RecruitingPhase 3NCT06263244

Specifying the Anti-inflammatory Effects of Ziltivekimab

Specifying the Anti-inflammatory Effects of Ziltivekimab With Diverse Imaging Modalities and In-depth Cellular Phenotyping

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

40 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

Atherosclerosis Inflammation

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

Min Age: 50 YearsMax Age: 85 Years

Inclusion Criteria3

Aged 50 years and older.
Multi-vessel coronary artery disease (defined as CAD-RADS ≥2).
Serum hsCRP level ≥2 mg/L.

Exclusion Criteria16

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.