Date

2022-08-01

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Study Sites • Sri Jayewardenepura General Hospital • National Hospital of Sri Lanka • National Hospital, Kandy • Kurunegala Teaching Hospital • Karapitiya Teaching Hospital Randomization: Subjects will be randomized with equal allocation (1:1) to sibeprenlimab or placebo. Randomization will be stratified by screening urine protein/creatinine ratio (uPCR; <2.0 g/g versus > 2.0 g/g), screening estimated glomerular filtration rate (eGFR; 30 - 44 mL/min versus >45 mL/min), and sodium-glucose cotransporter-2 inhibitor (SGLT2i) use at the time of randomization (yes or no). Approximately 450 subjects will be randomized with equal allocation (1:1) to sibeprenlimab or placebo (approximately 225 subjects per treatment) in a blinded manner. Subjects will be randomly assigned to a treatment group. The randomization code will be created by the sponsor following the standard operating procedures. Intervention: This trial will evaluate a dose of 400 mg sibeprenlimab compared with placebo. The Investigational Medicinal Product (IMP) (sibeprenlimab or placebo) will be administered Sub Cutaneously (SC) once every 4 weeks (total of 26 doses) by trained, qualified personnel designated by the investigator or sponsor. The IMP administration will be in the abdomen, thigh, or upper arm based on assignment at randomization. For all subjects, Dose 1 (Day 1), Dose 2 (Week 4), Dose 3 (Week 8), Dose 4 (Week 12), Dose 5 (Week 16), and Dose 7 (Week 24) will be injected SC in the abdomen. Dose 6 (Week 20) and Dose 8 (Week 28) will be rotated to either the thigh or upper arm based on assignment at randomization so that each subject has at least one IMP administration in each of the SC injection sites. From Dose 9 (Week 32) and onwards, subjects will be allowed to select which injection site they prefer for the IMP administration. The date and time of IMP administration, the volume of IMP administered, and the injection site location will be recorded for each IMP administration. The details of the placebo is given below: 25 mM histidine, 100 mM sorbitol, 50 mM arginine, 50 mM glutamic acid, 0.02% (w/v) PS-80, pH 6.2 Blinding: subjects, investigators, trial staff and sponsor, will remain blinded to treatment assignment until the final analysis of the key secondary endpoint of eGFR

Next Version

Study Sites • Sri Jayewardenepura General Hospital • National Hospital of Sri Lanka • National Hospital, Kandy • Kurunegala Teaching Hospital • Karapitiya Teaching Hospital Subjects will be randomized with equal allocation (1:1) to sibeprenlimab or placebo. Randomization will be stratified by screening urine protein/creatinine ratio (uPCR; ? 2.0 g/g versus > 2.0 g/g), screening estimated glomerular filtration rate (eGFR) calculated using the Chronic Kidney Disease-Epidemiology Collaboration creatinine eGFR equation (CKD-EPI equation) (30 - 44 mL/min/1.73m2 versus ? 45 mL/min/1.73m2), and sodium-glucose cotransporter-2 inhibitor (SGLT2i) use at the time of randomization (yes or no). This trial will evaluate a dose of 400 mg sibeprenlimab compared with placebo. The IMP will be administered SC once every 4 weeks (total of 26 doses) by trained, qualified personnel designated by the investigator or sponsor. The IMP administration will be in the abdomen, thigh, or upper arm based on assignment at randomization. For all subjects, Dose 1 (Day 1), Dose 2 (Week 4), Dose 3 (Week 8), Dose 4 (Week 12), Dose 5 (Week 16), and Dose 7 (Week 24) will be injected SC in the abdomen. Dose 6 (Week 20) and Dose 8 (Week 28) will be rotated to either the thigh or upper arm based on assignment at randomization so that each subject has at least one IMP administration in each of the SC injection sites. From Dose 9 (Week 32) onwards, subjects will be allowed to select which injection site they prefer for the IMP administration. The date and time of IMP administration, the volume of IMP administered, and the injection site location will be recorded for each IMP administration.