About the Study
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 & Exclusion Criteria
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
Patient Population
Patients 18 years and up with end-stage kidney disease (ESKD) undergoing dialysis with either diabetes mellites or ASCVD.
Study Timeline
Duration of Study Participation
Up to five years
Study Follow-Up
Monthly visits for IP infusion.
Sponsor/Funding
CSL Behring
Learn More
PL: Mandy Jones