Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
Actively Recruiting
About This Study
This phase 2b/3 multicenter, randomized, double-blind trial evaluates the efficacy and safety of clazakizumab (CSL300), a monoclonal antibody targeting IL-6, in patients with ESKD undergoing maintenance dialysis. The study population includes patients with systemic inflammation who have either established ASCVD or diabetes. Part 1 functions as a dose-finding phase, while Part 2 assesses the impact of clazakizumab on major cardiovascular outcomes compared to placebo. The primary objective is to determine if IL-6 inhibition reduces cardiovascular events in this high-risk population.
Who Can Participate?
✓ Inclusion Criteria
- •- Male or female at least 18 years of age
- •- A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks
- •- Serum hs-CRP ≥ 2.0 mg/L
- •- A diagnosis of diabetes mellitus OR ASCVD
✗ Exclusion Criteria
- •- Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3)
- •- Concomitant use of systemic immunosuppressant drugs
- •- Abnormal LFTs
- •- Any life-threatening disease expected to result in death within 12 months
- •- A history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease
- •-Clinically significant active infection or history of opportunistic or invasive fungal infection