POSIBIL6

Currently Recruiting: Sites

Study Drug/Intervention: Clazakizumab

Anticipated Sample Size: 2190 patients

Study Timeline: This study has a 24-month enrollment period. The last patient is expected to be enrolled in August 2026 with the last patient visit taking place in August 2029.

ClinicalTrials.gov ID:  NCT05485961

What is POSIBIL6?

POSIBIL6 is a two-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 cardiovascular (CV) outcomes and safety in subjects with atherosclerotic cardiovascular disease (ASCVD) or diabetes mellitus and evidence of systemic inflammation who are undergoing maintenance dialysis.

Study Objective

To evaluate the efficacy of CSL300 in reducing the risk of CV events (composite endpoint of CV death and myocardial infarction (MI)).

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

Patients 18 years and up with end-stage kidney disease (ESKD) undergoing dialysis with either diabetes mellites or ASCVD.

Duration of Study Participation

Up to five years

Study Follow-Up

Monthly visits for IP infusion.

CSL Behring

PL: Mandy Jones