Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)

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 inPart 2 (phase 3).

• Concomitant use of systemic immunosuppressant drugs.

• Part 1 (Phase 2b) excludes subjects with a positive TB or a history of latent TB,whereas Part 2 (Phase 3) excludes active TB but allows inclusion of subjects with alatent TB and at least 4 weeks of prophylactic TB treatment.

• 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 invasivefungal infection.