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Clinical Trials in the Netherlands / NCT06263244
Active, not recruiting Phase 3

Specifying the Anti-inflammatory Effects of Ziltivekimab

NCT06263244 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 3
Started
2024-05-03
Last updated
2026-08-06

Condition(s) studied

AtherosclerosisInflammation

Investigational drug(s) / intervention(s)

Ziltivekimab →Placebo

Ziltivekimab: Monoclonal antibody targeting IL-6

Placebo: Placebo

Study summary

The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics.

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Aged 50 years and older. * Multi-vessel coronary artery disease (defined as CAD-RADS ≥2). * Serum hsCRP level ≥2 mg/L. Exclusion Criteria: * Coronary stents in situ. * Chronic or recent (\<1 month) (serious) infections and/or clinical signs of acute (serious) infection. * History of severe auto-immune diseases, or other (severe) (recurrent or chronic) inflammatory disorders. * Use of preventive systemic antibiotics (antibiotics used to treat latent tuberculosis are exempted). * Stable lipid lowering treatment for less than 4 weeks, including statins, ezetimibe and PCSK9 inhibition. * Untreated latent tuberculosis, active hepatitis B (positive HBsAg and/or positive anti-HBc with detectable HBV DNA) or C, human immunodeficiency virus (HIV) not on stable antiretroviral regimen * Uncontrolled diabetes (HbA1c \>90 mmol/mol). * Renal insufficiency, defined as eGFR \<45 ml/min/1.73 m2. * Platelet count \<120,000 and \>450,000 /mm3. * Elevated liver enzymes (\>3 ULN of liver transaminases), acute liver failure or known (severe) liver disease. * Premenopausal women not using birth-control. * History of gastrointestinal perforation, active diverticulitis (within 5 years) or active inflammatory bowel disease (within 12 months). * Uncontrolled hypertension (systolic \>180 mmHg; diastolic \>110 mmHg). * Diagnosis of (active) malignancy in last 5 years. * Standard contra-indications to 68Ga-DOTATATE PET, and CT based on physician's experience and current practices. * Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Amsterdam UMC, location AMC Amsterdam Netherlands

More Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06263244 on ClinicalTrials.gov ↗ ← All trials in the Netherlands