Actively Recruiting

Phase 3
Age: 50Years - 85Years
All Genders
NCT06263244

Specifying the Anti-inflammatory Effects of Ziltivekimab

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-10-02

40

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Specifying the Anti-inflammatory Effects of Ziltivekimab

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 50 years and older.
  • Multi-vessel coronary artery disease (defined as CAD-RADS 2).
  • Serum hsCRP level 2 mg/L.
Not Eligible

You will not qualify if you...

  • Coronary stents in place.
  • Chronic or recent (less than 1 month) serious infections or signs of acute infection.
  • History of severe autoimmune diseases or other severe recurrent or chronic inflammatory disorders.
  • Use of preventive systemic antibiotics (except those for latent tuberculosis).
  • Stable lipid-lowering treatment for less than 4 weeks, including statins, ezetimibe, and PCSK9 inhibitors.
  • Untreated latent tuberculosis, active hepatitis B or C, or HIV not on stable antiretroviral therapy.
  • Uncontrolled diabetes (HbA1c over 90 mmol/mol).
  • Renal insufficiency (eGFR less than 45 ml/min/1.73 m2).
  • Platelet count less than 120,000 or greater than 450,000 per mm3.
  • Elevated liver enzymes (more than 3 times the upper limit of normal), acute liver failure, or 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 over 180 mmHg or diastolic over 110 mmHg).
  • Diagnosis of active malignancy in the last 5 years.
  • Standard contraindications to 68Ga-DOTATATE PET and CT.
  • Inability or unwillingness to follow study requirements or deemed unfit by the investigator.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC, location AMC

Amsterdam, Netherlands, 1105AZ

Actively Recruiting

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Research Team

C

Cheyenne Y.Y. Beverloo, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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