Trial to Evaluate Reduction in Inflammation in Patients W... | NCT04626505

ID	Type	Description	Link
U1111-1260-3695	Other Identifier	World Health Organization (WHO)
jRCT2031200216	Registry Identifier	JAPIC/jRCT

Name	Class
Sponsor: Corvidia Therapeutics Inc, a subsidiary of Novo Nordisk A/S	UNKNOWN

Label	Type	Description	Intervention Names
Ziltivekimab 15 mg	Experimental	Participants will receive ziltivekimab 15 mg for 12 weeks.	Drug: Ziltivekimab
Ziltivekimab 30 mg	Experimental	Participants will receive ziltivekimab 30 mg for 12 weeks.	Drug: Ziltivekimab
Placebo (ziltivekimab)	Placebo Comparator	Participants will receive placebo (ziltivekimab) for 12 weeks.	Drug: Placebo (ziltivekimab)

Name	Type	Description	Arm Group Labels	Other Names
Ziltivekimab	Drug	Administered subcutaneously (s.c., under skin) once every 4 weeks for 12 weeks	Ziltivekimab 15 mg Ziltivekimab 30 mg

Measure	Description	Time Frame
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) Levels From Baseline (Average of All Hs-CRP Values Prior to the Administration of Study Drug) to the End of Treatment (Average of Week 10 and Week 12)	Percent change in hs-CRP levels from baseline (average of the hs-CRP value prior to the administration of study drug) to the end of treatment (average of Week 10 and Week 12) is presented. Baseline was defined as the average of all hs-CRP values prior to the first administration of study drug at day 1 and end of treatment was defined as the average of hs-CRP values at week 10 and week 12.	Baseline (day 1), end of treatment (average of week 10 and week 12)

Measure	Description	Time Frame
Number of Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) was any undesirable event or any untoward medical occurrence that occurred in a participant during the course of the study or the protocol-defined time after study termination, whether or not that event was considered study drug-related. A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). Number of TEAEs from randomization (day 1) to week 20 are presented.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age equal to or above 20 years at the time of signing the Informed Consent Form
Stage 3 to 5 non-dialysis-dependent chronic kidney disease (NDD-CKD), ie, estimated glomerular filtration rate above 10 and below 60 mL/min/1.73 m^2 using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation
Serum hs-CRP level equal to or above 2.0 mg/L measured during the screening period. Note: Targeting patients with a history of advanced stage CKD, atherosclerotic cardiovascular disease, anemia, diabetic retinopathy, obesity, or elevated BMI, and diabetes for screening will help increase the chances of identifying patients with hs-CRP equal to or above2.0 mg/L 4. The patient agrees to comply with
The patient agrees to comply with the contraception and reproduction restrictions of the study as follows:
1. Women of childbearing potential must be using a method of contraception that is "highly effective" (ie, less than 1% failure rate) for at least 3 months following the last dose of study drug;
2. Postmenopausal women must have had no menstrual bleeding for at least 1 year before initial dosing and either be over the age of 60 years or have an elevated plasma follicle stimulating hormone level (ie, above 40 mIU/mL) at screening;
3. Women of childbearing potential must have a documented negative serum pregnancy test result at screening; and
4. All male patients, from the day of dosing until the final study visit, unless surgically sterile, must be willing to use a condom with a partner (male patients with partners of childbearing potential must be willing to use 2 effective methods of birth control, 1 should be condom with spermicide) to prevent pregnancy and drug exposure of a partner, and refrain from donating sperm or fathering a child; and
The patient must be willing and able to provide informed consent and abide all study requirements and restrictions.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from participation in the study:

Laboratory values

Absolute neutrophil count below 2.0 × 10^9/L during screening;
Platelet count below 120 × 10^9/L during screening;
Spot urine protein-creatinine ratio above 4000 mg/g (4.0 g/g) during screening;
Alanine aminotransferase or aspartate aminotransferase above 2.5 × upper limit of normal during screening;
Positive testing for tuberculosis during screening. blood testing (eg, QuantiFERON) is preferred, but a purified protein derivative (PPD) skin test read within 48 to 72 hours by a qualified healthcare professional may also be performed. If a patient is PPD positive but QuantiFERON negative, the patient is eligible;
Evidence of human immunodeficiency virus (HIV)-1 or HIV-2 infection by serology measured during screening;
Hepatitis B or C by serology (eg, hepatitis B surface antigen or hepatitis C antibody positive) measured during screening;

Medical conditions or diseases

Expected to require blood transfusion within 12 weeks post-randomization;
Thromboembolic event within 12 weeks prior to randomization;
Clinical evidence or suspicion of active infection;
History of peptic ulcer disease or gastrointestinal ulceration in the 12 months prior to randomization;
History of active diverticulitis in the 12 months prior to randomization;
History of inflammatory bowel disease that has been clinically active during the 12 months prior to randomization;
Uncontrolled hypertension (defined as an average systolic blood pressure above 160 mmHg or an average diastolic blood pressure above 100 mmHg) during screening. Patients may be re-evaluated within 2 weeks, at the discretion of the Principal Investigator, for this criterion if antihypertensive therapy has been started or increased as a result of initial screening blood pressure being above these limits;
Planned coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or any other major surgical procedure during the time frame of the study;
Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure within the past 6 months prior to randomization;
Prior gastric bypass surgery;
History of New York Heart Association (NYHA) Class IV congestive heart failure within 12 weeks prior to randomization;
Diagnosis of malignancy within 1 year prior to randomization with the exception of successfully treated nonmetastatic basal cell or squamous cell carcinomas of the skin and/or local carcinoma in situ of the cervix;
History of bone marrow or solid organ transplant or anticipated to receive an organ transplant during the time frame of the study;
Known allergy to the study drug or any of its ingredients;

Prior or current medications

Received an investigational drug within 30 days prior to screening;
Received a live vaccine product within 14 days of study drug administration or expect to receive live vaccine during the treatment period;
Expected to receive any investigational drug or any of the exclusionary drugs during the treatment period or safety follow-Up period;
Chronic use of systemic immunosuppressive drugs during the screening period or anticipated use of such drugs any time during the study. Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary. Oral prednisone up to 5 mg per day (or equivalent) is permitted if the dose has been stable for at least 4 weeks prior to Screening and no dose changes are planned during study participation. Short-term use of oral steroids for treatment of rash or asthma exacerbation is allowed;
Use of systemic antibiotics, systemic antivirals, or systemic antifungals during the screening period. Note: "Systemic" is defined as oral or intravenous drugs that are absorbed into the circulation;
Requirement of an indwelling catheter of any type; 28. Use of hypoxia-inducible factor (HIF) stabilizers or erythropoiesis-stimulating agents (ESA) within 6 weeks of randomization or during the treatment period;

General exclusions

Currently breastfeeding; or
Any condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would in the opinion of the Investigator increase the risk of participating in the study.

Facility	Status	City	State	ZIP	Country	Contacts
Ehime Medical Center		Ehime		791-0281	Japan

PubMed Identifier	Type	Citation	Retractions
37211246	Derived	Wada Y, Jensen C, Meyer ASP, Zonoozi AAM, Honda H. Efficacy and safety of interleukin-6 inhibition with ziltivekimab in patients at high risk of atherosclerotic events in Japan (RESCUE-2): A randomized, double-blind, placebo-controlled, phase 2 trial. J Cardiol. 2023 Oct;82(4):279-285. doi: 10.1016/j.jjcc.2023.05.006. Epub 2023 May 19.

ID	Title	Description
FG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
FG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 17, 2021	May 5, 2026

ID	Title	Description
BG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
BG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
BG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00013 BG00111 BG00212 BG00336

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) Levels From Baseline (Average of All Hs-CRP Values Prior to the Administration of Study Drug) to the End of Treatment (Average of Week 10 and Week 12)

Percent change in hs-CRP levels from baseline (average of the hs-CRP value prior to the administration of study drug) to the end of treatment (average of Week 10 and Week 12) is presented. Baseline was defined as the average of all hs-CRP values prior to the first administration of study drug at day 1 and end of treatment was defined as the average of hs-CRP values at week 10 and week 12.

The Intent-to-Treat (ITT) Population was defined as all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Median

Inter-Quartile Range

Percent change

Baseline (day 1), end of treatment (average of week 10 and week 12)

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants	OG00012 OG00111 OG00212

Title

Denominators

Categories

Title	Measurements
	OG000-27.01(-46.71 to -3.83) OG001-96.23(-98.89 to -91.67) OG002-93.41(-96.59 to -88.34)

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
OG000 OG001		Hodges-Lehmann method		<0.0001		Median of differences	-66.80			2-Sided	95	-87.79	-44.84					Superiority	Percent change from baseline was analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariate chronic kidney disease stage (3 versus 4 and 5) by aligning responses within each stratum defined by the covariate prior to analysis.

Secondary

Number of Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) was any undesirable event or any untoward medical occurrence that occurred in a participant during the course of the study or the protocol-defined time after study termination, whether or not that event was considered study drug-related. A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the safety follow-up period (week 20). Number of TEAEs from randomization (day 1) to week 20 are presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Number

Events

From randomization (Day 1) to week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Secondary

Number of Serious Adverse Events (SAEs)

An AE was any undesirable event or any untoward medical occurrence that occurred in a participant during the course of the study or the protocol-defined time after study termination, whether or not that event was considered study drug-related. An 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. ). Number of SAEs from randomization (day 1) to week 20 are presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Number

Events

From randomization (Day 1) to week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg

Secondary

Number of Participants With Vital Signs Parameters Exceeding Pre-defined Criteria

Number of participants with vital signs parameters (including systolic blood pressure, heart rate and respiratory rate) exceeding pre-defined criteria are presented. The pre-defined criteria were: 1) systolic blood pressure: greater than (>25) millimeters of mercury (mmHg) increase or decrease from baseline and >160 mmHg; 2) heart rate: >100 beats per minute; 3)respiratory rate: >24 breaths per minute.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

From randomization (Day 1) to week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Secondary

Change in Electrocardiogram (ECG)

The ECG was assessed by the investigator at baseline (Day 1) and week 20 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 20 are presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts

Secondary

Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase (LDH) and Lipase Pancreatic

Change from baseline (Day 1) to week 20 in alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, LDH and lipase pancreatic is presented.

The safety population included all randomized participants who received at least one dose of study drug. Number analyzed = Participants with available data for a specified category.

Posted

Mean

Standard Deviation

Units per liter (U/L)

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Secondary

Change From Baseline in Bicarbonate, Chloride, Potassium and Sodium

Change from baseline (Day 1) to Week 20 in bicarbonate, chloride, potassium and sodium is presented.

The safety population included all randomized participants who received at least one dose of study drug. 'Number Analyzed' = number of participants with available data for each category.

Posted

Mean

Standard Deviation

millimoles/L (mmol/L)

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Phosphate, Urate, Urea Nitrogen

Change from baseline (Day 1) to week 20 in bilirubin, calcium, creatinine, direct bilirubin, glucose, phosphate, urate and urea nitrogen is presented.

The safety population included all randomized participants who received at least one dose of study drug. 'Number Analyzed' = number of participants with available data for each category.

Posted

Mean

Standard Deviation

milligrams/deciliter (mg/dL)

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts

Secondary

Change From Baseline in Glomerular Filtration Rate

Change from baseline (Day 1) to week 20 in glomerular filtration rate is presented. Glomerular filtration rate was calculated by CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)creatinine equation.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

mL/min/1.73m^2

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Protein

Change from baseline (Day 1) to week 20 in protein is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

grams per deciliter (g/dL)

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Eosinophils, Leukocyctes, Lymphocytes, Monocytes, Neutrophils and Platelets

Change from baseline (Day 1) to week 20 in eosinophils, leukocyctes, lymphocytes, monocytes, neutrophils and platelets is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

cells*10^9/L

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Eosinophil/Leukocytes

Change from baseline (Day 1) to week 20 in eosinophil/leukocytes is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

Percentage of eosinophil/leukocytes

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Erythrocyte Mean Corpuscular Volume

Change from baseline (Day 1) to week 20 in erythrocyte mean corpuscular volume is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

femtoliters (fL)

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Erythrocytes

Change from baseline (Day 1) to week 20 in erythrocytes is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

cells x 10^12/L

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Erythrocyte Distribution Width

Change from baseline (Day 1) to week 20 in erythrocyte distribution width (ery. distribution width) is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

Percentage of ery. distribution width

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Hematocrit

Change from baseline (Day 1) to week 20 in hematocrit is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

Percentage of hematocrit

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Lymphocytes/Leukocytes

Change from baseline (Day 1) to week 20 in lymphocytes/leukocytes is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

Percentage of lymphocytes/leukocytes

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Monocytes/Leukocytes

Change from baseline (Day 1) to week 20 in monocytes/leukocytes is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

Percentage of monocytes/leukocytes

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Neutrophils/Leukocytes

Change from baseline (Day 1) to week 20 in neutrophils/leukocytes is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

Percentage of neutrophils/leukocytes

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Reticulocytes/Erythrocytes

Change from baseline (Day 1) to week 20 in reticulocytes/erythrocytes is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

Percentage of reticulocytes/erythrocytes

Baseline (Day 1), Week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Protein Creatinine Ratio

Change from baseline (Day 1) to week 12 in protein creatinine ratio is presented.

The safety population included all randomized participants who received at least one dose of study drug. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

grams per kilogram (g/kg)

Baseline (Day 1), Week 12

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Specific Gravity of Urine

Change from baseline (Day 1) to week 12 in specific gravity of urine is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

Ratio

Baseline (Day 1), Week 12

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Spot Urine Albumin, Spot Urine Creatinine, Spot Urine Protein and Urobilinogen

Change from baseline (Day 1) to week 12 in spot urine albumin, spot urine creatinine, spot urine protein and urobilinogen is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

milligrams/deciliter (mg/dL)

Baseline (Day 1), Week 12

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Change From Baseline in Urine pH

Change from baseline (Day 1) to week 12 in urine pH is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Mean

Standard Deviation

Baseline (Day 1), Week 12

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Drug

Percentage of participants with AEs leading to discontinuation of study drug is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Number

Percentage of participants

From randomization (Day 1) to week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants

Secondary

Number of Treatment Emergent Adverse Events of Special Interest (AESIs)

AESIs included serious infection, Common Terminology Criteria for Adverse Events (CTCAE) Grade greater than or equal to (>=) 3 injection-related reactions, gastrointestinal perforations, CTCAE Grade >=3 anaphylaxis that occurred at any time, even if considered unrelated to the study drug, neutrophil less than (<) 500/mm^3 (CTCAE Grade 4) or neutrophil <1000/mm^3 (CTCAE Grade 3) with evidence of concurrent infection, thrombocytopenia (platelet count <50,000/mm^3 [CTCAE Grade 3]) or platelet count <75,000/mm^3 (CTCAE Grade 2) with evidence of concurrent major bleeding and malignancies. Number of treatment emergent adverse events of special interest (AESIs) is presented.

The safety population included all randomized participants who received at least one dose of study drug.

Posted

Number

Events

From randomization (Day 1) to week 20

ID	Title	Description
OG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG002	Ziltivekimab 30 mg

Secondary

Number of Participants With Antidrug Antibodies (ADAs) to Ziltivekimab

Number of participants with ADAs to Ziltivekimab is presented. Data presented is partcipants who had at least 1 positive antibody sample (treatment-boosted or treatment-induced) at any time after their first Ziltivekimab administration.

Analysis population included all randomized participants who had one or more evaluable sample after their first Ziltivekimab administration.

Posted

Count of Participants

Participants

From randomization (Day 1) to week 20

ID	Title	Description
OG000	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.
OG001	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Administration site pruritus	General disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events1 affected11 at risk EG0020 events0 affected12 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Angular cheilitis	Gastrointestinal disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Atrial flutter	Cardiac disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Balance disorder	Nervous system disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Blood bilirubin increased	Investigations	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected11 at risk EG0020 events0 affected12 at risk
Blood pressure increased	Investigations	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Cardiac failure	Cardiac disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Chills	General disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Conjunctivitis	Infections and infestations	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Constipation	Gastrointestinal disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 22	Systematic Assessment	EG0002 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Dental caries	Gastrointestinal disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Enteritis	Gastrointestinal disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Eosinophil count increased	Investigations	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected11 at risk EG0020 events0 affected12 at risk
Gastritis	Gastrointestinal disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Headache	Nervous system disorders	MedDRA 22	Systematic Assessment	EG0002 events1 affected12 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
Hepatic enzyme increased	Investigations	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Hypothyroidism	Endocrine disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Infusion site reaction	General disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Injection site pruritus	General disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Injection site swelling	General disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0013 events1 affected11 at risk EG0020 events0 affected12 at risk
Insomnia	Psychiatric disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Lipase increased	Investigations	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Nausea	Gastrointestinal disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Paraproteinaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Periodontitis	Infections and infestations	MedDRA 22	Systematic Assessment	EG0003 events2 affected12 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Pulpitis dental	Infections and infestations	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Pyrexia	General disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
Scrotal exfoliation	Reproductive system and breast disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Seasonal allergy	Immune system disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
White blood cell count decreased	Investigations	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received Ziltivekimab matching placebo subcutaneously (S.C.) on week 0 (day 1), week 4 and week 8.	12	2	12	7	12
EG001	Ziltivekimab 15 mg	Participants received Ziltivekimab 15 mg S.C. on week 0 (day 1), week 4 and week 8.	11	2	11	10	11
EG002	Ziltivekimab 30 mg	Participants received Ziltivekimab 30 mg S.C. on week 0 (day 1), week 4 and week 8.	12	0	12	7	12

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Appendicitis	Infections and infestations	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Corona virus infection	Infections and infestations	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
Impaired healing	General disorders	MedDRA 22	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 22	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk