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

CSL Behring

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Atherosclerotic Cardiovascular Disease in Patients With ESKD

Treatments: Drug: Placebo; Drug: CSL300

Study type: Interventional

Funder types: Industry

Identifiers

NCT05485961

2022-500273-14-00 (Other Identifier)

CSL300_2301

Details and patient eligibility

About

This is a two-part, phase 2b and phase 3 combined 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 vs placebo on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.

Enrollment: 3,110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,110 participants in 6 patient groups, including a placebo group

CSL300 (low dose)(Phase 2b)

Experimental group

Description:

Intravenous (IV) administration

Treatment:

Drug: CSL300

CSL300 (medium dose)(Phase 2b)

Experimental group

Description:

IV administration

Treatment:

Drug: CSL300

CSL300 (high dose)(Phase 2b)

Experimental group

Description:

IV administration

Treatment:

Drug: CSL300

Placebo (Phase 2b)

Placebo Comparator group

Description:

IV administration

Treatment:

Drug: Placebo

CSL300 (Phase 3)

Experimental group

Description:

IV administration

Treatment:

Drug: CSL300

Placebo (Phase 3)

Placebo Comparator group

Description:

IV administration

Treatment:

Drug: Placebo