Deviation 0.05
|
0.04 10^9 eosinophils per liter
Standard Deviation 0.15
|
0.02 10^9 eosinophils per liter
Standard Deviation 0.07
|
-0.02 10^9 eosinophils per liter
Standard Deviation 0.06
|
|
Mean Change From Baseline in Eosinophils
Week 28
|
-0.01 10^9 eosinophils per liter
Standard Deviation 0.04
|
0.01 10^9 eosinophils per liter
Standard Deviation 0.07
|
0.01 10^9 eosinophils per liter
Standard Deviation 0.05
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.06
|
|
Mean Change From Baseline in Eosinophils
Week 32
|
-0.01 10^9 eosinophils per liter
Standard Deviation 0.06
|
0.01 10^9 eosinophils per liter
Standard Deviation 0.10
|
0.01 10^9 eosinophils per liter
Standard Deviation 0.05
|
-0.02 10^9 eosinophils per liter
Standard Deviation 0.04
|
|
Mean Change From Baseline in Eosinophils
Week 40
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.05
|
0.01 10^9 eosinophils per liter
Standard Deviation 0.06
|
0.02 10^9 eosinophils per liter
Standard Deviation 0.06
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.07
|
|
Mean Change From Baseline in Eosinophils
Week 48
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.04
|
-0.01 10^9 eosinophils per liter
Standard Deviation 0.05
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.06
|
0.00 10^9 eosinophils per liter
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Eosinophils/Leukocytes was measured in percentages (%).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Eosinophils/Leukocytes
Week 2
|
-0.19 % of Eosinophils per Leukocytes
Standard Deviation 1.07
|
0.07 % of Eosinophils per Leukocytes
Standard Deviation 0.86
|
-0.18 % of Eosinophils per Leukocytes
Standard Deviation 1.13
|
-0.29 % of Eosinophils per Leukocytes
Standard Deviation 1.22
|
|
Mean Change From Baseline in Eosinophils/Leukocytes
Week 4
|
-0.32 % of Eosinophils per Leukocytes
Standard Deviation 0.96
|
-0.05 % of Eosinophils per Leukocytes
Standard Deviation 1.26
|
-0.12 % of Eosinophils per Leukocytes
Standard Deviation 1.01
|
-0.26 % of Eosinophils per Leukocytes
Standard Deviation 0.94
|
|
Mean Change From Baseline in Eosinophils/Leukocytes
Week 8
|
-0.05 % of Eosinophils per Leukocytes
Standard Deviation 1.09
|
0.54 % of Eosinophils per Leukocytes
Standard Deviation 2.13
|
0.10 % of Eosinophils per Leukocytes
Standard Deviation 1.11
|
0.22 % of Eosinophils per Leukocytes
Standard Deviation 1.89
|
|
Mean Change From Baseline in Eosinophils/Leukocytes
Week 12
|
0.18 % of Eosinophils per Leukocytes
Standard Deviation 1.03
|
0.70 % of Eosinophils per Leukocytes
Standard Deviation 3.12
|
0.33 % of Eosinophils per Leukocytes
Standard Deviation 1.68
|
0.05 % of Eosinophils per Leukocytes
Standard Deviation 1.83
|
|
Mean Change From Baseline in Eosinophils/Leukocytes
Week 16
|
0.06 % of Eosinophils per Leukocytes
Standard Deviation 1.05
|
0.36 % of Eosinophils per Leukocytes
Standard Deviation 1.24
|
0.20 % of Eosinophils per Leukocytes
Standard Deviation 1.40
|
-0.11 % of Eosinophils per Leukocytes
Standard Deviation 1.33
|
|
Mean Change From Baseline in Eosinophils/Leukocytes
Week 20
|
0.04 % of Eosinophils per Leukocytes
Standard Deviation 1.11
|
0.83 % of Eosinophils per Leukocytes
Standard Deviation 3.58
|
0.11 % of Eosinophils per Leukocytes
Standard Deviation 1.24
|
-0.39 % of Eosinophils per Leukocytes
Standard Deviation 1.29
|
|
Mean Change From Baseline in Eosinophils/Leukocytes
Week 24
|
0.11 % of Eosinophils per Leukocytes
Standard Deviation 1.16
|
0.82 % of Eosinophils per Leukocytes
Standard Deviation 2.89
|
-0.01 % of Eosinophils per Leukocytes
Standard Deviation 1.22
|
0.06 % of Eosinophils per Leukocytes
Standard Deviation 1.63
|
|
Mean Change From Baseline in Eosinophils/Leukocytes
Week 28
|
0.06 % of Eosinophils per Leukocytes
Standard Deviation 1.00
|
0.21 % of Eosinophils per Leukocytes
Standard Deviation 1.33
|
0.18 % of Eosinophils per Leukocytes
Standard Deviation 1.02
|
-0.03 % of Eosinophils per Leukocytes
Standard Deviation 1.35
|
|
Mean Change From Baseline in Eosinophils/Leukocytes
Week 32
|
0.02 % of Eosinophils per Leukocytes
Standard Deviation 1.09
|
0.28 % of Eosinophils per Leukocytes
Standard Deviation 1.60
|
0.16 % of Eosinophils per Leukocytes
Standard Deviation 1.13
|
-0.20 % of Eosinophils per Leukocytes
Standard Deviation 1.03
|
|
Mean Change From Baseline in Eosinophils/Leukocytes
Week 40
|
-0.10 % of Eosinophils per Leukocytes
Standard Deviation 0.85
|
0.05 % of Eosinophils per Leukocytes
Standard Deviation 1.09
|
0.40 % of Eosinophils per Leukocytes
Standard Deviation 1.23
|
-0.09 % of Eosinophils per Leukocytes
Standard Deviation 1.47
|
|
Mean Change From Baseline in Eosinophils/Leukocytes
Week 48
|
0.09 % of Eosinophils per Leukocytes
Standard Deviation 1.02
|
-0.17 % of Eosinophils per Leukocytes
Standard Deviation 1.08
|
0.06 % of Eosinophils per Leukocytes
Standard Deviation 0.90
|
0.24 % of Eosinophils per Leukocytes
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Lymphocytes was measured in number of lymphocytes per liter (10\^9/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Lymphocytes
Week 2
|
-0.03 10^9 lymphocytes per liter
Standard Deviation 0.39
|
0.05 10^9 lymphocytes per liter
Standard Deviation 0.36
|
0.16 10^9 lymphocytes per liter
Standard Deviation 0.29
|
0.24 10^9 lymphocytes per liter
Standard Deviation 0.37
|
|
Mean Change From Baseline in Lymphocytes
Week 4
|
-0.04 10^9 lymphocytes per liter
Standard Deviation 0.36
|
-0.01 10^9 lymphocytes per liter
Standard Deviation 0.47
|
-0.01 10^9 lymphocytes per liter
Standard Deviation 0.41
|
0.23 10^9 lymphocytes per liter
Standard Deviation 0.42
|
|
Mean Change From Baseline in Lymphocytes
Week 8
|
-0.15 10^9 lymphocytes per liter
Standard Deviation 0.48
|
-0.03 10^9 lymphocytes per liter
Standard Deviation 0.39
|
0.06 10^9 lymphocytes per liter
Standard Deviation 0.46
|
0.14 10^9 lymphocytes per liter
Standard Deviation 0.50
|
|
Mean Change From Baseline in Lymphocytes
Week 12
|
-0.06 10^9 lymphocytes per liter
Standard Deviation 0.43
|
0.02 10^9 lymphocytes per liter
Standard Deviation 0.59
|
0.01 10^9 lymphocytes per liter
Standard Deviation 0.42
|
0.21 10^9 lymphocytes per liter
Standard Deviation 0.51
|
|
Mean Change From Baseline in Lymphocytes
Week 16
|
-0.09 10^9 lymphocytes per liter
Standard Deviation 0.52
|
-0.11 10^9 lymphocytes per liter
Standard Deviation 0.51
|
-0.02 10^9 lymphocytes per liter
Standard Deviation 0.47
|
0.04 10^9 lymphocytes per liter
Standard Deviation 0.40
|
|
Mean Change From Baseline in Lymphocytes
Week 20
|
-0.14 10^9 lymphocytes per liter
Standard Deviation 0.56
|
-0.13 10^9 lymphocytes per liter
Standard Deviation 0.54
|
0.02 10^9 lymphocytes per liter
Standard Deviation 0.39
|
0.13 10^9 lymphocytes per liter
Standard Deviation 0.55
|
|
Mean Change From Baseline in Lymphocytes
Week 24
|
-0.11 10^9 lymphocytes per liter
Standard Deviation 0.51
|
-0.08 10^9 lymphocytes per liter
Standard Deviation 0.60
|
-0.03 10^9 lymphocytes per liter
Standard Deviation 0.45
|
0.05 10^9 lymphocytes per liter
Standard Deviation 0.52
|
|
Mean Change From Baseline in Lymphocytes
Week 28
|
-0.04 10^9 lymphocytes per liter
Standard Deviation 0.57
|
-0.02 10^9 lymphocytes per liter
Standard Deviation 0.59
|
0.01 10^9 lymphocytes per liter
Standard Deviation 0.53
|
0.03 10^9 lymphocytes per liter
Standard Deviation 0.56
|
|
Mean Change From Baseline in Lymphocytes
Week 32
|
-0.11 10^9 lymphocytes per liter
Standard Deviation 0.57
|
-0.16 10^9 lymphocytes per liter
Standard Deviation 0.59
|
0.05 10^9 lymphocytes per liter
Standard Deviation 0.45
|
-0.02 10^9 lymphocytes per liter
Standard Deviation 0.44
|
|
Mean Change From Baseline in Lymphocytes
Week 40
|
-0.11 10^9 lymphocytes per liter
Standard Deviation 0.54
|
-0.11 10^9 lymphocytes per liter
Standard Deviation 0.52
|
-0.11 10^9 lymphocytes per liter
Standard Deviation 0.43
|
-0.03 10^9 lymphocytes per liter
Standard Deviation 0.48
|
|
Mean Change From Baseline in Lymphocytes
Week 48
|
-0.19 10^9 lymphocytes per liter
Standard Deviation 0.68
|
-0.19 10^9 lymphocytes per liter
Standard Deviation 0.60
|
-0.10 10^9 lymphocytes per liter
Standard Deviation 0.44
|
-0.02 10^9 lymphocytes per liter
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Lymphocytes/Leukocytes was measured in percentages (%).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Lymphocytes/Leukocytes
Week 2
|
-1.88 % of Lymphocytes per Leukocytes
Standard Deviation 9.01
|
0.19 % of Lymphocytes per Leukocytes
Standard Deviation 6.55
|
1.18 % of Lymphocytes per Leukocytes
Standard Deviation 6.09
|
2.61 % of Lymphocytes per Leukocytes
Standard Deviation 6.11
|
|
Mean Change From Baseline in Lymphocytes/Leukocytes
Week 4
|
-0.88 % of Lymphocytes per Leukocytes
Standard Deviation 7.09
|
-1.02 % of Lymphocytes per Leukocytes
Standard Deviation 6.34
|
-1.18 % of Lymphocytes per Leukocytes
Standard Deviation 9.93
|
0.97 % of Lymphocytes per Leukocytes
Standard Deviation 8.00
|
|
Mean Change From Baseline in Lymphocytes/Leukocytes
Week 8
|
-1.98 % of Lymphocytes per Leukocytes
Standard Deviation 10.59
|
-1.40 % of Lymphocytes per Leukocytes
Standard Deviation 7.13
|
0.56 % of Lymphocytes per Leukocytes
Standard Deviation 10.20
|
1.97 % of Lymphocytes per Leukocytes
Standard Deviation 8.51
|
|
Mean Change From Baseline in Lymphocytes/Leukocytes
Week 12
|
0.21 % of Lymphocytes per Leukocytes
Standard Deviation 7.87
|
0.56 % of Lymphocytes per Leukocytes
Standard Deviation 10.58
|
-0.44 % of Lymphocytes per Leukocytes
Standard Deviation 9.90
|
2.46 % of Lymphocytes per Leukocytes
Standard Deviation 10.18
|
|
Mean Change From Baseline in Lymphocytes/Leukocytes
Week 16
|
-0.91 % of Lymphocytes per Leukocytes
Standard Deviation 8.33
|
-1.49 % of Lymphocytes per Leukocytes
Standard Deviation 7.50
|
-1.18 % of Lymphocytes per Leukocytes
Standard Deviation 9.65
|
0.12 % of Lymphocytes per Leukocytes
Standard Deviation 9.34
|
|
Mean Change From Baseline in Lymphocytes/Leukocytes
Week 20
|
-1.97 % of Lymphocytes per Leukocytes
Standard Deviation 10.37
|
-0.66 % of Lymphocytes per Leukocytes
Standard Deviation 6.58
|
0.88 % of Lymphocytes per Leukocytes
Standard Deviation 10.69
|
0.71 % of Lymphocytes per Leukocytes
Standard Deviation 10.32
|
|
Mean Change From Baseline in Lymphocytes/Leukocytes
Week 24
|
-0.75 % of Lymphocytes per Leukocytes
Standard Deviation 8.69
|
-0.56 % of Lymphocytes per Leukocytes
Standard Deviation 7.35
|
-0.52 % of Lymphocytes per Leukocytes
Standard Deviation 10.55
|
1.85 % of Lymphocytes per Leukocytes
Standard Deviation 9.67
|
|
Mean Change From Baseline in Lymphocytes/Leukocytes
Week 28
|
-1.18 % of Lymphocytes per Leukocytes
Standard Deviation 8.27
|
-0.05 % of Lymphocytes per Leukocytes
Standard Deviation 8.51
|
-0.05 % of Lymphocytes per Leukocytes
Standard Deviation 9.97
|
1.61 % of Lymphocytes per Leukocytes
Standard Deviation 10.55
|
|
Mean Change From Baseline in Lymphocytes/Leukocytes
Week 32
|
-1.59 % of Lymphocytes per Leukocytes
Standard Deviation 7.69
|
-2.56 % of Lymphocytes per Leukocytes
Standard Deviation 6.51
|
-0.16 % of Lymphocytes per Leukocytes
Standard Deviation 7.70
|
0.70 % of Lymphocytes per Leukocytes
Standard Deviation 8.74
|
|
Mean Change From Baseline in Lymphocytes/Leukocytes
Week 40
|
-2.60 % of Lymphocytes per Leukocytes
Standard Deviation 9.18
|
-2.02 % of Lymphocytes per Leukocytes
Standard Deviation 5.99
|
-1.36 % of Lymphocytes per Leukocytes
Standard Deviation 10.12
|
0.33 % of Lymphocytes per Leukocytes
Standard Deviation 8.41
|
|
Mean Change From Baseline in Lymphocytes/Leukocytes
Week 48
|
-1.46 % of Lymphocytes per Leukocytes
Standard Deviation 11.29
|
-3.71 % of Lymphocytes per Leukocytes
Standard Deviation 7.41
|
-0.84 % of Lymphocytes per Leukocytes
Standard Deviation 9.42
|
1.69 % of Lymphocytes per Leukocytes
Standard Deviation 10.05
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Monocytes was measured in number of monocytes per liter (10\^9/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Monocytes
Week 2
|
-0.01 10^9 monocytes per liter
Standard Deviation 0.17
|
0.01 10^9 monocytes per liter
Standard Deviation 0.18
|
0.05 10^9 monocytes per liter
Standard Deviation 0.14
|
0.01 10^9 monocytes per liter
Standard Deviation 0.13
|
|
Mean Change From Baseline in Monocytes
Week 4
|
0.01 10^9 monocytes per liter
Standard Deviation 0.18
|
0.04 10^9 monocytes per liter
Standard Deviation 0.18
|
0.01 10^9 monocytes per liter
Standard Deviation 0.14
|
0.06 10^9 monocytes per liter
Standard Deviation 0.19
|
|
Mean Change From Baseline in Monocytes
Week 8
|
-0.03 10^9 monocytes per liter
Standard Deviation 0.18
|
0.04 10^9 monocytes per liter
Standard Deviation 0.18
|
0.03 10^9 monocytes per liter
Standard Deviation 0.16
|
0.02 10^9 monocytes per liter
Standard Deviation 0.17
|
|
Mean Change From Baseline in Monocytes
Week 12
|
-0.01 10^9 monocytes per liter
Standard Deviation 0.19
|
0.00 10^9 monocytes per liter
Standard Deviation 0.14
|
0.04 10^9 monocytes per liter
Standard Deviation 0.18
|
0.06 10^9 monocytes per liter
Standard Deviation 0.15
|
|
Mean Change From Baseline in Monocytes
Week 16
|
-0.01 10^9 monocytes per liter
Standard Deviation 0.17
|
0.01 10^9 monocytes per liter
Standard Deviation 0.17
|
0.05 10^9 monocytes per liter
Standard Deviation 0.18
|
0.03 10^9 monocytes per liter
Standard Deviation 0.14
|
|
Mean Change From Baseline in Monocytes
Week 20
|
-0.03 10^9 monocytes per liter
Standard Deviation 0.19
|
0.00 10^9 monocytes per liter
Standard Deviation 0.16
|
0.00 10^9 monocytes per liter
Standard Deviation 0.13
|
0.05 10^9 monocytes per liter
Standard Deviation 0.19
|
|
Mean Change From Baseline in Monocytes
Week 24
|
0.00 10^9 monocytes per liter
Standard Deviation 0.19
|
0.04 10^9 monocytes per liter
Standard Deviation 0.19
|
0.03 10^9 monocytes per liter
Standard Deviation 0.17
|
0.00 10^9 monocytes per liter
Standard Deviation 0.17
|
|
Mean Change From Baseline in Monocytes
Week 28
|
0.00 10^9 monocytes per liter
Standard Deviation 0.20
|
0.04 10^9 monocytes per liter
Standard Deviation 0.21
|
0.08 10^9 monocytes per liter
Standard Deviation 0.19
|
0.02 10^9 monocytes per liter
Standard Deviation 0.17
|
|
Mean Change From Baseline in Monocytes
Week 32
|
-0.01 10^9 monocytes per liter
Standard Deviation 0.18
|
0.02 10^9 monocytes per liter
Standard Deviation 0.19
|
0.05 10^9 monocytes per liter
Standard Deviation 0.23
|
-0.01 10^9 monocytes per liter
Standard Deviation 0.19
|
|
Mean Change From Baseline in Monocytes
Week 40
|
0.03 10^9 monocytes per liter
Standard Deviation 0.17
|
0.05 10^9 monocytes per liter
Standard Deviation 0.16
|
0.04 10^9 monocytes per liter
Standard Deviation 0.16
|
-0.01 10^9 monocytes per liter
Standard Deviation 0.18
|
|
Mean Change From Baseline in Monocytes
Week 48
|
-0.02 10^9 monocytes per liter
Standard Deviation 0.20
|
-0.01 10^9 monocytes per liter
Standard Deviation 0.13
|
0.03 10^9 monocytes per liter
Standard Deviation 0.15
|
-0.02 10^9 monocytes per liter
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Monocytes/Leukocytes was measured in percentages (%).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Monocytes/Leukocytes
Week 2
|
-0.87 % of Monocytes per Leukocytes
Standard Deviation 2.50
|
-0.07 % of Monocytes per Leukocytes
Standard Deviation 2.46
|
0.23 % of Monocytes per Leukocytes
Standard Deviation 3.03
|
-0.37 % of Monocytes per Leukocytes
Standard Deviation 2.25
|
|
Mean Change From Baseline in Monocytes/Leukocytes
Week 4
|
0.26 % of Monocytes per Leukocytes
Standard Deviation 3.30
|
0.27 % of Monocytes per Leukocytes
Standard Deviation 2.41
|
-0.16 % of Monocytes per Leukocytes
Standard Deviation 3.11
|
-0.24 % of Monocytes per Leukocytes
Standard Deviation 2.82
|
|
Mean Change From Baseline in Monocytes/Leukocytes
Week 8
|
-0.21 % of Monocytes per Leukocytes
Standard Deviation 3.47
|
0.07 % of Monocytes per Leukocytes
Standard Deviation 3.61
|
0.51 % of Monocytes per Leukocytes
Standard Deviation 3.83
|
0.08 % of Monocytes per Leukocytes
Standard Deviation 3.12
|
|
Mean Change From Baseline in Monocytes/Leukocytes
Week 12
|
0.07 % of Monocytes per Leukocytes
Standard Deviation 2.79
|
-0.11 % of Monocytes per Leukocytes
Standard Deviation 2.38
|
0.22 % of Monocytes per Leukocytes
Standard Deviation 3.37
|
0.45 % of Monocytes per Leukocytes
Standard Deviation 2.74
|
|
Mean Change From Baseline in Monocytes/Leukocytes
Week 16
|
0.06 % of Monocytes per Leukocytes
Standard Deviation 3.30
|
0.59 % of Monocytes per Leukocytes
Standard Deviation 2.85
|
0.43 % of Monocytes per Leukocytes
Standard Deviation 3.31
|
0.28 % of Monocytes per Leukocytes
Standard Deviation 3.13
|
|
Mean Change From Baseline in Monocytes/Leukocytes
Week 20
|
-0.27 % of Monocytes per Leukocytes
Standard Deviation 3.84
|
0.56 % of Monocytes per Leukocytes
Standard Deviation 3.08
|
0.33 % of Monocytes per Leukocytes
Standard Deviation 3.81
|
0.43 % of Monocytes per Leukocytes
Standard Deviation 3.39
|
|
Mean Change From Baseline in Monocytes/Leukocytes
Week 24
|
0.06 % of Monocytes per Leukocytes
Standard Deviation 3.45
|
0.84 % of Monocytes per Leukocytes
Standard Deviation 2.97
|
0.46 % of Monocytes per Leukocytes
Standard Deviation 3.00
|
0.41 % of Monocytes per Leukocytes
Standard Deviation 3.24
|
|
Mean Change From Baseline in Monocytes/Leukocytes
Week 28
|
-0.24 % of Monocytes per Leukocytes
Standard Deviation 3.54
|
0.69 % of Monocytes per Leukocytes
Standard Deviation 3.24
|
0.64 % of Monocytes per Leukocytes
Standard Deviation 3.67
|
0.94 % of Monocytes per Leukocytes
Standard Deviation 3.78
|
|
Mean Change From Baseline in Monocytes/Leukocytes
Week 32
|
-0.08 % of Monocytes per Leukocytes
Standard Deviation 3.11
|
0.13 % of Monocytes per Leukocytes
Standard Deviation 2.62
|
0.46 % of Monocytes per Leukocytes
Standard Deviation 3.91
|
-0.03 % of Monocytes per Leukocytes
Standard Deviation 3.76
|
|
Mean Change From Baseline in Monocytes/Leukocytes
Week 40
|
0.49 % of Monocytes per Leukocytes
Standard Deviation 3.55
|
0.64 % of Monocytes per Leukocytes
Standard Deviation 2.92
|
0.83 % of Monocytes per Leukocytes
Standard Deviation 3.69
|
0.59 % of Monocytes per Leukocytes
Standard Deviation 3.07
|
|
Mean Change From Baseline in Monocytes/Leukocytes
Week 48
|
-0.04 % of Monocytes per Leukocytes
Standard Deviation 3.79
|
-0.13 % of Monocytes per Leukocytes
Standard Deviation 2.41
|
0.47 % of Monocytes per Leukocytes
Standard Deviation 3.82
|
0.29 % of Monocytes per Leukocytes
Standard Deviation 3.30
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Neutrophils was measured in number of neutrophils per liter (10\^9/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Neutrophils
Week 4
|
0.07 10^9 neutrophils per liter
Standard Deviation 1.82
|
0.27 10^9 neutrophils per liter
Standard Deviation 1.40
|
0.21 10^9 neutrophils per liter
Standard Deviation 1.64
|
0.23 10^9 neutrophils per liter
Standard Deviation 1.96
|
|
Mean Change From Baseline in Neutrophils
Week 8
|
-0.13 10^9 neutrophils per liter
Standard Deviation 2.20
|
0.41 10^9 neutrophils per liter
Standard Deviation 1.32
|
-0.07 10^9 neutrophils per liter
Standard Deviation 1.53
|
-0.20 10^9 neutrophils per liter
Standard Deviation 1.49
|
|
Mean Change From Baseline in Neutrophils
Week 20
|
-0.07 10^9 neutrophils per liter
Standard Deviation 2.21
|
0.01 10^9 neutrophils per liter
Standard Deviation 1.22
|
-0.39 10^9 neutrophils per liter
Standard Deviation 1.69
|
0.09 10^9 neutrophils per liter
Standard Deviation 2.51
|
|
Mean Change From Baseline in Neutrophils
Week 24
|
-0.12 10^9 neutrophils per liter
Standard Deviation 2.24
|
-0.06 10^9 neutrophils per liter
Standard Deviation 1.54
|
-0.16 10^9 neutrophils per liter
Standard Deviation 1.77
|
-0.38 10^9 neutrophils per liter
Standard Deviation 1.92
|
|
Mean Change From Baseline in Neutrophils
Week 28
|
0.04 10^9 neutrophils per liter
Standard Deviation 1.81
|
0.13 10^9 neutrophils per liter
Standard Deviation 1.64
|
0.10 10^9 neutrophils per liter
Standard Deviation 1.91
|
-0.62 10^9 neutrophils per liter
Standard Deviation 1.78
|
|
Mean Change From Baseline in Neutrophils
Week 32
|
-0.07 10^9 neutrophils per liter
Standard Deviation 1.87
|
0.33 10^9 neutrophils per liter
Standard Deviation 1.27
|
0.07 10^9 neutrophils per liter
Standard Deviation 1.54
|
-0.40 10^9 neutrophils per liter
Standard Deviation 1.67
|
|
Mean Change From Baseline in Neutrophils
Week 40
|
0.16 10^9 neutrophils per liter
Standard Deviation 2.37
|
0.16 10^9 neutrophils per liter
Standard Deviation 1.31
|
-0.32 10^9 neutrophils per liter
Standard Deviation 1.57
|
-0.41 10^9 neutrophils per liter
Standard Deviation 1.88
|
|
Mean Change From Baseline in Neutrophils
Week 48
|
-0.29 10^9 neutrophils per liter
Standard Deviation 1.58
|
0.55 10^9 neutrophils per liter
Standard Deviation 1.15
|
-0.09 10^9 neutrophils per liter
Standard Deviation 2.02
|
-0.54 10^9 neutrophils per liter
Standard Deviation 1.78
|
|
Mean Change From Baseline in Neutrophils
Week 12
|
-0.24 10^9 neutrophils per liter
Standard Deviation 1.56
|
0.20 10^9 neutrophils per liter
Standard Deviation 1.65
|
0.10 10^9 neutrophils per liter
Standard Deviation 1.94
|
-0.01 10^9 neutrophils per liter
Standard Deviation 2.03
|
|
Mean Change From Baseline in Neutrophils
Week 16
|
-0.22 10^9 neutrophils per liter
Standard Deviation 2.13
|
0.20 10^9 neutrophils per liter
Standard Deviation 1.41
|
0.15 10^9 neutrophils per liter
Standard Deviation 1.61
|
-0.20 10^9 neutrophils per liter
Standard Deviation 2.14
|
|
Mean Change From Baseline in Neutrophils
Week 2
|
0.28 10^9 neutrophils per liter
Standard Deviation 2.43
|
0.26 10^9 neutrophils per liter
Standard Deviation 1.17
|
0.17 10^9 neutrophils per liter
Standard Deviation 1.33
|
-0.01 10^9 neutrophils per liter
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Neutrophils/Leukocytes was measured in percentages (%).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Neutrophils/Leukocytes
Week 2
|
2.99 % of Neutrophils per Leukocytes
Standard Deviation 10.73
|
-0.21 % of Neutrophils per Leukocytes
Standard Deviation 7.94
|
-1.20 % of Neutrophils per Leukocytes
Standard Deviation 8.40
|
-1.93 % of Neutrophils per Leukocytes
Standard Deviation 8.18
|
|
Mean Change From Baseline in Neutrophils/Leukocytes
Week 4
|
0.91 % of Neutrophils per Leukocytes
Standard Deviation 9.37
|
0.89 % of Neutrophils per Leukocytes
Standard Deviation 7.82
|
1.47 % of Neutrophils per Leukocytes
Standard Deviation 12.70
|
-0.37 % of Neutrophils per Leukocytes
Standard Deviation 10.27
|
|
Mean Change From Baseline in Neutrophils/Leukocytes
Week 8
|
2.15 % of Neutrophils per Leukocytes
Standard Deviation 12.95
|
0.79 % of Neutrophils per Leukocytes
Standard Deviation 8.80
|
-1.17 % of Neutrophils per Leukocytes
Standard Deviation 13.28
|
-2.23 % of Neutrophils per Leukocytes
Standard Deviation 10.92
|
|
Mean Change From Baseline in Neutrophils/Leukocytes
Week 12
|
-0.52 % of Neutrophils per Leukocytes
Standard Deviation 9.44
|
-1.25 % of Neutrophils per Leukocytes
Standard Deviation 11.78
|
-0.12 % of Neutrophils per Leukocytes
Standard Deviation 13.18
|
-2.90 % of Neutrophils per Leukocytes
Standard Deviation 12.85
|
|
Mean Change From Baseline in Neutrophils/Leukocytes
Week 16
|
0.77 % of Neutrophils per Leukocytes
Standard Deviation 11.02
|
0.54 % of Neutrophils per Leukocytes
Standard Deviation 8.50
|
0.56 % of Neutrophils per Leukocytes
Standard Deviation 12.48
|
-0.24 % of Neutrophils per Leukocytes
Standard Deviation 12.23
|
|
Mean Change From Baseline in Neutrophils/Leukocytes
Week 20
|
2.22 % of Neutrophils per Leukocytes
Standard Deviation 13.21
|
-0.73 % of Neutrophils per Leukocytes
Standard Deviation 8.42
|
-1.25 % of Neutrophils per Leukocytes
Standard Deviation 14.29
|
-0.71 % of Neutrophils per Leukocytes
Standard Deviation 13.91
|
|
Mean Change From Baseline in Neutrophils/Leukocytes
Week 24
|
0.65 % of Neutrophils per Leukocytes
Standard Deviation 11.48
|
-1.25 % of Neutrophils per Leukocytes
Standard Deviation 8.74
|
0.10 % of Neutrophils per Leukocytes
Standard Deviation 13.20
|
-2.30 % of Neutrophils per Leukocytes
Standard Deviation 12.41
|
|
Mean Change From Baseline in Neutrophils/Leukocytes
Week 28
|
1.28 % of Neutrophils per Leukocytes
Standard Deviation 10.38
|
-0.88 % of Neutrophils per Leukocytes
Standard Deviation 10.56
|
-0.77 % of Neutrophils per Leukocytes
Standard Deviation 13.27
|
-2.60 % of Neutrophils per Leukocytes
Standard Deviation 13.79
|
|
Mean Change From Baseline in Neutrophils/Leukocytes
Week 32
|
1.67 % of Neutrophils per Leukocytes
Standard Deviation 9.93
|
2.15 % of Neutrophils per Leukocytes
Standard Deviation 7.42
|
-0.47 % of Neutrophils per Leukocytes
Standard Deviation 9.80
|
-0.48 % of Neutrophils per Leukocytes
Standard Deviation 12.08
|
|
Mean Change From Baseline in Neutrophils/Leukocytes
Week 40
|
2.29 % of Neutrophils per Leukocytes
Standard Deviation 11.66
|
1.36 % of Neutrophils per Leukocytes
Standard Deviation 6.95
|
0.07 % of Neutrophils per Leukocytes
Standard Deviation 13.23
|
-0.93 % of Neutrophils per Leukocytes
Standard Deviation 11.50
|
|
Mean Change From Baseline in Neutrophils/Leukocytes
Week 48
|
1.41 % of Neutrophils per Leukocytes
Standard Deviation 13.58
|
4.09 % of Neutrophils per Leukocytes
Standard Deviation 8.40
|
0.30 % of Neutrophils per Leukocytes
Standard Deviation 12.47
|
-2.28 % of Neutrophils per Leukocytes
Standard Deviation 12.38
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Platelets was measured in number of platelets per liter (10\^9/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Platelets
Week 2
|
5.9 10^9 platelets per liter
Standard Deviation 33.2
|
10.0 10^9 platelets per liter
Standard Deviation 40.0
|
1.4 10^9 platelets per liter
Standard Deviation 47.5
|
-1.0 10^9 platelets per liter
Standard Deviation 52.0
|
|
Mean Change From Baseline in Platelets
Week 4
|
-5.2 10^9 platelets per liter
Standard Deviation 51.3
|
0.0 10^9 platelets per liter
Standard Deviation 32.4
|
4.9 10^9 platelets per liter
Standard Deviation 43.8
|
8.1 10^9 platelets per liter
Standard Deviation 42.6
|
|
Mean Change From Baseline in Platelets
Week 8
|
0.2 10^9 platelets per liter
Standard Deviation 45.3
|
-0.3 10^9 platelets per liter
Standard Deviation 40.3
|
3.9 10^9 platelets per liter
Standard Deviation 52.0
|
-6.4 10^9 platelets per liter
Standard Deviation 40.5
|
|
Mean Change From Baseline in Platelets
Week 12
|
-4.3 10^9 platelets per liter
Standard Deviation 50.6
|
-1.7 10^9 platelets per liter
Standard Deviation 38.8
|
-2.7 10^9 platelets per liter
Standard Deviation 49.0
|
1.8 10^9 platelets per liter
Standard Deviation 49.4
|
|
Mean Change From Baseline in Platelets
Week 16
|
0.7 10^9 platelets per liter
Standard Deviation 57.7
|
-0.7 10^9 platelets per liter
Standard Deviation 40.5
|
-1.5 10^9 platelets per liter
Standard Deviation 66.7
|
-2.3 10^9 platelets per liter
Standard Deviation 68.1
|
|
Mean Change From Baseline in Platelets
Week 20
|
9.2 10^9 platelets per liter
Standard Deviation 57.1
|
-3.3 10^9 platelets per liter
Standard Deviation 43.0
|
0.5 10^9 platelets per liter
Standard Deviation 44.6
|
0.8 10^9 platelets per liter
Standard Deviation 64.4
|
|
Mean Change From Baseline in Platelets
Week 24
|
0.2 10^9 platelets per liter
Standard Deviation 60.2
|
-5.2 10^9 platelets per liter
Standard Deviation 43.8
|
2.4 10^9 platelets per liter
Standard Deviation 68.6
|
1.7 10^9 platelets per liter
Standard Deviation 67.0
|
|
Mean Change From Baseline in Platelets
Week 28
|
3.6 10^9 platelets per liter
Standard Deviation 64.6
|
1.8 10^9 platelets per liter
Standard Deviation 52.6
|
-5.8 10^9 platelets per liter
Standard Deviation 71.9
|
1.5 10^9 platelets per liter
Standard Deviation 64.4
|
|
Mean Change From Baseline in Platelets
Week 32
|
4.0 10^9 platelets per liter
Standard Deviation 71.8
|
-1.9 10^9 platelets per liter
Standard Deviation 55.4
|
-4.6 10^9 platelets per liter
Standard Deviation 57.5
|
9.9 10^9 platelets per liter
Standard Deviation 93.8
|
|
Mean Change From Baseline in Platelets
Week 40
|
10.3 10^9 platelets per liter
Standard Deviation 74.9
|
14.2 10^9 platelets per liter
Standard Deviation 52.7
|
-8.8 10^9 platelets per liter
Standard Deviation 63.2
|
-1.5 10^9 platelets per liter
Standard Deviation 67.4
|
|
Mean Change From Baseline in Platelets
Week 48
|
7.1 10^9 platelets per liter
Standard Deviation 67.4
|
3.5 10^9 platelets per liter
Standard Deviation 58.2
|
-9.5 10^9 platelets per liter
Standard Deviation 70.9
|
-8.8 10^9 platelets per liter
Standard Deviation 66.5
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Week 2
|
33.0 cells/µL
Standard Deviation 313.6
|
77.7 cells/µL
Standard Deviation 383.6
|
106.6 cells/µL
Standard Deviation 283.1
|
126.9 cells/µL
Standard Deviation 338.9
|
|
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Week 4
|
-30.6 cells/µL
Standard Deviation 293.5
|
-47.7 cells/µL
Standard Deviation 504.3
|
24.0 cells/µL
Standard Deviation 394.9
|
227.2 cells/µL
Standard Deviation 412.1
|
|
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Week 8
|
-64.7 cells/µL
Standard Deviation 405.7
|
-58.6 cells/µL
Standard Deviation 422.8
|
-20.5 cells/µL
Standard Deviation 403.2
|
78.3 cells/µL
Standard Deviation 560.0
|
|
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Week 12
|
-44.2 cells/µL
Standard Deviation 283.2
|
-48.8 cells/µL
Standard Deviation 452.1
|
-57.8 cells/µL
Standard Deviation 385.1
|
43.7 cells/µL
Standard Deviation 599.3
|
|
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Week 16
|
-81.9 cells/µL
Standard Deviation 479.4
|
-141.2 cells/µL
Standard Deviation 516.1
|
-4.5 cells/µL
Standard Deviation 383.2
|
-45.4 cells/µL
Standard Deviation 520.8
|
|
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Week 20
|
-92.7 cells/µL
Standard Deviation 391.1
|
-173.4 cells/µL
Standard Deviation 490.9
|
5.9 cells/µL
Standard Deviation 352.9
|
-89.9 cells/µL
Standard Deviation 577.7
|
|
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Week 24
|
-85.8 cells/µL
Standard Deviation 472.5
|
-128.9 cells/µL
Standard Deviation 569.4
|
-88.5 cells/µL
Standard Deviation 462.1
|
-78.3 cells/µL
Standard Deviation 570.7
|
|
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Week 28
|
-27.6 cells/µL
Standard Deviation 507.3
|
-81.2 cells/µL
Standard Deviation 652.7
|
46.1 cells/µL
Standard Deviation 482.2
|
7.4 cells/µL
Standard Deviation 561.2
|
|
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Week 32
|
-70.9 cells/µL
Standard Deviation 428.4
|
-173.6 cells/µL
Standard Deviation 565.8
|
18.0 cells/µL
Standard Deviation 415.0
|
-90.5 cells/µL
Standard Deviation 504.0
|
|
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Week 40
|
-110.5 cells/µL
Standard Deviation 526.4
|
-166.9 cells/µL
Standard Deviation 542.2
|
-1.8 cells/µL
Standard Deviation 410.7
|
31.7 cells/µL
Standard Deviation 528.8
|
|
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Week 48
|
-115.6 cells/µL
Standard Deviation 581.1
|
-253.1 cells/µL
Standard Deviation 637.0
|
36.1 cells/µL
Standard Deviation 492.3
|
22.3 cells/µL
Standard Deviation 558.0
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
CD3/Lymphocytes was measured in percentages (%).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in CD3/Lymphocytes
Week 2
|
-0.7 % of CD3 per Leukocytes
Standard Deviation 6.1
|
-0.9 % of CD3 per Leukocytes
Standard Deviation 4.6
|
-2.0 % of CD3 per Leukocytes
Standard Deviation 5.7
|
-0.2 % of CD3 per Leukocytes
Standard Deviation 7.8
|
|
Mean Change From Baseline in CD3/Lymphocytes
Week 4
|
-2.1 % of CD3 per Leukocytes
Standard Deviation 7.3
|
-0.5 % of CD3 per Leukocytes
Standard Deviation 6.0
|
-1.9 % of CD3 per Leukocytes
Standard Deviation 5.0
|
-0.5 % of CD3 per Leukocytes
Standard Deviation 6.8
|
|
Mean Change From Baseline in CD3/Lymphocytes
Week 8
|
-0.9 % of CD3 per Leukocytes
Standard Deviation 6.1
|
-1.2 % of CD3 per Leukocytes
Standard Deviation 4.8
|
-2.6 % of CD3 per Leukocytes
Standard Deviation 5.9
|
0.6 % of CD3 per Leukocytes
Standard Deviation 9.5
|
|
Mean Change From Baseline in CD3/Lymphocytes
Week 12
|
-0.4 % of CD3 per Leukocytes
Standard Deviation 5.6
|
-1.1 % of CD3 per Leukocytes
Standard Deviation 8.2
|
-2.4 % of CD3 per Leukocytes
Standard Deviation 6.0
|
-0.1 % of CD3 per Leukocytes
Standard Deviation 9.2
|
|
Mean Change From Baseline in CD3/Lymphocytes
Week 16
|
-1.9 % of CD3 per Leukocytes
Standard Deviation 5.8
|
-1.6 % of CD3 per Leukocytes
Standard Deviation 7.8
|
-1.9 % of CD3 per Leukocytes
Standard Deviation 7.6
|
-1.4 % of CD3 per Leukocytes
Standard Deviation 7.9
|
|
Mean Change From Baseline in CD3/Lymphocytes
Week 20
|
-0.8 % of CD3 per Leukocytes
Standard Deviation 5.0
|
0.0 % of CD3 per Leukocytes
Standard Deviation 8.6
|
-2.3 % of CD3 per Leukocytes
Standard Deviation 6.9
|
0.6 % of CD3 per Leukocytes
Standard Deviation 9.2
|
|
Mean Change From Baseline in CD3/Lymphocytes
Week 24
|
0.0 % of CD3 per Leukocytes
Standard Deviation 6.5
|
-0.1 % of CD3 per Leukocytes
Standard Deviation 8.8
|
-1.8 % of CD3 per Leukocytes
Standard Deviation 6.6
|
18.7 % of CD3 per Leukocytes
Standard Deviation 114.3
|
|
Mean Change From Baseline in CD3/Lymphocytes
Week 28
|
-0.2 % of CD3 per Leukocytes
Standard Deviation 6.9
|
0.2 % of CD3 per Leukocytes
Standard Deviation 8.3
|
-2.9 % of CD3 per Leukocytes
Standard Deviation 7.2
|
0.9 % of CD3 per Leukocytes
Standard Deviation 10.2
|
|
Mean Change From Baseline in CD3/Lymphocytes
Week 32
|
-1.3 % of CD3 per Leukocytes
Standard Deviation 7.0
|
0.2 % of CD3 per Leukocytes
Standard Deviation 7.9
|
-1.8 % of CD3 per Leukocytes
Standard Deviation 6.8
|
1.4 % of CD3 per Leukocytes
Standard Deviation 8.5
|
|
Mean Change From Baseline in CD3/Lymphocytes
Week 40
|
0.2 % of CD3 per Leukocytes
Standard Deviation 6.7
|
1.4 % of CD3 per Leukocytes
Standard Deviation 6.9
|
0.5 % of CD3 per Leukocytes
Standard Deviation 6.5
|
3.3 % of CD3 per Leukocytes
Standard Deviation 7.9
|
|
Mean Change From Baseline in CD3/Lymphocytes
Week 48
|
1.3 % of CD3 per Leukocytes
Standard Deviation 8.0
|
0.3 % of CD3 per Leukocytes
Standard Deviation 7.6
|
0.1 % of CD3 per Leukocytes
Standard Deviation 6.2
|
4.5 % of CD3 per Leukocytes
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Week 2
|
9.6 cells/µL
Standard Deviation 56.7
|
12.3 cells/µL
Standard Deviation 76.2
|
24.8 cells/µL
Standard Deviation 71.0
|
63.4 cells/µL
Standard Deviation 133.5
|
|
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Week 4
|
-2.8 cells/µL
Standard Deviation 46.3
|
-31.2 cells/µL
Standard Deviation 177.0
|
9.2 cells/µL
Standard Deviation 60.5
|
82.8 cells/µL
Standard Deviation 154.5
|
|
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Week 8
|
-13.3 cells/µL
Standard Deviation 72.9
|
-29.4 cells/µL
Standard Deviation 183.5
|
8.7 cells/µL
Standard Deviation 70.8
|
19.4 cells/µL
Standard Deviation 146.4
|
|
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Week 12
|
-2.6 cells/µL
Standard Deviation 83.4
|
-48.1 cells/µL
Standard Deviation 207.1
|
-17.9 cells/µL
Standard Deviation 77.8
|
53.2 cells/µL
Standard Deviation 203.6
|
|
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Week 16
|
-12.5 cells/µL
Standard Deviation 84.3
|
-50.1 cells/µL
Standard Deviation 201.5
|
-10.0 cells/µL
Standard Deviation 92.4
|
13.2 cells/µL
Standard Deviation 147.8
|
|
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Week 20
|
-15.1 cells/µL
Standard Deviation 86.0
|
-75.4 cells/µL
Standard Deviation 216.6
|
-2.5 cells/µL
Standard Deviation 57.1
|
2.7 cells/µL
Standard Deviation 132.6
|
|
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Week 24
|
-15.0 cells/µL
Standard Deviation 89.3
|
-77.2 cells/µL
Standard Deviation 231.9
|
-20.3 cells/µL
Standard Deviation 72.0
|
-1.1 cells/µL
Standard Deviation 135.0
|
|
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Week 28
|
-20.6 cells/µL
Standard Deviation 106.7
|
-69.6 cells/µL
Standard Deviation 206.7
|
-13.1 cells/µL
Standard Deviation 84.5
|
-13.0 cells/µL
Standard Deviation 123.2
|
|
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Week 32
|
-14.3 cells/µL
Standard Deviation 106.3
|
-75.8 cells/µL
Standard Deviation 225.7
|
-10.4 cells/µL
Standard Deviation 93.0
|
-20.9 cells/µL
Standard Deviation 168.1
|
|
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Week 40
|
-24.8 cells/µL
Standard Deviation 103.3
|
-68.6 cells/µL
Standard Deviation 211.0
|
-26.9 cells/µL
Standard Deviation 83.0
|
-46.9 cells/µL
Standard Deviation 138.0
|
|
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Week 48
|
-37.0 cells/µL
Standard Deviation 132.7
|
-82.4 cells/µL
Standard Deviation 243.7
|
-15.5 cells/µL
Standard Deviation 83.2
|
-41.2 cells/µL
Standard Deviation 120.0
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
CD19/Lymphocytes was measured in percentages (%).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in CD19/Lymphocytes
Week 4
|
0.0 % of CD19 per Leukocytes
Standard Deviation 2.9
|
-0.5 % of CD19 per Leukocytes
Standard Deviation 3.7
|
0.7 % of CD19 per Leukocytes
Standard Deviation 3.3
|
2.8 % of CD19 per Leukocytes
Standard Deviation 5.7
|
|
Mean Change From Baseline in CD19/Lymphocytes
Week 8
|
0.1 % of CD19 per Leukocytes
Standard Deviation 2.8
|
-0.5 % of CD19 per Leukocytes
Standard Deviation 4.2
|
0.7 % of CD19 per Leukocytes
Standard Deviation 2.5
|
0.4 % of CD19 per Leukocytes
Standard Deviation 6.4
|
|
Mean Change From Baseline in CD19/Lymphocytes
Week 12
|
-0.2 % of CD19 per Leukocytes
Standard Deviation 3.2
|
-1.0 % of CD19 per Leukocytes
Standard Deviation 3.9
|
-0.4 % of CD19 per Leukocytes
Standard Deviation 3.1
|
1.7 % of CD19 per Leukocytes
Standard Deviation 7.9
|
|
Mean Change From Baseline in CD19/Lymphocytes
Week 16
|
0.0 % of CD19 per Leukocytes
Standard Deviation 4.7
|
-1.2 % of CD19 per Leukocytes
Standard Deviation 5.0
|
-0.4 % of CD19 per Leukocytes
Standard Deviation 3.3
|
0.7 % of CD19 per Leukocytes
Standard Deviation 5.9
|
|
Mean Change From Baseline in CD19/Lymphocytes
Week 20
|
-0.4 % of CD19 per Leukocytes
Standard Deviation 3.8
|
-2.1 % of CD19 per Leukocytes
Standard Deviation 6.2
|
-0.3 % of CD19 per Leukocytes
Standard Deviation 3.0
|
-0.2 % of CD19 per Leukocytes
Standard Deviation 6.9
|
|
Mean Change From Baseline in CD19/Lymphocytes
Week 24
|
-0.9 % of CD19 per Leukocytes
Standard Deviation 4.5
|
-2.0 % of CD19 per Leukocytes
Standard Deviation 6.5
|
-0.6 % of CD19 per Leukocytes
Standard Deviation 3.3
|
-0.3 % of CD19 per Leukocytes
Standard Deviation 7.3
|
|
Mean Change From Baseline in CD19/Lymphocytes
Week 28
|
-1.2 % of CD19 per Leukocytes
Standard Deviation 5.4
|
-2.5 % of CD19 per Leukocytes
Standard Deviation 5.9
|
-1.1 % of CD19 per Leukocytes
Standard Deviation 3.3
|
-1.0 % of CD19 per Leukocytes
Standard Deviation 6.6
|
|
Mean Change From Baseline in CD19/Lymphocytes
Week 32
|
-0.4 % of CD19 per Leukocytes
Standard Deviation 4.7
|
-2.4 % of CD19 per Leukocytes
Standard Deviation 5.5
|
-0.6 % of CD19 per Leukocytes
Standard Deviation 4.4
|
-1.6 % of CD19 per Leukocytes
Standard Deviation 6.3
|
|
Mean Change From Baseline in CD19/Lymphocytes
Week 40
|
-1.2 % of CD19 per Leukocytes
Standard Deviation 4.7
|
-2.6 % of CD19 per Leukocytes
Standard Deviation 5.4
|
-1.9 % of CD19 per Leukocytes
Standard Deviation 4.2
|
-3.4 % of CD19 per Leukocytes
Standard Deviation 6.7
|
|
Mean Change From Baseline in CD19/Lymphocytes
Week 48
|
-1.2 % of CD19 per Leukocytes
Standard Deviation 6.8
|
-2.6 % of CD19 per Leukocytes
Standard Deviation 7.2
|
-1.6 % of CD19 per Leukocytes
Standard Deviation 4.9
|
-3.3 % of CD19 per Leukocytes
Standard Deviation 6.2
|
|
Mean Change From Baseline in CD19/Lymphocytes
Week 2
|
-0.3 % of CD19 per Leukocytes
Standard Deviation 2.1
|
-0.1 % of CD19 per Leukocytes
Standard Deviation 3.0
|
1.0 % of CD19 per Leukocytes
Standard Deviation 3.5
|
1.5 % of CD19 per Leukocytes
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Aspartate Aminotransferase was measured in units per liter (U/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Aspartate Aminotransferase
Week 2
|
-0.5 U/L
Standard Deviation 8.8
|
0.2 U/L
Standard Deviation 8.0
|
4.3 U/L
Standard Deviation 43.1
|
0.0 U/L
Standard Deviation 7.2
|
|
Mean Change From Baseline in Aspartate Aminotransferase
Week 4
|
-0.1 U/L
Standard Deviation 11.2
|
0.2 U/L
Standard Deviation 7.4
|
-1.1 U/L
Standard Deviation 7.6
|
-1.9 U/L
Standard Deviation 8.0
|
|
Mean Change From Baseline in Aspartate Aminotransferase
Week 8
|
-0.1 U/L
Standard Deviation 8.7
|
-1.5 U/L
Standard Deviation 6.2
|
0.5 U/L
Standard Deviation 13.0
|
-1.1 U/L
Standard Deviation 8.1
|
|
Mean Change From Baseline in Aspartate Aminotransferase
Week 12
|
5.1 U/L
Standard Deviation 27.0
|
0.9 U/L
Standard Deviation 6.2
|
-1.8 U/L
Standard Deviation 10.0
|
-2.9 U/L
Standard Deviation 7.1
|
|
Mean Change From Baseline in Aspartate Aminotransferase
Week 16
|
0.4 U/L
Standard Deviation 7.7
|
0.0 U/L
Standard Deviation 6.3
|
-2.3 U/L
Standard Deviation 11.6
|
-2.8 U/L
Standard Deviation 8.4
|
|
Mean Change From Baseline in Aspartate Aminotransferase
Week 20
|
4.1 U/L
Standard Deviation 24.1
|
1.0 U/L
Standard Deviation 11.5
|
-0.7 U/L
Standard Deviation 13.8
|
-3.8 U/L
Standard Deviation 8.1
|
|
Mean Change From Baseline in Aspartate Aminotransferase
Week 24
|
0.6 U/L
Standard Deviation 11.8
|
1.6 U/L
Standard Deviation 10.4
|
-1.8 U/L
Standard Deviation 11.5
|
-3.8 U/L
Standard Deviation 8.4
|
|
Mean Change From Baseline in Aspartate Aminotransferase
Week 28
|
0.0 U/L
Standard Deviation 12.3
|
0.0 U/L
Standard Deviation 10.2
|
-1.5 U/L
Standard Deviation 11.1
|
-3.4 U/L
Standard Deviation 9.1
|
|
Mean Change From Baseline in Aspartate Aminotransferase
Week 32
|
-0.3 U/L
Standard Deviation 11.0
|
0.3 U/L
Standard Deviation 6.8
|
-0.7 U/L
Standard Deviation 12.9
|
-3.4 U/L
Standard Deviation 9.2
|
|
Mean Change From Baseline in Aspartate Aminotransferase
Week 40
|
-0.6 U/L
Standard Deviation 10.2
|
0.1 U/L
Standard Deviation 9.1
|
-0.3 U/L
Standard Deviation 11.5
|
-1.5 U/L
Standard Deviation 9.8
|
|
Mean Change From Baseline in Aspartate Aminotransferase
Week 48
|
1.1 U/L
Standard Deviation 10.8
|
0.1 U/L
Standard Deviation 13.1
|
1.4 U/L
Standard Deviation 13.4
|
-2.1 U/L
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Alanine Aminotransferase was measured in units per liter (U/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Alanine Aminotransferase
Week 2
|
2.4 U/L
Standard Deviation 14.1
|
2.6 U/L
Standard Deviation 10.6
|
0.5 U/L
Standard Deviation 11.1
|
-0.1 U/L
Standard Deviation 8.6
|
|
Mean Change From Baseline in Alanine Aminotransferase
Week 4
|
0.8 U/L
Standard Deviation 9.9
|
-0.5 U/L
Standard Deviation 8.5
|
0.9 U/L
Standard Deviation 7.4
|
0.3 U/L
Standard Deviation 8.2
|
|
Mean Change From Baseline in Alanine Aminotransferase
Week 8
|
0.2 U/L
Standard Deviation 10.2
|
-0.8 U/L
Standard Deviation 8.3
|
5.3 U/L
Standard Deviation 28.8
|
-0.6 U/L
Standard Deviation 9.6
|
|
Mean Change From Baseline in Alanine Aminotransferase
Week 12
|
7.0 U/L
Standard Deviation 21.3
|
0.8 U/L
Standard Deviation 14.3
|
-0.8 U/L
Standard Deviation 8.1
|
-0.1 U/L
Standard Deviation 7.6
|
|
Mean Change From Baseline in Alanine Aminotransferase
Week 16
|
1.5 U/L
Standard Deviation 13.3
|
-0.4 U/L
Standard Deviation 9.3
|
0.0 U/L
Standard Deviation 10.3
|
-1.1 U/L
Standard Deviation 7.8
|
|
Mean Change From Baseline in Alanine Aminotransferase
Week 20
|
5.3 U/L
Standard Deviation 23.6
|
-0.2 U/L
Standard Deviation 10.2
|
1.4 U/L
Standard Deviation 10.8
|
-3.7 U/L
Standard Deviation 6.3
|
|
Mean Change From Baseline in Alanine Aminotransferase
Week 24
|
3.1 U/L
Standard Deviation 20.9
|
0.5 U/L
Standard Deviation 14.1
|
2.0 U/L
Standard Deviation 12.0
|
-2.8 U/L
Standard Deviation 7.7
|
|
Mean Change From Baseline in Alanine Aminotransferase
Week 28
|
1.0 U/L
Standard Deviation 13.9
|
0.7 U/L
Standard Deviation 10.5
|
-0.4 U/L
Standard Deviation 9.3
|
-2.7 U/L
Standard Deviation 7.2
|
|
Mean Change From Baseline in Alanine Aminotransferase
Week 32
|
1.2 U/L
Standard Deviation 13.4
|
-0.5 U/L
Standard Deviation 10.3
|
1.3 U/L
Standard Deviation 10.8
|
-3.2 U/L
Standard Deviation 6.1
|
|
Mean Change From Baseline in Alanine Aminotransferase
Week 40
|
-0.5 U/L
Standard Deviation 13.4
|
2.6 U/L
Standard Deviation 12.8
|
3.0 U/L
Standard Deviation 12.9
|
-0.7 U/L
Standard Deviation 8.3
|
|
Mean Change From Baseline in Alanine Aminotransferase
Week 48
|
0.4 U/L
Standard Deviation 11.5
|
-1.2 U/L
Standard Deviation 10.4
|
3.5 U/L
Standard Deviation 17.0
|
-1.1 U/L
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Alkaline Phosphatase was measured in units per liter (U/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Alkaline Phosphatase
Week 2
|
1.8 U/L
Standard Deviation 10.7
|
2.4 U/L
Standard Deviation 10.6
|
1.5 U/L
Standard Deviation 8.0
|
-3.6 U/L
Standard Deviation 10.1
|
|
Mean Change From Baseline in Alkaline Phosphatase
Week 4
|
-1.7 U/L
Standard Deviation 9.7
|
0.7 U/L
Standard Deviation 9.2
|
-0.7 U/L
Standard Deviation 8.4
|
-4.7 U/L
Standard Deviation 9.4
|
|
Mean Change From Baseline in Alkaline Phosphatase
Week 8
|
1.7 U/L
Standard Deviation 12.9
|
2.4 U/L
Standard Deviation 12.7
|
1.8 U/L
Standard Deviation 15.6
|
-6.1 U/L
Standard Deviation 11.0
|
|
Mean Change From Baseline in Alkaline Phosphatase
Week 12
|
2.2 U/L
Standard Deviation 11.6
|
4.2 U/L
Standard Deviation 16.4
|
1.9 U/L
Standard Deviation 12.9
|
-4.4 U/L
Standard Deviation 11.8
|
|
Mean Change From Baseline in Alkaline Phosphatase
Week 16
|
3.1 U/L
Standard Deviation 10.7
|
2.7 U/L
Standard Deviation 13.0
|
0.0 U/L
Standard Deviation 10.4
|
-6.7 U/L
Standard Deviation 12.8
|
|
Mean Change From Baseline in Alkaline Phosphatase
Week 20
|
3.9 U/L
Standard Deviation 14.0
|
1.4 U/L
Standard Deviation 11.8
|
1.4 U/L
Standard Deviation 11.8
|
-7.4 U/L
Standard Deviation 11.2
|
|
Mean Change From Baseline in Alkaline Phosphatase
Week 24
|
4.7 U/L
Standard Deviation 15.0
|
3.7 U/L
Standard Deviation 14.0
|
2.8 U/L
Standard Deviation 11.6
|
-2.7 U/L
Standard Deviation 14.0
|
|
Mean Change From Baseline in Alkaline Phosphatase
Week 28
|
2.8 U/L
Standard Deviation 14.0
|
3.1 U/L
Standard Deviation 14.2
|
1.9 U/L
Standard Deviation 9.5
|
-2.1 U/L
Standard Deviation 13.5
|
|
Mean Change From Baseline in Alkaline Phosphatase
Week 32
|
3.8 U/L
Standard Deviation 14.6
|
2.7 U/L
Standard Deviation 16.0
|
3.2 U/L
Standard Deviation 12.1
|
1.0 U/L
Standard Deviation 15.9
|
|
Mean Change From Baseline in Alkaline Phosphatase
Week 40
|
2.4 U/L
Standard Deviation 17.1
|
1.3 U/L
Standard Deviation 13.1
|
2.7 U/L
Standard Deviation 13.0
|
-3.0 U/L
Standard Deviation 18.0
|
|
Mean Change From Baseline in Alkaline Phosphatase
Week 48
|
2.6 U/L
Standard Deviation 13.3
|
4.0 U/L
Standard Deviation 16.8
|
5.5 U/L
Standard Deviation 12.8
|
-4.5 U/L
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Gamma Glutamyl Transferase was measured in units per liter (U/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Gamma Glutamyl Transferase
Week 2
|
0.3 U/L
Standard Deviation 7.6
|
2.0 U/L
Standard Deviation 11.5
|
8.8 U/L
Standard Deviation 68.9
|
-3.4 U/L
Standard Deviation 24.3
|
|
Mean Change From Baseline in Gamma Glutamyl Transferase
Week 4
|
2.1 U/L
Standard Deviation 8.7
|
-1.3 U/L
Standard Deviation 8.8
|
2.7 U/L
Standard Deviation 28.5
|
-6.5 U/L
Standard Deviation 35.5
|
|
Mean Change From Baseline in Gamma Glutamyl Transferase
Week 8
|
3.5 U/L
Standard Deviation 23.0
|
0.3 U/L
Standard Deviation 10.5
|
-2.8 U/L
Standard Deviation 49.3
|
-9.2 U/L
Standard Deviation 43.3
|
|
Mean Change From Baseline in Gamma Glutamyl Transferase
Week 12
|
4.1 U/L
Standard Deviation 21.0
|
0.5 U/L
Standard Deviation 13.4
|
-5.1 U/L
Standard Deviation 29.3
|
-8.3 U/L
Standard Deviation 46.1
|
|
Mean Change From Baseline in Gamma Glutamyl Transferase
Week 16
|
6.5 U/L
Standard Deviation 20.2
|
2.1 U/L
Standard Deviation 12.5
|
-6.1 U/L
Standard Deviation 45.0
|
-10.6 U/L
Standard Deviation 47.7
|
|
Mean Change From Baseline in Gamma Glutamyl Transferase
Week 20
|
3.5 U/L
Standard Deviation 14.1
|
0.2 U/L
Standard Deviation 13.4
|
-3.7 U/L
Standard Deviation 50.3
|
-8.5 U/L
Standard Deviation 50.5
|
|
Mean Change From Baseline in Gamma Glutamyl Transferase
Week 24
|
7.1 U/L
Standard Deviation 22.0
|
4.0 U/L
Standard Deviation 18.7
|
-0.4 U/L
Standard Deviation 53.1
|
-9.5 U/L
Standard Deviation 47.2
|
|
Mean Change From Baseline in Gamma Glutamyl Transferase
Week 28
|
4.6 U/L
Standard Deviation 25.7
|
2.2 U/L
Standard Deviation 18.3
|
-7.0 U/L
Standard Deviation 46.8
|
0.0 U/L
Standard Deviation 23.1
|
|
Mean Change From Baseline in Gamma Glutamyl Transferase
Week 32
|
4.4 U/L
Standard Deviation 28.6
|
1.5 U/L
Standard Deviation 16.7
|
-5.9 U/L
Standard Deviation 44.5
|
-8.2 U/L
Standard Deviation 37.4
|
|
Mean Change From Baseline in Gamma Glutamyl Transferase
Week 40
|
3.4 U/L
Standard Deviation 41.3
|
5.7 U/L
Standard Deviation 32.4
|
0.4 U/L
Standard Deviation 10.1
|
-9.1 U/L
Standard Deviation 45.3
|
|
Mean Change From Baseline in Gamma Glutamyl Transferase
Week 48
|
1.8 U/L
Standard Deviation 11.4
|
5.3 U/L
Standard Deviation 23.9
|
4.7 U/L
Standard Deviation 21.6
|
-9.8 U/L
Standard Deviation 44.5
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Bilirubin was measured in micromols per liter (µmol/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Bilirubin
Week 2
|
0.35 μmol/L
Standard Deviation 2.72
|
-0.48 μmol/L
Standard Deviation 2.71
|
0.28 μmol/L
Standard Deviation 2.38
|
-0.78 μmol/L
Standard Deviation 3.13
|
|
Mean Change From Baseline in Bilirubin
Week 4
|
0.07 μmol/L
Standard Deviation 2.50
|
-0.18 μmol/L
Standard Deviation 2.09
|
-0.05 μmol/L
Standard Deviation 2.14
|
-0.79 μmol/L
Standard Deviation 2.80
|
|
Mean Change From Baseline in Bilirubin
Week 8
|
-0.09 μmol/L
Standard Deviation 2.66
|
-0.69 μmol/L
Standard Deviation 2.22
|
-0.19 μmol/L
Standard Deviation 2.13
|
-0.23 μmol/L
Standard Deviation 2.80
|
|
Mean Change From Baseline in Bilirubin
Week 12
|
-0.04 μmol/L
Standard Deviation 2.60
|
-0.70 μmol/L
Standard Deviation 2.74
|
0.37 μmol/L
Standard Deviation 2.17
|
-0.33 μmol/L
Standard Deviation 3.28
|
|
Mean Change From Baseline in Bilirubin
Week 16
|
0.06 μmol/L
Standard Deviation 2.41
|
-0.45 μmol/L
Standard Deviation 2.43
|
-0.20 μmol/L
Standard Deviation 2.71
|
-0.51 μmol/L
Standard Deviation 3.64
|
|
Mean Change From Baseline in Bilirubin
Week 20
|
-0.54 μmol/L
Standard Deviation 2.89
|
-0.38 μmol/L
Standard Deviation 2.51
|
0.51 μmol/L
Standard Deviation 2.81
|
-0.30 μmol/L
Standard Deviation 3.03
|
|
Mean Change From Baseline in Bilirubin
Week 24
|
0.08 μmol/L
Standard Deviation 2.75
|
-0.14 μmol/L
Standard Deviation 2.86
|
0.54 μmol/L
Standard Deviation 2.18
|
-0.38 μmol/L
Standard Deviation 3.57
|
|
Mean Change From Baseline in Bilirubin
Week 28
|
-0.10 μmol/L
Standard Deviation 2.98
|
-0.26 μmol/L
Standard Deviation 3.23
|
0.79 μmol/L
Standard Deviation 2.71
|
-0.82 μmol/L
Standard Deviation 2.61
|
|
Mean Change From Baseline in Bilirubin
Week 32
|
0.09 μmol/L
Standard Deviation 2.75
|
-0.38 μmol/L
Standard Deviation 2.61
|
0.93 μmol/L
Standard Deviation 3.18
|
-0.38 μmol/L
Standard Deviation 3.61
|
|
Mean Change From Baseline in Bilirubin
Week 40
|
-0.26 μmol/L
Standard Deviation 3.70
|
0.07 μmol/L
Standard Deviation 3.18
|
1.03 μmol/L
Standard Deviation 2.35
|
-0.15 μmol/L
Standard Deviation 2.64
|
|
Mean Change From Baseline in Bilirubin
Week 48
|
0.69 μmol/L
Standard Deviation 3.57
|
-0.50 μmol/L
Standard Deviation 3.12
|
0.79 μmol/L
Standard Deviation 3.04
|
-0.20 μmol/L
Standard Deviation 2.52
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Direct Bilirubin was measured in micromols per liter (µmol/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Direct Bilirubin
Week 2
|
0.03 μmol/L
Standard Deviation 0.92
|
-0.06 μmol/L
Standard Deviation 0.92
|
0.09 μmol/L
Standard Deviation 1.12
|
-0.24 μmol/L
Standard Deviation 1.10
|
|
Mean Change From Baseline in Direct Bilirubin
Week 4
|
0.10 μmol/L
Standard Deviation 1.03
|
0.03 μmol/L
Standard Deviation 0.75
|
-0.04 μmol/L
Standard Deviation 0.82
|
-0.10 μmol/L
Standard Deviation 0.93
|
|
Mean Change From Baseline in Direct Bilirubin
Week 8
|
0.03 μmol/L
Standard Deviation 0.91
|
-0.18 μmol/L
Standard Deviation 0.55
|
-0.17 μmol/L
Standard Deviation 0.86
|
0.03 μmol/L
Standard Deviation 1.10
|
|
Mean Change From Baseline in Direct Bilirubin
Week 12
|
0.15 μmol/L
Standard Deviation 0.99
|
-0.07 μmol/L
Standard Deviation 0.95
|
-0.01 μmol/L
Standard Deviation 1.06
|
-0.05 μmol/L
Standard Deviation 1.30
|
|
Mean Change From Baseline in Direct Bilirubin
Week 16
|
0.18 μmol/L
Standard Deviation 0.81
|
-0.01 μmol/L
Standard Deviation 0.66
|
-0.07 μmol/L
Standard Deviation 1.04
|
-0.01 μmol/L
Standard Deviation 1.40
|
|
Mean Change From Baseline in Direct Bilirubin
Week 20
|
-0.04 μmol/L
Standard Deviation 0.95
|
0.07 μmol/L
Standard Deviation 0.91
|
0.02 μmol/L
Standard Deviation 0.94
|
0.00 μmol/L
Standard Deviation 1.19
|
|
Mean Change From Baseline in Direct Bilirubin
Week 24
|
0.05 μmol/L
Standard Deviation 1.10
|
0.14 μmol/L
Standard Deviation 0.95
|
0.08 μmol/L
Standard Deviation 1.02
|
-0.08 μmol/L
Standard Deviation 1.25
|
|
Mean Change From Baseline in Direct Bilirubin
Week 28
|
0.06 μmol/L
Standard Deviation 1.06
|
-0.06 μmol/L
Standard Deviation 1.00
|
0.11 μmol/L
Standard Deviation 0.80
|
-0.06 μmol/L
Standard Deviation 1.15
|
|
Mean Change From Baseline in Direct Bilirubin
Week 32
|
0.12 μmol/L
Standard Deviation 1.16
|
0.05 μmol/L
Standard Deviation 0.90
|
0.21 μmol/L
Standard Deviation 1.21
|
-0.04 μmol/L
Standard Deviation 1.36
|
|
Mean Change From Baseline in Direct Bilirubin
Week 40
|
0.07 μmol/L
Standard Deviation 1.31
|
0.03 μmol/L
Standard Deviation 0.76
|
0.23 μmol/L
Standard Deviation 1.00
|
0.07 μmol/L
Standard Deviation 1.05
|
|
Mean Change From Baseline in Direct Bilirubin
Week 48
|
0.31 μmol/L
Standard Deviation 1.34
|
-0.05 μmol/L
Standard Deviation 1.01
|
0.20 μmol/L
Standard Deviation 1.25
|
0.08 μmol/L
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Lactate Dehydrogenase was measured in units per liter (U/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Lactate Dehydrogenase
Week 2
|
-3.3 U/L
Standard Deviation 27.8
|
-7.8 U/L
Standard Deviation 21.2
|
-5.9 U/L
Standard Deviation 35.2
|
-12.8 U/L
Standard Deviation 24.8
|
|
Mean Change From Baseline in Lactate Dehydrogenase
Week 4
|
-3.0 U/L
Standard Deviation 23.4
|
-3.7 U/L
Standard Deviation 37.0
|
-5.6 U/L
Standard Deviation 35.6
|
-18.5 U/L
Standard Deviation 34.1
|
|
Mean Change From Baseline in Lactate Dehydrogenase
Week 8
|
-5.7 U/L
Standard Deviation 27.4
|
-11.8 U/L
Standard Deviation 31.5
|
-9.2 U/L
Standard Deviation 39.0
|
-20.4 U/L
Standard Deviation 37.4
|
|
Mean Change From Baseline in Lactate Dehydrogenase
Week 12
|
3.0 U/L
Standard Deviation 28.7
|
-7.4 U/L
Standard Deviation 34.6
|
-11.1 U/L
Standard Deviation 45.1
|
-24.4 U/L
Standard Deviation 39.0
|
|
Mean Change From Baseline in Lactate Dehydrogenase
Week 16
|
-2.2 U/L
Standard Deviation 25.5
|
-11.1 U/L
Standard Deviation 29.9
|
-10.6 U/L
Standard Deviation 48.6
|
-22.4 U/L
Standard Deviation 43.3
|
|
Mean Change From Baseline in Lactate Dehydrogenase
Week 20
|
-0.7 U/L
Standard Deviation 33.9
|
-10.8 U/L
Standard Deviation 37.0
|
-9.9 U/L
Standard Deviation 47.8
|
-28.5 U/L
Standard Deviation 32.1
|
|
Mean Change From Baseline in Lactate Dehydrogenase
Week 24
|
-4.5 U/L
Standard Deviation 31.3
|
-14.3 U/L
Standard Deviation 31.5
|
-14.6 U/L
Standard Deviation 34.4
|
-29.3 U/L
Standard Deviation 32.2
|
|
Mean Change From Baseline in Lactate Dehydrogenase
Week 28
|
0.0 U/L
Standard Deviation 40.8
|
-16.0 U/L
Standard Deviation 40.9
|
-13.2 U/L
Standard Deviation 35.0
|
-34.8 U/L
Standard Deviation 36.9
|
|
Mean Change From Baseline in Lactate Dehydrogenase
Week 32
|
5.0 U/L
Standard Deviation 55.0
|
-9.9 U/L
Standard Deviation 43.4
|
-8.1 U/L
Standard Deviation 33.5
|
-22.9 U/L
Standard Deviation 40.6
|
|
Mean Change From Baseline in Lactate Dehydrogenase
Week 40
|
-1.6 U/L
Standard Deviation 38.1
|
-2.9 U/L
Standard Deviation 41.1
|
-8.0 U/L
Standard Deviation 28.4
|
-20.5 U/L
Standard Deviation 40.1
|
|
Mean Change From Baseline in Lactate Dehydrogenase
Week 48
|
-8.8 U/L
Standard Deviation 35.2
|
-4.2 U/L
Standard Deviation 54.3
|
-1.5 U/L
Standard Deviation 32.7
|
-16.0 U/L
Standard Deviation 36.3
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Creatinine was measured in micromols per liter (µmol/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Creatinine
Week 2
|
0.9 μmol/L
Standard Deviation 9.1
|
-0.1 μmol/L
Standard Deviation 8.0
|
1.5 μmol/L
Standard Deviation 5.8
|
0.6 μmol/L
Standard Deviation 7.2
|
|
Mean Change From Baseline in Creatinine
Week 4
|
-0.8 μmol/L
Standard Deviation 8.9
|
-0.2 μmol/L
Standard Deviation 9.3
|
-0.6 μmol/L
Standard Deviation 7.3
|
-1.4 μmol/L
Standard Deviation 8.2
|
|
Mean Change From Baseline in Creatinine
Week 8
|
0.5 μmol/L
Standard Deviation 7.0
|
0.3 μmol/L
Standard Deviation 7.6
|
-0.5 μmol/L
Standard Deviation 6.9
|
0.1 μmol/L
Standard Deviation 8.4
|
|
Mean Change From Baseline in Creatinine
Week 12
|
-0.3 μmol/L
Standard Deviation 7.0
|
1.4 μmol/L
Standard Deviation 7.5
|
-0.4 μmol/L
Standard Deviation 6.4
|
-0.7 μmol/L
Standard Deviation 8.2
|
|
Mean Change From Baseline in Creatinine
Week 16
|
-0.1 μmol/L
Standard Deviation 9.8
|
1.0 μmol/L
Standard Deviation 8.2
|
0.7 μmol/L
Standard Deviation 6.8
|
-1.1 μmol/L
Standard Deviation 9.4
|
|
Mean Change From Baseline in Creatinine
Week 20
|
0.7 μmol/L
Standard Deviation 8.6
|
1.4 μmol/L
Standard Deviation 10.2
|
0.8 μmol/L
Standard Deviation 6.9
|
-0.3 μmol/L
Standard Deviation 7.7
|
|
Mean Change From Baseline in Creatinine
Week 24
|
0.0 μmol/L
Standard Deviation 8.8
|
0.8 μmol/L
Standard Deviation 8.8
|
0.3 μmol/L
Standard Deviation 6.6
|
0.9 μmol/L
Standard Deviation 9.7
|
|
Mean Change From Baseline in Creatinine
Week 28
|
2.5 μmol/L
Standard Deviation 10.0
|
2.7 μmol/L
Standard Deviation 10.0
|
1.0 μmol/L
Standard Deviation 7.8
|
-0.9 μmol/L
Standard Deviation 7.8
|
|
Mean Change From Baseline in Creatinine
Week 32
|
5.5 μmol/L
Standard Deviation 35.7
|
0.5 μmol/L
Standard Deviation 8.1
|
3.6 μmol/L
Standard Deviation 7.8
|
1.6 μmol/L
Standard Deviation 11.2
|
|
Mean Change From Baseline in Creatinine
Week 40
|
2.3 μmol/L
Standard Deviation 9.5
|
2.2 μmol/L
Standard Deviation 8.5
|
3.9 μmol/L
Standard Deviation 6.0
|
3.0 μmol/L
Standard Deviation 8.4
|
|
Mean Change From Baseline in Creatinine
Week 48
|
1.9 μmol/L
Standard Deviation 10.6
|
0.7 μmol/L
Standard Deviation 7.6
|
2.5 μmol/L
Standard Deviation 5.2
|
2.9 μmol/L
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Urea Nitrogen was measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Urea Nitrogen
Week 2
|
0.28 mmol/L
Standard Deviation 1.55
|
-0.09 mmol/L
Standard Deviation 1.23
|
-0.05 mmol/L
Standard Deviation 1.32
|
-0.02 mmol/L
Standard Deviation 1.31
|
|
Mean Change From Baseline in Urea Nitrogen
Week 4
|
-0.07 mmol/L
Standard Deviation 1.21
|
-0.33 mmol/L
Standard Deviation 1.52
|
-0.14 mmol/L
Standard Deviation 1.20
|
0.04 mmol/L
Standard Deviation 1.19
|
|
Mean Change From Baseline in Urea Nitrogen
Week 8
|
0.06 mmol/L
Standard Deviation 1.25
|
-0.26 mmol/L
Standard Deviation 1.22
|
-0.19 mmol/L
Standard Deviation 1.07
|
0.17 mmol/L
Standard Deviation 1.59
|
|
Mean Change From Baseline in Urea Nitrogen
Week 12
|
0.03 mmol/L
Standard Deviation 1.13
|
-0.39 mmol/L
Standard Deviation 1.31
|
-0.29 mmol/L
Standard Deviation 1.17
|
-0.22 mmol/L
Standard Deviation 1.15
|
|
Mean Change From Baseline in Urea Nitrogen
Week 16
|
0.19 mmol/L
Standard Deviation 1.35
|
-0.18 mmol/L
Standard Deviation 1.40
|
0.19 mmol/L
Standard Deviation 1.49
|
-0.03 mmol/L
Standard Deviation 1.41
|
|
Mean Change From Baseline in Urea Nitrogen
Week 20
|
-0.18 mmol/L
Standard Deviation 1.29
|
-0.20 mmol/L
Standard Deviation 1.33
|
-0.25 mmol/L
Standard Deviation 1.22
|
-0.16 mmol/L
Standard Deviation 1.08
|
|
Mean Change From Baseline in Urea Nitrogen
Week 24
|
0.08 mmol/L
Standard Deviation 1.69
|
-0.44 mmol/L
Standard Deviation 1.38
|
-0.13 mmol/L
Standard Deviation 1.18
|
-0.09 mmol/L
Standard Deviation 1.50
|
|
Mean Change From Baseline in Urea Nitrogen
Week 28
|
0.13 mmol/L
Standard Deviation 1.38
|
0.03 mmol/L
Standard Deviation 1.61
|
-0.23 mmol/L
Standard Deviation 1.26
|
-0.22 mmol/L
Standard Deviation 1.14
|
|
Mean Change From Baseline in Urea Nitrogen
Week 32
|
0.40 mmol/L
Standard Deviation 2.37
|
-0.30 mmol/L
Standard Deviation 1.65
|
0.21 mmol/L
Standard Deviation 1.17
|
0.10 mmol/L
Standard Deviation 1.43
|
|
Mean Change From Baseline in Urea Nitrogen
Week 40
|
0.29 mmol/L
Standard Deviation 1.54
|
0.10 mmol/L
Standard Deviation 1.73
|
0.21 mmol/L
Standard Deviation 1.20
|
0.14 mmol/L
Standard Deviation 1.43
|
|
Mean Change From Baseline in Urea Nitrogen
Week 48
|
0.05 mmol/L
Standard Deviation 1.22
|
-0.31 mmol/L
Standard Deviation 1.54
|
0.23 mmol/L
Standard Deviation 1.38
|
-0.02 mmol/L
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Sodium was measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Sodium
Week 2
|
-0.1 mmol/L
Standard Deviation 1.9
|
-0.4 mmol/L
Standard Deviation 2.4
|
0.1 mmol/L
Standard Deviation 1.6
|
0.0 mmol/L
Standard Deviation 2.2
|
|
Mean Change From Baseline in Sodium
Week 4
|
-0.3 mmol/L
Standard Deviation 2.0
|
-0.6 mmol/L
Standard Deviation 2.1
|
0.3 mmol/L
Standard Deviation 2.1
|
-0.1 mmol/L
Standard Deviation 2.4
|
|
Mean Change From Baseline in Sodium
Week 8
|
0.1 mmol/L
Standard Deviation 2.2
|
-0.4 mmol/L
Standard Deviation 2.4
|
0.3 mmol/L
Standard Deviation 2.2
|
0.1 mmol/L
Standard Deviation 2.3
|
|
Mean Change From Baseline in Sodium
Week 12
|
-0.3 mmol/L
Standard Deviation 2.0
|
-0.5 mmol/L
Standard Deviation 2.0
|
0.2 mmol/L
Standard Deviation 2.0
|
0.1 mmol/L
Standard Deviation 2.3
|
|
Mean Change From Baseline in Sodium
Week 16
|
-0.4 mmol/L
Standard Deviation 2.3
|
-0.2 mmol/L
Standard Deviation 1.9
|
0.0 mmol/L
Standard Deviation 2.0
|
-0.2 mmol/L
Standard Deviation 2.3
|
|
Mean Change From Baseline in Sodium
Week 20
|
0.3 mmol/L
Standard Deviation 2.2
|
-0.8 mmol/L
Standard Deviation 2.2
|
-0.1 mmol/L
Standard Deviation 2.0
|
-0.5 mmol/L
Standard Deviation 2.4
|
|
Mean Change From Baseline in Sodium
Week 24
|
-0.1 mmol/L
Standard Deviation 2.5
|
-0.4 mmol/L
Standard Deviation 2.2
|
0.0 mmol/L
Standard Deviation 2.2
|
-0.3 mmol/L
Standard Deviation 2.1
|
|
Mean Change From Baseline in Sodium
Week 28
|
0.0 mmol/L
Standard Deviation 1.9
|
-0.4 mmol/L
Standard Deviation 2.4
|
0.2 mmol/L
Standard Deviation 1.9
|
0.1 mmol/L
Standard Deviation 2.3
|
|
Mean Change From Baseline in Sodium
Week 32
|
0.0 mmol/L
Standard Deviation 2.3
|
-0.8 mmol/L
Standard Deviation 3.2
|
0.1 mmol/L
Standard Deviation 2.1
|
0.2 mmol/L
Standard Deviation 2.2
|
|
Mean Change From Baseline in Sodium
Week 40
|
-0.1 mmol/L
Standard Deviation 2.2
|
-1.2 mmol/L
Standard Deviation 2.2
|
-0.1 mmol/L
Standard Deviation 1.6
|
-0.3 mmol/L
Standard Deviation 2.4
|
|
Mean Change From Baseline in Sodium
Week 48
|
-0.4 mmol/L
Standard Deviation 2.0
|
-1.1 mmol/L
Standard Deviation 2.6
|
-0.5 mmol/L
Standard Deviation 1.7
|
0.2 mmol/L
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Potassium was measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Potassium
Week 2
|
0.04 mmol/L
Standard Deviation 0.45
|
0.15 mmol/L
Standard Deviation 0.40
|
0.00 mmol/L
Standard Deviation 0.36
|
-0.03 mmol/L
Standard Deviation 0.37
|
|
Mean Change From Baseline in Potassium
Week 4
|
0.06 mmol/L
Standard Deviation 0.44
|
0.08 mmol/L
Standard Deviation 0.35
|
-0.07 mmol/L
Standard Deviation 0.41
|
-0.12 mmol/L
Standard Deviation 0.40
|
|
Mean Change From Baseline in Potassium
Week 8
|
-0.04 mmol/L
Standard Deviation 0.40
|
0.11 mmol/L
Standard Deviation 0.38
|
0.00 mmol/L
Standard Deviation 0.35
|
-0.07 mmol/L
Standard Deviation 0.40
|
|
Mean Change From Baseline in Potassium
Week 12
|
-0.01 mmol/L
Standard Deviation 0.33
|
0.02 mmol/L
Standard Deviation 0.31
|
-0.07 mmol/L
Standard Deviation 0.41
|
-0.12 mmol/L
Standard Deviation 0.34
|
|
Mean Change From Baseline in Potassium
Week 16
|
-0.01 mmol/L
Standard Deviation 0.34
|
0.16 mmol/L
Standard Deviation 0.33
|
-0.09 mmol/L
Standard Deviation 0.42
|
-0.05 mmol/L
Standard Deviation 0.33
|
|
Mean Change From Baseline in Potassium
Week 20
|
0.04 mmol/L
Standard Deviation 0.38
|
0.14 mmol/L
Standard Deviation 0.33
|
-0.04 mmol/L
Standard Deviation 0.46
|
-0.08 mmol/L
Standard Deviation 0.37
|
|
Mean Change From Baseline in Potassium
Week 24
|
0.06 mmol/L
Standard Deviation 0.43
|
0.07 mmol/L
Standard Deviation 0.39
|
0.03 mmol/L
Standard Deviation 0.33
|
-0.11 mmol/L
Standard Deviation 0.37
|
|
Mean Change From Baseline in Potassium
Week 28
|
0.09 mmol/L
Standard Deviation 0.43
|
0.12 mmol/L
Standard Deviation 0.47
|
0.06 mmol/L
Standard Deviation 0.42
|
0.03 mmol/L
Standard Deviation 0.45
|
|
Mean Change From Baseline in Potassium
Week 32
|
0.03 mmol/L
Standard Deviation 0.44
|
0.07 mmol/L
Standard Deviation 0.44
|
0.10 mmol/L
Standard Deviation 0.46
|
-0.05 mmol/L
Standard Deviation 0.38
|
|
Mean Change From Baseline in Potassium
Week 40
|
0.06 mmol/L
Standard Deviation 0.33
|
0.16 mmol/L
Standard Deviation 0.51
|
0.16 mmol/L
Standard Deviation 0.39
|
-0.06 mmol/L
Standard Deviation 0.37
|
|
Mean Change From Baseline in Potassium
Week 48
|
-0.01 mmol/L
Standard Deviation 0.30
|
0.00 mmol/L
Standard Deviation 0.30
|
-0.02 mmol/L
Standard Deviation 0.39
|
-0.07 mmol/L
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Calcium was measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Calcium
Week 2
|
0.008 mmol/L
Standard Deviation 0.104
|
-0.001 mmol/L
Standard Deviation 0.103
|
0.004 mmol/L
Standard Deviation 0.088
|
-0.008 mmol/L
Standard Deviation 0.092
|
|
Mean Change From Baseline in Calcium
Week 4
|
0.007 mmol/L
Standard Deviation 0.108
|
-0.018 mmol/L
Standard Deviation 0.099
|
-0.018 mmol/L
Standard Deviation 0.090
|
-0.001 mmol/L
Standard Deviation 0.086
|
|
Mean Change From Baseline in Calcium
Week 8
|
-0.006 mmol/L
Standard Deviation 0.093
|
-0.033 mmol/L
Standard Deviation 0.117
|
-0.014 mmol/L
Standard Deviation 0.106
|
-0.003 mmol/L
Standard Deviation 0.089
|
|
Mean Change From Baseline in Calcium
Week 12
|
0.006 mmol/L
Standard Deviation 0.108
|
-0.011 mmol/L
Standard Deviation 0.121
|
-0.013 mmol/L
Standard Deviation 0.097
|
-0.004 mmol/L
Standard Deviation 0.111
|
|
Mean Change From Baseline in Calcium
Week 16
|
-0.025 mmol/L
Standard Deviation 0.106
|
-0.004 mmol/L
Standard Deviation 0.088
|
-0.013 mmol/L
Standard Deviation 0.095
|
-0.024 mmol/L
Standard Deviation 0.119
|
|
Mean Change From Baseline in Calcium
Week 20
|
-0.036 mmol/L
Standard Deviation 0.116
|
-0.020 mmol/L
Standard Deviation 0.084
|
-0.015 mmol/L
Standard Deviation 0.108
|
0.005 mmol/L
Standard Deviation 0.080
|
|
Mean Change From Baseline in Calcium
Week 24
|
-0.027 mmol/L
Standard Deviation 0.106
|
-0.026 mmol/L
Standard Deviation 0.094
|
-0.012 mmol/L
Standard Deviation 0.095
|
0.007 mmol/L
Standard Deviation 0.100
|
|
Mean Change From Baseline in Calcium
Week 28
|
-0.031 mmol/L
Standard Deviation 0.121
|
-0.039 mmol/L
Standard Deviation 0.091
|
-0.016 mmol/L
Standard Deviation 0.113
|
-0.014 mmol/L
Standard Deviation 0.092
|
|
Mean Change From Baseline in Calcium
Week 32
|
0.003 mmol/L
Standard Deviation 0.098
|
-0.043 mmol/L
Standard Deviation 0.099
|
0.019 mmol/L
Standard Deviation 0.107
|
-0.001 mmol/L
Standard Deviation 0.105
|
|
Mean Change From Baseline in Calcium
Week 40
|
-0.027 mmol/L
Standard Deviation 0.114
|
-0.022 mmol/L
Standard Deviation 0.115
|
0.006 mmol/L
Standard Deviation 0.115
|
-0.012 mmol/L
Standard Deviation 0.105
|
|
Mean Change From Baseline in Calcium
Week 48
|
-0.013 mmol/L
Standard Deviation 0.096
|
-0.037 mmol/L
Standard Deviation 0.119
|
-0.004 mmol/L
Standard Deviation 0.104
|
-0.017 mmol/L
Standard Deviation 0.110
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Phosphate was measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Phosphate
Week 48
|
0.032 mmol/L
Standard Deviation 0.183
|
-0.012 mmol/L
Standard Deviation 0.167
|
-0.044 mmol/L
Standard Deviation 0.214
|
0.035 mmol/L
Standard Deviation 0.190
|
|
Mean Change From Baseline in Phosphate
Week 2
|
0.044 mmol/L
Standard Deviation 0.163
|
0.032 mmol/L
Standard Deviation 0.192
|
-0.047 mmol/L
Standard Deviation 0.230
|
0.033 mmol/L
Standard Deviation 0.168
|
|
Mean Change From Baseline in Phosphate
Week 4
|
-0.004 mmol/L
Standard Deviation 0.162
|
-0.029 mmol/L
Standard Deviation 0.185
|
-0.070 mmol/L
Standard Deviation 0.187
|
0.020 mmol/L
Standard Deviation 0.163
|
|
Mean Change From Baseline in Phosphate
Week 8
|
0.006 mmol/L
Standard Deviation 0.178
|
-0.063 mmol/L
Standard Deviation 0.225
|
-0.028 mmol/L
Standard Deviation 0.207
|
0.051 mmol/L
Standard Deviation 0.187
|
|
Mean Change From Baseline in Phosphate
Week 12
|
0.029 mmol/L
Standard Deviation 0.159
|
-0.004 mmol/L
Standard Deviation 0.149
|
-0.015 mmol/L
Standard Deviation 0.236
|
0.045 mmol/L
Standard Deviation 0.183
|
|
Mean Change From Baseline in Phosphate
Week 16
|
-0.010 mmol/L
Standard Deviation 0.186
|
0.012 mmol/L
Standard Deviation 0.182
|
-0.025 mmol/L
Standard Deviation 0.195
|
0.005 mmol/L
Standard Deviation 0.178
|
|
Mean Change From Baseline in Phosphate
Week 20
|
-0.030 mmol/L
Standard Deviation 0.208
|
-0.037 mmol/L
Standard Deviation 0.244
|
-0.031 mmol/L
Standard Deviation 0.177
|
0.013 mmol/L
Standard Deviation 0.187
|
|
Mean Change From Baseline in Phosphate
Week 24
|
-0.013 mmol/L
Standard Deviation 0.181
|
-0.042 mmol/L
Standard Deviation 0.160
|
-0.040 mmol/L
Standard Deviation 0.229
|
0.035 mmol/L
Standard Deviation 0.200
|
|
Mean Change From Baseline in Phosphate
Week 28
|
-0.024 mmol/L
Standard Deviation 0.189
|
0.008 mmol/L
Standard Deviation 0.238
|
-0.031 mmol/L
Standard Deviation 0.232
|
0.037 mmol/L
Standard Deviation 0.184
|
|
Mean Change From Baseline in Phosphate
Week 32
|
-0.002 mmol/L
Standard Deviation 0.217
|
-0.056 mmol/L
Standard Deviation 0.223
|
0.015 mmol/L
Standard Deviation 0.220
|
0.030 mmol/L
Standard Deviation 0.190
|
|
Mean Change From Baseline in Phosphate
Week 40
|
0.018 mmol/L
Standard Deviation 0.207
|
0.009 mmol/L
Standard Deviation 0.196
|
-0.022 mmol/L
Standard Deviation 0.208
|
0.034 mmol/L
Standard Deviation 0.224
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Cholesterol was measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Cholesterol
Week 2
|
0.00 mmol/L
Standard Deviation 0.49
|
-0.07 mmol/L
Standard Deviation 0.46
|
-0.06 mmol/L
Standard Deviation 0.51
|
-0.19 mmol/L
Standard Deviation 0.47
|
|
Mean Change From Baseline in Cholesterol
Week 4
|
-0.08 mmol/L
Standard Deviation 0.49
|
-0.03 mmol/L
Standard Deviation 0.46
|
-0.07 mmol/L
Standard Deviation 0.68
|
-0.07 mmol/L
Standard Deviation 0.57
|
|
Mean Change From Baseline in Cholesterol
Week 8
|
-0.09 mmol/L
Standard Deviation 0.57
|
-0.07 mmol/L
Standard Deviation 0.46
|
-0.15 mmol/L
Standard Deviation 0.81
|
-0.17 mmol/L
Standard Deviation 0.59
|
|
Mean Change From Baseline in Cholesterol
Week 12
|
-0.14 mmol/L
Standard Deviation 0.72
|
-0.16 mmol/L
Standard Deviation 0.61
|
-0.23 mmol/L
Standard Deviation 0.68
|
-0.10 mmol/L
Standard Deviation 0.75
|
|
Mean Change From Baseline in Cholesterol
Week 16
|
-0.16 mmol/L
Standard Deviation 0.80
|
-0.16 mmol/L
Standard Deviation 0.66
|
-0.35 mmol/L
Standard Deviation 0.80
|
-0.27 mmol/L
Standard Deviation 0.72
|
|
Mean Change From Baseline in Cholesterol
Week 20
|
-0.27 mmol/L
Standard Deviation 0.77
|
-0.22 mmol/L
Standard Deviation 0.60
|
-0.42 mmol/L
Standard Deviation 0.81
|
-0.23 mmol/L
Standard Deviation 0.85
|
|
Mean Change From Baseline in Cholesterol
Week 24
|
-0.12 mmol/L
Standard Deviation 0.87
|
-0.17 mmol/L
Standard Deviation 0.66
|
-0.28 mmol/L
Standard Deviation 0.96
|
-0.16 mmol/L
Standard Deviation 0.78
|
|
Mean Change From Baseline in Cholesterol
Week 28
|
-0.17 mmol/L
Standard Deviation 0.89
|
-0.37 mmol/L
Standard Deviation 0.63
|
-0.35 mmol/L
Standard Deviation 0.97
|
-0.29 mmol/L
Standard Deviation 0.80
|
|
Mean Change From Baseline in Cholesterol
Week 32
|
-0.13 mmol/L
Standard Deviation 0.86
|
-0.22 mmol/L
Standard Deviation 0.63
|
-0.16 mmol/L
Standard Deviation 0.83
|
-0.15 mmol/L
Standard Deviation 0.81
|
|
Mean Change From Baseline in Cholesterol
Week 40
|
-0.34 mmol/L
Standard Deviation 0.87
|
-0.25 mmol/L
Standard Deviation 0.80
|
-0.19 mmol/L
Standard Deviation 0.77
|
-0.13 mmol/L
Standard Deviation 1.15
|
|
Mean Change From Baseline in Cholesterol
Week 48
|
-0.40 mmol/L
Standard Deviation 0.80
|
-0.36 mmol/L
Standard Deviation 0.74
|
-0.23 mmol/L
Standard Deviation 0.97
|
-0.18 mmol/L
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Triglycerides was measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Triglycerides
Week 2
|
-0.176 mmol/L
Standard Deviation 1.593
|
0.046 mmol/L
Standard Deviation 0.683
|
0.110 mmol/L
Standard Deviation 0.855
|
0.183 mmol/L
Standard Deviation 0.751
|
|
Mean Change From Baseline in Triglycerides
Week 4
|
-0.189 mmol/L
Standard Deviation 1.212
|
-0.004 mmol/L
Standard Deviation 0.510
|
-0.030 mmol/L
Standard Deviation 0.471
|
0.084 mmol/L
Standard Deviation 0.529
|
|
Mean Change From Baseline in Triglycerides
Week 8
|
-0.182 mmol/L
Standard Deviation 1.554
|
0.076 mmol/L
Standard Deviation 0.582
|
-0.084 mmol/L
Standard Deviation 0.498
|
0.046 mmol/L
Standard Deviation 0.585
|
|
Mean Change From Baseline in Triglycerides
Week 12
|
-0.265 mmol/L
Standard Deviation 1.445
|
0.088 mmol/L
Standard Deviation 0.713
|
0.063 mmol/L
Standard Deviation 0.578
|
0.009 mmol/L
Standard Deviation 0.514
|
|
Mean Change From Baseline in Triglycerides
Week 16
|
-0.164 mmol/L
Standard Deviation 1.345
|
0.099 mmol/L
Standard Deviation 1.488
|
0.142 mmol/L
Standard Deviation 0.580
|
0.112 mmol/L
Standard Deviation 1.035
|
|
Mean Change From Baseline in Triglycerides
Week 20
|
-0.233 mmol/L
Standard Deviation 1.391
|
-0.104 mmol/L
Standard Deviation 0.837
|
0.008 mmol/L
Standard Deviation 0.622
|
-0.060 mmol/L
Standard Deviation 0.707
|
|
Mean Change From Baseline in Triglycerides
Week 24
|
-0.263 mmol/L
Standard Deviation 1.515
|
-0.045 mmol/L
Standard Deviation 0.774
|
-0.013 mmol/L
Standard Deviation 0.608
|
-0.030 mmol/L
Standard Deviation 0.707
|
|
Mean Change From Baseline in Triglycerides
Week 28
|
-0.013 mmol/L
Standard Deviation 1.559
|
-0.125 mmol/L
Standard Deviation 0.782
|
-0.043 mmol/L
Standard Deviation 0.423
|
-0.036 mmol/L
Standard Deviation 0.663
|
|
Mean Change From Baseline in Triglycerides
Week 32
|
-0.260 mmol/L
Standard Deviation 1.418
|
0.045 mmol/L
Standard Deviation 0.717
|
0.057 mmol/L
Standard Deviation 0.532
|
0.112 mmol/L
Standard Deviation 0.718
|
|
Mean Change From Baseline in Triglycerides
Week 40
|
-0.134 mmol/L
Standard Deviation 1.175
|
-0.159 mmol/L
Standard Deviation 0.765
|
0.177 mmol/L
Standard Deviation 0.821
|
0.022 mmol/L
Standard Deviation 0.644
|
|
Mean Change From Baseline in Triglycerides
Week 48
|
-0.242 mmol/L
Standard Deviation 1.516
|
-0.149 mmol/L
Standard Deviation 0.758
|
0.114 mmol/L
Standard Deviation 0.507
|
0.054 mmol/L
Standard Deviation 0.752
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Protein was measured in grams per liter (g/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Protein
Week 2
|
-0.2 g/L
Standard Deviation 3.7
|
-1.2 g/L
Standard Deviation 4.0
|
-1.0 g/L
Standard Deviation 4.2
|
-1.1 g/L
Standard Deviation 3.8
|
|
Mean Change From Baseline in Protein
Week 4
|
-1.5 g/L
Standard Deviation 4.4
|
-1.6 g/L
Standard Deviation 4.2
|
-1.5 g/L
Standard Deviation 4.7
|
-1.7 g/L
Standard Deviation 4.4
|
|
Mean Change From Baseline in Protein
Week 8
|
-1.1 g/L
Standard Deviation 4.4
|
-2.1 g/L
Standard Deviation 4.1
|
-1.8 g/L
Standard Deviation 5.7
|
-2.0 g/L
Standard Deviation 3.9
|
|
Mean Change From Baseline in Protein
Week 12
|
-0.8 g/L
Standard Deviation 3.8
|
-1.3 g/L
Standard Deviation 4.7
|
-1.4 g/L
Standard Deviation 5.2
|
-1.2 g/L
Standard Deviation 5.8
|
|
Mean Change From Baseline in Protein
Week 16
|
-1.2 g/L
Standard Deviation 5.2
|
-0.3 g/L
Standard Deviation 4.1
|
-2.3 g/L
Standard Deviation 5.6
|
-3.8 g/L
Standard Deviation 5.0
|
|
Mean Change From Baseline in Protein
Week 20
|
-2.7 g/L
Standard Deviation 6.0
|
-1.6 g/L
Standard Deviation 4.6
|
-2.6 g/L
Standard Deviation 4.7
|
-3.1 g/L
Standard Deviation 5.4
|
|
Mean Change From Baseline in Protein
Week 24
|
-2.2 g/L
Standard Deviation 7.5
|
-1.8 g/L
Standard Deviation 4.6
|
-1.8 g/L
Standard Deviation 5.5
|
-2.0 g/L
Standard Deviation 4.7
|
|
Mean Change From Baseline in Protein
Week 28
|
-3.1 g/L
Standard Deviation 7.4
|
-2.4 g/L
Standard Deviation 4.6
|
-2.5 g/L
Standard Deviation 5.7
|
-3.6 g/L
Standard Deviation 6.4
|
|
Mean Change From Baseline in Protein
Week 32
|
-1.4 g/L
Standard Deviation 6.9
|
-1.5 g/L
Standard Deviation 5.7
|
-0.8 g/L
Standard Deviation 5.0
|
-1.9 g/L
Standard Deviation 6.4
|
|
Mean Change From Baseline in Protein
Week 40
|
-2.2 g/L
Standard Deviation 6.5
|
-0.9 g/L
Standard Deviation 5.0
|
-1.8 g/L
Standard Deviation 5.3
|
-2.6 g/L
Standard Deviation 6.1
|
|
Mean Change From Baseline in Protein
Week 48
|
-2.3 g/L
Standard Deviation 6.2
|
-2.4 g/L
Standard Deviation 5.9
|
-0.9 g/L
Standard Deviation 5.1
|
-3.4 g/L
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Albumin was measured in grams per liter (g/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Albumin
Week 2
|
0.1 g/L
Standard Deviation 2.1
|
-0.4 g/L
Standard Deviation 2.4
|
-0.5 g/L
Standard Deviation 2.4
|
-0.5 g/L
Standard Deviation 1.9
|
|
Mean Change From Baseline in Albumin
Week 4
|
-0.5 g/L
Standard Deviation 2.4
|
-0.4 g/L
Standard Deviation 2.3
|
-0.2 g/L
Standard Deviation 2.4
|
-0.3 g/L
Standard Deviation 1.9
|
|
Mean Change From Baseline in Albumin
Week 8
|
-0.3 g/L
Standard Deviation 2.3
|
-0.3 g/L
Standard Deviation 2.5
|
-0.3 g/L
Standard Deviation 3.0
|
0.1 g/L
Standard Deviation 2.2
|
|
Mean Change From Baseline in Albumin
Week 12
|
-0.1 g/L
Standard Deviation 2.2
|
0.2 g/L
Standard Deviation 2.7
|
0.2 g/L
Standard Deviation 2.7
|
0.7 g/L
Standard Deviation 3.0
|
|
Mean Change From Baseline in Albumin
Week 16
|
0.0 g/L
Standard Deviation 2.5
|
1.0 g/L
Standard Deviation 2.5
|
0.1 g/L
Standard Deviation 2.9
|
-0.2 g/L
Standard Deviation 2.9
|
|
Mean Change From Baseline in Albumin
Week 20
|
-0.7 g/L
Standard Deviation 2.7
|
0.1 g/L
Standard Deviation 2.7
|
0.4 g/L
Standard Deviation 2.4
|
0.4 g/L
Standard Deviation 2.2
|
|
Mean Change From Baseline in Albumin
Week 24
|
-0.1 g/L
Standard Deviation 2.9
|
0.0 g/L
Standard Deviation 2.1
|
0.4 g/L
Standard Deviation 2.4
|
1.2 g/L
Standard Deviation 2.7
|
|
Mean Change From Baseline in Albumin
Week 28
|
-0.7 g/L
Standard Deviation 3.0
|
-0.4 g/L
Standard Deviation 2.3
|
0.1 g/L
Standard Deviation 2.9
|
0.1 g/L
Standard Deviation 2.6
|
|
Mean Change From Baseline in Albumin
Week 32
|
0.6 g/L
Standard Deviation 2.8
|
-0.1 g/L
Standard Deviation 3.0
|
0.9 g/L
Standard Deviation 3.2
|
0.7 g/L
Standard Deviation 2.8
|
|
Mean Change From Baseline in Albumin
Week 40
|
0.1 g/L
Standard Deviation 2.8
|
-0.1 g/L
Standard Deviation 2.9
|
0.2 g/L
Standard Deviation 2.6
|
0.3 g/L
Standard Deviation 3.0
|
|
Mean Change From Baseline in Albumin
Week 48
|
0.1 g/L
Standard Deviation 2.8
|
-0.7 g/L
Standard Deviation 3.0
|
0.2 g/L
Standard Deviation 3.0
|
-0.8 g/L
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Glucose was measured in millimoles per liter (mmol/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Glucose
Week 2
|
0.18 mmol/L
Standard Deviation 0.75
|
0.26 mmol/L
Standard Deviation 0.70
|
0.09 mmol/L
Standard Deviation 0.78
|
0.13 mmol/L
Standard Deviation 1.28
|
|
Mean Change From Baseline in Glucose
Week 4
|
0.04 mmol/L
Standard Deviation 0.71
|
0.03 mmol/L
Standard Deviation 0.70
|
-0.04 mmol/L
Standard Deviation 0.90
|
0.11 mmol/L
Standard Deviation 1.10
|
|
Mean Change From Baseline in Glucose
Week 8
|
0.17 mmol/L
Standard Deviation 0.66
|
0.12 mmol/L
Standard Deviation 0.90
|
0.23 mmol/L
Standard Deviation 0.95
|
0.12 mmol/L
Standard Deviation 1.16
|
|
Mean Change From Baseline in Glucose
Week 12
|
-0.08 mmol/L
Standard Deviation 0.69
|
0.08 mmol/L
Standard Deviation 0.66
|
-0.13 mmol/L
Standard Deviation 0.79
|
-0.15 mmol/L
Standard Deviation 0.99
|
|
Mean Change From Baseline in Glucose
Week 16
|
0.11 mmol/L
Standard Deviation 0.77
|
0.06 mmol/L
Standard Deviation 0.63
|
0.16 mmol/L
Standard Deviation 0.92
|
-0.18 mmol/L
Standard Deviation 1.47
|
|
Mean Change From Baseline in Glucose
Week 20
|
0.16 mmol/L
Standard Deviation 0.85
|
0.20 mmol/L
Standard Deviation 0.84
|
0.13 mmol/L
Standard Deviation 0.83
|
-0.08 mmol/L
Standard Deviation 1.01
|
|
Mean Change From Baseline in Glucose
Week 24
|
-0.07 mmol/L
Standard Deviation 0.85
|
0.05 mmol/L
Standard Deviation 0.49
|
-0.09 mmol/L
Standard Deviation 0.73
|
-0.22 mmol/L
Standard Deviation 1.06
|
|
Mean Change From Baseline in Glucose
Week 28
|
0.22 mmol/L
Standard Deviation 1.01
|
0.09 mmol/L
Standard Deviation 0.76
|
-0.01 mmol/L
Standard Deviation 0.74
|
0.07 mmol/L
Standard Deviation 1.22
|
|
Mean Change From Baseline in Glucose
Week 32
|
-0.04 mmol/L
Standard Deviation 0.72
|
-0.07 mmol/L
Standard Deviation 0.63
|
-0.08 mmol/L
Standard Deviation 0.65
|
0.06 mmol/L
Standard Deviation 1.10
|
|
Mean Change From Baseline in Glucose
Week 40
|
-0.05 mmol/L
Standard Deviation 0.62
|
0.08 mmol/L
Standard Deviation 0.71
|
-0.09 mmol/L
Standard Deviation 0.68
|
-0.08 mmol/L
Standard Deviation 1.07
|
|
Mean Change From Baseline in Glucose
Week 48
|
-0.14 mmol/L
Standard Deviation 0.78
|
-0.11 mmol/L
Standard Deviation 0.61
|
-0.06 mmol/L
Standard Deviation 0.64
|
-0.14 mmol/L
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Lipase, Pancreatic was measured in units per liter (U/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Lipase, Pancreatic
Week 8
|
-3.1 U/L
Standard Deviation 9.2
|
3.7 U/L
Standard Deviation 11.8
|
2.0 U/L
Standard Deviation 20.0
|
-1.8 U/L
Standard Deviation 10.3
|
|
Mean Change From Baseline in Lipase, Pancreatic
Week 12
|
-0.5 U/L
Standard Deviation 8.7
|
1.0 U/L
Standard Deviation 11.1
|
-0.7 U/L
Standard Deviation 13.4
|
-0.6 U/L
Standard Deviation 9.6
|
|
Mean Change From Baseline in Lipase, Pancreatic
Week 2
|
-1.1 U/L
Standard Deviation 10.5
|
2.2 U/L
Standard Deviation 11.9
|
0.1 U/L
Standard Deviation 9.2
|
-0.2 U/L
Standard Deviation 7.5
|
|
Mean Change From Baseline in Lipase, Pancreatic
Week 4
|
-2.1 U/L
Standard Deviation 9.8
|
0.9 U/L
Standard Deviation 9.1
|
0.1 U/L
Standard Deviation 10.6
|
-1.2 U/L
Standard Deviation 10.0
|
|
Mean Change From Baseline in Lipase, Pancreatic
Week 16
|
0.4 U/L
Standard Deviation 7.4
|
2.7 U/L
Standard Deviation 8.4
|
0.5 U/L
Standard Deviation 11.3
|
-0.2 U/L
Standard Deviation 11.8
|
|
Mean Change From Baseline in Lipase, Pancreatic
Week 20
|
-0.6 U/L
Standard Deviation 10.4
|
2.1 U/L
Standard Deviation 8.0
|
-0.9 U/L
Standard Deviation 9.0
|
-1.7 U/L
Standard Deviation 9.3
|
|
Mean Change From Baseline in Lipase, Pancreatic
Week 24
|
-0.5 U/L
Standard Deviation 11.0
|
-0.1 U/L
Standard Deviation 9.1
|
-0.1 U/L
Standard Deviation 8.1
|
1.2 U/L
Standard Deviation 11.8
|
|
Mean Change From Baseline in Lipase, Pancreatic
Week 28
|
1.6 U/L
Standard Deviation 13.1
|
1.7 U/L
Standard Deviation 10.5
|
0.5 U/L
Standard Deviation 11.9
|
1.7 U/L
Standard Deviation 14.1
|
|
Mean Change From Baseline in Lipase, Pancreatic
Week 32
|
1.1 U/L
Standard Deviation 15.1
|
1.0 U/L
Standard Deviation 11.0
|
1.2 U/L
Standard Deviation 10.6
|
3.8 U/L
Standard Deviation 21.6
|
|
Mean Change From Baseline in Lipase, Pancreatic
Week 40
|
1.2 U/L
Standard Deviation 11.0
|
1.3 U/L
Standard Deviation 7.0
|
-0.3 U/L
Standard Deviation 8.9
|
2.5 U/L
Standard Deviation 8.9
|
|
Mean Change From Baseline in Lipase, Pancreatic
Week 48
|
1.4 U/L
Standard Deviation 10.1
|
2.2 U/L
Standard Deviation 10.0
|
0.3 U/L
Standard Deviation 10.7
|
3.7 U/L
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Creatine Kinase was measured in units per liter (U/L).
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Creatine Kinase
Week 2
|
-3.0 U/L
Standard Deviation 67.1
|
-2.2 U/L
Standard Deviation 55.6
|
-2.2 U/L
Standard Deviation 18.2
|
0.1 U/L
Standard Deviation 46.5
|
|
Mean Change From Baseline in Creatine Kinase
Week 4
|
29.6 U/L
Standard Deviation 218.4
|
-6.2 U/L
Standard Deviation 54.8
|
3.2 U/L
Standard Deviation 22.0
|
-16.9 U/L
Standard Deviation 56.5
|
|
Mean Change From Baseline in Creatine Kinase
Week 8
|
-4.9 U/L
Standard Deviation 56.9
|
-8.5 U/L
Standard Deviation 52.7
|
-1.5 U/L
Standard Deviation 23.6
|
-4.6 U/L
Standard Deviation 122.1
|
|
Mean Change From Baseline in Creatine Kinase
Week 12
|
-6.3 U/L
Standard Deviation 57.5
|
-8.4 U/L
Standard Deviation 85.8
|
-3.0 U/L
Standard Deviation 22.4
|
-29.4 U/L
Standard Deviation 80.7
|
|
Mean Change From Baseline in Creatine Kinase
Week 16
|
0.9 U/L
Standard Deviation 59.4
|
-11.5 U/L
Standard Deviation 105.1
|
-7.5 U/L
Standard Deviation 22.2
|
-23.2 U/L
Standard Deviation 106.3
|
|
Mean Change From Baseline in Creatine Kinase
Week 20
|
-8.2 U/L
Standard Deviation 60.0
|
5.9 U/L
Standard Deviation 149.1
|
-3.5 U/L
Standard Deviation 22.2
|
-33.4 U/L
Standard Deviation 95.3
|
|
Mean Change From Baseline in Creatine Kinase
Week 24
|
-6.4 U/L
Standard Deviation 48.6
|
-5.4 U/L
Standard Deviation 123.7
|
-2.6 U/L
Standard Deviation 27.4
|
-27.7 U/L
Standard Deviation 98.9
|
|
Mean Change From Baseline in Creatine Kinase
Week 28
|
-1.5 U/L
Standard Deviation 67.3
|
-19.1 U/L
Standard Deviation 131.5
|
-0.7 U/L
Standard Deviation 25.4
|
-36.7 U/L
Standard Deviation 103.8
|
|
Mean Change From Baseline in Creatine Kinase
Week 32
|
2.0 U/L
Standard Deviation 67.0
|
-10.0 U/L
Standard Deviation 167.0
|
34.0 U/L
Standard Deviation 222.1
|
-24.2 U/L
Standard Deviation 91.2
|
|
Mean Change From Baseline in Creatine Kinase
Week 40
|
9.9 U/L
Standard Deviation 109.1
|
-20.4 U/L
Standard Deviation 131.4
|
-2.7 U/L
Standard Deviation 25.4
|
-16.3 U/L
Standard Deviation 106.4
|
|
Mean Change From Baseline in Creatine Kinase
Week 48
|
7.8 U/L
Standard Deviation 67.3
|
-20.4 U/L
Standard Deviation 138.3
|
-3.6 U/L
Standard Deviation 25.5
|
-33.4 U/L
Standard Deviation 106.5
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in pH
Week 48
|
-0.11 pH
Standard Deviation 0.66
|
0.06 pH
Standard Deviation 0.73
|
-0.11 pH
Standard Deviation 0.74
|
-0.08 pH
Standard Deviation 0.72
|
|
Mean Change From Baseline in pH
Week 2
|
-0.01 pH
Standard Deviation 0.66
|
0.03 pH
Standard Deviation 0.62
|
-0.07 pH
Standard Deviation 0.67
|
0.15 pH
Standard Deviation 0.78
|
|
Mean Change From Baseline in pH
Week 4
|
0.10 pH
Standard Deviation 0.77
|
0.15 pH
Standard Deviation 0.52
|
0.06 pH
Standard Deviation 0.72
|
0.16 pH
Standard Deviation 0.74
|
|
Mean Change From Baseline in pH
Week 8
|
-0.12 pH
Standard Deviation 0.79
|
0.00 pH
Standard Deviation 0.62
|
-0.08 pH
Standard Deviation 0.56
|
-0.04 pH
Standard Deviation 0.65
|
|
Mean Change From Baseline in pH
Week 12
|
0.00 pH
Standard Deviation 0.81
|
0.15 pH
Standard Deviation 0.69
|
0.03 pH
Standard Deviation 0.79
|
0.20 pH
Standard Deviation 0.83
|
|
Mean Change From Baseline in pH
Week 16
|
-0.02 pH
Standard Deviation 0.61
|
0.00 pH
Standard Deviation 0.51
|
-0.09 pH
Standard Deviation 0.81
|
0.11 pH
Standard Deviation 0.69
|
|
Mean Change From Baseline in pH
Week 20
|
-0.11 pH
Standard Deviation 0.75
|
-0.01 pH
Standard Deviation 0.59
|
0.06 pH
Standard Deviation 0.58
|
0.07 pH
Standard Deviation 0.88
|
|
Mean Change From Baseline in pH
Week 24
|
0.03 pH
Standard Deviation 0.85
|
-0.01 pH
Standard Deviation 0.46
|
-0.11 pH
Standard Deviation 0.81
|
0.02 pH
Standard Deviation 0.81
|
|
Mean Change From Baseline in pH
Week 28
|
-0.13 pH
Standard Deviation 0.84
|
-0.06 pH
Standard Deviation 0.57
|
-0.05 pH
Standard Deviation 0.73
|
-0.01 pH
Standard Deviation 0.69
|
|
Mean Change From Baseline in pH
Week 32
|
-0.02 pH
Standard Deviation 0.75
|
-0.03 pH
Standard Deviation 0.55
|
-0.18 pH
Standard Deviation 0.66
|
0.09 pH
Standard Deviation 0.86
|
|
Mean Change From Baseline in pH
Week 40
|
-0.14 pH
Standard Deviation 0.81
|
0.19 pH
Standard Deviation 0.66
|
-0.21 pH
Standard Deviation 0.81
|
-0.07 pH
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Erythrocytes (/HPF)
Week 2
|
-6.8 % of Erythrocytes per HPF
Standard Deviation 53.7
|
0.1 % of Erythrocytes per HPF
Standard Deviation 8.4
|
0.2 % of Erythrocytes per HPF
Standard Deviation 2.4
|
0.9 % of Erythrocytes per HPF
Standard Deviation 7.9
|
|
Mean Change From Baseline in Erythrocytes (/HPF)
Week 4
|
-8.7 % of Erythrocytes per HPF
Standard Deviation 52.6
|
-0.8 % of Erythrocytes per HPF
Standard Deviation 4.1
|
1.4 % of Erythrocytes per HPF
Standard Deviation 10.5
|
-0.6 % of Erythrocytes per HPF
Standard Deviation 3.2
|
|
Mean Change From Baseline in Erythrocytes (/HPF)
Week 8
|
-8.7 % of Erythrocytes per HPF
Standard Deviation 53.5
|
-0.3 % of Erythrocytes per HPF
Standard Deviation 6.9
|
0.4 % of Erythrocytes per HPF
Standard Deviation 6.1
|
0.0 % of Erythrocytes per HPF
Standard Deviation 6.8
|
|
Mean Change From Baseline in Erythrocytes (/HPF)
Week 12
|
-8.6 % of Erythrocytes per HPF
Standard Deviation 52.6
|
1.3 % of Erythrocytes per HPF
Standard Deviation 17.4
|
-0.4 % of Erythrocytes per HPF
Standard Deviation 2.4
|
17.4 % of Erythrocytes per HPF
Standard Deviation 118.5
|
|
Mean Change From Baseline in Erythrocytes (/HPF)
Week 16
|
-5.7 % of Erythrocytes per HPF
Standard Deviation 48.0
|
-1.3 % of Erythrocytes per HPF
Standard Deviation 4.1
|
-0.6 % of Erythrocytes per HPF
Standard Deviation 2.6
|
-0.5 % of Erythrocytes per HPF
Standard Deviation 5.5
|
|
Mean Change From Baseline in Erythrocytes (/HPF)
Week 20
|
-7.7 % of Erythrocytes per HPF
Standard Deviation 53.7
|
-1.0 % of Erythrocytes per HPF
Standard Deviation 3.5
|
-0.1 % of Erythrocytes per HPF
Standard Deviation 3.9
|
-0.6 % of Erythrocytes per HPF
Standard Deviation 4.4
|
|
Mean Change From Baseline in Erythrocytes (/HPF)
Week 24
|
-7.2 % of Erythrocytes per HPF
Standard Deviation 53.5
|
-1.2 % of Erythrocytes per HPF
Standard Deviation 3.9
|
-0.3 % of Erythrocytes per HPF
Standard Deviation 2.3
|
-0.9 % of Erythrocytes per HPF
Standard Deviation 4.6
|
|
Mean Change From Baseline in Erythrocytes (/HPF)
Week 28
|
-7.6 % of Erythrocytes per HPF
Standard Deviation 51.3
|
-1.3 % of Erythrocytes per HPF
Standard Deviation 4.2
|
-0.7 % of Erythrocytes per HPF
Standard Deviation 2.9
|
3.0 % of Erythrocytes per HPF
Standard Deviation 16.9
|
|
Mean Change From Baseline in Erythrocytes (/HPF)
Week 32
|
-8.5 % of Erythrocytes per HPF
Standard Deviation 52.5
|
4.9 % of Erythrocytes per HPF
Standard Deviation 41.8
|
0.0 % of Erythrocytes per HPF
Standard Deviation 3.9
|
0.1 % of Erythrocytes per HPF
Standard Deviation 4.5
|
|
Mean Change From Baseline in Erythrocytes (/HPF)
Week 40
|
-9.1 % of Erythrocytes per HPF
Standard Deviation 53.2
|
3.5 % of Erythrocytes per HPF
Standard Deviation 18.8
|
-0.5 % of Erythrocytes per HPF
Standard Deviation 3.5
|
0.4 % of Erythrocytes per HPF
Standard Deviation 5.4
|
|
Mean Change From Baseline in Erythrocytes (/HPF)
Week 48
|
-9.7 % of Erythrocytes per HPF
Standard Deviation 56.3
|
-0.4 % of Erythrocytes per HPF
Standard Deviation 5.4
|
1.9 % of Erythrocytes per HPF
Standard Deviation 15.5
|
0.1 % of Erythrocytes per HPF
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: From Baseline (Week 1) to Week 48Population: The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
Outcome measures
| Measure |
SOC + Placebo iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS).
|
SOC + DZP 6mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 24mg/kg iv Q4W (FAS)
n=45 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
SOC + DZP 45mg/kg iv Q4W (FAS)
n=47 Participants
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Leukocytes (/HPF)
Week 2
|
-0.1 % of Leukocytes per HPF
Standard Deviation 11.4
|
-1.4 % of Leukocytes per HPF
Standard Deviation 8.1
|
-0.8 % of Leukocytes per HPF
Standard Deviation 2.9
|
2.9 % of Leukocytes per HPF
Standard Deviation 13.7
|
|
Mean Change From Baseline in Leukocytes (/HPF)
Week 4
|
-0.2 % of Leukocytes per HPF
Standard Deviation 9.0
|
-0.6 % of Leukocytes per HPF
Standard Deviation 8.5
|
-0.7 % of Leukocytes per HPF
Standard Deviation 4.5
|
3.0 % of Leukocytes per HPF
Standard Deviation 12.6
|
|
Mean Change From Baseline in Leukocytes (/HPF)
Week 8
|
-1.2 % of Leukocytes per HPF
Standard Deviation 10.4
|
4.8 % of Leukocytes per HPF
Standard Deviation 29.3
|
-0.3 % of Leukocytes per HPF
Standard Deviation 6.8
|
3.0 % of Leukocytes per HPF
Standard Deviation 14.4
|
|
Mean Change From Baseline in Leukocytes (/HPF)
Week 12
|
-1.1 % of Leukocytes per HPF
Standard Deviation 11.3
|
4.4 % of Leukocytes per HPF
Standard Deviation 42.2
|
-1.3 % of Leukocytes per HPF
Standard Deviation 4.2
|
2.7 % of Leukocytes per HPF
Standard Deviation 13.9
|
|
Mean Change From Baseline in Leukocytes (/HPF)
Week 16
|
0.1 % of Leukocytes per HPF
Standard Deviation 9.6
|
-1.6 % of Leukocytes per HPF
Standard Deviation 12.5
|
-0.2 % of Leukocytes per HPF
Standard Deviation 9.6
|
1.8 % of Leukocytes per HPF
Standard Deviation 12.9
|
|
Mean Change From Baseline in Leukocytes (/HPF)
Week 20
|
-0.1 % of Leukocytes per HPF
Standard Deviation 10.1
|
3.7 % of Leukocytes per HPF
Standard Deviation 13.3
|
0.4 % of Leukocytes per HPF
Standard Deviation 9.8
|
1.7 % of Leukocytes per HPF
Standard Deviation 4.0
|
|
Mean Change From Baseline in Leukocytes (/HPF)
Week 24
|
-1.0 % of Leukocytes per HPF
Standard Deviation 10.9
|
10.7 % of Leukocytes per HPF
Standard Deviation 52.1
|
-0.7 % of Leukocytes per HPF
Standard Deviation 4.5
|
0.4 % of Leukocytes per HPF
Standard Deviation 4.5
|
|
Mean Change From Baseline in Leukocytes (/HPF)
Week 28
|
-0.2 % of Leukocytes per HPF
Standard Deviation 9.6
|
2.4 % of Leukocytes per HPF
Standard Deviation 9.7
|
-1.1 % of Leukocytes per HPF
Standard Deviation 4.4
|
2.0 % of Leukocytes per HPF
Standard Deviation 10.1
|
|
Mean Change From Baseline in Leukocytes (/HPF)
Week 32
|
-0.6 % of Leukocytes per HPF
Standard Deviation 10.8
|
-0.5 % of Leukocytes per HPF
Standard Deviation 13.5
|
-1.0 % of Leukocytes per HPF
Standard Deviation 5.4
|
4.1 % of Leukocytes per HPF
Standard Deviation 15.7
|
|
Mean Change From Baseline in Leukocytes (/HPF)
Week 40
|
-1.6 % of Leukocytes per HPF
Standard Deviation 10.4
|
2.2 % of Leukocytes per HPF
Standard Deviation 19.8
|
1.4 % of Leukocytes per HPF
Standard Deviation 7.7
|
6.8 % of Leukocytes per HPF
Standard Deviation 30.9
|
|
Mean Change From Baseline in Leukocytes (/HPF)
Week 48
|
-0.3 % of Leukocytes per HPF
Standard Deviation 8.9
|
10.8 % of Leukocytes per HPF
Standard Deviation 71.9
|
-1.0 % of Leukocytes per HPF
Standard Deviation 4.0
|
0.8 % of Leukocytes per HPF
Standard Deviation 5.3
|
Adverse Events
SOC + Placebo iv Q4W (SS)
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
SOC + DZP 6mg/kg iv Q4W (SS)
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
SOC + DZP 24mg/kg iv Q4W (SS)
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
SOC + DZP 45mg/kg iv Q4W (SS)
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOC + Placebo iv Q4W (SS)
n=45 participants at risk
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).
|
SOC + DZP 6mg/kg iv Q4W (SS)
n=45 participants at risk
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
|
SOC + DZP 24mg/kg iv Q4W (SS)
n=45 participants at risk
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
|
SOC + DZP 45mg/kg iv Q4W (SS)
n=47 participants at risk
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Gastrointestinal disorders
Anastomotic ulcer perforation
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Cellulitis
|
2.2%
1/45 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Herpes zoster
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Influenza
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
4.4%
2/45 • Number of events 3 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.1%
1/47 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Renal and urinary disorders
Lupus nephritis
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Vascular disorders
Deep vein thrombosis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
Other adverse events
| Measure |
SOC + Placebo iv Q4W (SS)
n=45 participants at risk
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS).
|
SOC + DZP 6mg/kg iv Q4W (SS)
n=45 participants at risk
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
|
SOC + DZP 24mg/kg iv Q4W (SS)
n=45 participants at risk
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
|
SOC + DZP 45mg/kg iv Q4W (SS)
n=47 participants at risk
This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
6.4%
3/47 • Number of events 3 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Gastrointestinal disorders
Nausea
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
5/45 • Number of events 5 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
11.1%
5/45 • Number of events 5 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
11.1%
5/45 • Number of events 6 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
8.5%
4/47 • Number of events 4 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
4/45 • Number of events 5 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
10.6%
5/47 • Number of events 6 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Pharyngitis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
8.9%
4/45 • Number of events 6 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
6.4%
3/47 • Number of events 4 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Urinary tract infection
|
4.4%
2/45 • Number of events 3 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
6.7%
3/45 • Number of events 5 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Investigations
Hepatic enzyme increased
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Nervous system disorders
Headache
|
11.1%
5/45 • Number of events 5 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
11.1%
5/45 • Number of events 13 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Nervous system disorders
Migraine
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/45 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
6.4%
3/47 • Number of events 3 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
0.00%
0/47 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
|
Vascular disorders
Hypertension
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
6.7%
3/45 • Number of events 4 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from Baseline (Week 1) until end of the study (Week 48)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60