| 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:
- 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.
- No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score.
- 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).
- No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
| 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). | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (FAS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (FAS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (FAS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS. | | OG003 | SOC + DZP 45mg/kg iv Q4W (FAS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 45mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the FAS. |
| | Units | Counts |
|---|
| Participants | - OG00043
- OG00143
- OG00244
- OG003
|
| | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 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. | MCP-Mod | | =0.0727 | The lowest p-value (z-statistic with the highest value) was used to establish proof of dose response. | | | | | | | | | | | | | Superiority | |
|
| 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:
- 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.
- No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score.
- 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).
- No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
| 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). | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (FAS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Full Analysis Set (FAS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (FAS) | |
|
| 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. | The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. | Posted | | Number | | percentage of participants | | From Baseline (Week 1) until end of the study (Week 48) | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| 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.
| The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. | Posted | | Number | | percentage of participants | | From Baseline (Week 1) until end of the study (Week 48) | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| 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.
| The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. | Posted | | Number | | percentage of participants | | From Baseline (Week 1) until end of the study (Week 48) | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| 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. | The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. | Posted | | Number | | percentage of participants | | From Baseline (Week 1) until end of the study (Week 48) | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Systolic Blood Pressure | Blood pressure was measured in millimetre of mercury (mmHg). | 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. | Posted | | Mean | Standard Deviation | mmHg | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Diastolic Blood Pressure | Blood pressure was measured in millimetre of mercury (mmHg). | 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. | Posted | | Mean | Standard Deviation | mmHg | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Pulse Rate | Pulse Rate was measured in beats per minute (beats/min). | 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. | Posted | | Mean | Standard Deviation | beats/min | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Temperature | Temperature was measured in Grad Celsius (°C). | 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. | Posted | | Mean | Standard Deviation | Temperature (C) | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Weight | Weight was measured in kilograms (kg). | 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. | Posted | | Mean | Standard Deviation | kg | | Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Height | Height was measured in centimeters (cm). | The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. | Posted | | Mean | Standard Deviation | cm | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| 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). | The Safety Set (SS) consisted of all study participants who were randomized and received at least 1 dose (any amount) of study drug. | Posted | | Count of Participants | | Participants | | Screening, Week 4, Week 24, Week 28 and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) |
|
| Secondary | Mean Change From Baseline in Hemoglobin | Hemoglobin was measured in grams per liter (g/L). | 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. | Posted | | Mean | Standard Deviation | g/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Hematocrit | Hematocrit was measured in volume percentage (%) of red blood cells in blood. | 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. | Posted | | Mean | Standard Deviation | volume % of red blood cells | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Erythrocytes | Erythrocytes was measured in number of erythrocytes per liter (10^12/L). | 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. | Posted | | Mean | Standard Deviation | 10^12 erythrocytes per liter | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume | Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL). | 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. | Posted | | Mean | Standard Deviation | Femtolitres (fL) | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | g/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | |
|
| Secondary | Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin | Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg). | 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. | Posted | | Mean | Standard Deviation | Picograms (pg) | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Leukocytes | Leukocytes was measured in number of leukocytes per liter (10^9/L). | 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. | Posted | | Mean | Standard Deviation | 10^9 leukocytes per liter | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Basophils | Basophils was measured in number of basophils per liter (10^9/L). | 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. | Posted | | Mean | Standard Deviation | 10^9 basophils per liter | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Basophils/Leukocytes | Basophils/Leukocytes was measured in percentages (%). | 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. | Posted | | Mean | Standard Deviation | % of Basophils per Leukocytes | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Eosinophils | Eosinophils was measured in number of eosinophils per liter (10^9/L). | 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. | Posted | | Mean | Standard Deviation | 10^9 eosinophils per liter | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Eosinophils/Leukocytes | Eosinophils/Leukocytes was measured in percentages (%). | 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. | Posted | | Mean | Standard Deviation | % of Eosinophils per Leukocytes | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Lymphocytes | Lymphocytes was measured in number of lymphocytes per liter (10^9/L). | 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. | Posted | | Mean | Standard Deviation | 10^9 lymphocytes per liter | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Lymphocytes/Leukocytes | Lymphocytes/Leukocytes was measured in percentages (%). | 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. | Posted | | Mean | Standard Deviation | % of Lymphocytes per Leukocytes | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Monocytes | Monocytes was measured in number of monocytes per liter (10^9/L). | 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. | Posted | | Mean | Standard Deviation | 10^9 monocytes per liter | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Monocytes/Leukocytes | Monocytes/Leukocytes was measured in percentages (%). | 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. | Posted | | Mean | Standard Deviation | % of Monocytes per Leukocytes | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Neutrophils | Neutrophils was measured in number of neutrophils per liter (10^9/L). | 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. | Posted | | Mean | Standard Deviation | 10^9 neutrophils per liter | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Neutrophils/Leukocytes | Neutrophils/Leukocytes was measured in percentages (%). | 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. | Posted | | Mean | Standard Deviation | % of Neutrophils per Leukocytes | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Platelets | Platelets was measured in number of platelets per liter (10^9/L). | 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. | Posted | | Mean | Standard Deviation | 10^9 platelets per liter | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Cluster of Differentiation 3 (CD3) | Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL). | 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. | Posted | | Mean | Standard Deviation | cells/µL | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in CD3/Lymphocytes | CD3/Lymphocytes was measured in percentages (%). | 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. | Posted | | Mean | Standard Deviation | % of CD3 per Leukocytes | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Cluster of Differentiation 19 (CD19) | Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL). | 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. | Posted | | Mean | Standard Deviation | cells/µL | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in CD19/Lymphocytes | CD19/Lymphocytes was measured in percentages (%). | 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. | Posted | | Mean | Standard Deviation | % of CD19 per Leukocytes | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Aspartate Aminotransferase | Aspartate Aminotransferase was measured in units per liter (U/L). | 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. | Posted | | Mean | Standard Deviation | U/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Alanine Aminotransferase | Alanine Aminotransferase was measured in units per liter (U/L). | 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. | Posted | | Mean | Standard Deviation | U/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Alkaline Phosphatase | Alkaline Phosphatase was measured in units per liter (U/L). | 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. | Posted | | Mean | Standard Deviation | U/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Gamma Glutamyl Transferase | Gamma Glutamyl Transferase was measured in units per liter (U/L). | 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. | Posted | | Mean | Standard Deviation | U/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Bilirubin | Bilirubin was measured in micromols per liter (µmol/L). | 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. | Posted | | Mean | Standard Deviation | μmol/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Direct Bilirubin | Direct Bilirubin was measured in micromols per liter (µmol/L). | 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. | Posted | | Mean | Standard Deviation | μmol/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Lactate Dehydrogenase | Lactate Dehydrogenase was measured in units per liter (U/L). | 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. | Posted | | Mean | Standard Deviation | U/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Creatinine | Creatinine was measured in micromols per liter (µmol/L). | 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. | Posted | | Mean | Standard Deviation | μmol/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Urea Nitrogen | Urea Nitrogen was measured in millimoles per liter (mmol/L). | 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. | Posted | | Mean | Standard Deviation | mmol/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Sodium | Sodium was measured in millimoles per liter (mmol/L). | 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. | Posted | | Mean | Standard Deviation | mmol/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Potassium | Potassium was measured in millimoles per liter (mmol/L). | 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. | Posted | | Mean | Standard Deviation | mmol/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Calcium | Calcium was measured in millimoles per liter (mmol/L). | 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. | Posted | | Mean | Standard Deviation | mmol/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Phosphate | Phosphate was measured in millimoles per liter (mmol/L). | 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. | Posted | | Mean | Standard Deviation | mmol/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Cholesterol | Cholesterol was measured in millimoles per liter (mmol/L). | 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. | Posted | | Mean | Standard Deviation | mmol/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Triglycerides | Triglycerides was measured in millimoles per liter (mmol/L). | 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. | Posted | | Mean | Standard Deviation | mmol/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Protein | Protein was measured in grams per liter (g/L). | 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. | Posted | | Mean | Standard Deviation | g/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Albumin | Albumin was measured in grams per liter (g/L). | 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. | Posted | | Mean | Standard Deviation | g/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Glucose | Glucose was measured in millimoles per liter (mmol/L). | 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. | Posted | | Mean | Standard Deviation | mmol/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Lipase, Pancreatic | Lipase, Pancreatic was measured in units per liter (U/L). | 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. | Posted | | Mean | Standard Deviation | U/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Creatine Kinase | Creatine Kinase was measured in units per liter (U/L). | 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. | Posted | | Mean | Standard Deviation | U/L | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in pH | | 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. | Posted | | Mean | Standard Deviation | pH | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Erythrocytes (/HPF) | | 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. | Posted | | Mean | Standard Deviation | % of Erythrocytes per HPF | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|
| Secondary | Mean Change From Baseline in Leukocytes (/HPF) | | 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. | Posted | | Mean | Standard Deviation | % of Leukocytes per HPF | | From Baseline (Week 1) to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | SOC + Placebo iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive Placebo intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the Safety Set (SS). | | OG001 | SOC + DZP 6mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 6mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. | | OG002 | SOC + DZP 24mg/kg iv Q4W (SS) | This arm consisted of participants who received stable standard-of-care (SOC) medications at study entry and were randomized to receive dapirolizumab pegol (DZP) 24mg/kg intravenous (iv) infusion every 4 weeks (Q4W) during the 24-week Double-Blind Treatment Period. Participants formed the SS. |
|