| Primary | Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels | Percent change from baseline in hs-CRP levels at week 13 are presented. | ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Median | Inter-Quartile Range | Percent change | | Baseline (average of the hs-CRP value prior to randomization and day 1), week 13 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG003 | Ziltivekimab 30 mg | Participants received SC injection of 30 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. |
| | Units | Counts |
|---|
| Participants | - OG00057
- OG00158
- OG00261
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-4.49(-35.54 to 46.27)
- OG001-76.57(-86.89 to -57.14)
- OG002-88.12(-92.11 to -78.95)
- OG003
|
|
| | 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 |
|---|
| Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (greater than or equal to (>=) 11 or less than (<) 11 grams per deciliter (g/dL)) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis. | Hodges-Lehmann method | | <0.0001 | | Median Difference (Final Values) | -66.20 | | | 2-Sided | 95 | -86.15 | -49.12 | | | | | Superiority | | |
|
| Secondary | Percent Change From Baseline in Serum Amyloid A (SAA) | Percent change from baseline in SAA at week 13 are presented. | ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Median | Inter-Quartile Range | Percent change | | Baseline (average of the values at week -1 and day 1), week 13 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG003 |
|
| Secondary | Percent Change From Baseline in Fibrinogen | Percent change from baseline in fibrinogen at week 13 are presented. | ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Median | Inter-Quartile Range | Percent change | | Baseline (day 1), week 13 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG003 | Ziltivekimab 30 mg |
|
| Secondary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious AEs (TESAEs), Severe Hematologic AEs, Severe Non-hematologic AEs, and AEs Leading to Drug Discontinuation | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAEs are defined as AEs that initiated or worsened on or after the date of first dose of study drug up to the end of safety-follow-up. A SAE was defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. TEAEs that met any of these criteria were considered severe hematologic AEs: grade 3 neutropenia, grade 3 anemia, grade 3 leukopenia, grade 3 lymphopenia, grade 3 eosinophilia, and grade 3 thrombocytopenia. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | Percentage of participants | | From week 0 to week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 |
|
| Secondary | Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Events | Bleeding events were classified using the TIMI bleeding classification as follows: 1) major: intracranial hemorrhage or a >=5 g/dL decrease in the hemoglobin concentration or a >=15 percent (%) absolute decrease in the hematocrit; 2) minor: (a) observed blood loss: >=3 g/dL decrease in the hemoglobin concentration or >=10% decrease in the hematocrit. (b) no observed blood loss: >=4 g/dL decrease in the hemoglobin concentration or >=12% decrease in the hematocrit; 3) minimal: any clinically overt sign of hemorrhage (including imaging) that was associated with a < 3 g/dL decrease in the hemoglobin concentration or <9% decrease in the hematocrit. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | Percentage of participants | | From week 0 to week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. |
|
| Secondary | Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) | An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AESI included serious infections, malignancies, anaphylaxis occurring at any time, even if considered unrelated to the study drug, gastrointestinal perforations, hypersensitivity reaction during investigational product (IP) administration, neutrophils per cubic millimeter (500/mm^3) (severe) or neutrophils <1000/mm^3 (severe) with evidence of concurrent infection, severe injection-related reactions, thrombocytopenia (platelet count <50,000/mm^3 (severe)) or platelet count <75,000/mm^3 (moderate) with evidence of concurrent TIMI major bleeding. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | Percentage of participants | | From week 0 to week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. |
|
| Secondary | Change in Systolic Blood Pressure (SBP) | Change from baseline in systolic blood pressure at week 32 are presented. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | Millimeters of mercury (mmHg) | | Baseline (week 1), week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG003 |
|
| Secondary | Change in Diastolic Blood Pressure (DBP) | Change from baseline in diastolic blood pressure at week 32 are presented. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | mmHg | | Baseline (week 1), week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG003 |
|
| Secondary | Change in Respiratory Rate | Change from baseline in respiratory rate at week 32 are presented. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | Breaths per minute (breaths/min) | | Baseline (week 1), week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG003 |
|
| Secondary | Change in Body Mass Index (BMI) | Change from baseline in BMI at week 24 are presented. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | Kilograms per square meter (kg/m^2) | | Baseline (week 1), week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG003 |
|
| Secondary | Change in Heart Rate | Change from baseline in heart rate at Week 32 are presented. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | Beats per minute (beats/min) | | Baseline (week 1), week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG003 | Ziltivekimab 30 mg |
|
| Secondary | Change in Temperature | Change from baseline in temperature at week 32 are presented. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | Degree Celsius (°C) | | Baseline (week 1), week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG003 | Ziltivekimab 30 mg |
|
| Secondary | Change in Electrocardiogram (ECG) | The ECG was assessed by the investigator at baseline (week -1) and week 24 and categorised as abnormal clinically significant, abnormal not clinically significant, indeterminate, normal, not evaluable and unknown. Number of participants in each ECG category at baseline and week 24 are presented. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data and 'Number Analyzed' = number of participants with available data for each category. | Posted | | Count of Participants | | Participants | | Baseline (week -1), Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. |
|
| Secondary | Change in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AAT) Levels | Change from baseline in ALP, ALT and AAT levels at week 32 are presented. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | Units per liter (U/L) | | Baseline (week 1), week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | |
|
| Secondary | Change in Bicarbonate, Chloride, Potassium, Sodium | Change from baseline in bicarbonate, chloride, potassium, sodium at week 32 are presented. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | millimoles per liter (mmol/L) | | Baseline (week 1), week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG003 |
|
| Secondary | Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen | Change from baseline in direct bilirubin, bilirubin, calcium, creatinine, glucose, phosphate and urea nitrogen at week 32 are presented. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | | Baseline (week 1), week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. |
|
| Secondary | Follicle Stimulating Hormone (FSH) Levels | FSH levels at baseline (week -1) are presented. | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Mean | Standard Deviation | International units per liter (IU/L) | | Baseline (week -1) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg | Participants received SC injection of 15 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG003 |
|
| Secondary | Number of Participants With Anti-drug Antibodies (ADAs) | Participants who had at least 1 positive sample (treatment-boosted or treatment-induced) at any time after their first Ziltivekimab administration were classified as positive for ADAs. In the instance that a participant had a positive sample at the baseline visit, the participant was considered positive only if the peak titer of the post-treatment sample was at least 2-fold higher (i.e., >=2-fold) than the titer of the baseline sample. Number of participants positive for antibodies to Ziltivekimab are presented. | Analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | | Count of Participants | | Participants | | From week 0 to week 32 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received subcutaneous (SC) injection of placebo matched to Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG001 | Ziltivekimab 7.5 mg | Participants received SC injection of 7.5 mg Ziltivekimab once in every 28 days at weeks 1, 5, 9, 13, 17 and 21. Participants were followed up for safety from week 25 through week 32. | | OG002 | Ziltivekimab 15 mg |
|