Specifying the Anti-inflammatory Effects of Ziltivekimab

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT06263244
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Atherosclerosis
  • Inflammation

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Ziltivekimab — DRUG
    Monoclonal antibody targeting IL-6
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

First listed
Feb 16, 2024
Start date
May 3, 2024
Status verified
Aug 2026
Primary completion
Sep 4, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Ziltivekimab
    15 mg ziltivekimab subcutaneously once per month for 5 months
  • Placebo Comparator: Placebo
    Placebo, subcutaneously, once per month for 5 months

Primary Outcome Measure

TBRmax coronary arteries [ Time Frame: 5.5 months ]

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