Systemic Lupus Erythematosus (SLE)
Conditions
Keywords
Systemic Lupus Erythematosus (SLE), Dapirolizumab Pegol (DZP)
Brief summary
The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.
Interventions
DRUGPlacebo
Solution for infusion, 0,9% saline
DRUGDapirolizumab pegol (DZP)
Solution for infusion
Sponsors
UCB Biopharma S.P.R.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by Systemic Lupus International Collaborating Clinics (SLICC) classification criteria * Moderate to severe SLE disease activity * Evidence for at least 1 of the following SLE markers: * Anti-dsDNA antibodies confirmed by central laboratory or * Low complement confirmed by central laboratory or * Antinuclear antibody (ANA) titer of \>= 1:80 in combination with at least 1 of the following: Historical positivity for anti-dsDNA or Positivity for extractable nuclear antigen (anti-ENA) confirmed by central laboratory * The subject is receiving stable SLE standard-of-care medication
Exclusion criteria
* Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE * Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments. * New or worsening Class III or IV lupus nephritis * Chronic kidney failure stage 3b * Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study * Clinically significant active or latent infection (eg. chronic viral hepatitis B or C) * Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection * Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug * History of thromboembolic events within 12 months of screening * Subject has used protocol defined prohibited medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least One Adverse Events (AEs) | From Baseline (Week 1) until end of the study (Week 48) | 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. |
| Percentage of Participants With a Serious Adverse Event (SAE) | From Baseline (Week 1) until end of the study (Week 48) | 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. |
| Percentage of Participants With at Least One Adverse Events (AEs) of Interest | From Baseline (Week 1) until end of the study (Week 48) | 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. |
| Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE) | From Baseline (Week 1) until end of the study (Week 48) | 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. |
| Mean Change From Baseline in Systolic Blood Pressure | From Baseline (Week 1) to Week 48 | Blood pressure was measured in millimetre of mercury (mmHg). |
| Mean Change From Baseline in Diastolic Blood Pressure | From Baseline (Week 1) to Week 48 | Blood pressure was measured in millimetre of mercury (mmHg). |
| Mean Change From Baseline in Pulse Rate | From Baseline (Week 1) to Week 48 | Pulse Rate was measured in beats per minute (beats/min). |
| Mean Change From Baseline in Temperature | From Baseline (Week 1) to Week 48 | Temperature was measured in Grad Celsius (°C). |
| Mean Change From Baseline in Weight | Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20 | Weight was measured in kilograms (kg). |
| Mean Change From Baseline in Height | From Baseline (Week 1) to Week 48 | Height was measured in centimeters (cm). |
| Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Screening, Week 4, Week 24, Week 28 and Week 48 | 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). |
| Mean Change From Baseline in Hemoglobin | From Baseline (Week 1) to Week 48 | Hemoglobin was measured in grams per liter (g/L). |
| Mean Change From Baseline in Hematocrit | From Baseline (Week 1) to Week 48 | Hematocrit was measured in volume percentage (%) of red blood cells in blood. |
| Mean Change From Baseline in Erythrocytes | From Baseline (Week 1) to Week 48 | Erythrocytes was measured in number of erythrocytes per liter (10\^12/L). |
| Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | From Baseline (Week 1) to Week 48 | Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL). |
| Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | From Baseline (Week 1) to Week 48 | Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L). |
| Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | From Baseline (Week 1) to Week 48 | Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg). |
| Mean Change From Baseline in Leukocytes | From Baseline (Week 1) to Week 48 | Leukocytes was measured in number of leukocytes per liter (10\^9/L). |
| Mean Change From Baseline in Basophils | From Baseline (Week 1) to Week 48 | Basophils was measured in number of basophils per liter (10\^9/L). |
| Mean Change From Baseline in Basophils/Leukocytes | From Baseline (Week 1) to Week 48 | Basophils/Leukocytes was measured in percentages (%). |
| Mean Change From Baseline in Eosinophils | From Baseline (Week 1) to Week 48 | Eosinophils was measured in number of eosinophils per liter (10\^9/L). |
| Mean Change From Baseline in Eosinophils/Leukocytes | From Baseline (Week 1) to Week 48 | Eosinophils/Leukocytes was measured in percentages (%). |
| Mean Change From Baseline in Lymphocytes | From Baseline (Week 1) to Week 48 | Lymphocytes was measured in number of lymphocytes per liter (10\^9/L). |
| Mean Change From Baseline in CD19/Lymphocytes | From Baseline (Week 1) to Week 48 | CD19/Lymphocytes was measured in percentages (%). |
| Mean Change From Baseline in Lymphocytes/Leukocytes | From Baseline (Week 1) to Week 48 | Lymphocytes/Leukocytes was measured in percentages (%). |
| Mean Change From Baseline in Monocytes | From Baseline (Week 1) to Week 48 | Monocytes was measured in number of monocytes per liter (10\^9/L). |
| Mean Change From Baseline in Monocytes/Leukocytes | From Baseline (Week 1) to Week 48 | Monocytes/Leukocytes was measured in percentages (%). |
| Mean Change From Baseline in Neutrophils | From Baseline (Week 1) to Week 48 | Neutrophils was measured in number of neutrophils per liter (10\^9/L). |
| Mean Change From Baseline in Neutrophils/Leukocytes | From Baseline (Week 1) to Week 48 | Neutrophils/Leukocytes was measured in percentages (%). |
| Mean Change From Baseline in Platelets | From Baseline (Week 1) to Week 48 | Platelets was measured in number of platelets per liter (10\^9/L). |
| Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | From Baseline (Week 1) to Week 48 | Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL). |
| Mean Change From Baseline in CD3/Lymphocytes | From Baseline (Week 1) to Week 48 | CD3/Lymphocytes was measured in percentages (%). |
| Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | From Baseline (Week 1) to Week 48 | Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL). |
| Mean Change From Baseline in Aspartate Aminotransferase | From Baseline (Week 1) to Week 48 | Aspartate Aminotransferase was measured in units per liter (U/L). |
| Mean Change From Baseline in Alanine Aminotransferase | From Baseline (Week 1) to Week 48 | Alanine Aminotransferase was measured in units per liter (U/L). |
| Mean Change From Baseline in Alkaline Phosphatase | From Baseline (Week 1) to Week 48 | Alkaline Phosphatase was measured in units per liter (U/L). |
| Mean Change From Baseline in Gamma Glutamyl Transferase | From Baseline (Week 1) to Week 48 | Gamma Glutamyl Transferase was measured in units per liter (U/L). |
| Mean Change From Baseline in Bilirubin | From Baseline (Week 1) to Week 48 | Bilirubin was measured in micromols per liter (µmol/L). |
| Mean Change From Baseline in Direct Bilirubin | From Baseline (Week 1) to Week 48 | Direct Bilirubin was measured in micromols per liter (µmol/L). |
| Mean Change From Baseline in Lactate Dehydrogenase | From Baseline (Week 1) to Week 48 | Lactate Dehydrogenase was measured in units per liter (U/L). |
| Mean Change From Baseline in Creatinine | From Baseline (Week 1) to Week 48 | Creatinine was measured in micromols per liter (µmol/L). |
| Mean Change From Baseline in Urea Nitrogen | From Baseline (Week 1) to Week 48 | Urea Nitrogen was measured in millimoles per liter (mmol/L). |
| Mean Change From Baseline in Sodium | From Baseline (Week 1) to Week 48 | Sodium was measured in millimoles per liter (mmol/L). |
| Mean Change From Baseline in Potassium | From Baseline (Week 1) to Week 48 | Potassium was measured in millimoles per liter (mmol/L). |
| Mean Change From Baseline in Calcium | From Baseline (Week 1) to Week 48 | Calcium was measured in millimoles per liter (mmol/L). |
| Mean Change From Baseline in Phosphate | From Baseline (Week 1) to Week 48 | Phosphate was measured in millimoles per liter (mmol/L). |
| Mean Change From Baseline in Cholesterol | From Baseline (Week 1) to Week 48 | Cholesterol was measured in millimoles per liter (mmol/L). |
| Mean Change From Baseline in Triglycerides | From Baseline (Week 1) to Week 48 | Triglycerides was measured in millimoles per liter (mmol/L). |
| Mean Change From Baseline in Protein | From Baseline (Week 1) to Week 48 | Protein was measured in grams per liter (g/L). |
| The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24 | Week 24 | 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. |
| Mean Change From Baseline in Glucose | From Baseline (Week 1) to Week 48 | Glucose was measured in millimoles per liter (mmol/L). |
| Mean Change From Baseline in Lipase, Pancreatic | From Baseline (Week 1) to Week 48 | Lipase, Pancreatic was measured in units per liter (U/L). |
| Mean Change From Baseline in Creatine Kinase | From Baseline (Week 1) to Week 48 | Creatine Kinase was measured in units per liter (U/L). |
| Mean Change From Baseline in pH | From Baseline (Week 1) to Week 48 | — |
| Mean Change From Baseline in Erythrocytes (/HPF) | From Baseline (Week 1) to Week 48 | — |
| Mean Change From Baseline in Leukocytes (/HPF) | From Baseline (Week 1) to Week 48 | — |
| Mean Change From Baseline in Albumin | From Baseline (Week 1) to Week 48 | Albumin was measured in grams per liter (g/L). |
Countries
Bulgaria, Chile, Colombia, Germany, Hungary, Mexico, Peru, Poland, Romania, Russia, Spain, Ukraine, United States
Participant flow
Recruitment details
The study started to enroll patients in June 2016 and concluded in November 2018.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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. | 45 |
| 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. | 45 |
| 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. | 47 |
| Total Title | 182 |
| Total | 364 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-Blind Period (Week 1 to Week 24) | Adverse Event | 1 | 0 | 0 | 0 |
| Double-Blind Period (Week 1 to Week 24) | Consent withdrawal after Week 24 | 0 | 1 | 0 | 0 |
| Double-Blind Period (Week 1 to Week 24) | Withdrawal by Subject | 0 | 0 | 1 | 2 |
| Observational Period (Wk 24 to Wk 48) | Lost to Follow-up | 2 | 0 | 1 | 1 |
| Observational Period (Wk 24 to Wk 48) | Patient moved out of state | 0 | 1 | 0 | 0 |
| Observational Period (Wk 24 to Wk 48) | Withdrawal by Subject | 4 | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | SOC + Placebo iv Q4W | SOC + DZP 6mg/kg iv Q4W | SOC + DZP 24mg/kg iv Q4W | SOC + DZP 45mg/kg iv Q4W | Total Title |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 44 Participants | 44 Participants | 46 Participants | 178 Participants |
| Age, Continuous | 43.50 years STANDARD_DEVIATION 12.79 | 40.81 years STANDARD_DEVIATION 11.55 | 42.77 years STANDARD_DEVIATION 10.42 | 38.94 years STANDARD_DEVIATION 12.92 | 41.48 years STANDARD_DEVIATION 12.01 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 4 Participants | 1 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Other/Mixed | 14 Participants | 14 Participants | 9 Participants | 13 Participants | 50 Participants |
| Race/Ethnicity, Customized White | 27 Participants | 26 Participants | 33 Participants | 27 Participants | 113 Participants |
| Sex: Female, Male Female | 41 Participants | 42 Participants | 40 Participants | 43 Participants | 166 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 | 0 / 45 | 0 / 47 |
| other Total, other adverse events | 19 / 45 | 23 / 45 | 22 / 45 | 21 / 47 |
| serious Total, serious adverse events | 6 / 45 | 5 / 45 | 6 / 45 | 5 / 47 |
Outcome results
Primary
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
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.
Time frame: Week 24
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOC + Placebo iv Q4W (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 |
| SOC + DZP 6mg/kg iv Q4W (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 |
| SOC + DZP 24mg/kg iv Q4W (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 |
| SOC + DZP 45mg/kg iv Q4W (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 |
Comparison: Multiple contrast testing (MCP-mod methodology) was used to test for a statistically significant dose-response relationship between the primary endpoint (BICLA at Week 24) and dose, which would indicate a drug effect of DZP over Placebo.~The best fitting statistically significant model could be used to estimate the dose needed to achieve desired treatment effect.p-value: =0.0727MCP-Mod
Secondary
Mean Change From Baseline in Alanine Aminotransferase
Alanine Aminotransferase was measured in units per liter (U/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 2 | 2.4 U/L | Standard Deviation 14.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 12 | 7.0 U/L | Standard Deviation 21.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 28 | 1.0 U/L | Standard Deviation 13.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 4 | 0.8 U/L | Standard Deviation 9.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 24 | 3.1 U/L | Standard Deviation 20.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 16 | 1.5 U/L | Standard Deviation 13.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 8 | 0.2 U/L | Standard Deviation 10.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 48 | 0.4 U/L | Standard Deviation 11.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 40 | -0.5 U/L | Standard Deviation 13.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 20 | 5.3 U/L | Standard Deviation 23.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 32 | 1.2 U/L | Standard Deviation 13.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 20 | -0.2 U/L | Standard Deviation 10.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 32 | -0.5 U/L | Standard Deviation 10.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 24 | 0.5 U/L | Standard Deviation 14.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 28 | 0.7 U/L | Standard Deviation 10.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 8 | -0.8 U/L | Standard Deviation 8.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 48 | -1.2 U/L | Standard Deviation 10.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 12 | 0.8 U/L | Standard Deviation 14.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 40 | 2.6 U/L | Standard Deviation 12.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 16 | -0.4 U/L | Standard Deviation 9.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 4 | -0.5 U/L | Standard Deviation 8.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 2 | 2.6 U/L | Standard Deviation 10.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 40 | 3.0 U/L | Standard Deviation 12.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 2 | 0.5 U/L | Standard Deviation 11.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 4 | 0.9 U/L | Standard Deviation 7.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 8 | 5.3 U/L | Standard Deviation 28.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 12 | -0.8 U/L | Standard Deviation 8.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 16 | 0.0 U/L | Standard Deviation 10.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 20 | 1.4 U/L | Standard Deviation 10.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 24 | 2.0 U/L | Standard Deviation 12 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 28 | -0.4 U/L | Standard Deviation 9.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 32 | 1.3 U/L | Standard Deviation 10.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 48 | 3.5 U/L | Standard Deviation 17 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 20 | -3.7 U/L | Standard Deviation 6.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 48 | -1.1 U/L | Standard Deviation 7.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 32 | -3.2 U/L | Standard Deviation 6.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 16 | -1.1 U/L | Standard Deviation 7.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 12 | -0.1 U/L | Standard Deviation 7.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 8 | -0.6 U/L | Standard Deviation 9.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 40 | -0.7 U/L | Standard Deviation 8.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 4 | 0.3 U/L | Standard Deviation 8.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 2 | -0.1 U/L | Standard Deviation 8.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 28 | -2.7 U/L | Standard Deviation 7.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alanine Aminotransferase | Week 24 | -2.8 U/L | Standard Deviation 7.7 |
Secondary
Mean Change From Baseline in Albumin
Albumin was measured in grams per liter (g/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 16 | 0.0 g/L | Standard Deviation 2.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 2 | 0.1 g/L | Standard Deviation 2.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 20 | -0.7 g/L | Standard Deviation 2.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 24 | -0.1 g/L | Standard Deviation 2.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 40 | 0.1 g/L | Standard Deviation 2.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 4 | -0.5 g/L | Standard Deviation 2.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 32 | 0.6 g/L | Standard Deviation 2.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 8 | -0.3 g/L | Standard Deviation 2.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 12 | -0.1 g/L | Standard Deviation 2.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 48 | 0.1 g/L | Standard Deviation 2.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 28 | -0.7 g/L | Standard Deviation 3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 4 | -0.4 g/L | Standard Deviation 2.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 16 | 1.0 g/L | Standard Deviation 2.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 40 | -0.1 g/L | Standard Deviation 2.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 24 | 0.0 g/L | Standard Deviation 2.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 28 | -0.4 g/L | Standard Deviation 2.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 20 | 0.1 g/L | Standard Deviation 2.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 2 | -0.4 g/L | Standard Deviation 2.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 12 | 0.2 g/L | Standard Deviation 2.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 8 | -0.3 g/L | Standard Deviation 2.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 32 | -0.1 g/L | Standard Deviation 3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 48 | -0.7 g/L | Standard Deviation 3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 32 | 0.9 g/L | Standard Deviation 3.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 40 | 0.2 g/L | Standard Deviation 2.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 2 | -0.5 g/L | Standard Deviation 2.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 4 | -0.2 g/L | Standard Deviation 2.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 8 | -0.3 g/L | Standard Deviation 3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 12 | 0.2 g/L | Standard Deviation 2.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 16 | 0.1 g/L | Standard Deviation 2.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 20 | 0.4 g/L | Standard Deviation 2.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 24 | 0.4 g/L | Standard Deviation 2.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 28 | 0.1 g/L | Standard Deviation 2.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 48 | 0.2 g/L | Standard Deviation 3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 24 | 1.2 g/L | Standard Deviation 2.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 12 | 0.7 g/L | Standard Deviation 3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 8 | 0.1 g/L | Standard Deviation 2.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 48 | -0.8 g/L | Standard Deviation 3.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 28 | 0.1 g/L | Standard Deviation 2.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 4 | -0.3 g/L | Standard Deviation 1.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 2 | -0.5 g/L | Standard Deviation 1.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 40 | 0.3 g/L | Standard Deviation 3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 20 | 0.4 g/L | Standard Deviation 2.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 16 | -0.2 g/L | Standard Deviation 2.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Albumin | Week 32 | 0.7 g/L | Standard Deviation 2.8 |
Secondary
Mean Change From Baseline in Alkaline Phosphatase
Alkaline Phosphatase was measured in units per liter (U/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 2 | 1.8 U/L | Standard Deviation 10.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 12 | 2.2 U/L | Standard Deviation 11.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 28 | 2.8 U/L | Standard Deviation 14 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 4 | -1.7 U/L | Standard Deviation 9.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 24 | 4.7 U/L | Standard Deviation 15 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 16 | 3.1 U/L | Standard Deviation 10.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 8 | 1.7 U/L | Standard Deviation 12.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 48 | 2.6 U/L | Standard Deviation 13.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 40 | 2.4 U/L | Standard Deviation 17.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 20 | 3.9 U/L | Standard Deviation 14 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 32 | 3.8 U/L | Standard Deviation 14.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 20 | 1.4 U/L | Standard Deviation 11.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 32 | 2.7 U/L | Standard Deviation 16 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 24 | 3.7 U/L | Standard Deviation 14 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 28 | 3.1 U/L | Standard Deviation 14.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 8 | 2.4 U/L | Standard Deviation 12.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 48 | 4.0 U/L | Standard Deviation 16.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 12 | 4.2 U/L | Standard Deviation 16.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 40 | 1.3 U/L | Standard Deviation 13.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 16 | 2.7 U/L | Standard Deviation 13 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 4 | 0.7 U/L | Standard Deviation 9.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 2 | 2.4 U/L | Standard Deviation 10.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 40 | 2.7 U/L | Standard Deviation 13 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 2 | 1.5 U/L | Standard Deviation 8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 4 | -0.7 U/L | Standard Deviation 8.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 8 | 1.8 U/L | Standard Deviation 15.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 12 | 1.9 U/L | Standard Deviation 12.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 16 | 0.0 U/L | Standard Deviation 10.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 20 | 1.4 U/L | Standard Deviation 11.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 24 | 2.8 U/L | Standard Deviation 11.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 28 | 1.9 U/L | Standard Deviation 9.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 32 | 3.2 U/L | Standard Deviation 12.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 48 | 5.5 U/L | Standard Deviation 12.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 20 | -7.4 U/L | Standard Deviation 11.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 48 | -4.5 U/L | Standard Deviation 18.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 32 | 1.0 U/L | Standard Deviation 15.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 16 | -6.7 U/L | Standard Deviation 12.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 12 | -4.4 U/L | Standard Deviation 11.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 8 | -6.1 U/L | Standard Deviation 11 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 40 | -3.0 U/L | Standard Deviation 18 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 4 | -4.7 U/L | Standard Deviation 9.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 2 | -3.6 U/L | Standard Deviation 10.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 28 | -2.1 U/L | Standard Deviation 13.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Alkaline Phosphatase | Week 24 | -2.7 U/L | Standard Deviation 14 |
Secondary
Mean Change From Baseline in Aspartate Aminotransferase
Aspartate Aminotransferase was measured in units per liter (U/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 2 | -0.5 U/L | Standard Deviation 8.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 12 | 5.1 U/L | Standard Deviation 27 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 28 | 0.0 U/L | Standard Deviation 12.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 4 | -0.1 U/L | Standard Deviation 11.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 24 | 0.6 U/L | Standard Deviation 11.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 16 | 0.4 U/L | Standard Deviation 7.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 8 | -0.1 U/L | Standard Deviation 8.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 48 | 1.1 U/L | Standard Deviation 10.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 40 | -0.6 U/L | Standard Deviation 10.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 20 | 4.1 U/L | Standard Deviation 24.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 32 | -0.3 U/L | Standard Deviation 11 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 20 | 1.0 U/L | Standard Deviation 11.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 32 | 0.3 U/L | Standard Deviation 6.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 24 | 1.6 U/L | Standard Deviation 10.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 28 | 0.0 U/L | Standard Deviation 10.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 8 | -1.5 U/L | Standard Deviation 6.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 48 | 0.1 U/L | Standard Deviation 13.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 12 | 0.9 U/L | Standard Deviation 6.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 40 | 0.1 U/L | Standard Deviation 9.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 16 | 0.0 U/L | Standard Deviation 6.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 4 | 0.2 U/L | Standard Deviation 7.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 2 | 0.2 U/L | Standard Deviation 8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 40 | -0.3 U/L | Standard Deviation 11.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 2 | 4.3 U/L | Standard Deviation 43.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 4 | -1.1 U/L | Standard Deviation 7.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 8 | 0.5 U/L | Standard Deviation 13 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 12 | -1.8 U/L | Standard Deviation 10 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 16 | -2.3 U/L | Standard Deviation 11.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 20 | -0.7 U/L | Standard Deviation 13.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 24 | -1.8 U/L | Standard Deviation 11.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 28 | -1.5 U/L | Standard Deviation 11.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 32 | -0.7 U/L | Standard Deviation 12.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 48 | 1.4 U/L | Standard Deviation 13.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 20 | -3.8 U/L | Standard Deviation 8.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 48 | -2.1 U/L | Standard Deviation 8.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 32 | -3.4 U/L | Standard Deviation 9.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 16 | -2.8 U/L | Standard Deviation 8.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 12 | -2.9 U/L | Standard Deviation 7.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 8 | -1.1 U/L | Standard Deviation 8.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 40 | -1.5 U/L | Standard Deviation 9.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 4 | -1.9 U/L | Standard Deviation 8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 2 | 0.0 U/L | Standard Deviation 7.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 28 | -3.4 U/L | Standard Deviation 9.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Aspartate Aminotransferase | Week 24 | -3.8 U/L | Standard Deviation 8.4 |
Secondary
Mean Change From Baseline in Basophils
Basophils was measured in number of basophils per liter (10\^9/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 2 | 0.01 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 12 | 0.01 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 28 | 0.02 10^9 basophils per liter | Standard Deviation 0.05 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 4 | 0.01 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 24 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 16 | 0.01 10^9 basophils per liter | Standard Deviation 0.04 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 8 | 0.01 10^9 basophils per liter | Standard Deviation 0.04 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 48 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 40 | 0.00 10^9 basophils per liter | Standard Deviation 0.02 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 20 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 32 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 20 | 0.01 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 32 | 0.00 10^9 basophils per liter | Standard Deviation 0.02 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 24 | 0.02 10^9 basophils per liter | Standard Deviation 0.04 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 28 | 0.01 10^9 basophils per liter | Standard Deviation 0.04 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 8 | 0.01 10^9 basophils per liter | Standard Deviation 0.04 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 48 | 0.00 10^9 basophils per liter | Standard Deviation 0.02 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 12 | 0.01 10^9 basophils per liter | Standard Deviation 0.04 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 40 | 0.00 10^9 basophils per liter | Standard Deviation 0.02 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 16 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 4 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 2 | 0.02 10^9 basophils per liter | Standard Deviation 0.04 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 40 | 0.01 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 2 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 4 | 0.01 10^9 basophils per liter | Standard Deviation 0.04 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 8 | 0.01 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 12 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 16 | 0.01 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 20 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 24 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 28 | 0.00 10^9 basophils per liter | Standard Deviation 0.02 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 32 | 0.01 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 48 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 20 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 48 | 0.01 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 32 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 16 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 12 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 8 | 0.00 10^9 basophils per liter | Standard Deviation 0.02 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 40 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 4 | 0.00 10^9 basophils per liter | Standard Deviation 0.02 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 2 | 0.00 10^9 basophils per liter | Standard Deviation 0.02 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 28 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils | Week 24 | 0.00 10^9 basophils per liter | Standard Deviation 0.03 |
Secondary
Mean Change From Baseline in Basophils/Leukocytes
Basophils/Leukocytes was measured in percentages (%).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 2 | -0.05 % of Basophils per Leukocytes | Standard Deviation 0.23 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 12 | 0.04 % of Basophils per Leukocytes | Standard Deviation 0.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 28 | 0.08 % of Basophils per Leukocytes | Standard Deviation 0.54 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 4 | 0.03 % of Basophils per Leukocytes | Standard Deviation 0.27 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 24 | -0.04 % of Basophils per Leukocytes | Standard Deviation 0.31 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 16 | 0.01 % of Basophils per Leukocytes | Standard Deviation 0.25 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 8 | 0.08 % of Basophils per Leukocytes | Standard Deviation 0.42 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 48 | -0.01 % of Basophils per Leukocytes | Standard Deviation 0.29 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 40 | -0.08 % of Basophils per Leukocytes | Standard Deviation 0.24 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 20 | -0.02 % of Basophils per Leukocytes | Standard Deviation 0.26 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 32 | -0.03 % of Basophils per Leukocytes | Standard Deviation 0.29 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 20 | 0.00 % of Basophils per Leukocytes | Standard Deviation 0.27 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 32 | 0.00 % of Basophils per Leukocytes | Standard Deviation 0.23 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 24 | 0.15 % of Basophils per Leukocytes | Standard Deviation 0.44 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 28 | 0.03 % of Basophils per Leukocytes | Standard Deviation 0.29 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 8 | 0.03 % of Basophils per Leukocytes | Standard Deviation 0.32 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 48 | -0.08 % of Basophils per Leukocytes | Standard Deviation 0.21 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 12 | 0.09 % of Basophils per Leukocytes | Standard Deviation 0.48 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 40 | -0.03 % of Basophils per Leukocytes | Standard Deviation 0.25 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 16 | 0.00 % of Basophils per Leukocytes | Standard Deviation 0.28 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 4 | -0.06 % of Basophils per Leukocytes | Standard Deviation 0.26 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 2 | 0.02 % of Basophils per Leukocytes | Standard Deviation 0.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 40 | 0.07 % of Basophils per Leukocytes | Standard Deviation 0.29 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 2 | -0.05 % of Basophils per Leukocytes | Standard Deviation 0.31 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 4 | -0.01 % of Basophils per Leukocytes | Standard Deviation 0.43 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 8 | 0.00 % of Basophils per Leukocytes | Standard Deviation 0.33 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 12 | 0.00 % of Basophils per Leukocytes | Standard Deviation 0.25 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 16 | -0.02 % of Basophils per Leukocytes | Standard Deviation 0.31 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 20 | -0.07 % of Basophils per Leukocytes | Standard Deviation 0.29 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 24 | -0.03 % of Basophils per Leukocytes | Standard Deviation 0.24 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 28 | 0.00 % of Basophils per Leukocytes | Standard Deviation 0.24 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 32 | 0.01 % of Basophils per Leukocytes | Standard Deviation 0.25 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 48 | 0.02 % of Basophils per Leukocytes | Standard Deviation 0.25 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 20 | -0.04 % of Basophils per Leukocytes | Standard Deviation 0.32 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 48 | 0.06 % of Basophils per Leukocytes | Standard Deviation 0.28 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 32 | 0.01 % of Basophils per Leukocytes | Standard Deviation 0.25 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 16 | -0.05 % of Basophils per Leukocytes | Standard Deviation 0.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 12 | -0.07 % of Basophils per Leukocytes | Standard Deviation 0.28 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 8 | -0.06 % of Basophils per Leukocytes | Standard Deviation 0.23 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 40 | 0.01 % of Basophils per Leukocytes | Standard Deviation 0.29 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 4 | -0.07 % of Basophils per Leukocytes | Standard Deviation 0.26 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 2 | -0.03 % of Basophils per Leukocytes | Standard Deviation 0.27 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 28 | 0.07 % of Basophils per Leukocytes | Standard Deviation 0.32 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Basophils/Leukocytes | Week 24 | -0.03 % of Basophils per Leukocytes | Standard Deviation 0.21 |
Secondary
Mean Change From Baseline in Bilirubin
Bilirubin was measured in micromols per liter (µmol/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 2 | 0.35 μmol/L | Standard Deviation 2.72 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 12 | -0.04 μmol/L | Standard Deviation 2.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 28 | -0.10 μmol/L | Standard Deviation 2.98 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 4 | 0.07 μmol/L | Standard Deviation 2.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 24 | 0.08 μmol/L | Standard Deviation 2.75 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 16 | 0.06 μmol/L | Standard Deviation 2.41 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 8 | -0.09 μmol/L | Standard Deviation 2.66 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 48 | 0.69 μmol/L | Standard Deviation 3.57 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 40 | -0.26 μmol/L | Standard Deviation 3.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 20 | -0.54 μmol/L | Standard Deviation 2.89 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 32 | 0.09 μmol/L | Standard Deviation 2.75 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 20 | -0.38 μmol/L | Standard Deviation 2.51 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 32 | -0.38 μmol/L | Standard Deviation 2.61 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 24 | -0.14 μmol/L | Standard Deviation 2.86 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 28 | -0.26 μmol/L | Standard Deviation 3.23 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 8 | -0.69 μmol/L | Standard Deviation 2.22 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 48 | -0.50 μmol/L | Standard Deviation 3.12 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 12 | -0.70 μmol/L | Standard Deviation 2.74 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 40 | 0.07 μmol/L | Standard Deviation 3.18 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 16 | -0.45 μmol/L | Standard Deviation 2.43 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 4 | -0.18 μmol/L | Standard Deviation 2.09 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 2 | -0.48 μmol/L | Standard Deviation 2.71 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 40 | 1.03 μmol/L | Standard Deviation 2.35 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 2 | 0.28 μmol/L | Standard Deviation 2.38 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 4 | -0.05 μmol/L | Standard Deviation 2.14 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 8 | -0.19 μmol/L | Standard Deviation 2.13 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 12 | 0.37 μmol/L | Standard Deviation 2.17 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 16 | -0.20 μmol/L | Standard Deviation 2.71 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 20 | 0.51 μmol/L | Standard Deviation 2.81 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 24 | 0.54 μmol/L | Standard Deviation 2.18 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 28 | 0.79 μmol/L | Standard Deviation 2.71 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 32 | 0.93 μmol/L | Standard Deviation 3.18 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 48 | 0.79 μmol/L | Standard Deviation 3.04 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 20 | -0.30 μmol/L | Standard Deviation 3.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 48 | -0.20 μmol/L | Standard Deviation 2.52 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 32 | -0.38 μmol/L | Standard Deviation 3.61 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 16 | -0.51 μmol/L | Standard Deviation 3.64 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 12 | -0.33 μmol/L | Standard Deviation 3.28 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 8 | -0.23 μmol/L | Standard Deviation 2.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 40 | -0.15 μmol/L | Standard Deviation 2.64 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 4 | -0.79 μmol/L | Standard Deviation 2.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 2 | -0.78 μmol/L | Standard Deviation 3.13 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 28 | -0.82 μmol/L | Standard Deviation 2.61 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Bilirubin | Week 24 | -0.38 μmol/L | Standard Deviation 3.57 |
Secondary
Mean Change From Baseline in Calcium
Calcium was measured in millimoles per liter (mmol/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 2 | 0.008 mmol/L | Standard Deviation 0.104 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 12 | 0.006 mmol/L | Standard Deviation 0.108 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 28 | -0.031 mmol/L | Standard Deviation 0.121 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 4 | 0.007 mmol/L | Standard Deviation 0.108 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 24 | -0.027 mmol/L | Standard Deviation 0.106 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 16 | -0.025 mmol/L | Standard Deviation 0.106 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 8 | -0.006 mmol/L | Standard Deviation 0.093 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 48 | -0.013 mmol/L | Standard Deviation 0.096 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 40 | -0.027 mmol/L | Standard Deviation 0.114 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 20 | -0.036 mmol/L | Standard Deviation 0.116 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 32 | 0.003 mmol/L | Standard Deviation 0.098 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 20 | -0.020 mmol/L | Standard Deviation 0.084 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 32 | -0.043 mmol/L | Standard Deviation 0.099 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 24 | -0.026 mmol/L | Standard Deviation 0.094 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 28 | -0.039 mmol/L | Standard Deviation 0.091 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 8 | -0.033 mmol/L | Standard Deviation 0.117 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 48 | -0.037 mmol/L | Standard Deviation 0.119 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 12 | -0.011 mmol/L | Standard Deviation 0.121 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 40 | -0.022 mmol/L | Standard Deviation 0.115 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 16 | -0.004 mmol/L | Standard Deviation 0.088 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 4 | -0.018 mmol/L | Standard Deviation 0.099 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 2 | -0.001 mmol/L | Standard Deviation 0.103 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 40 | 0.006 mmol/L | Standard Deviation 0.115 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 2 | 0.004 mmol/L | Standard Deviation 0.088 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 4 | -0.018 mmol/L | Standard Deviation 0.09 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 8 | -0.014 mmol/L | Standard Deviation 0.106 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 12 | -0.013 mmol/L | Standard Deviation 0.097 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 16 | -0.013 mmol/L | Standard Deviation 0.095 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 20 | -0.015 mmol/L | Standard Deviation 0.108 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 24 | -0.012 mmol/L | Standard Deviation 0.095 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 28 | -0.016 mmol/L | Standard Deviation 0.113 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 32 | 0.019 mmol/L | Standard Deviation 0.107 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 48 | -0.004 mmol/L | Standard Deviation 0.104 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 20 | 0.005 mmol/L | Standard Deviation 0.08 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 48 | -0.017 mmol/L | Standard Deviation 0.11 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 32 | -0.001 mmol/L | Standard Deviation 0.105 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 16 | -0.024 mmol/L | Standard Deviation 0.119 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 12 | -0.004 mmol/L | Standard Deviation 0.111 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 8 | -0.003 mmol/L | Standard Deviation 0.089 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 40 | -0.012 mmol/L | Standard Deviation 0.105 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 4 | -0.001 mmol/L | Standard Deviation 0.086 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 2 | -0.008 mmol/L | Standard Deviation 0.092 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 28 | -0.014 mmol/L | Standard Deviation 0.092 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Calcium | Week 24 | 0.007 mmol/L | Standard Deviation 0.1 |
Secondary
Mean Change From Baseline in CD19/Lymphocytes
CD19/Lymphocytes was measured in percentages (%).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 2 | -0.3 % of CD19 per Leukocytes | Standard Deviation 2.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 12 | -0.2 % of CD19 per Leukocytes | Standard Deviation 3.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 28 | -1.2 % of CD19 per Leukocytes | Standard Deviation 5.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 4 | 0.0 % of CD19 per Leukocytes | Standard Deviation 2.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 24 | -0.9 % of CD19 per Leukocytes | Standard Deviation 4.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 16 | 0.0 % of CD19 per Leukocytes | Standard Deviation 4.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 8 | 0.1 % of CD19 per Leukocytes | Standard Deviation 2.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 48 | -1.2 % of CD19 per Leukocytes | Standard Deviation 6.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 40 | -1.2 % of CD19 per Leukocytes | Standard Deviation 4.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 20 | -0.4 % of CD19 per Leukocytes | Standard Deviation 3.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 32 | -0.4 % of CD19 per Leukocytes | Standard Deviation 4.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 20 | -2.1 % of CD19 per Leukocytes | Standard Deviation 6.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 32 | -2.4 % of CD19 per Leukocytes | Standard Deviation 5.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 24 | -2.0 % of CD19 per Leukocytes | Standard Deviation 6.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 28 | -2.5 % of CD19 per Leukocytes | Standard Deviation 5.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 8 | -0.5 % of CD19 per Leukocytes | Standard Deviation 4.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 48 | -2.6 % of CD19 per Leukocytes | Standard Deviation 7.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 12 | -1.0 % of CD19 per Leukocytes | Standard Deviation 3.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 40 | -2.6 % of CD19 per Leukocytes | Standard Deviation 5.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 16 | -1.2 % of CD19 per Leukocytes | Standard Deviation 5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 4 | -0.5 % of CD19 per Leukocytes | Standard Deviation 3.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 2 | -0.1 % of CD19 per Leukocytes | Standard Deviation 3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 40 | -1.9 % of CD19 per Leukocytes | Standard Deviation 4.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 2 | 1.0 % of CD19 per Leukocytes | Standard Deviation 3.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 4 | 0.7 % of CD19 per Leukocytes | Standard Deviation 3.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 8 | 0.7 % of CD19 per Leukocytes | Standard Deviation 2.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 12 | -0.4 % of CD19 per Leukocytes | Standard Deviation 3.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 16 | -0.4 % of CD19 per Leukocytes | Standard Deviation 3.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 20 | -0.3 % of CD19 per Leukocytes | Standard Deviation 3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 24 | -0.6 % of CD19 per Leukocytes | Standard Deviation 3.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 28 | -1.1 % of CD19 per Leukocytes | Standard Deviation 3.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 32 | -0.6 % of CD19 per Leukocytes | Standard Deviation 4.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 48 | -1.6 % of CD19 per Leukocytes | Standard Deviation 4.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 20 | -0.2 % of CD19 per Leukocytes | Standard Deviation 6.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 48 | -3.3 % of CD19 per Leukocytes | Standard Deviation 6.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 32 | -1.6 % of CD19 per Leukocytes | Standard Deviation 6.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 16 | 0.7 % of CD19 per Leukocytes | Standard Deviation 5.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 12 | 1.7 % of CD19 per Leukocytes | Standard Deviation 7.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 8 | 0.4 % of CD19 per Leukocytes | Standard Deviation 6.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 40 | -3.4 % of CD19 per Leukocytes | Standard Deviation 6.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 4 | 2.8 % of CD19 per Leukocytes | Standard Deviation 5.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 2 | 1.5 % of CD19 per Leukocytes | Standard Deviation 5.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 28 | -1.0 % of CD19 per Leukocytes | Standard Deviation 6.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD19/Lymphocytes | Week 24 | -0.3 % of CD19 per Leukocytes | Standard Deviation 7.3 |
Secondary
Mean Change From Baseline in CD3/Lymphocytes
CD3/Lymphocytes was measured in percentages (%).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 2 | -0.7 % of CD3 per Leukocytes | Standard Deviation 6.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 12 | -0.4 % of CD3 per Leukocytes | Standard Deviation 5.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 28 | -0.2 % of CD3 per Leukocytes | Standard Deviation 6.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 4 | -2.1 % of CD3 per Leukocytes | Standard Deviation 7.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 24 | 0.0 % of CD3 per Leukocytes | Standard Deviation 6.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 16 | -1.9 % of CD3 per Leukocytes | Standard Deviation 5.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 8 | -0.9 % of CD3 per Leukocytes | Standard Deviation 6.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 48 | 1.3 % of CD3 per Leukocytes | Standard Deviation 8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 40 | 0.2 % of CD3 per Leukocytes | Standard Deviation 6.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 20 | -0.8 % of CD3 per Leukocytes | Standard Deviation 5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 32 | -1.3 % of CD3 per Leukocytes | Standard Deviation 7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 20 | 0.0 % of CD3 per Leukocytes | Standard Deviation 8.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 32 | 0.2 % of CD3 per Leukocytes | Standard Deviation 7.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 24 | -0.1 % of CD3 per Leukocytes | Standard Deviation 8.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 28 | 0.2 % of CD3 per Leukocytes | Standard Deviation 8.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 8 | -1.2 % of CD3 per Leukocytes | Standard Deviation 4.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 48 | 0.3 % of CD3 per Leukocytes | Standard Deviation 7.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 12 | -1.1 % of CD3 per Leukocytes | Standard Deviation 8.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 40 | 1.4 % of CD3 per Leukocytes | Standard Deviation 6.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 16 | -1.6 % of CD3 per Leukocytes | Standard Deviation 7.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 4 | -0.5 % of CD3 per Leukocytes | Standard Deviation 6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 2 | -0.9 % of CD3 per Leukocytes | Standard Deviation 4.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 40 | 0.5 % of CD3 per Leukocytes | Standard Deviation 6.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 2 | -2.0 % of CD3 per Leukocytes | Standard Deviation 5.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 4 | -1.9 % of CD3 per Leukocytes | Standard Deviation 5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 8 | -2.6 % of CD3 per Leukocytes | Standard Deviation 5.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 12 | -2.4 % of CD3 per Leukocytes | Standard Deviation 6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 16 | -1.9 % of CD3 per Leukocytes | Standard Deviation 7.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 20 | -2.3 % of CD3 per Leukocytes | Standard Deviation 6.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 24 | -1.8 % of CD3 per Leukocytes | Standard Deviation 6.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 28 | -2.9 % of CD3 per Leukocytes | Standard Deviation 7.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 32 | -1.8 % of CD3 per Leukocytes | Standard Deviation 6.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 48 | 0.1 % of CD3 per Leukocytes | Standard Deviation 6.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 20 | 0.6 % of CD3 per Leukocytes | Standard Deviation 9.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 48 | 4.5 % of CD3 per Leukocytes | Standard Deviation 7.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 32 | 1.4 % of CD3 per Leukocytes | Standard Deviation 8.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 16 | -1.4 % of CD3 per Leukocytes | Standard Deviation 7.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 12 | -0.1 % of CD3 per Leukocytes | Standard Deviation 9.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 8 | 0.6 % of CD3 per Leukocytes | Standard Deviation 9.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 40 | 3.3 % of CD3 per Leukocytes | Standard Deviation 7.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 4 | -0.5 % of CD3 per Leukocytes | Standard Deviation 6.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 2 | -0.2 % of CD3 per Leukocytes | Standard Deviation 7.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 28 | 0.9 % of CD3 per Leukocytes | Standard Deviation 10.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in CD3/Lymphocytes | Week 24 | 18.7 % of CD3 per Leukocytes | Standard Deviation 114.3 |
Secondary
Mean Change From Baseline in Cholesterol
Cholesterol was measured in millimoles per liter (mmol/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 2 | 0.00 mmol/L | Standard Deviation 0.49 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 12 | -0.14 mmol/L | Standard Deviation 0.72 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 28 | -0.17 mmol/L | Standard Deviation 0.89 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 4 | -0.08 mmol/L | Standard Deviation 0.49 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 24 | -0.12 mmol/L | Standard Deviation 0.87 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 16 | -0.16 mmol/L | Standard Deviation 0.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 8 | -0.09 mmol/L | Standard Deviation 0.57 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 48 | -0.40 mmol/L | Standard Deviation 0.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 40 | -0.34 mmol/L | Standard Deviation 0.87 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 20 | -0.27 mmol/L | Standard Deviation 0.77 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 32 | -0.13 mmol/L | Standard Deviation 0.86 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 20 | -0.22 mmol/L | Standard Deviation 0.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 32 | -0.22 mmol/L | Standard Deviation 0.63 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 24 | -0.17 mmol/L | Standard Deviation 0.66 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 28 | -0.37 mmol/L | Standard Deviation 0.63 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 8 | -0.07 mmol/L | Standard Deviation 0.46 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 48 | -0.36 mmol/L | Standard Deviation 0.74 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 12 | -0.16 mmol/L | Standard Deviation 0.61 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 40 | -0.25 mmol/L | Standard Deviation 0.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 16 | -0.16 mmol/L | Standard Deviation 0.66 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 4 | -0.03 mmol/L | Standard Deviation 0.46 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 2 | -0.07 mmol/L | Standard Deviation 0.46 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 40 | -0.19 mmol/L | Standard Deviation 0.77 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 2 | -0.06 mmol/L | Standard Deviation 0.51 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 4 | -0.07 mmol/L | Standard Deviation 0.68 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 8 | -0.15 mmol/L | Standard Deviation 0.81 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 12 | -0.23 mmol/L | Standard Deviation 0.68 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 16 | -0.35 mmol/L | Standard Deviation 0.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 20 | -0.42 mmol/L | Standard Deviation 0.81 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 24 | -0.28 mmol/L | Standard Deviation 0.96 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 28 | -0.35 mmol/L | Standard Deviation 0.97 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 32 | -0.16 mmol/L | Standard Deviation 0.83 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 48 | -0.23 mmol/L | Standard Deviation 0.97 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 20 | -0.23 mmol/L | Standard Deviation 0.85 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 48 | -0.18 mmol/L | Standard Deviation 1.09 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 32 | -0.15 mmol/L | Standard Deviation 0.81 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 16 | -0.27 mmol/L | Standard Deviation 0.72 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 12 | -0.10 mmol/L | Standard Deviation 0.75 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 8 | -0.17 mmol/L | Standard Deviation 0.59 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 40 | -0.13 mmol/L | Standard Deviation 1.15 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 4 | -0.07 mmol/L | Standard Deviation 0.57 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 2 | -0.19 mmol/L | Standard Deviation 0.47 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 28 | -0.29 mmol/L | Standard Deviation 0.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cholesterol | Week 24 | -0.16 mmol/L | Standard Deviation 0.78 |
Secondary
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 2 | 9.6 cells/µL | Standard Deviation 56.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 12 | -2.6 cells/µL | Standard Deviation 83.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 28 | -20.6 cells/µL | Standard Deviation 106.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 4 | -2.8 cells/µL | Standard Deviation 46.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 24 | -15.0 cells/µL | Standard Deviation 89.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 16 | -12.5 cells/µL | Standard Deviation 84.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 8 | -13.3 cells/µL | Standard Deviation 72.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 48 | -37.0 cells/µL | Standard Deviation 132.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 40 | -24.8 cells/µL | Standard Deviation 103.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 20 | -15.1 cells/µL | Standard Deviation 86 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 32 | -14.3 cells/µL | Standard Deviation 106.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 20 | -75.4 cells/µL | Standard Deviation 216.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 32 | -75.8 cells/µL | Standard Deviation 225.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 24 | -77.2 cells/µL | Standard Deviation 231.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 28 | -69.6 cells/µL | Standard Deviation 206.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 8 | -29.4 cells/µL | Standard Deviation 183.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 48 | -82.4 cells/µL | Standard Deviation 243.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 12 | -48.1 cells/µL | Standard Deviation 207.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 40 | -68.6 cells/µL | Standard Deviation 211 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 16 | -50.1 cells/µL | Standard Deviation 201.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 4 | -31.2 cells/µL | Standard Deviation 177 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 2 | 12.3 cells/µL | Standard Deviation 76.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 40 | -26.9 cells/µL | Standard Deviation 83 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 2 | 24.8 cells/µL | Standard Deviation 71 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 4 | 9.2 cells/µL | Standard Deviation 60.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 8 | 8.7 cells/µL | Standard Deviation 70.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 12 | -17.9 cells/µL | Standard Deviation 77.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 16 | -10.0 cells/µL | Standard Deviation 92.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 20 | -2.5 cells/µL | Standard Deviation 57.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 24 | -20.3 cells/µL | Standard Deviation 72 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 28 | -13.1 cells/µL | Standard Deviation 84.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 32 | -10.4 cells/µL | Standard Deviation 93 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 48 | -15.5 cells/µL | Standard Deviation 83.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 20 | 2.7 cells/µL | Standard Deviation 132.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 48 | -41.2 cells/µL | Standard Deviation 120 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 32 | -20.9 cells/µL | Standard Deviation 168.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 16 | 13.2 cells/µL | Standard Deviation 147.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 12 | 53.2 cells/µL | Standard Deviation 203.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 8 | 19.4 cells/µL | Standard Deviation 146.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 40 | -46.9 cells/µL | Standard Deviation 138 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 4 | 82.8 cells/µL | Standard Deviation 154.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 2 | 63.4 cells/µL | Standard Deviation 133.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 28 | -13.0 cells/µL | Standard Deviation 123.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Week 24 | -1.1 cells/µL | Standard Deviation 135 |
Secondary
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 2 | 33.0 cells/µL | Standard Deviation 313.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 12 | -44.2 cells/µL | Standard Deviation 283.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 28 | -27.6 cells/µL | Standard Deviation 507.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 4 | -30.6 cells/µL | Standard Deviation 293.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 24 | -85.8 cells/µL | Standard Deviation 472.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 16 | -81.9 cells/µL | Standard Deviation 479.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 8 | -64.7 cells/µL | Standard Deviation 405.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 48 | -115.6 cells/µL | Standard Deviation 581.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 40 | -110.5 cells/µL | Standard Deviation 526.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 20 | -92.7 cells/µL | Standard Deviation 391.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 32 | -70.9 cells/µL | Standard Deviation 428.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 20 | -173.4 cells/µL | Standard Deviation 490.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 32 | -173.6 cells/µL | Standard Deviation 565.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 24 | -128.9 cells/µL | Standard Deviation 569.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 28 | -81.2 cells/µL | Standard Deviation 652.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 8 | -58.6 cells/µL | Standard Deviation 422.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 48 | -253.1 cells/µL | Standard Deviation 637 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 12 | -48.8 cells/µL | Standard Deviation 452.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 40 | -166.9 cells/µL | Standard Deviation 542.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 16 | -141.2 cells/µL | Standard Deviation 516.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 4 | -47.7 cells/µL | Standard Deviation 504.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 2 | 77.7 cells/µL | Standard Deviation 383.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 40 | -1.8 cells/µL | Standard Deviation 410.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 2 | 106.6 cells/µL | Standard Deviation 283.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 4 | 24.0 cells/µL | Standard Deviation 394.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 8 | -20.5 cells/µL | Standard Deviation 403.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 12 | -57.8 cells/µL | Standard Deviation 385.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 16 | -4.5 cells/µL | Standard Deviation 383.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 20 | 5.9 cells/µL | Standard Deviation 352.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 24 | -88.5 cells/µL | Standard Deviation 462.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 28 | 46.1 cells/µL | Standard Deviation 482.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 32 | 18.0 cells/µL | Standard Deviation 415 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 48 | 36.1 cells/µL | Standard Deviation 492.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 20 | -89.9 cells/µL | Standard Deviation 577.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 48 | 22.3 cells/µL | Standard Deviation 558 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 32 | -90.5 cells/µL | Standard Deviation 504 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 16 | -45.4 cells/µL | Standard Deviation 520.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 12 | 43.7 cells/µL | Standard Deviation 599.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 8 | 78.3 cells/µL | Standard Deviation 560 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 40 | 31.7 cells/µL | Standard Deviation 528.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 4 | 227.2 cells/µL | Standard Deviation 412.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 2 | 126.9 cells/µL | Standard Deviation 338.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 28 | 7.4 cells/µL | Standard Deviation 561.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Week 24 | -78.3 cells/µL | Standard Deviation 570.7 |
Secondary
Mean Change From Baseline in Creatine Kinase
Creatine Kinase was measured in units per liter (U/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 2 | -3.0 U/L | Standard Deviation 67.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 12 | -6.3 U/L | Standard Deviation 57.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 28 | -1.5 U/L | Standard Deviation 67.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 4 | 29.6 U/L | Standard Deviation 218.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 24 | -6.4 U/L | Standard Deviation 48.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 16 | 0.9 U/L | Standard Deviation 59.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 8 | -4.9 U/L | Standard Deviation 56.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 48 | 7.8 U/L | Standard Deviation 67.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 40 | 9.9 U/L | Standard Deviation 109.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 20 | -8.2 U/L | Standard Deviation 60 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 32 | 2.0 U/L | Standard Deviation 67 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 20 | 5.9 U/L | Standard Deviation 149.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 32 | -10.0 U/L | Standard Deviation 167 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 24 | -5.4 U/L | Standard Deviation 123.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 28 | -19.1 U/L | Standard Deviation 131.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 8 | -8.5 U/L | Standard Deviation 52.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 48 | -20.4 U/L | Standard Deviation 138.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 12 | -8.4 U/L | Standard Deviation 85.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 40 | -20.4 U/L | Standard Deviation 131.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 16 | -11.5 U/L | Standard Deviation 105.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 4 | -6.2 U/L | Standard Deviation 54.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 2 | -2.2 U/L | Standard Deviation 55.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 40 | -2.7 U/L | Standard Deviation 25.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 2 | -2.2 U/L | Standard Deviation 18.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 4 | 3.2 U/L | Standard Deviation 22 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 8 | -1.5 U/L | Standard Deviation 23.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 12 | -3.0 U/L | Standard Deviation 22.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 16 | -7.5 U/L | Standard Deviation 22.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 20 | -3.5 U/L | Standard Deviation 22.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 24 | -2.6 U/L | Standard Deviation 27.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 28 | -0.7 U/L | Standard Deviation 25.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 32 | 34.0 U/L | Standard Deviation 222.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 48 | -3.6 U/L | Standard Deviation 25.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 20 | -33.4 U/L | Standard Deviation 95.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 48 | -33.4 U/L | Standard Deviation 106.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 32 | -24.2 U/L | Standard Deviation 91.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 16 | -23.2 U/L | Standard Deviation 106.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 12 | -29.4 U/L | Standard Deviation 80.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 8 | -4.6 U/L | Standard Deviation 122.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 40 | -16.3 U/L | Standard Deviation 106.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 4 | -16.9 U/L | Standard Deviation 56.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 2 | 0.1 U/L | Standard Deviation 46.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 28 | -36.7 U/L | Standard Deviation 103.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatine Kinase | Week 24 | -27.7 U/L | Standard Deviation 98.9 |
Secondary
Mean Change From Baseline in Creatinine
Creatinine was measured in micromols per liter (µmol/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 2 | 0.9 μmol/L | Standard Deviation 9.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 12 | -0.3 μmol/L | Standard Deviation 7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 28 | 2.5 μmol/L | Standard Deviation 10 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 4 | -0.8 μmol/L | Standard Deviation 8.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 24 | 0.0 μmol/L | Standard Deviation 8.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 16 | -0.1 μmol/L | Standard Deviation 9.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 8 | 0.5 μmol/L | Standard Deviation 7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 48 | 1.9 μmol/L | Standard Deviation 10.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 40 | 2.3 μmol/L | Standard Deviation 9.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 20 | 0.7 μmol/L | Standard Deviation 8.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 32 | 5.5 μmol/L | Standard Deviation 35.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 20 | 1.4 μmol/L | Standard Deviation 10.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 32 | 0.5 μmol/L | Standard Deviation 8.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 24 | 0.8 μmol/L | Standard Deviation 8.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 28 | 2.7 μmol/L | Standard Deviation 10 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 8 | 0.3 μmol/L | Standard Deviation 7.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 48 | 0.7 μmol/L | Standard Deviation 7.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 12 | 1.4 μmol/L | Standard Deviation 7.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 40 | 2.2 μmol/L | Standard Deviation 8.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 16 | 1.0 μmol/L | Standard Deviation 8.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 4 | -0.2 μmol/L | Standard Deviation 9.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 2 | -0.1 μmol/L | Standard Deviation 8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 40 | 3.9 μmol/L | Standard Deviation 6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 2 | 1.5 μmol/L | Standard Deviation 5.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 4 | -0.6 μmol/L | Standard Deviation 7.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 8 | -0.5 μmol/L | Standard Deviation 6.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 12 | -0.4 μmol/L | Standard Deviation 6.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 16 | 0.7 μmol/L | Standard Deviation 6.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 20 | 0.8 μmol/L | Standard Deviation 6.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 24 | 0.3 μmol/L | Standard Deviation 6.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 28 | 1.0 μmol/L | Standard Deviation 7.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 32 | 3.6 μmol/L | Standard Deviation 7.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 48 | 2.5 μmol/L | Standard Deviation 5.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 20 | -0.3 μmol/L | Standard Deviation 7.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 48 | 2.9 μmol/L | Standard Deviation 9.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 32 | 1.6 μmol/L | Standard Deviation 11.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 16 | -1.1 μmol/L | Standard Deviation 9.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 12 | -0.7 μmol/L | Standard Deviation 8.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 8 | 0.1 μmol/L | Standard Deviation 8.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 40 | 3.0 μmol/L | Standard Deviation 8.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 4 | -1.4 μmol/L | Standard Deviation 8.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 2 | 0.6 μmol/L | Standard Deviation 7.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 28 | -0.9 μmol/L | Standard Deviation 7.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Creatinine | Week 24 | 0.9 μmol/L | Standard Deviation 9.7 |
Secondary
Mean Change From Baseline in Diastolic Blood Pressure
Blood pressure was measured in millimetre of mercury (mmHg).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 28 | 1.5 mmHg | Standard Deviation 9.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 24 | 1.9 mmHg | Standard Deviation 11.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 12 | -0.9 mmHg | Standard Deviation 8.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 48 | 1.4 mmHg | Standard Deviation 9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 20 | 1.5 mmHg | Standard Deviation 8.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 16 | -0.3 mmHg | Standard Deviation 8.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 40 | 1.0 mmHg | Standard Deviation 9.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 2 | 2.1 mmHg | Standard Deviation 10.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 6 | 1.0 mmHg | Standard Deviation 10 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 44 | 0.8 mmHg | Standard Deviation 10.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 36 | 3.4 mmHg | Standard Deviation 9.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 32 | 2.3 mmHg | Standard Deviation 10.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 8 | 1.1 mmHg | Standard Deviation 9.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 4 | -0.7 mmHg | Standard Deviation 7.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 36 | 1.4 mmHg | Standard Deviation 10.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 2 | 1.4 mmHg | Standard Deviation 8.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 4 | -1.5 mmHg | Standard Deviation 6.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 6 | 1.5 mmHg | Standard Deviation 8.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 8 | 0.4 mmHg | Standard Deviation 9.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 12 | -0.3 mmHg | Standard Deviation 6.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 16 | -1.3 mmHg | Standard Deviation 7.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 20 | -1.1 mmHg | Standard Deviation 8.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 24 | 1.6 mmHg | Standard Deviation 8.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 28 | -0.2 mmHg | Standard Deviation 8.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 32 | 2.8 mmHg | Standard Deviation 9.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 40 | 2.6 mmHg | Standard Deviation 7.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 44 | 1.5 mmHg | Standard Deviation 8.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 48 | 2.3 mmHg | Standard Deviation 8.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 36 | 1.4 mmHg | Standard Deviation 8.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 44 | 0.4 mmHg | Standard Deviation 9.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 4 | -1.7 mmHg | Standard Deviation 8.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 8 | 0.1 mmHg | Standard Deviation 8.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 40 | 0.5 mmHg | Standard Deviation 9.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 2 | 1.5 mmHg | Standard Deviation 9.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 32 | 0.7 mmHg | Standard Deviation 10.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 24 | 2.3 mmHg | Standard Deviation 10.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 16 | -0.7 mmHg | Standard Deviation 9.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 6 | 1.8 mmHg | Standard Deviation 10 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 12 | -2.2 mmHg | Standard Deviation 9.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 48 | 1.1 mmHg | Standard Deviation 9.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 20 | -0.7 mmHg | Standard Deviation 9.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 28 | 1.4 mmHg | Standard Deviation 8.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 20 | 0.9 mmHg | Standard Deviation 8.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 24 | 0.6 mmHg | Standard Deviation 8.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 44 | 2.2 mmHg | Standard Deviation 10.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 28 | 2.5 mmHg | Standard Deviation 8.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 6 | 1.9 mmHg | Standard Deviation 7.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 32 | 2.3 mmHg | Standard Deviation 8.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 4 | -0.1 mmHg | Standard Deviation 8.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 36 | 2.2 mmHg | Standard Deviation 8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 48 | 2.4 mmHg | Standard Deviation 8.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 40 | 3.6 mmHg | Standard Deviation 8.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 12 | -0.3 mmHg | Standard Deviation 6.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 2 | 2.4 mmHg | Standard Deviation 8.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 16 | -0.1 mmHg | Standard Deviation 7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Diastolic Blood Pressure | Week 8 | 1.0 mmHg | Standard Deviation 8 |
Secondary
Mean Change From Baseline in Direct Bilirubin
Direct Bilirubin was measured in micromols per liter (µmol/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 2 | 0.03 μmol/L | Standard Deviation 0.92 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 12 | 0.15 μmol/L | Standard Deviation 0.99 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 28 | 0.06 μmol/L | Standard Deviation 1.06 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 4 | 0.10 μmol/L | Standard Deviation 1.03 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 24 | 0.05 μmol/L | Standard Deviation 1.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 16 | 0.18 μmol/L | Standard Deviation 0.81 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 8 | 0.03 μmol/L | Standard Deviation 0.91 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 48 | 0.31 μmol/L | Standard Deviation 1.34 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 40 | 0.07 μmol/L | Standard Deviation 1.31 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 20 | -0.04 μmol/L | Standard Deviation 0.95 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 32 | 0.12 μmol/L | Standard Deviation 1.16 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 20 | 0.07 μmol/L | Standard Deviation 0.91 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 32 | 0.05 μmol/L | Standard Deviation 0.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 24 | 0.14 μmol/L | Standard Deviation 0.95 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 28 | -0.06 μmol/L | Standard Deviation 1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 8 | -0.18 μmol/L | Standard Deviation 0.55 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 48 | -0.05 μmol/L | Standard Deviation 1.01 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 12 | -0.07 μmol/L | Standard Deviation 0.95 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 40 | 0.03 μmol/L | Standard Deviation 0.76 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 16 | -0.01 μmol/L | Standard Deviation 0.66 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 4 | 0.03 μmol/L | Standard Deviation 0.75 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 2 | -0.06 μmol/L | Standard Deviation 0.92 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 40 | 0.23 μmol/L | Standard Deviation 1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 2 | 0.09 μmol/L | Standard Deviation 1.12 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 4 | -0.04 μmol/L | Standard Deviation 0.82 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 8 | -0.17 μmol/L | Standard Deviation 0.86 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 12 | -0.01 μmol/L | Standard Deviation 1.06 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 16 | -0.07 μmol/L | Standard Deviation 1.04 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 20 | 0.02 μmol/L | Standard Deviation 0.94 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 24 | 0.08 μmol/L | Standard Deviation 1.02 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 28 | 0.11 μmol/L | Standard Deviation 0.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 32 | 0.21 μmol/L | Standard Deviation 1.21 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 48 | 0.20 μmol/L | Standard Deviation 1.25 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 20 | 0.00 μmol/L | Standard Deviation 1.19 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 48 | 0.08 μmol/L | Standard Deviation 0.98 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 32 | -0.04 μmol/L | Standard Deviation 1.36 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 16 | -0.01 μmol/L | Standard Deviation 1.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 12 | -0.05 μmol/L | Standard Deviation 1.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 8 | 0.03 μmol/L | Standard Deviation 1.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 40 | 0.07 μmol/L | Standard Deviation 1.05 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 4 | -0.10 μmol/L | Standard Deviation 0.93 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 2 | -0.24 μmol/L | Standard Deviation 1.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 28 | -0.06 μmol/L | Standard Deviation 1.15 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Direct Bilirubin | Week 24 | -0.08 μmol/L | Standard Deviation 1.25 |
Secondary
Mean Change From Baseline in Eosinophils
Eosinophils was measured in number of eosinophils per liter (10\^9/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 2 | -0.01 10^9 eosinophils per liter | Standard Deviation 0.04 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 12 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.04 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 28 | -0.01 10^9 eosinophils per liter | Standard Deviation 0.04 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 4 | -0.01 10^9 eosinophils per liter | Standard Deviation 0.04 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 24 | -0.01 10^9 eosinophils per liter | Standard Deviation 0.05 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 16 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.05 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 8 | -0.01 10^9 eosinophils per liter | Standard Deviation 0.04 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 48 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.04 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 40 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.05 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 20 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.05 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 32 | -0.01 10^9 eosinophils per liter | Standard Deviation 0.06 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 20 | 0.04 10^9 eosinophils per liter | Standard Deviation 0.24 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 32 | 0.01 10^9 eosinophils per liter | Standard Deviation 0.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 24 | 0.04 10^9 eosinophils per liter | Standard Deviation 0.15 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 28 | 0.01 10^9 eosinophils per liter | Standard Deviation 0.07 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 8 | 0.03 10^9 eosinophils per liter | Standard Deviation 0.16 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 48 | -0.01 10^9 eosinophils per liter | Standard Deviation 0.05 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 12 | 0.04 10^9 eosinophils per liter | Standard Deviation 0.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 40 | 0.01 10^9 eosinophils per liter | Standard Deviation 0.06 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 16 | 0.02 10^9 eosinophils per liter | Standard Deviation 0.11 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 4 | -0.01 10^9 eosinophils per liter | Standard Deviation 0.06 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 2 | 0.01 10^9 eosinophils per liter | Standard Deviation 0.06 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 40 | 0.02 10^9 eosinophils per liter | Standard Deviation 0.06 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 2 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.09 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 4 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.04 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 8 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.04 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 12 | 0.02 10^9 eosinophils per liter | Standard Deviation 0.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 16 | 0.01 10^9 eosinophils per liter | Standard Deviation 0.05 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 20 | 0.01 10^9 eosinophils per liter | Standard Deviation 0.05 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 24 | 0.02 10^9 eosinophils per liter | Standard Deviation 0.07 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 28 | 0.01 10^9 eosinophils per liter | Standard Deviation 0.05 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 32 | 0.01 10^9 eosinophils per liter | Standard Deviation 0.05 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 48 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.06 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 20 | -0.01 10^9 eosinophils per liter | Standard Deviation 0.05 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 48 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.06 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 32 | -0.02 10^9 eosinophils per liter | Standard Deviation 0.04 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 16 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.06 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 12 | 0.02 10^9 eosinophils per liter | Standard Deviation 0.17 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 8 | 0.01 10^9 eosinophils per liter | Standard Deviation 0.07 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 40 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.07 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 4 | -0.01 10^9 eosinophils per liter | Standard Deviation 0.04 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 2 | -0.01 10^9 eosinophils per liter | Standard Deviation 0.05 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 28 | 0.00 10^9 eosinophils per liter | Standard Deviation 0.06 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils | Week 24 | -0.02 10^9 eosinophils per liter | Standard Deviation 0.06 |
Secondary
Mean Change From Baseline in Eosinophils/Leukocytes
Eosinophils/Leukocytes was measured in percentages (%).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 2 | -0.19 % of Eosinophils per Leukocytes | Standard Deviation 1.07 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 12 | 0.18 % of Eosinophils per Leukocytes | Standard Deviation 1.03 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 28 | 0.06 % of Eosinophils per Leukocytes | Standard Deviation 1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 4 | -0.32 % of Eosinophils per Leukocytes | Standard Deviation 0.96 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 24 | 0.11 % of Eosinophils per Leukocytes | Standard Deviation 1.16 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 16 | 0.06 % of Eosinophils per Leukocytes | Standard Deviation 1.05 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 8 | -0.05 % of Eosinophils per Leukocytes | Standard Deviation 1.09 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 48 | 0.09 % of Eosinophils per Leukocytes | Standard Deviation 1.02 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 40 | -0.10 % of Eosinophils per Leukocytes | Standard Deviation 0.85 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 20 | 0.04 % of Eosinophils per Leukocytes | Standard Deviation 1.11 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 32 | 0.02 % of Eosinophils per Leukocytes | Standard Deviation 1.09 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 20 | 0.83 % of Eosinophils per Leukocytes | Standard Deviation 3.58 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 32 | 0.28 % of Eosinophils per Leukocytes | Standard Deviation 1.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 24 | 0.82 % of Eosinophils per Leukocytes | Standard Deviation 2.89 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 28 | 0.21 % of Eosinophils per Leukocytes | Standard Deviation 1.33 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 8 | 0.54 % of Eosinophils per Leukocytes | Standard Deviation 2.13 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 48 | -0.17 % of Eosinophils per Leukocytes | Standard Deviation 1.08 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 12 | 0.70 % of Eosinophils per Leukocytes | Standard Deviation 3.12 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 40 | 0.05 % of Eosinophils per Leukocytes | Standard Deviation 1.09 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 16 | 0.36 % of Eosinophils per Leukocytes | Standard Deviation 1.24 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 4 | -0.05 % of Eosinophils per Leukocytes | Standard Deviation 1.26 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 2 | 0.07 % of Eosinophils per Leukocytes | Standard Deviation 0.86 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 40 | 0.40 % of Eosinophils per Leukocytes | Standard Deviation 1.23 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 2 | -0.18 % of Eosinophils per Leukocytes | Standard Deviation 1.13 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 4 | -0.12 % of Eosinophils per Leukocytes | Standard Deviation 1.01 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 8 | 0.10 % of Eosinophils per Leukocytes | Standard Deviation 1.11 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 12 | 0.33 % of Eosinophils per Leukocytes | Standard Deviation 1.68 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 16 | 0.20 % of Eosinophils per Leukocytes | Standard Deviation 1.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 20 | 0.11 % of Eosinophils per Leukocytes | Standard Deviation 1.24 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 24 | -0.01 % of Eosinophils per Leukocytes | Standard Deviation 1.22 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 28 | 0.18 % of Eosinophils per Leukocytes | Standard Deviation 1.02 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 32 | 0.16 % of Eosinophils per Leukocytes | Standard Deviation 1.13 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 48 | 0.06 % of Eosinophils per Leukocytes | Standard Deviation 0.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 20 | -0.39 % of Eosinophils per Leukocytes | Standard Deviation 1.29 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 48 | 0.24 % of Eosinophils per Leukocytes | Standard Deviation 1.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 32 | -0.20 % of Eosinophils per Leukocytes | Standard Deviation 1.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 16 | -0.11 % of Eosinophils per Leukocytes | Standard Deviation 1.33 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 12 | 0.05 % of Eosinophils per Leukocytes | Standard Deviation 1.83 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 8 | 0.22 % of Eosinophils per Leukocytes | Standard Deviation 1.89 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 40 | -0.09 % of Eosinophils per Leukocytes | Standard Deviation 1.47 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 4 | -0.26 % of Eosinophils per Leukocytes | Standard Deviation 0.94 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 2 | -0.29 % of Eosinophils per Leukocytes | Standard Deviation 1.22 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 28 | -0.03 % of Eosinophils per Leukocytes | Standard Deviation 1.35 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Eosinophils/Leukocytes | Week 24 | 0.06 % of Eosinophils per Leukocytes | Standard Deviation 1.63 |
Secondary
Mean Change From Baseline in Erythrocytes
Erythrocytes was measured in number of erythrocytes per liter (10\^12/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 2 | -0.004 10^12 erythrocytes per liter | Standard Deviation 0.246 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 12 | -0.024 10^12 erythrocytes per liter | Standard Deviation 0.271 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 28 | 0.018 10^12 erythrocytes per liter | Standard Deviation 0.34 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 4 | -0.080 10^12 erythrocytes per liter | Standard Deviation 0.243 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 24 | 0.005 10^12 erythrocytes per liter | Standard Deviation 0.308 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 16 | -0.002 10^12 erythrocytes per liter | Standard Deviation 0.312 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 8 | -0.039 10^12 erythrocytes per liter | Standard Deviation 0.224 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 48 | -0.024 10^12 erythrocytes per liter | Standard Deviation 0.332 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 40 | -0.005 10^12 erythrocytes per liter | Standard Deviation 0.343 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 20 | -0.029 10^12 erythrocytes per liter | Standard Deviation 0.333 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 32 | 0.048 10^12 erythrocytes per liter | Standard Deviation 0.32 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 20 | 0.062 10^12 erythrocytes per liter | Standard Deviation 0.309 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 32 | 0.001 10^12 erythrocytes per liter | Standard Deviation 0.284 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 24 | 0.036 10^12 erythrocytes per liter | Standard Deviation 0.312 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 28 | -0.040 10^12 erythrocytes per liter | Standard Deviation 0.304 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 8 | -0.039 10^12 erythrocytes per liter | Standard Deviation 0.28 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 48 | -0.018 10^12 erythrocytes per liter | Standard Deviation 0.295 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 12 | 0.014 10^12 erythrocytes per liter | Standard Deviation 0.292 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 40 | 0.042 10^12 erythrocytes per liter | Standard Deviation 0.382 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 16 | 0.041 10^12 erythrocytes per liter | Standard Deviation 0.36 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 4 | -0.018 10^12 erythrocytes per liter | Standard Deviation 0.293 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 2 | -0.035 10^12 erythrocytes per liter | Standard Deviation 0.237 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 40 | 0.054 10^12 erythrocytes per liter | Standard Deviation 0.368 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 2 | -0.032 10^12 erythrocytes per liter | Standard Deviation 0.223 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 4 | -0.052 10^12 erythrocytes per liter | Standard Deviation 0.273 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 8 | -0.069 10^12 erythrocytes per liter | Standard Deviation 0.262 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 12 | -0.010 10^12 erythrocytes per liter | Standard Deviation 0.267 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 16 | 0.000 10^12 erythrocytes per liter | Standard Deviation 0.302 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 20 | -0.001 10^12 erythrocytes per liter | Standard Deviation 0.325 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 24 | 0.013 10^12 erythrocytes per liter | Standard Deviation 0.319 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 28 | 0.019 10^12 erythrocytes per liter | Standard Deviation 0.346 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 32 | 0.032 10^12 erythrocytes per liter | Standard Deviation 0.289 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 48 | 0.017 10^12 erythrocytes per liter | Standard Deviation 0.299 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 20 | -0.047 10^12 erythrocytes per liter | Standard Deviation 0.302 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 48 | -0.028 10^12 erythrocytes per liter | Standard Deviation 0.245 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 32 | 0.027 10^12 erythrocytes per liter | Standard Deviation 0.277 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 16 | -0.051 10^12 erythrocytes per liter | Standard Deviation 0.265 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 12 | 0.019 10^12 erythrocytes per liter | Standard Deviation 0.226 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 8 | -0.044 10^12 erythrocytes per liter | Standard Deviation 0.242 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 40 | 0.060 10^12 erythrocytes per liter | Standard Deviation 0.256 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 4 | -0.033 10^12 erythrocytes per liter | Standard Deviation 0.21 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 2 | -0.028 10^12 erythrocytes per liter | Standard Deviation 0.237 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 28 | -0.050 10^12 erythrocytes per liter | Standard Deviation 0.27 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes | Week 24 | -0.038 10^12 erythrocytes per liter | Standard Deviation 0.24 |
Secondary
Mean Change From Baseline in Erythrocytes (/HPF)
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 2 | -6.8 % of Erythrocytes per HPF | Standard Deviation 53.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 12 | -8.6 % of Erythrocytes per HPF | Standard Deviation 52.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 28 | -7.6 % of Erythrocytes per HPF | Standard Deviation 51.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 4 | -8.7 % of Erythrocytes per HPF | Standard Deviation 52.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 24 | -7.2 % of Erythrocytes per HPF | Standard Deviation 53.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 16 | -5.7 % of Erythrocytes per HPF | Standard Deviation 48 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 8 | -8.7 % of Erythrocytes per HPF | Standard Deviation 53.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 48 | -9.7 % of Erythrocytes per HPF | Standard Deviation 56.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 40 | -9.1 % of Erythrocytes per HPF | Standard Deviation 53.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 20 | -7.7 % of Erythrocytes per HPF | Standard Deviation 53.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 32 | -8.5 % of Erythrocytes per HPF | Standard Deviation 52.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 20 | -1.0 % of Erythrocytes per HPF | Standard Deviation 3.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 32 | 4.9 % of Erythrocytes per HPF | Standard Deviation 41.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 24 | -1.2 % of Erythrocytes per HPF | Standard Deviation 3.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 28 | -1.3 % of Erythrocytes per HPF | Standard Deviation 4.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 8 | -0.3 % of Erythrocytes per HPF | Standard Deviation 6.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 48 | -0.4 % of Erythrocytes per HPF | Standard Deviation 5.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 12 | 1.3 % of Erythrocytes per HPF | Standard Deviation 17.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 40 | 3.5 % of Erythrocytes per HPF | Standard Deviation 18.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 16 | -1.3 % of Erythrocytes per HPF | Standard Deviation 4.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 4 | -0.8 % of Erythrocytes per HPF | Standard Deviation 4.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 2 | 0.1 % of Erythrocytes per HPF | Standard Deviation 8.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 40 | -0.5 % of Erythrocytes per HPF | Standard Deviation 3.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 2 | 0.2 % of Erythrocytes per HPF | Standard Deviation 2.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 4 | 1.4 % of Erythrocytes per HPF | Standard Deviation 10.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 8 | 0.4 % of Erythrocytes per HPF | Standard Deviation 6.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 12 | -0.4 % of Erythrocytes per HPF | Standard Deviation 2.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 16 | -0.6 % of Erythrocytes per HPF | Standard Deviation 2.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 20 | -0.1 % of Erythrocytes per HPF | Standard Deviation 3.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 24 | -0.3 % of Erythrocytes per HPF | Standard Deviation 2.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 28 | -0.7 % of Erythrocytes per HPF | Standard Deviation 2.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 32 | 0.0 % of Erythrocytes per HPF | Standard Deviation 3.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 48 | 1.9 % of Erythrocytes per HPF | Standard Deviation 15.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 20 | -0.6 % of Erythrocytes per HPF | Standard Deviation 4.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 48 | 0.1 % of Erythrocytes per HPF | Standard Deviation 4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 32 | 0.1 % of Erythrocytes per HPF | Standard Deviation 4.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 16 | -0.5 % of Erythrocytes per HPF | Standard Deviation 5.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 12 | 17.4 % of Erythrocytes per HPF | Standard Deviation 118.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 8 | 0.0 % of Erythrocytes per HPF | Standard Deviation 6.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 40 | 0.4 % of Erythrocytes per HPF | Standard Deviation 5.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 4 | -0.6 % of Erythrocytes per HPF | Standard Deviation 3.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 2 | 0.9 % of Erythrocytes per HPF | Standard Deviation 7.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 28 | 3.0 % of Erythrocytes per HPF | Standard Deviation 16.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes (/HPF) | Week 24 | -0.9 % of Erythrocytes per HPF | Standard Deviation 4.6 |
Secondary
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 2 | 0.12 Picograms (pg) | Standard Deviation 0.71 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 12 | 0.04 Picograms (pg) | Standard Deviation 1.08 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 28 | 0.01 Picograms (pg) | Standard Deviation 1.68 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 4 | 0.31 Picograms (pg) | Standard Deviation 0.63 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 24 | -0.13 Picograms (pg) | Standard Deviation 1.57 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 16 | 0.03 Picograms (pg) | Standard Deviation 1.43 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 8 | 0.20 Picograms (pg) | Standard Deviation 0.87 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 48 | 0.02 Picograms (pg) | Standard Deviation 2.58 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 40 | 0.17 Picograms (pg) | Standard Deviation 2.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 20 | 0.00 Picograms (pg) | Standard Deviation 1.49 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 32 | 0.01 Picograms (pg) | Standard Deviation 2.12 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 20 | -0.39 Picograms (pg) | Standard Deviation 1.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 32 | -0.33 Picograms (pg) | Standard Deviation 1.28 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 24 | -0.43 Picograms (pg) | Standard Deviation 1.39 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 28 | -0.55 Picograms (pg) | Standard Deviation 1.45 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 8 | -0.25 Picograms (pg) | Standard Deviation 0.87 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 48 | -0.21 Picograms (pg) | Standard Deviation 1.48 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 12 | -0.25 Picograms (pg) | Standard Deviation 1.03 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 40 | -0.40 Picograms (pg) | Standard Deviation 1.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 16 | -0.36 Picograms (pg) | Standard Deviation 1.31 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 4 | -0.06 Picograms (pg) | Standard Deviation 0.79 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 2 | -0.18 Picograms (pg) | Standard Deviation 0.65 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 40 | 0.03 Picograms (pg) | Standard Deviation 2.32 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 2 | 0.04 Picograms (pg) | Standard Deviation 0.43 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 4 | 0.04 Picograms (pg) | Standard Deviation 0.64 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 8 | 0.04 Picograms (pg) | Standard Deviation 0.81 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 12 | -0.09 Picograms (pg) | Standard Deviation 1.25 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 16 | -0.20 Picograms (pg) | Standard Deviation 1.52 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 20 | -0.10 Picograms (pg) | Standard Deviation 1.63 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 24 | -0.25 Picograms (pg) | Standard Deviation 1.96 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 28 | -0.15 Picograms (pg) | Standard Deviation 2.09 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 32 | -0.06 Picograms (pg) | Standard Deviation 2.39 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 48 | 0.06 Picograms (pg) | Standard Deviation 2.55 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 20 | -0.26 Picograms (pg) | Standard Deviation 1.24 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 48 | 0.10 Picograms (pg) | Standard Deviation 1.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 32 | -0.48 Picograms (pg) | Standard Deviation 1.63 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 16 | -0.31 Picograms (pg) | Standard Deviation 1.19 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 12 | -0.12 Picograms (pg) | Standard Deviation 0.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 8 | -0.04 Picograms (pg) | Standard Deviation 0.74 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 40 | -0.09 Picograms (pg) | Standard Deviation 2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 4 | 0.02 Picograms (pg) | Standard Deviation 0.65 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 2 | 0.00 Picograms (pg) | Standard Deviation 0.47 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 28 | -0.44 Picograms (pg) | Standard Deviation 1.68 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Week 24 | -0.44 Picograms (pg) | Standard Deviation 1.42 |
Secondary
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 2 | -2.3 g/L | Standard Deviation 9.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 12 | 0.5 g/L | Standard Deviation 11.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 28 | 1.6 g/L | Standard Deviation 13.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 4 | 1.4 g/L | Standard Deviation 8.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 24 | 0.0 g/L | Standard Deviation 13.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 16 | 1.6 g/L | Standard Deviation 13.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 8 | 1.7 g/L | Standard Deviation 11.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 48 | 3.6 g/L | Standard Deviation 17.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 40 | 3.4 g/L | Standard Deviation 17.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 20 | 1.6 g/L | Standard Deviation 12.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 32 | 1.7 g/L | Standard Deviation 18.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 20 | -0.9 g/L | Standard Deviation 11.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 32 | 1.1 g/L | Standard Deviation 13.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 24 | 1.0 g/L | Standard Deviation 13.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 28 | -1.3 g/L | Standard Deviation 14.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 8 | -3.8 g/L | Standard Deviation 13.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 48 | -0.6 g/L | Standard Deviation 16.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 12 | -0.6 g/L | Standard Deviation 10.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 40 | 0.8 g/L | Standard Deviation 16.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 16 | -1.5 g/L | Standard Deviation 10.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 4 | -0.9 g/L | Standard Deviation 10.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 2 | -2.6 g/L | Standard Deviation 10.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 40 | 0.1 g/L | Standard Deviation 15.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 2 | 0.7 g/L | Standard Deviation 9.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 4 | 2.7 g/L | Standard Deviation 8.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 8 | 2.1 g/L | Standard Deviation 8.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 12 | 0.6 g/L | Standard Deviation 12.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 16 | 2.3 g/L | Standard Deviation 11.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 20 | 2.4 g/L | Standard Deviation 11.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 24 | 0.4 g/L | Standard Deviation 12.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 28 | 1.7 g/L | Standard Deviation 13.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 32 | 1.2 g/L | Standard Deviation 15 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 48 | 2.9 g/L | Standard Deviation 14.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 20 | 0.4 g/L | Standard Deviation 12.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 48 | 0.0 g/L | Standard Deviation 13.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 32 | -1.4 g/L | Standard Deviation 16 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 16 | -0.2 g/L | Standard Deviation 14.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 12 | 0.5 g/L | Standard Deviation 12.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 8 | -0.1 g/L | Standard Deviation 11.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 40 | 0.1 g/L | Standard Deviation 15.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 4 | -1.2 g/L | Standard Deviation 12.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 2 | -1.9 g/L | Standard Deviation 10.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 28 | -0.6 g/L | Standard Deviation 16.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration | Week 24 | -1.2 g/L | Standard Deviation 13.1 |
Secondary
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 2 | 1.01 Femtolitres (fL) | Standard Deviation 2.28 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 12 | 0.06 Femtolitres (fL) | Standard Deviation 3.57 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 28 | -0.33 Femtolitres (fL) | Standard Deviation 3.61 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 4 | 0.60 Femtolitres (fL) | Standard Deviation 2.35 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 24 | -0.23 Femtolitres (fL) | Standard Deviation 3.83 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 16 | -0.25 Femtolitres (fL) | Standard Deviation 3.41 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 8 | 0.23 Femtolitres (fL) | Standard Deviation 3.48 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 48 | -0.98 Femtolitres (fL) | Standard Deviation 5.34 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 40 | -0.36 Femtolitres (fL) | Standard Deviation 5.34 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 20 | -0.37 Femtolitres (fL) | Standard Deviation 3.73 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 32 | -0.27 Femtolitres (fL) | Standard Deviation 4.45 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 20 | -0.92 Femtolitres (fL) | Standard Deviation 4.58 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 32 | -1.33 Femtolitres (fL) | Standard Deviation 4.32 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 24 | -1.63 Femtolitres (fL) | Standard Deviation 4.07 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 28 | -1.40 Femtolitres (fL) | Standard Deviation 4.61 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 8 | -0.30 Femtolitres (fL) | Standard Deviation 5.36 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 48 | -0.50 Femtolitres (fL) | Standard Deviation 4.97 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 12 | -0.52 Femtolitres (fL) | Standard Deviation 3.44 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 40 | -1.46 Femtolitres (fL) | Standard Deviation 4.72 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 16 | -0.65 Femtolitres (fL) | Standard Deviation 4.38 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 4 | 0.08 Femtolitres (fL) | Standard Deviation 2.66 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 2 | 0.24 Femtolitres (fL) | Standard Deviation 2.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 40 | 0.07 Femtolitres (fL) | Standard Deviation 6.27 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 2 | -0.09 Femtolitres (fL) | Standard Deviation 2.66 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 4 | -0.68 Femtolitres (fL) | Standard Deviation 2.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 8 | -0.54 Femtolitres (fL) | Standard Deviation 2.85 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 12 | -0.55 Femtolitres (fL) | Standard Deviation 4.67 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 16 | -1.38 Femtolitres (fL) | Standard Deviation 4.87 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 20 | -1.00 Femtolitres (fL) | Standard Deviation 5.01 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 24 | -0.92 Femtolitres (fL) | Standard Deviation 6.51 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 28 | -0.96 Femtolitres (fL) | Standard Deviation 6.46 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 32 | -0.45 Femtolitres (fL) | Standard Deviation 6.81 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 48 | -0.63 Femtolitres (fL) | Standard Deviation 6.92 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 20 | -0.97 Femtolitres (fL) | Standard Deviation 3.54 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 48 | 0.34 Femtolitres (fL) | Standard Deviation 4.31 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 32 | -1.06 Femtolitres (fL) | Standard Deviation 4.69 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 16 | -0.97 Femtolitres (fL) | Standard Deviation 3.62 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 12 | -0.57 Femtolitres (fL) | Standard Deviation 3.09 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 8 | -0.16 Femtolitres (fL) | Standard Deviation 2.79 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 40 | -0.24 Femtolitres (fL) | Standard Deviation 4.85 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 4 | 0.40 Femtolitres (fL) | Standard Deviation 3.02 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 2 | 0.45 Femtolitres (fL) | Standard Deviation 2.96 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 28 | -1.21 Femtolitres (fL) | Standard Deviation 4.91 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Week 24 | -1.05 Femtolitres (fL) | Standard Deviation 4 |
Secondary
Mean Change From Baseline in Gamma Glutamyl Transferase
Gamma Glutamyl Transferase was measured in units per liter (U/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 2 | 0.3 U/L | Standard Deviation 7.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 12 | 4.1 U/L | Standard Deviation 21 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 28 | 4.6 U/L | Standard Deviation 25.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 4 | 2.1 U/L | Standard Deviation 8.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 24 | 7.1 U/L | Standard Deviation 22 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 16 | 6.5 U/L | Standard Deviation 20.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 8 | 3.5 U/L | Standard Deviation 23 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 48 | 1.8 U/L | Standard Deviation 11.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 40 | 3.4 U/L | Standard Deviation 41.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 20 | 3.5 U/L | Standard Deviation 14.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 32 | 4.4 U/L | Standard Deviation 28.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 20 | 0.2 U/L | Standard Deviation 13.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 32 | 1.5 U/L | Standard Deviation 16.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 24 | 4.0 U/L | Standard Deviation 18.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 28 | 2.2 U/L | Standard Deviation 18.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 8 | 0.3 U/L | Standard Deviation 10.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 48 | 5.3 U/L | Standard Deviation 23.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 12 | 0.5 U/L | Standard Deviation 13.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 40 | 5.7 U/L | Standard Deviation 32.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 16 | 2.1 U/L | Standard Deviation 12.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 4 | -1.3 U/L | Standard Deviation 8.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 2 | 2.0 U/L | Standard Deviation 11.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 40 | 0.4 U/L | Standard Deviation 10.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 2 | 8.8 U/L | Standard Deviation 68.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 4 | 2.7 U/L | Standard Deviation 28.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 8 | -2.8 U/L | Standard Deviation 49.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 12 | -5.1 U/L | Standard Deviation 29.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 16 | -6.1 U/L | Standard Deviation 45 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 20 | -3.7 U/L | Standard Deviation 50.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 24 | -0.4 U/L | Standard Deviation 53.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 28 | -7.0 U/L | Standard Deviation 46.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 32 | -5.9 U/L | Standard Deviation 44.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 48 | 4.7 U/L | Standard Deviation 21.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 20 | -8.5 U/L | Standard Deviation 50.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 48 | -9.8 U/L | Standard Deviation 44.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 32 | -8.2 U/L | Standard Deviation 37.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 16 | -10.6 U/L | Standard Deviation 47.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 12 | -8.3 U/L | Standard Deviation 46.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 8 | -9.2 U/L | Standard Deviation 43.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 40 | -9.1 U/L | Standard Deviation 45.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 4 | -6.5 U/L | Standard Deviation 35.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 2 | -3.4 U/L | Standard Deviation 24.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 28 | 0.0 U/L | Standard Deviation 23.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Gamma Glutamyl Transferase | Week 24 | -9.5 U/L | Standard Deviation 47.2 |
Secondary
Mean Change From Baseline in Glucose
Glucose was measured in millimoles per liter (mmol/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 2 | 0.18 mmol/L | Standard Deviation 0.75 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 12 | -0.08 mmol/L | Standard Deviation 0.69 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 28 | 0.22 mmol/L | Standard Deviation 1.01 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 4 | 0.04 mmol/L | Standard Deviation 0.71 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 24 | -0.07 mmol/L | Standard Deviation 0.85 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 16 | 0.11 mmol/L | Standard Deviation 0.77 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 8 | 0.17 mmol/L | Standard Deviation 0.66 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 48 | -0.14 mmol/L | Standard Deviation 0.78 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 40 | -0.05 mmol/L | Standard Deviation 0.62 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 20 | 0.16 mmol/L | Standard Deviation 0.85 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 32 | -0.04 mmol/L | Standard Deviation 0.72 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 20 | 0.20 mmol/L | Standard Deviation 0.84 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 32 | -0.07 mmol/L | Standard Deviation 0.63 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 24 | 0.05 mmol/L | Standard Deviation 0.49 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 28 | 0.09 mmol/L | Standard Deviation 0.76 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 8 | 0.12 mmol/L | Standard Deviation 0.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 48 | -0.11 mmol/L | Standard Deviation 0.61 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 12 | 0.08 mmol/L | Standard Deviation 0.66 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 40 | 0.08 mmol/L | Standard Deviation 0.71 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 16 | 0.06 mmol/L | Standard Deviation 0.63 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 4 | 0.03 mmol/L | Standard Deviation 0.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 2 | 0.26 mmol/L | Standard Deviation 0.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 40 | -0.09 mmol/L | Standard Deviation 0.68 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 2 | 0.09 mmol/L | Standard Deviation 0.78 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 4 | -0.04 mmol/L | Standard Deviation 0.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 8 | 0.23 mmol/L | Standard Deviation 0.95 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 12 | -0.13 mmol/L | Standard Deviation 0.79 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 16 | 0.16 mmol/L | Standard Deviation 0.92 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 20 | 0.13 mmol/L | Standard Deviation 0.83 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 24 | -0.09 mmol/L | Standard Deviation 0.73 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 28 | -0.01 mmol/L | Standard Deviation 0.74 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 32 | -0.08 mmol/L | Standard Deviation 0.65 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 48 | -0.06 mmol/L | Standard Deviation 0.64 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 20 | -0.08 mmol/L | Standard Deviation 1.01 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 48 | -0.14 mmol/L | Standard Deviation 1.25 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 32 | 0.06 mmol/L | Standard Deviation 1.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 16 | -0.18 mmol/L | Standard Deviation 1.47 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 12 | -0.15 mmol/L | Standard Deviation 0.99 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 8 | 0.12 mmol/L | Standard Deviation 1.16 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 40 | -0.08 mmol/L | Standard Deviation 1.07 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 4 | 0.11 mmol/L | Standard Deviation 1.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 2 | 0.13 mmol/L | Standard Deviation 1.28 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 28 | 0.07 mmol/L | Standard Deviation 1.22 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Glucose | Week 24 | -0.22 mmol/L | Standard Deviation 1.06 |
Secondary
Mean Change From Baseline in Height
Height was measured in centimeters (cm).
Time frame: From Baseline (Week 1) to 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Height | NA cm |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Height | NA cm |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Height | NA cm |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Height | NA cm |
Secondary
Mean Change From Baseline in Hematocrit
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 2 | 0.42 volume % of red blood cells | Standard Deviation 2.52 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 12 | -0.23 volume % of red blood cells | Standard Deviation 2.67 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 28 | 0.03 volume % of red blood cells | Standard Deviation 2.98 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 4 | -0.46 volume % of red blood cells | Standard Deviation 2.29 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 24 | -0.09 volume % of red blood cells | Standard Deviation 2.61 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 16 | -0.12 volume % of red blood cells | Standard Deviation 2.86 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 8 | -0.27 volume % of red blood cells | Standard Deviation 2.23 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 48 | -0.59 volume % of red blood cells | Standard Deviation 3.51 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 40 | -0.20 volume % of red blood cells | Standard Deviation 3.32 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 20 | -0.41 volume % of red blood cells | Standard Deviation 3.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 32 | 0.29 volume % of red blood cells | Standard Deviation 2.89 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 20 | 0.13 volume % of red blood cells | Standard Deviation 2.99 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 32 | -0.62 volume % of red blood cells | Standard Deviation 2.86 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 24 | -0.40 volume % of red blood cells | Standard Deviation 3.19 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 28 | -1.02 volume % of red blood cells | Standard Deviation 3.23 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 8 | -0.12 volume % of red blood cells | Standard Deviation 2.94 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 48 | -0.37 volume % of red blood cells | Standard Deviation 3.58 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 12 | -0.13 volume % of red blood cells | Standard Deviation 2.72 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 40 | -0.24 volume % of red blood cells | Standard Deviation 4.37 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 16 | 0.05 volume % of red blood cells | Standard Deviation 3.25 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 4 | -0.17 volume % of red blood cells | Standard Deviation 2.75 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 2 | -0.25 volume % of red blood cells | Standard Deviation 2.26 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 40 | 0.58 volume % of red blood cells | Standard Deviation 4.11 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 2 | -0.32 volume % of red blood cells | Standard Deviation 2.37 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 4 | -0.79 volume % of red blood cells | Standard Deviation 2.92 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 8 | -0.86 volume % of red blood cells | Standard Deviation 2.72 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 12 | -0.32 volume % of red blood cells | Standard Deviation 3.39 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 16 | -0.57 volume % of red blood cells | Standard Deviation 3.32 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 20 | -0.42 volume % of red blood cells | Standard Deviation 3.32 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 24 | -0.29 volume % of red blood cells | Standard Deviation 3.14 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 28 | -0.22 volume % of red blood cells | Standard Deviation 3.99 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 32 | 0.17 volume % of red blood cells | Standard Deviation 3.43 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 48 | -0.08 volume % of red blood cells | Standard Deviation 3.21 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 20 | -0.80 volume % of red blood cells | Standard Deviation 2.83 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 48 | -0.11 volume % of red blood cells | Standard Deviation 2.54 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 32 | -0.21 volume % of red blood cells | Standard Deviation 2.82 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 16 | -0.84 volume % of red blood cells | Standard Deviation 2.95 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 12 | -0.02 volume % of red blood cells | Standard Deviation 2.54 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 8 | -0.42 volume % of red blood cells | Standard Deviation 2.31 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 40 | 0.37 volume % of red blood cells | Standard Deviation 2.72 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 4 | -0.11 volume % of red blood cells | Standard Deviation 2.31 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 2 | 0.00 volume % of red blood cells | Standard Deviation 2.71 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 28 | -0.89 volume % of red blood cells | Standard Deviation 2.47 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hematocrit | Week 24 | -0.76 volume % of red blood cells | Standard Deviation 2.33 |
Secondary
Mean Change From Baseline in Hemoglobin
Hemoglobin was measured in grams per liter (g/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 2 | 0.4 g/L | Standard Deviation 6.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 12 | -0.5 g/L | Standard Deviation 9.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 28 | 0.7 g/L | Standard Deviation 10.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 4 | -1.0 g/L | Standard Deviation 7.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 24 | -0.4 g/L | Standard Deviation 9.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 16 | 0.3 g/L | Standard Deviation 10.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 8 | -0.3 g/L | Standard Deviation 7.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 48 | -0.5 g/L | Standard Deviation 14.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 40 | 0.7 g/L | Standard Deviation 13.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 20 | -0.7 g/L | Standard Deviation 11.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 32 | 1.6 g/L | Standard Deviation 12.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 20 | 0.3 g/L | Standard Deviation 9.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 32 | -1.3 g/L | Standard Deviation 9.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 24 | -0.7 g/L | Standard Deviation 11.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 28 | -3.4 g/L | Standard Deviation 11 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 8 | -1.9 g/L | Standard Deviation 7.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 48 | -1.5 g/L | Standard Deviation 11.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 12 | -0.5 g/L | Standard Deviation 8.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 40 | -0.3 g/L | Standard Deviation 13.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 16 | -0.3 g/L | Standard Deviation 10 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 4 | -0.7 g/L | Standard Deviation 7.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 2 | -1.8 g/L | Standard Deviation 5.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 40 | 1.9 g/L | Standard Deviation 14.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 2 | -0.7 g/L | Standard Deviation 6.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 4 | -1.4 g/L | Standard Deviation 8.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 8 | -1.9 g/L | Standard Deviation 8.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 12 | -0.5 g/L | Standard Deviation 10.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 16 | -0.8 g/L | Standard Deviation 10.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 20 | -0.5 g/L | Standard Deviation 10.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 24 | -0.7 g/L | Standard Deviation 10.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 28 | 0.0 g/L | Standard Deviation 14.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 32 | 1.0 g/L | Standard Deviation 12.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 48 | 0.9 g/L | Standard Deviation 12.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 20 | -2.4 g/L | Standard Deviation 7.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 48 | -0.7 g/L | Standard Deviation 10 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 32 | -1.3 g/L | Standard Deviation 9.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 16 | -2.7 g/L | Standard Deviation 8.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 12 | 0.2 g/L | Standard Deviation 8.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 8 | -1.3 g/L | Standard Deviation 7.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 40 | 1.1 g/L | Standard Deviation 11 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 4 | -0.8 g/L | Standard Deviation 5.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 2 | -0.7 g/L | Standard Deviation 6.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 28 | -3.1 g/L | Standard Deviation 9.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Hemoglobin | Week 24 | -2.9 g/L | Standard Deviation 8.1 |
Secondary
Mean Change From Baseline in Lactate Dehydrogenase
Lactate Dehydrogenase was measured in units per liter (U/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 2 | -3.3 U/L | Standard Deviation 27.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 12 | 3.0 U/L | Standard Deviation 28.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 28 | 0.0 U/L | Standard Deviation 40.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 4 | -3.0 U/L | Standard Deviation 23.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 24 | -4.5 U/L | Standard Deviation 31.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 16 | -2.2 U/L | Standard Deviation 25.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 8 | -5.7 U/L | Standard Deviation 27.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 48 | -8.8 U/L | Standard Deviation 35.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 40 | -1.6 U/L | Standard Deviation 38.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 20 | -0.7 U/L | Standard Deviation 33.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 32 | 5.0 U/L | Standard Deviation 55 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 20 | -10.8 U/L | Standard Deviation 37 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 32 | -9.9 U/L | Standard Deviation 43.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 24 | -14.3 U/L | Standard Deviation 31.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 28 | -16.0 U/L | Standard Deviation 40.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 8 | -11.8 U/L | Standard Deviation 31.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 48 | -4.2 U/L | Standard Deviation 54.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 12 | -7.4 U/L | Standard Deviation 34.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 40 | -2.9 U/L | Standard Deviation 41.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 16 | -11.1 U/L | Standard Deviation 29.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 4 | -3.7 U/L | Standard Deviation 37 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 2 | -7.8 U/L | Standard Deviation 21.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 40 | -8.0 U/L | Standard Deviation 28.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 2 | -5.9 U/L | Standard Deviation 35.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 4 | -5.6 U/L | Standard Deviation 35.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 8 | -9.2 U/L | Standard Deviation 39 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 12 | -11.1 U/L | Standard Deviation 45.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 16 | -10.6 U/L | Standard Deviation 48.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 20 | -9.9 U/L | Standard Deviation 47.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 24 | -14.6 U/L | Standard Deviation 34.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 28 | -13.2 U/L | Standard Deviation 35 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 32 | -8.1 U/L | Standard Deviation 33.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 48 | -1.5 U/L | Standard Deviation 32.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 20 | -28.5 U/L | Standard Deviation 32.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 48 | -16.0 U/L | Standard Deviation 36.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 32 | -22.9 U/L | Standard Deviation 40.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 16 | -22.4 U/L | Standard Deviation 43.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 12 | -24.4 U/L | Standard Deviation 39 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 8 | -20.4 U/L | Standard Deviation 37.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 40 | -20.5 U/L | Standard Deviation 40.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 4 | -18.5 U/L | Standard Deviation 34.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 2 | -12.8 U/L | Standard Deviation 24.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 28 | -34.8 U/L | Standard Deviation 36.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lactate Dehydrogenase | Week 24 | -29.3 U/L | Standard Deviation 32.2 |
Secondary
Mean Change From Baseline in Leukocytes
Leukocytes was measured in number of leukocytes per liter (10\^9/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 2 | 0.34 10^9 leukocytes per liter | Standard Deviation 2.45 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 12 | -0.27 10^9 leukocytes per liter | Standard Deviation 1.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 28 | 0.05 10^9 leukocytes per liter | Standard Deviation 2.04 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 4 | 0.10 10^9 leukocytes per liter | Standard Deviation 1.88 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 24 | -0.22 10^9 leukocytes per liter | Standard Deviation 2.41 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 16 | -0.31 10^9 leukocytes per liter | Standard Deviation 2.18 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 8 | -0.25 10^9 leukocytes per liter | Standard Deviation 2.12 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 48 | -0.49 10^9 leukocytes per liter | Standard Deviation 1.83 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 40 | 0.17 10^9 leukocytes per liter | Standard Deviation 2.54 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 20 | -0.24 10^9 leukocytes per liter | Standard Deviation 2.27 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 32 | -0.14 10^9 leukocytes per liter | Standard Deviation 2.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 20 | -0.06 10^9 leukocytes per liter | Standard Deviation 1.59 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 32 | 0.08 10^9 leukocytes per liter | Standard Deviation 1.64 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 24 | -0.12 10^9 leukocytes per liter | Standard Deviation 1.83 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 28 | 0.06 10^9 leukocytes per liter | Standard Deviation 1.93 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 8 | 0.46 10^9 leukocytes per liter | Standard Deviation 1.41 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 48 | 0.30 10^9 leukocytes per liter | Standard Deviation 1.53 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 12 | 0.18 10^9 leukocytes per liter | Standard Deviation 1.73 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 40 | 0.04 10^9 leukocytes per liter | Standard Deviation 1.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 16 | 0.13 10^9 leukocytes per liter | Standard Deviation 1.55 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 4 | 0.27 10^9 leukocytes per liter | Standard Deviation 1.63 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 2 | 0.27 10^9 leukocytes per liter | Standard Deviation 1.23 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 40 | -0.35 10^9 leukocytes per liter | Standard Deviation 1.49 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 2 | 0.49 10^9 leukocytes per liter | Standard Deviation 1.46 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 4 | 0.25 10^9 leukocytes per liter | Standard Deviation 1.47 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 8 | -0.05 10^9 leukocytes per liter | Standard Deviation 1.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 12 | 0.17 10^9 leukocytes per liter | Standard Deviation 2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 16 | 0.21 10^9 leukocytes per liter | Standard Deviation 1.69 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 20 | -0.22 10^9 leukocytes per liter | Standard Deviation 1.74 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 24 | -0.14 10^9 leukocytes per liter | Standard Deviation 1.75 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 28 | 0.26 10^9 leukocytes per liter | Standard Deviation 2.04 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 32 | 0.19 10^9 leukocytes per liter | Standard Deviation 1.67 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 48 | -0.14 10^9 leukocytes per liter | Standard Deviation 2.06 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 20 | 0.30 10^9 leukocytes per liter | Standard Deviation 2.61 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 48 | -0.62 10^9 leukocytes per liter | Standard Deviation 1.87 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 32 | -0.44 10^9 leukocytes per liter | Standard Deviation 1.68 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 16 | -0.20 10^9 leukocytes per liter | Standard Deviation 2.12 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 12 | 0.23 10^9 leukocytes per liter | Standard Deviation 2.01 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 8 | -0.10 10^9 leukocytes per liter | Standard Deviation 1.65 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 40 | -0.49 10^9 leukocytes per liter | Standard Deviation 1.96 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 4 | 0.52 10^9 leukocytes per liter | Standard Deviation 2.11 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 2 | 0.20 10^9 leukocytes per liter | Standard Deviation 1.62 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 28 | -0.58 10^9 leukocytes per liter | Standard Deviation 1.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes | Week 24 | -0.34 10^9 leukocytes per liter | Standard Deviation 1.97 |
Secondary
Mean Change From Baseline in Leukocytes (/HPF)
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 2 | -0.1 % of Leukocytes per HPF | Standard Deviation 11.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 12 | -1.1 % of Leukocytes per HPF | Standard Deviation 11.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 28 | -0.2 % of Leukocytes per HPF | Standard Deviation 9.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 4 | -0.2 % of Leukocytes per HPF | Standard Deviation 9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 24 | -1.0 % of Leukocytes per HPF | Standard Deviation 10.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 16 | 0.1 % of Leukocytes per HPF | Standard Deviation 9.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 8 | -1.2 % of Leukocytes per HPF | Standard Deviation 10.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 48 | -0.3 % of Leukocytes per HPF | Standard Deviation 8.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 40 | -1.6 % of Leukocytes per HPF | Standard Deviation 10.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 20 | -0.1 % of Leukocytes per HPF | Standard Deviation 10.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 32 | -0.6 % of Leukocytes per HPF | Standard Deviation 10.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 20 | 3.7 % of Leukocytes per HPF | Standard Deviation 13.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 32 | -0.5 % of Leukocytes per HPF | Standard Deviation 13.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 24 | 10.7 % of Leukocytes per HPF | Standard Deviation 52.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 28 | 2.4 % of Leukocytes per HPF | Standard Deviation 9.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 8 | 4.8 % of Leukocytes per HPF | Standard Deviation 29.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 48 | 10.8 % of Leukocytes per HPF | Standard Deviation 71.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 12 | 4.4 % of Leukocytes per HPF | Standard Deviation 42.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 40 | 2.2 % of Leukocytes per HPF | Standard Deviation 19.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 16 | -1.6 % of Leukocytes per HPF | Standard Deviation 12.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 4 | -0.6 % of Leukocytes per HPF | Standard Deviation 8.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 2 | -1.4 % of Leukocytes per HPF | Standard Deviation 8.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 40 | 1.4 % of Leukocytes per HPF | Standard Deviation 7.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 2 | -0.8 % of Leukocytes per HPF | Standard Deviation 2.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 4 | -0.7 % of Leukocytes per HPF | Standard Deviation 4.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 8 | -0.3 % of Leukocytes per HPF | Standard Deviation 6.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 12 | -1.3 % of Leukocytes per HPF | Standard Deviation 4.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 16 | -0.2 % of Leukocytes per HPF | Standard Deviation 9.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 20 | 0.4 % of Leukocytes per HPF | Standard Deviation 9.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 24 | -0.7 % of Leukocytes per HPF | Standard Deviation 4.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 28 | -1.1 % of Leukocytes per HPF | Standard Deviation 4.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 32 | -1.0 % of Leukocytes per HPF | Standard Deviation 5.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 48 | -1.0 % of Leukocytes per HPF | Standard Deviation 4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 20 | 1.7 % of Leukocytes per HPF | Standard Deviation 4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 48 | 0.8 % of Leukocytes per HPF | Standard Deviation 5.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 32 | 4.1 % of Leukocytes per HPF | Standard Deviation 15.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 16 | 1.8 % of Leukocytes per HPF | Standard Deviation 12.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 12 | 2.7 % of Leukocytes per HPF | Standard Deviation 13.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 8 | 3.0 % of Leukocytes per HPF | Standard Deviation 14.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 40 | 6.8 % of Leukocytes per HPF | Standard Deviation 30.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 4 | 3.0 % of Leukocytes per HPF | Standard Deviation 12.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 2 | 2.9 % of Leukocytes per HPF | Standard Deviation 13.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 28 | 2.0 % of Leukocytes per HPF | Standard Deviation 10.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Leukocytes (/HPF) | Week 24 | 0.4 % of Leukocytes per HPF | Standard Deviation 4.5 |
Secondary
Mean Change From Baseline in Lipase, Pancreatic
Lipase, Pancreatic was measured in units per liter (U/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 2 | -1.1 U/L | Standard Deviation 10.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 12 | -0.5 U/L | Standard Deviation 8.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 28 | 1.6 U/L | Standard Deviation 13.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 4 | -2.1 U/L | Standard Deviation 9.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 24 | -0.5 U/L | Standard Deviation 11 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 16 | 0.4 U/L | Standard Deviation 7.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 8 | -3.1 U/L | Standard Deviation 9.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 48 | 1.4 U/L | Standard Deviation 10.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 40 | 1.2 U/L | Standard Deviation 11 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 20 | -0.6 U/L | Standard Deviation 10.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 32 | 1.1 U/L | Standard Deviation 15.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 20 | 2.1 U/L | Standard Deviation 8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 32 | 1.0 U/L | Standard Deviation 11 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 24 | -0.1 U/L | Standard Deviation 9.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 28 | 1.7 U/L | Standard Deviation 10.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 8 | 3.7 U/L | Standard Deviation 11.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 48 | 2.2 U/L | Standard Deviation 10 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 12 | 1.0 U/L | Standard Deviation 11.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 40 | 1.3 U/L | Standard Deviation 7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 16 | 2.7 U/L | Standard Deviation 8.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 4 | 0.9 U/L | Standard Deviation 9.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 2 | 2.2 U/L | Standard Deviation 11.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 40 | -0.3 U/L | Standard Deviation 8.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 2 | 0.1 U/L | Standard Deviation 9.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 4 | 0.1 U/L | Standard Deviation 10.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 8 | 2.0 U/L | Standard Deviation 20 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 12 | -0.7 U/L | Standard Deviation 13.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 16 | 0.5 U/L | Standard Deviation 11.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 20 | -0.9 U/L | Standard Deviation 9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 24 | -0.1 U/L | Standard Deviation 8.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 28 | 0.5 U/L | Standard Deviation 11.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 32 | 1.2 U/L | Standard Deviation 10.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 48 | 0.3 U/L | Standard Deviation 10.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 20 | -1.7 U/L | Standard Deviation 9.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 48 | 3.7 U/L | Standard Deviation 10.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 32 | 3.8 U/L | Standard Deviation 21.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 16 | -0.2 U/L | Standard Deviation 11.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 12 | -0.6 U/L | Standard Deviation 9.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 8 | -1.8 U/L | Standard Deviation 10.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 40 | 2.5 U/L | Standard Deviation 8.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 4 | -1.2 U/L | Standard Deviation 10 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 2 | -0.2 U/L | Standard Deviation 7.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 28 | 1.7 U/L | Standard Deviation 14.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lipase, Pancreatic | Week 24 | 1.2 U/L | Standard Deviation 11.8 |
Secondary
Mean Change From Baseline in Lymphocytes
Lymphocytes was measured in number of lymphocytes per liter (10\^9/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 2 | -0.03 10^9 lymphocytes per liter | Standard Deviation 0.39 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 12 | -0.06 10^9 lymphocytes per liter | Standard Deviation 0.43 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 28 | -0.04 10^9 lymphocytes per liter | Standard Deviation 0.57 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 4 | -0.04 10^9 lymphocytes per liter | Standard Deviation 0.36 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 24 | -0.11 10^9 lymphocytes per liter | Standard Deviation 0.51 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 16 | -0.09 10^9 lymphocytes per liter | Standard Deviation 0.52 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 8 | -0.15 10^9 lymphocytes per liter | Standard Deviation 0.48 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 48 | -0.19 10^9 lymphocytes per liter | Standard Deviation 0.68 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 40 | -0.11 10^9 lymphocytes per liter | Standard Deviation 0.54 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 20 | -0.14 10^9 lymphocytes per liter | Standard Deviation 0.56 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 32 | -0.11 10^9 lymphocytes per liter | Standard Deviation 0.57 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 20 | -0.13 10^9 lymphocytes per liter | Standard Deviation 0.54 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 32 | -0.16 10^9 lymphocytes per liter | Standard Deviation 0.59 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 24 | -0.08 10^9 lymphocytes per liter | Standard Deviation 0.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 28 | -0.02 10^9 lymphocytes per liter | Standard Deviation 0.59 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 8 | -0.03 10^9 lymphocytes per liter | Standard Deviation 0.39 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 48 | -0.19 10^9 lymphocytes per liter | Standard Deviation 0.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 12 | 0.02 10^9 lymphocytes per liter | Standard Deviation 0.59 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 40 | -0.11 10^9 lymphocytes per liter | Standard Deviation 0.52 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 16 | -0.11 10^9 lymphocytes per liter | Standard Deviation 0.51 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 4 | -0.01 10^9 lymphocytes per liter | Standard Deviation 0.47 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 2 | 0.05 10^9 lymphocytes per liter | Standard Deviation 0.36 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 40 | -0.11 10^9 lymphocytes per liter | Standard Deviation 0.43 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 2 | 0.16 10^9 lymphocytes per liter | Standard Deviation 0.29 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 4 | -0.01 10^9 lymphocytes per liter | Standard Deviation 0.41 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 8 | 0.06 10^9 lymphocytes per liter | Standard Deviation 0.46 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 12 | 0.01 10^9 lymphocytes per liter | Standard Deviation 0.42 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 16 | -0.02 10^9 lymphocytes per liter | Standard Deviation 0.47 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 20 | 0.02 10^9 lymphocytes per liter | Standard Deviation 0.39 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 24 | -0.03 10^9 lymphocytes per liter | Standard Deviation 0.45 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 28 | 0.01 10^9 lymphocytes per liter | Standard Deviation 0.53 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 32 | 0.05 10^9 lymphocytes per liter | Standard Deviation 0.45 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 48 | -0.10 10^9 lymphocytes per liter | Standard Deviation 0.44 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 20 | 0.13 10^9 lymphocytes per liter | Standard Deviation 0.55 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 48 | -0.02 10^9 lymphocytes per liter | Standard Deviation 0.49 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 32 | -0.02 10^9 lymphocytes per liter | Standard Deviation 0.44 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 16 | 0.04 10^9 lymphocytes per liter | Standard Deviation 0.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 12 | 0.21 10^9 lymphocytes per liter | Standard Deviation 0.51 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 8 | 0.14 10^9 lymphocytes per liter | Standard Deviation 0.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 40 | -0.03 10^9 lymphocytes per liter | Standard Deviation 0.48 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 4 | 0.23 10^9 lymphocytes per liter | Standard Deviation 0.42 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 2 | 0.24 10^9 lymphocytes per liter | Standard Deviation 0.37 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 28 | 0.03 10^9 lymphocytes per liter | Standard Deviation 0.56 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes | Week 24 | 0.05 10^9 lymphocytes per liter | Standard Deviation 0.52 |
Secondary
Mean Change From Baseline in Lymphocytes/Leukocytes
Lymphocytes/Leukocytes was measured in percentages (%).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 2 | -1.88 % of Lymphocytes per Leukocytes | Standard Deviation 9.01 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 12 | 0.21 % of Lymphocytes per Leukocytes | Standard Deviation 7.87 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 28 | -1.18 % of Lymphocytes per Leukocytes | Standard Deviation 8.27 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 4 | -0.88 % of Lymphocytes per Leukocytes | Standard Deviation 7.09 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 24 | -0.75 % of Lymphocytes per Leukocytes | Standard Deviation 8.69 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 16 | -0.91 % of Lymphocytes per Leukocytes | Standard Deviation 8.33 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 8 | -1.98 % of Lymphocytes per Leukocytes | Standard Deviation 10.59 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 48 | -1.46 % of Lymphocytes per Leukocytes | Standard Deviation 11.29 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 40 | -2.60 % of Lymphocytes per Leukocytes | Standard Deviation 9.18 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 20 | -1.97 % of Lymphocytes per Leukocytes | Standard Deviation 10.37 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 32 | -1.59 % of Lymphocytes per Leukocytes | Standard Deviation 7.69 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 20 | -0.66 % of Lymphocytes per Leukocytes | Standard Deviation 6.58 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 32 | -2.56 % of Lymphocytes per Leukocytes | Standard Deviation 6.51 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 24 | -0.56 % of Lymphocytes per Leukocytes | Standard Deviation 7.35 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 28 | -0.05 % of Lymphocytes per Leukocytes | Standard Deviation 8.51 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 8 | -1.40 % of Lymphocytes per Leukocytes | Standard Deviation 7.13 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 48 | -3.71 % of Lymphocytes per Leukocytes | Standard Deviation 7.41 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 12 | 0.56 % of Lymphocytes per Leukocytes | Standard Deviation 10.58 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 40 | -2.02 % of Lymphocytes per Leukocytes | Standard Deviation 5.99 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 16 | -1.49 % of Lymphocytes per Leukocytes | Standard Deviation 7.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 4 | -1.02 % of Lymphocytes per Leukocytes | Standard Deviation 6.34 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 2 | 0.19 % of Lymphocytes per Leukocytes | Standard Deviation 6.55 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 40 | -1.36 % of Lymphocytes per Leukocytes | Standard Deviation 10.12 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 2 | 1.18 % of Lymphocytes per Leukocytes | Standard Deviation 6.09 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 4 | -1.18 % of Lymphocytes per Leukocytes | Standard Deviation 9.93 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 8 | 0.56 % of Lymphocytes per Leukocytes | Standard Deviation 10.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 12 | -0.44 % of Lymphocytes per Leukocytes | Standard Deviation 9.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 16 | -1.18 % of Lymphocytes per Leukocytes | Standard Deviation 9.65 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 20 | 0.88 % of Lymphocytes per Leukocytes | Standard Deviation 10.69 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 24 | -0.52 % of Lymphocytes per Leukocytes | Standard Deviation 10.55 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 28 | -0.05 % of Lymphocytes per Leukocytes | Standard Deviation 9.97 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 32 | -0.16 % of Lymphocytes per Leukocytes | Standard Deviation 7.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 48 | -0.84 % of Lymphocytes per Leukocytes | Standard Deviation 9.42 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 20 | 0.71 % of Lymphocytes per Leukocytes | Standard Deviation 10.32 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 48 | 1.69 % of Lymphocytes per Leukocytes | Standard Deviation 10.05 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 32 | 0.70 % of Lymphocytes per Leukocytes | Standard Deviation 8.74 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 16 | 0.12 % of Lymphocytes per Leukocytes | Standard Deviation 9.34 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 12 | 2.46 % of Lymphocytes per Leukocytes | Standard Deviation 10.18 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 8 | 1.97 % of Lymphocytes per Leukocytes | Standard Deviation 8.51 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 40 | 0.33 % of Lymphocytes per Leukocytes | Standard Deviation 8.41 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 4 | 0.97 % of Lymphocytes per Leukocytes | Standard Deviation 8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 2 | 2.61 % of Lymphocytes per Leukocytes | Standard Deviation 6.11 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 28 | 1.61 % of Lymphocytes per Leukocytes | Standard Deviation 10.55 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Lymphocytes/Leukocytes | Week 24 | 1.85 % of Lymphocytes per Leukocytes | Standard Deviation 9.67 |
Secondary
Mean Change From Baseline in Monocytes
Monocytes was measured in number of monocytes per liter (10\^9/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 2 | -0.01 10^9 monocytes per liter | Standard Deviation 0.17 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 12 | -0.01 10^9 monocytes per liter | Standard Deviation 0.19 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 28 | 0.00 10^9 monocytes per liter | Standard Deviation 0.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 4 | 0.01 10^9 monocytes per liter | Standard Deviation 0.18 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 24 | 0.00 10^9 monocytes per liter | Standard Deviation 0.19 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 16 | -0.01 10^9 monocytes per liter | Standard Deviation 0.17 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 8 | -0.03 10^9 monocytes per liter | Standard Deviation 0.18 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 48 | -0.02 10^9 monocytes per liter | Standard Deviation 0.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 40 | 0.03 10^9 monocytes per liter | Standard Deviation 0.17 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 20 | -0.03 10^9 monocytes per liter | Standard Deviation 0.19 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 32 | -0.01 10^9 monocytes per liter | Standard Deviation 0.18 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 20 | 0.00 10^9 monocytes per liter | Standard Deviation 0.16 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 32 | 0.02 10^9 monocytes per liter | Standard Deviation 0.19 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 24 | 0.04 10^9 monocytes per liter | Standard Deviation 0.19 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 28 | 0.04 10^9 monocytes per liter | Standard Deviation 0.21 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 8 | 0.04 10^9 monocytes per liter | Standard Deviation 0.18 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 48 | -0.01 10^9 monocytes per liter | Standard Deviation 0.13 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 12 | 0.00 10^9 monocytes per liter | Standard Deviation 0.14 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 40 | 0.05 10^9 monocytes per liter | Standard Deviation 0.16 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 16 | 0.01 10^9 monocytes per liter | Standard Deviation 0.17 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 4 | 0.04 10^9 monocytes per liter | Standard Deviation 0.18 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 2 | 0.01 10^9 monocytes per liter | Standard Deviation 0.18 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 40 | 0.04 10^9 monocytes per liter | Standard Deviation 0.16 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 2 | 0.05 10^9 monocytes per liter | Standard Deviation 0.14 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 4 | 0.01 10^9 monocytes per liter | Standard Deviation 0.14 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 8 | 0.03 10^9 monocytes per liter | Standard Deviation 0.16 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 12 | 0.04 10^9 monocytes per liter | Standard Deviation 0.18 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 16 | 0.05 10^9 monocytes per liter | Standard Deviation 0.18 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 20 | 0.00 10^9 monocytes per liter | Standard Deviation 0.13 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 24 | 0.03 10^9 monocytes per liter | Standard Deviation 0.17 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 28 | 0.08 10^9 monocytes per liter | Standard Deviation 0.19 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 32 | 0.05 10^9 monocytes per liter | Standard Deviation 0.23 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 48 | 0.03 10^9 monocytes per liter | Standard Deviation 0.15 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 20 | 0.05 10^9 monocytes per liter | Standard Deviation 0.19 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 48 | -0.02 10^9 monocytes per liter | Standard Deviation 0.18 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 32 | -0.01 10^9 monocytes per liter | Standard Deviation 0.19 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 16 | 0.03 10^9 monocytes per liter | Standard Deviation 0.14 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 12 | 0.06 10^9 monocytes per liter | Standard Deviation 0.15 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 8 | 0.02 10^9 monocytes per liter | Standard Deviation 0.17 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 40 | -0.01 10^9 monocytes per liter | Standard Deviation 0.18 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 4 | 0.06 10^9 monocytes per liter | Standard Deviation 0.19 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 2 | 0.01 10^9 monocytes per liter | Standard Deviation 0.13 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 28 | 0.02 10^9 monocytes per liter | Standard Deviation 0.17 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes | Week 24 | 0.00 10^9 monocytes per liter | Standard Deviation 0.17 |
Secondary
Mean Change From Baseline in Monocytes/Leukocytes
Monocytes/Leukocytes was measured in percentages (%).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 2 | -0.87 % of Monocytes per Leukocytes | Standard Deviation 2.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 12 | 0.07 % of Monocytes per Leukocytes | Standard Deviation 2.79 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 28 | -0.24 % of Monocytes per Leukocytes | Standard Deviation 3.54 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 4 | 0.26 % of Monocytes per Leukocytes | Standard Deviation 3.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 24 | 0.06 % of Monocytes per Leukocytes | Standard Deviation 3.45 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 16 | 0.06 % of Monocytes per Leukocytes | Standard Deviation 3.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 8 | -0.21 % of Monocytes per Leukocytes | Standard Deviation 3.47 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 48 | -0.04 % of Monocytes per Leukocytes | Standard Deviation 3.79 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 40 | 0.49 % of Monocytes per Leukocytes | Standard Deviation 3.55 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 20 | -0.27 % of Monocytes per Leukocytes | Standard Deviation 3.84 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 32 | -0.08 % of Monocytes per Leukocytes | Standard Deviation 3.11 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 20 | 0.56 % of Monocytes per Leukocytes | Standard Deviation 3.08 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 32 | 0.13 % of Monocytes per Leukocytes | Standard Deviation 2.62 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 24 | 0.84 % of Monocytes per Leukocytes | Standard Deviation 2.97 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 28 | 0.69 % of Monocytes per Leukocytes | Standard Deviation 3.24 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 8 | 0.07 % of Monocytes per Leukocytes | Standard Deviation 3.61 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 48 | -0.13 % of Monocytes per Leukocytes | Standard Deviation 2.41 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 12 | -0.11 % of Monocytes per Leukocytes | Standard Deviation 2.38 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 40 | 0.64 % of Monocytes per Leukocytes | Standard Deviation 2.92 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 16 | 0.59 % of Monocytes per Leukocytes | Standard Deviation 2.85 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 4 | 0.27 % of Monocytes per Leukocytes | Standard Deviation 2.41 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 2 | -0.07 % of Monocytes per Leukocytes | Standard Deviation 2.46 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 40 | 0.83 % of Monocytes per Leukocytes | Standard Deviation 3.69 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 2 | 0.23 % of Monocytes per Leukocytes | Standard Deviation 3.03 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 4 | -0.16 % of Monocytes per Leukocytes | Standard Deviation 3.11 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 8 | 0.51 % of Monocytes per Leukocytes | Standard Deviation 3.83 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 12 | 0.22 % of Monocytes per Leukocytes | Standard Deviation 3.37 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 16 | 0.43 % of Monocytes per Leukocytes | Standard Deviation 3.31 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 20 | 0.33 % of Monocytes per Leukocytes | Standard Deviation 3.81 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 24 | 0.46 % of Monocytes per Leukocytes | Standard Deviation 3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 28 | 0.64 % of Monocytes per Leukocytes | Standard Deviation 3.67 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 32 | 0.46 % of Monocytes per Leukocytes | Standard Deviation 3.91 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 48 | 0.47 % of Monocytes per Leukocytes | Standard Deviation 3.82 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 20 | 0.43 % of Monocytes per Leukocytes | Standard Deviation 3.39 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 48 | 0.29 % of Monocytes per Leukocytes | Standard Deviation 3.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 32 | -0.03 % of Monocytes per Leukocytes | Standard Deviation 3.76 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 16 | 0.28 % of Monocytes per Leukocytes | Standard Deviation 3.13 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 12 | 0.45 % of Monocytes per Leukocytes | Standard Deviation 2.74 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 8 | 0.08 % of Monocytes per Leukocytes | Standard Deviation 3.12 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 40 | 0.59 % of Monocytes per Leukocytes | Standard Deviation 3.07 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 4 | -0.24 % of Monocytes per Leukocytes | Standard Deviation 2.82 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 2 | -0.37 % of Monocytes per Leukocytes | Standard Deviation 2.25 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 28 | 0.94 % of Monocytes per Leukocytes | Standard Deviation 3.78 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Monocytes/Leukocytes | Week 24 | 0.41 % of Monocytes per Leukocytes | Standard Deviation 3.24 |
Secondary
Mean Change From Baseline in Neutrophils
Neutrophils was measured in number of neutrophils per liter (10\^9/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 2 | 0.28 10^9 neutrophils per liter | Standard Deviation 2.43 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 12 | -0.24 10^9 neutrophils per liter | Standard Deviation 1.56 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 28 | 0.04 10^9 neutrophils per liter | Standard Deviation 1.81 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 4 | 0.07 10^9 neutrophils per liter | Standard Deviation 1.82 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 24 | -0.12 10^9 neutrophils per liter | Standard Deviation 2.24 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 16 | -0.22 10^9 neutrophils per liter | Standard Deviation 2.13 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 8 | -0.13 10^9 neutrophils per liter | Standard Deviation 2.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 48 | -0.29 10^9 neutrophils per liter | Standard Deviation 1.58 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 40 | 0.16 10^9 neutrophils per liter | Standard Deviation 2.37 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 20 | -0.07 10^9 neutrophils per liter | Standard Deviation 2.21 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 32 | -0.07 10^9 neutrophils per liter | Standard Deviation 1.87 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 20 | 0.01 10^9 neutrophils per liter | Standard Deviation 1.22 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 32 | 0.33 10^9 neutrophils per liter | Standard Deviation 1.27 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 24 | -0.06 10^9 neutrophils per liter | Standard Deviation 1.54 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 28 | 0.13 10^9 neutrophils per liter | Standard Deviation 1.64 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 8 | 0.41 10^9 neutrophils per liter | Standard Deviation 1.32 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 48 | 0.55 10^9 neutrophils per liter | Standard Deviation 1.15 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 12 | 0.20 10^9 neutrophils per liter | Standard Deviation 1.65 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 40 | 0.16 10^9 neutrophils per liter | Standard Deviation 1.31 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 16 | 0.20 10^9 neutrophils per liter | Standard Deviation 1.41 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 4 | 0.27 10^9 neutrophils per liter | Standard Deviation 1.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 2 | 0.26 10^9 neutrophils per liter | Standard Deviation 1.17 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 40 | -0.32 10^9 neutrophils per liter | Standard Deviation 1.57 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 2 | 0.17 10^9 neutrophils per liter | Standard Deviation 1.33 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 4 | 0.21 10^9 neutrophils per liter | Standard Deviation 1.64 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 8 | -0.07 10^9 neutrophils per liter | Standard Deviation 1.53 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 12 | 0.10 10^9 neutrophils per liter | Standard Deviation 1.94 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 16 | 0.15 10^9 neutrophils per liter | Standard Deviation 1.61 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 20 | -0.39 10^9 neutrophils per liter | Standard Deviation 1.69 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 24 | -0.16 10^9 neutrophils per liter | Standard Deviation 1.77 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 28 | 0.10 10^9 neutrophils per liter | Standard Deviation 1.91 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 32 | 0.07 10^9 neutrophils per liter | Standard Deviation 1.54 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 48 | -0.09 10^9 neutrophils per liter | Standard Deviation 2.02 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 20 | 0.09 10^9 neutrophils per liter | Standard Deviation 2.51 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 48 | -0.54 10^9 neutrophils per liter | Standard Deviation 1.78 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 32 | -0.40 10^9 neutrophils per liter | Standard Deviation 1.67 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 16 | -0.20 10^9 neutrophils per liter | Standard Deviation 2.14 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 12 | -0.01 10^9 neutrophils per liter | Standard Deviation 2.03 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 8 | -0.20 10^9 neutrophils per liter | Standard Deviation 1.49 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 40 | -0.41 10^9 neutrophils per liter | Standard Deviation 1.88 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 4 | 0.23 10^9 neutrophils per liter | Standard Deviation 1.96 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 2 | -0.01 10^9 neutrophils per liter | Standard Deviation 1.46 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 28 | -0.62 10^9 neutrophils per liter | Standard Deviation 1.78 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils | Week 24 | -0.38 10^9 neutrophils per liter | Standard Deviation 1.92 |
Secondary
Mean Change From Baseline in Neutrophils/Leukocytes
Neutrophils/Leukocytes was measured in percentages (%).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 2 | 2.99 % of Neutrophils per Leukocytes | Standard Deviation 10.73 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 12 | -0.52 % of Neutrophils per Leukocytes | Standard Deviation 9.44 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 28 | 1.28 % of Neutrophils per Leukocytes | Standard Deviation 10.38 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 4 | 0.91 % of Neutrophils per Leukocytes | Standard Deviation 9.37 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 24 | 0.65 % of Neutrophils per Leukocytes | Standard Deviation 11.48 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 16 | 0.77 % of Neutrophils per Leukocytes | Standard Deviation 11.02 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 8 | 2.15 % of Neutrophils per Leukocytes | Standard Deviation 12.95 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 48 | 1.41 % of Neutrophils per Leukocytes | Standard Deviation 13.58 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 40 | 2.29 % of Neutrophils per Leukocytes | Standard Deviation 11.66 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 20 | 2.22 % of Neutrophils per Leukocytes | Standard Deviation 13.21 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 32 | 1.67 % of Neutrophils per Leukocytes | Standard Deviation 9.93 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 20 | -0.73 % of Neutrophils per Leukocytes | Standard Deviation 8.42 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 32 | 2.15 % of Neutrophils per Leukocytes | Standard Deviation 7.42 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 24 | -1.25 % of Neutrophils per Leukocytes | Standard Deviation 8.74 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 28 | -0.88 % of Neutrophils per Leukocytes | Standard Deviation 10.56 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 8 | 0.79 % of Neutrophils per Leukocytes | Standard Deviation 8.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 48 | 4.09 % of Neutrophils per Leukocytes | Standard Deviation 8.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 12 | -1.25 % of Neutrophils per Leukocytes | Standard Deviation 11.78 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 40 | 1.36 % of Neutrophils per Leukocytes | Standard Deviation 6.95 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 16 | 0.54 % of Neutrophils per Leukocytes | Standard Deviation 8.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 4 | 0.89 % of Neutrophils per Leukocytes | Standard Deviation 7.82 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 2 | -0.21 % of Neutrophils per Leukocytes | Standard Deviation 7.94 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 40 | 0.07 % of Neutrophils per Leukocytes | Standard Deviation 13.23 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 2 | -1.20 % of Neutrophils per Leukocytes | Standard Deviation 8.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 4 | 1.47 % of Neutrophils per Leukocytes | Standard Deviation 12.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 8 | -1.17 % of Neutrophils per Leukocytes | Standard Deviation 13.28 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 12 | -0.12 % of Neutrophils per Leukocytes | Standard Deviation 13.18 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 16 | 0.56 % of Neutrophils per Leukocytes | Standard Deviation 12.48 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 20 | -1.25 % of Neutrophils per Leukocytes | Standard Deviation 14.29 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 24 | 0.10 % of Neutrophils per Leukocytes | Standard Deviation 13.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 28 | -0.77 % of Neutrophils per Leukocytes | Standard Deviation 13.27 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 32 | -0.47 % of Neutrophils per Leukocytes | Standard Deviation 9.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 48 | 0.30 % of Neutrophils per Leukocytes | Standard Deviation 12.47 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 20 | -0.71 % of Neutrophils per Leukocytes | Standard Deviation 13.91 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 48 | -2.28 % of Neutrophils per Leukocytes | Standard Deviation 12.38 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 32 | -0.48 % of Neutrophils per Leukocytes | Standard Deviation 12.08 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 16 | -0.24 % of Neutrophils per Leukocytes | Standard Deviation 12.23 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 12 | -2.90 % of Neutrophils per Leukocytes | Standard Deviation 12.85 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 8 | -2.23 % of Neutrophils per Leukocytes | Standard Deviation 10.92 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 40 | -0.93 % of Neutrophils per Leukocytes | Standard Deviation 11.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 4 | -0.37 % of Neutrophils per Leukocytes | Standard Deviation 10.27 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 2 | -1.93 % of Neutrophils per Leukocytes | Standard Deviation 8.18 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 28 | -2.60 % of Neutrophils per Leukocytes | Standard Deviation 13.79 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Neutrophils/Leukocytes | Week 24 | -2.30 % of Neutrophils per Leukocytes | Standard Deviation 12.41 |
Secondary
Mean Change From Baseline in pH
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in pH | Week 2 | -0.01 pH | Standard Deviation 0.66 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in pH | Week 12 | 0.00 pH | Standard Deviation 0.81 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in pH | Week 28 | -0.13 pH | Standard Deviation 0.84 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in pH | Week 4 | 0.10 pH | Standard Deviation 0.77 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in pH | Week 24 | 0.03 pH | Standard Deviation 0.85 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in pH | Week 16 | -0.02 pH | Standard Deviation 0.61 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in pH | Week 8 | -0.12 pH | Standard Deviation 0.79 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in pH | Week 48 | -0.11 pH | Standard Deviation 0.66 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in pH | Week 40 | -0.14 pH | Standard Deviation 0.81 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in pH | Week 20 | -0.11 pH | Standard Deviation 0.75 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in pH | Week 32 | -0.02 pH | Standard Deviation 0.75 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 20 | -0.01 pH | Standard Deviation 0.59 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 32 | -0.03 pH | Standard Deviation 0.55 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 24 | -0.01 pH | Standard Deviation 0.46 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 28 | -0.06 pH | Standard Deviation 0.57 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 8 | 0.00 pH | Standard Deviation 0.62 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 48 | 0.06 pH | Standard Deviation 0.73 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 12 | 0.15 pH | Standard Deviation 0.69 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 40 | 0.19 pH | Standard Deviation 0.66 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 16 | 0.00 pH | Standard Deviation 0.51 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 4 | 0.15 pH | Standard Deviation 0.52 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 2 | 0.03 pH | Standard Deviation 0.62 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 40 | -0.21 pH | Standard Deviation 0.81 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 2 | -0.07 pH | Standard Deviation 0.67 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 4 | 0.06 pH | Standard Deviation 0.72 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 8 | -0.08 pH | Standard Deviation 0.56 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 12 | 0.03 pH | Standard Deviation 0.79 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 16 | -0.09 pH | Standard Deviation 0.81 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 20 | 0.06 pH | Standard Deviation 0.58 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 24 | -0.11 pH | Standard Deviation 0.81 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 28 | -0.05 pH | Standard Deviation 0.73 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 32 | -0.18 pH | Standard Deviation 0.66 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 48 | -0.11 pH | Standard Deviation 0.74 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 20 | 0.07 pH | Standard Deviation 0.88 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 48 | -0.08 pH | Standard Deviation 0.72 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 32 | 0.09 pH | Standard Deviation 0.86 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 16 | 0.11 pH | Standard Deviation 0.69 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 12 | 0.20 pH | Standard Deviation 0.83 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 8 | -0.04 pH | Standard Deviation 0.65 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 40 | -0.07 pH | Standard Deviation 0.62 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 4 | 0.16 pH | Standard Deviation 0.74 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 2 | 0.15 pH | Standard Deviation 0.78 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 28 | -0.01 pH | Standard Deviation 0.69 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in pH | Week 24 | 0.02 pH | Standard Deviation 0.81 |
Secondary
Mean Change From Baseline in Phosphate
Phosphate was measured in millimoles per liter (mmol/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 2 | 0.044 mmol/L | Standard Deviation 0.163 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 12 | 0.029 mmol/L | Standard Deviation 0.159 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 28 | -0.024 mmol/L | Standard Deviation 0.189 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 4 | -0.004 mmol/L | Standard Deviation 0.162 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 24 | -0.013 mmol/L | Standard Deviation 0.181 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 16 | -0.010 mmol/L | Standard Deviation 0.186 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 8 | 0.006 mmol/L | Standard Deviation 0.178 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 48 | 0.032 mmol/L | Standard Deviation 0.183 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 40 | 0.018 mmol/L | Standard Deviation 0.207 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 20 | -0.030 mmol/L | Standard Deviation 0.208 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 32 | -0.002 mmol/L | Standard Deviation 0.217 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 20 | -0.037 mmol/L | Standard Deviation 0.244 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 32 | -0.056 mmol/L | Standard Deviation 0.223 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 24 | -0.042 mmol/L | Standard Deviation 0.16 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 28 | 0.008 mmol/L | Standard Deviation 0.238 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 8 | -0.063 mmol/L | Standard Deviation 0.225 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 48 | -0.012 mmol/L | Standard Deviation 0.167 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 12 | -0.004 mmol/L | Standard Deviation 0.149 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 40 | 0.009 mmol/L | Standard Deviation 0.196 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 16 | 0.012 mmol/L | Standard Deviation 0.182 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 4 | -0.029 mmol/L | Standard Deviation 0.185 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 2 | 0.032 mmol/L | Standard Deviation 0.192 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 40 | -0.022 mmol/L | Standard Deviation 0.208 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 2 | -0.047 mmol/L | Standard Deviation 0.23 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 4 | -0.070 mmol/L | Standard Deviation 0.187 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 8 | -0.028 mmol/L | Standard Deviation 0.207 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 12 | -0.015 mmol/L | Standard Deviation 0.236 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 16 | -0.025 mmol/L | Standard Deviation 0.195 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 20 | -0.031 mmol/L | Standard Deviation 0.177 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 24 | -0.040 mmol/L | Standard Deviation 0.229 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 28 | -0.031 mmol/L | Standard Deviation 0.232 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 32 | 0.015 mmol/L | Standard Deviation 0.22 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 48 | -0.044 mmol/L | Standard Deviation 0.214 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 20 | 0.013 mmol/L | Standard Deviation 0.187 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 48 | 0.035 mmol/L | Standard Deviation 0.19 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 32 | 0.030 mmol/L | Standard Deviation 0.19 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 16 | 0.005 mmol/L | Standard Deviation 0.178 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 12 | 0.045 mmol/L | Standard Deviation 0.183 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 8 | 0.051 mmol/L | Standard Deviation 0.187 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 40 | 0.034 mmol/L | Standard Deviation 0.224 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 4 | 0.020 mmol/L | Standard Deviation 0.163 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 2 | 0.033 mmol/L | Standard Deviation 0.168 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 28 | 0.037 mmol/L | Standard Deviation 0.184 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Phosphate | Week 24 | 0.035 mmol/L | Standard Deviation 0.2 |
Secondary
Mean Change From Baseline in Platelets
Platelets was measured in number of platelets per liter (10\^9/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 2 | 5.9 10^9 platelets per liter | Standard Deviation 33.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 12 | -4.3 10^9 platelets per liter | Standard Deviation 50.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 28 | 3.6 10^9 platelets per liter | Standard Deviation 64.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 4 | -5.2 10^9 platelets per liter | Standard Deviation 51.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 24 | 0.2 10^9 platelets per liter | Standard Deviation 60.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 16 | 0.7 10^9 platelets per liter | Standard Deviation 57.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 8 | 0.2 10^9 platelets per liter | Standard Deviation 45.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 48 | 7.1 10^9 platelets per liter | Standard Deviation 67.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 40 | 10.3 10^9 platelets per liter | Standard Deviation 74.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 20 | 9.2 10^9 platelets per liter | Standard Deviation 57.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 32 | 4.0 10^9 platelets per liter | Standard Deviation 71.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 20 | -3.3 10^9 platelets per liter | Standard Deviation 43 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 32 | -1.9 10^9 platelets per liter | Standard Deviation 55.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 24 | -5.2 10^9 platelets per liter | Standard Deviation 43.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 28 | 1.8 10^9 platelets per liter | Standard Deviation 52.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 8 | -0.3 10^9 platelets per liter | Standard Deviation 40.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 48 | 3.5 10^9 platelets per liter | Standard Deviation 58.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 12 | -1.7 10^9 platelets per liter | Standard Deviation 38.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 40 | 14.2 10^9 platelets per liter | Standard Deviation 52.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 16 | -0.7 10^9 platelets per liter | Standard Deviation 40.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 4 | 0.0 10^9 platelets per liter | Standard Deviation 32.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 2 | 10.0 10^9 platelets per liter | Standard Deviation 40 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 40 | -8.8 10^9 platelets per liter | Standard Deviation 63.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 2 | 1.4 10^9 platelets per liter | Standard Deviation 47.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 4 | 4.9 10^9 platelets per liter | Standard Deviation 43.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 8 | 3.9 10^9 platelets per liter | Standard Deviation 52 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 12 | -2.7 10^9 platelets per liter | Standard Deviation 49 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 16 | -1.5 10^9 platelets per liter | Standard Deviation 66.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 20 | 0.5 10^9 platelets per liter | Standard Deviation 44.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 24 | 2.4 10^9 platelets per liter | Standard Deviation 68.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 28 | -5.8 10^9 platelets per liter | Standard Deviation 71.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 32 | -4.6 10^9 platelets per liter | Standard Deviation 57.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 48 | -9.5 10^9 platelets per liter | Standard Deviation 70.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 20 | 0.8 10^9 platelets per liter | Standard Deviation 64.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 48 | -8.8 10^9 platelets per liter | Standard Deviation 66.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 32 | 9.9 10^9 platelets per liter | Standard Deviation 93.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 16 | -2.3 10^9 platelets per liter | Standard Deviation 68.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 12 | 1.8 10^9 platelets per liter | Standard Deviation 49.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 8 | -6.4 10^9 platelets per liter | Standard Deviation 40.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 40 | -1.5 10^9 platelets per liter | Standard Deviation 67.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 4 | 8.1 10^9 platelets per liter | Standard Deviation 42.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 2 | -1.0 10^9 platelets per liter | Standard Deviation 52 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 28 | 1.5 10^9 platelets per liter | Standard Deviation 64.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Platelets | Week 24 | 1.7 10^9 platelets per liter | Standard Deviation 67 |
Secondary
Mean Change From Baseline in Potassium
Potassium was measured in millimoles per liter (mmol/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 2 | 0.04 mmol/L | Standard Deviation 0.45 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 12 | -0.01 mmol/L | Standard Deviation 0.33 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 28 | 0.09 mmol/L | Standard Deviation 0.43 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 4 | 0.06 mmol/L | Standard Deviation 0.44 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 24 | 0.06 mmol/L | Standard Deviation 0.43 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 16 | -0.01 mmol/L | Standard Deviation 0.34 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 8 | -0.04 mmol/L | Standard Deviation 0.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 48 | -0.01 mmol/L | Standard Deviation 0.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 40 | 0.06 mmol/L | Standard Deviation 0.33 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 20 | 0.04 mmol/L | Standard Deviation 0.38 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 32 | 0.03 mmol/L | Standard Deviation 0.44 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 20 | 0.14 mmol/L | Standard Deviation 0.33 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 32 | 0.07 mmol/L | Standard Deviation 0.44 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 24 | 0.07 mmol/L | Standard Deviation 0.39 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 28 | 0.12 mmol/L | Standard Deviation 0.47 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 8 | 0.11 mmol/L | Standard Deviation 0.38 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 48 | 0.00 mmol/L | Standard Deviation 0.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 12 | 0.02 mmol/L | Standard Deviation 0.31 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 40 | 0.16 mmol/L | Standard Deviation 0.51 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 16 | 0.16 mmol/L | Standard Deviation 0.33 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 4 | 0.08 mmol/L | Standard Deviation 0.35 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 2 | 0.15 mmol/L | Standard Deviation 0.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 40 | 0.16 mmol/L | Standard Deviation 0.39 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 2 | 0.00 mmol/L | Standard Deviation 0.36 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 4 | -0.07 mmol/L | Standard Deviation 0.41 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 8 | 0.00 mmol/L | Standard Deviation 0.35 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 12 | -0.07 mmol/L | Standard Deviation 0.41 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 16 | -0.09 mmol/L | Standard Deviation 0.42 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 20 | -0.04 mmol/L | Standard Deviation 0.46 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 24 | 0.03 mmol/L | Standard Deviation 0.33 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 28 | 0.06 mmol/L | Standard Deviation 0.42 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 32 | 0.10 mmol/L | Standard Deviation 0.46 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 48 | -0.02 mmol/L | Standard Deviation 0.39 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 20 | -0.08 mmol/L | Standard Deviation 0.37 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 48 | -0.07 mmol/L | Standard Deviation 0.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 32 | -0.05 mmol/L | Standard Deviation 0.38 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 16 | -0.05 mmol/L | Standard Deviation 0.33 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 12 | -0.12 mmol/L | Standard Deviation 0.34 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 8 | -0.07 mmol/L | Standard Deviation 0.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 40 | -0.06 mmol/L | Standard Deviation 0.37 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 4 | -0.12 mmol/L | Standard Deviation 0.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 2 | -0.03 mmol/L | Standard Deviation 0.37 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 28 | 0.03 mmol/L | Standard Deviation 0.45 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Potassium | Week 24 | -0.11 mmol/L | Standard Deviation 0.37 |
Secondary
Mean Change From Baseline in Protein
Protein was measured in grams per liter (g/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 2 | -0.2 g/L | Standard Deviation 3.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 12 | -0.8 g/L | Standard Deviation 3.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 28 | -3.1 g/L | Standard Deviation 7.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 4 | -1.5 g/L | Standard Deviation 4.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 24 | -2.2 g/L | Standard Deviation 7.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 16 | -1.2 g/L | Standard Deviation 5.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 8 | -1.1 g/L | Standard Deviation 4.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 48 | -2.3 g/L | Standard Deviation 6.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 40 | -2.2 g/L | Standard Deviation 6.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 20 | -2.7 g/L | Standard Deviation 6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 32 | -1.4 g/L | Standard Deviation 6.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 20 | -1.6 g/L | Standard Deviation 4.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 32 | -1.5 g/L | Standard Deviation 5.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 24 | -1.8 g/L | Standard Deviation 4.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 28 | -2.4 g/L | Standard Deviation 4.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 8 | -2.1 g/L | Standard Deviation 4.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 48 | -2.4 g/L | Standard Deviation 5.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 12 | -1.3 g/L | Standard Deviation 4.7 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 40 | -0.9 g/L | Standard Deviation 5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 16 | -0.3 g/L | Standard Deviation 4.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 4 | -1.6 g/L | Standard Deviation 4.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 2 | -1.2 g/L | Standard Deviation 4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 40 | -1.8 g/L | Standard Deviation 5.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 2 | -1.0 g/L | Standard Deviation 4.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 4 | -1.5 g/L | Standard Deviation 4.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 8 | -1.8 g/L | Standard Deviation 5.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 12 | -1.4 g/L | Standard Deviation 5.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 16 | -2.3 g/L | Standard Deviation 5.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 20 | -2.6 g/L | Standard Deviation 4.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 24 | -1.8 g/L | Standard Deviation 5.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 28 | -2.5 g/L | Standard Deviation 5.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 32 | -0.8 g/L | Standard Deviation 5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 48 | -0.9 g/L | Standard Deviation 5.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 20 | -3.1 g/L | Standard Deviation 5.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 48 | -3.4 g/L | Standard Deviation 6.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 32 | -1.9 g/L | Standard Deviation 6.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 16 | -3.8 g/L | Standard Deviation 5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 12 | -1.2 g/L | Standard Deviation 5.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 8 | -2.0 g/L | Standard Deviation 3.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 40 | -2.6 g/L | Standard Deviation 6.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 4 | -1.7 g/L | Standard Deviation 4.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 2 | -1.1 g/L | Standard Deviation 3.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 28 | -3.6 g/L | Standard Deviation 6.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Protein | Week 24 | -2.0 g/L | Standard Deviation 4.7 |
Secondary
Mean Change From Baseline in Pulse Rate
Pulse Rate was measured in beats per minute (beats/min).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 28 | 0.6 beats/min | Standard Deviation 11.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 24 | -1.5 beats/min | Standard Deviation 10.7 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 12 | 0.6 beats/min | Standard Deviation 10.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 48 | -0.2 beats/min | Standard Deviation 11.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 20 | 0.3 beats/min | Standard Deviation 10.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 16 | -0.8 beats/min | Standard Deviation 9.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 40 | -0.1 beats/min | Standard Deviation 10.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 2 | -0.2 beats/min | Standard Deviation 8.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 6 | -0.7 beats/min | Standard Deviation 10.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 44 | -0.2 beats/min | Standard Deviation 10.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 36 | -0.7 beats/min | Standard Deviation 10.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 32 | 0.4 beats/min | Standard Deviation 9.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 8 | 1.3 beats/min | Standard Deviation 9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 4 | 1.7 beats/min | Standard Deviation 9.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 36 | 0.2 beats/min | Standard Deviation 8.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 2 | 0.2 beats/min | Standard Deviation 10.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 4 | 1.5 beats/min | Standard Deviation 8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 6 | 0.1 beats/min | Standard Deviation 8.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 8 | 0.3 beats/min | Standard Deviation 9.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 12 | 1.1 beats/min | Standard Deviation 9.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 16 | 0.3 beats/min | Standard Deviation 8.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 20 | 1.1 beats/min | Standard Deviation 9.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 24 | 0.8 beats/min | Standard Deviation 10.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 28 | 1.3 beats/min | Standard Deviation 10.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 32 | 1.3 beats/min | Standard Deviation 10.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 40 | -0.1 beats/min | Standard Deviation 9.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 44 | -0.1 beats/min | Standard Deviation 9.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 48 | -0.7 beats/min | Standard Deviation 10.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 36 | 0.7 beats/min | Standard Deviation 10.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 44 | 0.3 beats/min | Standard Deviation 11.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 4 | 0.4 beats/min | Standard Deviation 8.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 8 | 1.4 beats/min | Standard Deviation 10.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 40 | 0.6 beats/min | Standard Deviation 10.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 2 | 2.3 beats/min | Standard Deviation 9.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 32 | 0.8 beats/min | Standard Deviation 11.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 24 | -0.3 beats/min | Standard Deviation 10.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 16 | 0.9 beats/min | Standard Deviation 10.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 6 | 0.8 beats/min | Standard Deviation 8.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 12 | -0.3 beats/min | Standard Deviation 10.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 48 | -0.9 beats/min | Standard Deviation 11.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 20 | 0.8 beats/min | Standard Deviation 9.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 28 | 0.0 beats/min | Standard Deviation 9.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 20 | 0.4 beats/min | Standard Deviation 6.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 24 | -1.0 beats/min | Standard Deviation 8.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 44 | -0.6 beats/min | Standard Deviation 8.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 28 | 0.6 beats/min | Standard Deviation 8.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 6 | -0.6 beats/min | Standard Deviation 8.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 32 | -2.1 beats/min | Standard Deviation 11 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 4 | -3.3 beats/min | Standard Deviation 9.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 36 | -0.2 beats/min | Standard Deviation 9.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 48 | -2.0 beats/min | Standard Deviation 7.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 40 | -1.3 beats/min | Standard Deviation 9.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 12 | -1.5 beats/min | Standard Deviation 9.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 2 | -0.9 beats/min | Standard Deviation 10.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 16 | -1.6 beats/min | Standard Deviation 10.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Pulse Rate | Week 8 | -2.6 beats/min | Standard Deviation 10.2 |
Secondary
Mean Change From Baseline in Sodium
Sodium was measured in millimoles per liter (mmol/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 2 | -0.1 mmol/L | Standard Deviation 1.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 12 | -0.3 mmol/L | Standard Deviation 2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 28 | 0.0 mmol/L | Standard Deviation 1.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 4 | -0.3 mmol/L | Standard Deviation 2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 24 | -0.1 mmol/L | Standard Deviation 2.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 16 | -0.4 mmol/L | Standard Deviation 2.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 8 | 0.1 mmol/L | Standard Deviation 2.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 48 | -0.4 mmol/L | Standard Deviation 2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 40 | -0.1 mmol/L | Standard Deviation 2.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 20 | 0.3 mmol/L | Standard Deviation 2.2 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 32 | 0.0 mmol/L | Standard Deviation 2.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 20 | -0.8 mmol/L | Standard Deviation 2.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 32 | -0.8 mmol/L | Standard Deviation 3.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 24 | -0.4 mmol/L | Standard Deviation 2.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 28 | -0.4 mmol/L | Standard Deviation 2.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 8 | -0.4 mmol/L | Standard Deviation 2.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 48 | -1.1 mmol/L | Standard Deviation 2.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 12 | -0.5 mmol/L | Standard Deviation 2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 40 | -1.2 mmol/L | Standard Deviation 2.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 16 | -0.2 mmol/L | Standard Deviation 1.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 4 | -0.6 mmol/L | Standard Deviation 2.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 2 | -0.4 mmol/L | Standard Deviation 2.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 40 | -0.1 mmol/L | Standard Deviation 1.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 2 | 0.1 mmol/L | Standard Deviation 1.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 4 | 0.3 mmol/L | Standard Deviation 2.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 8 | 0.3 mmol/L | Standard Deviation 2.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 12 | 0.2 mmol/L | Standard Deviation 2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 16 | 0.0 mmol/L | Standard Deviation 2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 20 | -0.1 mmol/L | Standard Deviation 2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 24 | 0.0 mmol/L | Standard Deviation 2.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 28 | 0.2 mmol/L | Standard Deviation 1.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 32 | 0.1 mmol/L | Standard Deviation 2.1 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 48 | -0.5 mmol/L | Standard Deviation 1.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 20 | -0.5 mmol/L | Standard Deviation 2.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 48 | 0.2 mmol/L | Standard Deviation 2.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 32 | 0.2 mmol/L | Standard Deviation 2.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 16 | -0.2 mmol/L | Standard Deviation 2.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 12 | 0.1 mmol/L | Standard Deviation 2.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 8 | 0.1 mmol/L | Standard Deviation 2.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 40 | -0.3 mmol/L | Standard Deviation 2.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 4 | -0.1 mmol/L | Standard Deviation 2.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 2 | 0.0 mmol/L | Standard Deviation 2.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 28 | 0.1 mmol/L | Standard Deviation 2.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Sodium | Week 24 | -0.3 mmol/L | Standard Deviation 2.1 |
Secondary
Mean Change From Baseline in Systolic Blood Pressure
Blood pressure was measured in millimetre of mercury (mmHg).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 28 | 1.8 mmHg | Standard Deviation 12.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 8 | 0.5 mmHg | Standard Deviation 12.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 44 | 0.1 mmHg | Standard Deviation 12.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 24 | -0.7 mmHg | Standard Deviation 14.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 20 | 1.6 mmHg | Standard Deviation 9.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 16 | 2.1 mmHg | Standard Deviation 12.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 40 | -1.0 mmHg | Standard Deviation 14.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 4 | 0.6 mmHg | Standard Deviation 10.8 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 2 | 3.3 mmHg | Standard Deviation 12.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 12 | -0.7 mmHg | Standard Deviation 10.1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 36 | 2.1 mmHg | Standard Deviation 11 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 6 | 0.3 mmHg | Standard Deviation 11.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 48 | -1.5 mmHg | Standard Deviation 11.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 32 | 2.2 mmHg | Standard Deviation 11.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 36 | 3.1 mmHg | Standard Deviation 12.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 12 | 3.2 mmHg | Standard Deviation 10.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 2 | 5.1 mmHg | Standard Deviation 10.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 4 | 1.0 mmHg | Standard Deviation 7.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 6 | 4.0 mmHg | Standard Deviation 9.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 8 | 3.3 mmHg | Standard Deviation 12.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 16 | 2.1 mmHg | Standard Deviation 11.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 20 | 2.6 mmHg | Standard Deviation 9.8 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 24 | 1.1 mmHg | Standard Deviation 13.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 28 | 3.7 mmHg | Standard Deviation 13.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 32 | 3.0 mmHg | Standard Deviation 13.2 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 40 | 6.2 mmHg | Standard Deviation 12.9 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 44 | 3.3 mmHg | Standard Deviation 14.1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 48 | 4.9 mmHg | Standard Deviation 14.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 8 | -2.4 mmHg | Standard Deviation 9.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 44 | 1.3 mmHg | Standard Deviation 10.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 24 | 0.3 mmHg | Standard Deviation 11 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 28 | 0.9 mmHg | Standard Deviation 10.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 6 | 2.3 mmHg | Standard Deviation 11 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 12 | -3.0 mmHg | Standard Deviation 11.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 32 | 0.4 mmHg | Standard Deviation 11.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 4 | -2.0 mmHg | Standard Deviation 8.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 36 | 0.2 mmHg | Standard Deviation 10.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 40 | -2.0 mmHg | Standard Deviation 11.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 2 | 0.7 mmHg | Standard Deviation 10.7 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 16 | -2.8 mmHg | Standard Deviation 10.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 48 | 0.1 mmHg | Standard Deviation 10.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 20 | -1.7 mmHg | Standard Deviation 12.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 20 | 1.5 mmHg | Standard Deviation 11.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 36 | 2.4 mmHg | Standard Deviation 12.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 2 | 3.2 mmHg | Standard Deviation 9.9 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 24 | 3.6 mmHg | Standard Deviation 9.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 6 | 2.4 mmHg | Standard Deviation 10.6 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 44 | 4.2 mmHg | Standard Deviation 11.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 48 | 4.4 mmHg | Standard Deviation 12 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 28 | 2.5 mmHg | Standard Deviation 11.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 16 | 0.9 mmHg | Standard Deviation 11.1 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 40 | 2.5 mmHg | Standard Deviation 11.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 12 | 0.8 mmHg | Standard Deviation 9.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 32 | 4.3 mmHg | Standard Deviation 13.7 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 4 | 0.6 mmHg | Standard Deviation 12.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Systolic Blood Pressure | Week 8 | -0.7 mmHg | Standard Deviation 11.9 |
Secondary
Mean Change From Baseline in Temperature
Temperature was measured in Grad Celsius (°C).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 28 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 24 | -0.1 Temperature (C) | Standard Deviation 0.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 12 | -0.1 Temperature (C) | Standard Deviation 0.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 48 | -0.1 Temperature (C) | Standard Deviation 0.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 20 | -0.1 Temperature (C) | Standard Deviation 0.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 16 | -0.1 Temperature (C) | Standard Deviation 0.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 40 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 2 | -0.1 Temperature (C) | Standard Deviation 0.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 6 | -0.2 Temperature (C) | Standard Deviation 0.5 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 44 | 0.0 Temperature (C) | Standard Deviation 0.6 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 36 | -0.1 Temperature (C) | Standard Deviation 0.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 32 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 8 | -0.1 Temperature (C) | Standard Deviation 0.4 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 4 | -0.1 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 36 | 0.0 Temperature (C) | Standard Deviation 0.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 2 | 0.0 Temperature (C) | Standard Deviation 0.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 4 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 6 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 8 | -0.1 Temperature (C) | Standard Deviation 0.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 12 | -0.1 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 16 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 20 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 24 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 28 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 32 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 40 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 44 | 0.0 Temperature (C) | Standard Deviation 0.5 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 48 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 36 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 44 | 0.1 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 4 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 8 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 40 | 0.0 Temperature (C) | Standard Deviation 0.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 2 | 0.1 Temperature (C) | Standard Deviation 0.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 32 | 0.1 Temperature (C) | Standard Deviation 0.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 24 | 0.1 Temperature (C) | Standard Deviation 0.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 16 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 6 | 0.1 Temperature (C) | Standard Deviation 0.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 12 | 0.0 Temperature (C) | Standard Deviation 0.3 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 48 | 0.0 Temperature (C) | Standard Deviation 0.5 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 20 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 28 | 0.1 Temperature (C) | Standard Deviation 0.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 20 | 0.0 Temperature (C) | Standard Deviation 0.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 24 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 44 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 28 | 0.1 Temperature (C) | Standard Deviation 0.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 6 | 0.0 Temperature (C) | Standard Deviation 0.5 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 32 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 4 | 0.0 Temperature (C) | Standard Deviation 0.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 36 | 0.1 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 48 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 40 | 0.1 Temperature (C) | Standard Deviation 0.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 12 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 2 | 0.0 Temperature (C) | Standard Deviation 0.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 16 | 0.0 Temperature (C) | Standard Deviation 0.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Temperature | Week 8 | 0.0 Temperature (C) | Standard Deviation 0.4 |
Secondary
Mean Change From Baseline in Triglycerides
Triglycerides was measured in millimoles per liter (mmol/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 2 | -0.176 mmol/L | Standard Deviation 1.593 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 12 | -0.265 mmol/L | Standard Deviation 1.445 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 28 | -0.013 mmol/L | Standard Deviation 1.559 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 4 | -0.189 mmol/L | Standard Deviation 1.212 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 24 | -0.263 mmol/L | Standard Deviation 1.515 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 16 | -0.164 mmol/L | Standard Deviation 1.345 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 8 | -0.182 mmol/L | Standard Deviation 1.554 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 48 | -0.242 mmol/L | Standard Deviation 1.516 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 40 | -0.134 mmol/L | Standard Deviation 1.175 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 20 | -0.233 mmol/L | Standard Deviation 1.391 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 32 | -0.260 mmol/L | Standard Deviation 1.418 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 20 | -0.104 mmol/L | Standard Deviation 0.837 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 32 | 0.045 mmol/L | Standard Deviation 0.717 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 24 | -0.045 mmol/L | Standard Deviation 0.774 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 28 | -0.125 mmol/L | Standard Deviation 0.782 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 8 | 0.076 mmol/L | Standard Deviation 0.582 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 48 | -0.149 mmol/L | Standard Deviation 0.758 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 12 | 0.088 mmol/L | Standard Deviation 0.713 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 40 | -0.159 mmol/L | Standard Deviation 0.765 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 16 | 0.099 mmol/L | Standard Deviation 1.488 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 4 | -0.004 mmol/L | Standard Deviation 0.51 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 2 | 0.046 mmol/L | Standard Deviation 0.683 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 40 | 0.177 mmol/L | Standard Deviation 0.821 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 2 | 0.110 mmol/L | Standard Deviation 0.855 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 4 | -0.030 mmol/L | Standard Deviation 0.471 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 8 | -0.084 mmol/L | Standard Deviation 0.498 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 12 | 0.063 mmol/L | Standard Deviation 0.578 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 16 | 0.142 mmol/L | Standard Deviation 0.58 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 20 | 0.008 mmol/L | Standard Deviation 0.622 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 24 | -0.013 mmol/L | Standard Deviation 0.608 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 28 | -0.043 mmol/L | Standard Deviation 0.423 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 32 | 0.057 mmol/L | Standard Deviation 0.532 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 48 | 0.114 mmol/L | Standard Deviation 0.507 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 20 | -0.060 mmol/L | Standard Deviation 0.707 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 48 | 0.054 mmol/L | Standard Deviation 0.752 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 32 | 0.112 mmol/L | Standard Deviation 0.718 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 16 | 0.112 mmol/L | Standard Deviation 1.035 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 12 | 0.009 mmol/L | Standard Deviation 0.514 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 8 | 0.046 mmol/L | Standard Deviation 0.585 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 40 | 0.022 mmol/L | Standard Deviation 0.644 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 4 | 0.084 mmol/L | Standard Deviation 0.529 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 2 | 0.183 mmol/L | Standard Deviation 0.751 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 28 | -0.036 mmol/L | Standard Deviation 0.663 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Triglycerides | Week 24 | -0.030 mmol/L | Standard Deviation 0.707 |
Secondary
Mean Change From Baseline in Urea Nitrogen
Urea Nitrogen was measured in millimoles per liter (mmol/L).
Time frame: From Baseline (Week 1) to 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. Here, 'n' (Number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 2 | 0.28 mmol/L | Standard Deviation 1.55 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 12 | 0.03 mmol/L | Standard Deviation 1.13 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 28 | 0.13 mmol/L | Standard Deviation 1.38 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 4 | -0.07 mmol/L | Standard Deviation 1.21 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 24 | 0.08 mmol/L | Standard Deviation 1.69 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 16 | 0.19 mmol/L | Standard Deviation 1.35 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 8 | 0.06 mmol/L | Standard Deviation 1.25 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 48 | 0.05 mmol/L | Standard Deviation 1.22 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 40 | 0.29 mmol/L | Standard Deviation 1.54 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 20 | -0.18 mmol/L | Standard Deviation 1.29 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 32 | 0.40 mmol/L | Standard Deviation 2.37 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 20 | -0.20 mmol/L | Standard Deviation 1.33 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 32 | -0.30 mmol/L | Standard Deviation 1.65 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 24 | -0.44 mmol/L | Standard Deviation 1.38 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 28 | 0.03 mmol/L | Standard Deviation 1.61 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 8 | -0.26 mmol/L | Standard Deviation 1.22 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 48 | -0.31 mmol/L | Standard Deviation 1.54 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 12 | -0.39 mmol/L | Standard Deviation 1.31 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 40 | 0.10 mmol/L | Standard Deviation 1.73 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 16 | -0.18 mmol/L | Standard Deviation 1.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 4 | -0.33 mmol/L | Standard Deviation 1.52 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 2 | -0.09 mmol/L | Standard Deviation 1.23 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 40 | 0.21 mmol/L | Standard Deviation 1.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 2 | -0.05 mmol/L | Standard Deviation 1.32 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 4 | -0.14 mmol/L | Standard Deviation 1.2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 8 | -0.19 mmol/L | Standard Deviation 1.07 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 12 | -0.29 mmol/L | Standard Deviation 1.17 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 16 | 0.19 mmol/L | Standard Deviation 1.49 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 20 | -0.25 mmol/L | Standard Deviation 1.22 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 24 | -0.13 mmol/L | Standard Deviation 1.18 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 28 | -0.23 mmol/L | Standard Deviation 1.26 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 32 | 0.21 mmol/L | Standard Deviation 1.17 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 48 | 0.23 mmol/L | Standard Deviation 1.38 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 20 | -0.16 mmol/L | Standard Deviation 1.08 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 48 | -0.02 mmol/L | Standard Deviation 1.56 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 32 | 0.10 mmol/L | Standard Deviation 1.43 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 16 | -0.03 mmol/L | Standard Deviation 1.41 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 12 | -0.22 mmol/L | Standard Deviation 1.15 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 8 | 0.17 mmol/L | Standard Deviation 1.59 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 40 | 0.14 mmol/L | Standard Deviation 1.43 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 4 | 0.04 mmol/L | Standard Deviation 1.19 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 2 | -0.02 mmol/L | Standard Deviation 1.31 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 28 | -0.22 mmol/L | Standard Deviation 1.14 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Urea Nitrogen | Week 24 | -0.09 mmol/L | Standard Deviation 1.5 |
Secondary
Mean Change From Baseline in Weight
Weight was measured in kilograms (kg).
Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 12 | 0.4 kg | Standard Deviation 2.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 4 | 0.0 kg | Standard Deviation 1 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 16 | 0.3 kg | Standard Deviation 2.3 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 8 | 0.3 kg | Standard Deviation 1.9 |
| SOC + Placebo iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 20 | 0.3 kg | Standard Deviation 2.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 8 | 0.6 kg | Standard Deviation 1.4 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 12 | 0.5 kg | Standard Deviation 1.6 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 16 | 0.7 kg | Standard Deviation 2.3 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 4 | 0.2 kg | Standard Deviation 1 |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 20 | 0.7 kg | Standard Deviation 2.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 8 | 0.6 kg | Standard Deviation 1.8 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 20 | 1.0 kg | Standard Deviation 2.6 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 4 | 0.4 kg | Standard Deviation 0.9 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 12 | 0.5 kg | Standard Deviation 2 |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 16 | 0.8 kg | Standard Deviation 2.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 12 | 0.6 kg | Standard Deviation 2.3 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 4 | 0.3 kg | Standard Deviation 1.2 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 16 | 0.5 kg | Standard Deviation 2.4 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 8 | 0.4 kg | Standard Deviation 1.8 |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Mean Change From Baseline in Weight | Week 20 | 0.5 kg | Standard Deviation 2.8 |
Secondary
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
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).
Time frame: Screening, Week 4, Week 24, Week 28 and 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 28 | 1 Participants |
| SOC + Placebo iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 4 | 11 Participants |
| SOC + Placebo iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 48 | 8 Participants |
| SOC + Placebo iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 24 | 9 Participants |
| SOC + Placebo iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Screening | 8 Participants |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 24 | 7 Participants |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 28 | 0 Participants |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 48 | 7 Participants |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 4 | 12 Participants |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Screening | 11 Participants |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 24 | 6 Participants |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Screening | 6 Participants |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 4 | 7 Participants |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 28 | 0 Participants |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 48 | 11 Participants |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 28 | 0 Participants |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 4 | 10 Participants |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Screening | 6 Participants |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 24 | 10 Participants |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings | Week 48 | 9 Participants |
Secondary
Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE) | 8.9 percentage of participants |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE) | 0 percentage of participants |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE) | 4.4 percentage of participants |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE) | 4.3 percentage of participants |
Secondary
Percentage of Participants With a Serious Adverse Event (SAE)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Percentage of Participants With a Serious Adverse Event (SAE) | 13.3 percentage of participants |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Percentage of Participants With a Serious Adverse Event (SAE) | 11.1 percentage of participants |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Percentage of Participants With a Serious Adverse Event (SAE) | 13.3 percentage of participants |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Percentage of Participants With a Serious Adverse Event (SAE) | 10.6 percentage of participants |
Secondary
Percentage of Participants With at Least One Adverse Events (AEs)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Percentage of Participants With at Least One Adverse Events (AEs) | 66.7 percentage of participants |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Percentage of Participants With at Least One Adverse Events (AEs) | 66.7 percentage of participants |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Percentage of Participants With at Least One Adverse Events (AEs) | 82.2 percentage of participants |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Percentage of Participants With at Least One Adverse Events (AEs) | 74.5 percentage of participants |
Secondary
Percentage of Participants With at Least One Adverse Events (AEs) of Interest
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOC + Placebo iv Q4W (FAS) | Percentage of Participants With at Least One Adverse Events (AEs) of Interest | 24.4 percentage of participants |
| SOC + DZP 6mg/kg iv Q4W (FAS) | Percentage of Participants With at Least One Adverse Events (AEs) of Interest | 26.7 percentage of participants |
| SOC + DZP 24mg/kg iv Q4W (FAS) | Percentage of Participants With at Least One Adverse Events (AEs) of Interest | 28.9 percentage of participants |
| SOC + DZP 45mg/kg iv Q4W (FAS) | Percentage of Participants With at Least One Adverse Events (AEs) of Interest | 25.5 percentage of participants |
Secondary
The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24
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.
Time frame: Week 24
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOC + Placebo iv Q4W (FAS) | The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24 | 37.2 percentage of participants |
| SOC + DZP 6mg/kg iv Q4W (FAS) | The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24 | 48.8 percentage of participants |
| SOC + DZP 24mg/kg iv Q4W (FAS) | The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24 | 54.5 percentage of participants |
| SOC + DZP 45mg/kg iv Q4W (FAS) | The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24 | 52.2 percentage of participants |
Comparison: Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.p-value: =0.269995% CI: [0.7, 3.8]Chi-squared
Comparison: Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.p-value: =0.103695% CI: [0.9, 4.8]Chi-squared
Comparison: Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.p-value: =0.151895% CI: [0.8, 4.3]Chi-squared
Comparison: Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.95% CI: [-9.2, 32.4]Chi-squared
Comparison: Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.95% CI: [-3.3, 38]Chi-squared
Comparison: Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.95% CI: [-5.5, 35.4]Chi-squared
Comparison: Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.95% CI: [-8.7, 32.5]Chi-squared
Comparison: Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.95% CI: [-3.2, 38.3]Chi-squared
Comparison: Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.95% CI: [-5.2, 35.6]Chi-squared