Specifying the Anti-inflammatory Effects of Ziltivekimab
Recruiting
Phase 3Interventional Study
AtherosclerosisInflammation
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
40 (estimated)
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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.
* Hi…
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.
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