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NCT05485961 Clinical Trial

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis

Atherosclerotic Cardiovascular Disease Clinical Trial

Official title:
A Phase 2b/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05485961
Other study ID # CSL300_2301
Secondary ID 2022-500273-14-0
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received
Last updated
Start date October 21, 2022
Est. completion date December 2028

Study information
Verified date June 2024
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double blind, placebo controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on CV outcomes and safety in subjects with ASCVD or diabetes mellitus and evidence of systemic inflammation who are undergoing maintenance dialysis.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CSL300
Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6
• Placebo
0.9% w/v NaCl
• Placebo
Part 2 (Phase 3): Matching the excipient content and concentration of the CSL300 product, minus the active ingredient
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Sponsors (1)
Lead Sponsor Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b) Up to 12 weeks
Primary Time to first occurrence of CV death or MI (Phase 3) Approximately 5 years
Secondary Percent of subjects achieving hs-CRP < 2.0 mg/L (Phase 2b) Week 12
Secondary Change from baseline in log-transformed hs-CRP (Phase 2b) Up to 24 weeks
Secondary Mean change from Baseline in SAA (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in sPLA2 (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in fibrinogen (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in PAI-1 (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in Lp (a) (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in Hepcidin (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in hemoglobin (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in ESA (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in ERI (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in iron (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in TIBC (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in TSAT (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in ferritin (Phase 2b) Up to 12 weeks
Secondary Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b) Up to 24 weeks
Secondary Peak Plasma Concentration (Cmax) for CSL300 (Phase 2b) Up to 24 weeks
Secondary Trough Plasma Concentration (Ctrough) for CSL300 (Phase 2b) Up to 24 weeks
Secondary Time to Maximum Plasma Concentration (Tmax) for CSL300 (Phase 2b) Up to 24 weeks
Secondary Percent of subjects with AE, SAE, including AESIs (Phase 2b) Up to 32 weeks
Secondary Mean change from Baseline in WBC (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in neutrophils (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in platelets (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in AST (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in ALT (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in total bilirubin (Phase 2b) Up to 12 weeks
Secondary Mean change from Baseline in lipid panel (Phase 2b) Lipid panel consists of TC, LDL-C, HDL-C, triglyceride Up to 12 weeks
Secondary Titer of confirmed antibodies specific to CSL300 (Phase 2b) Up to 12 weeks
Secondary Time to first occurrence of all-cause death or MI (Phase 3) Approximately 5 years
Secondary Time to first occurrence of CV death, MI, or ischemic stroke (Phase 3) Approximately 5 years
Secondary Time to first occurrence of CV death (Phase 3) Approximately 5 years
Secondary Time to first occurrence of CV death, MI or major adverse limb event (Phase 3) Approximately 5 years
Secondary Time to first occurrence of all-cause death (Phase 3) Approximately 5 years
Secondary Time to first occurrence of CV death, MI, or hospitalization for heart failure (Phase 3) Approximately 5 years
Secondary Total number of CV hospitalizations (Phase 3) Approximately 5 years
Secondary Total number of HF hospitalizations and urgent visits (Phase 3) Approximately 5 years
Secondary Total number of hospitalizations (Phase 3) Approximately 5 years
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