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2024-515893-29-01Active, not recruitingPhase 2/3

Specifying the Anti-inflammatory Effects of Ziltivekimab (SPIDER)

Specifying the anti-inflammatory effects of ziltivekimab with diverse imaging modalities and in-depth cellular phenotyping (SPIDER)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Nov 2024

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Brief summary (registry, in English)

The objective of this study is to research whether ziltivekimab therapy for 20 weeks reduces arterial wall inflammation, as assessed by state-of-the-art imaging modalities, and reduces systemic inflammatory tone, as assessed by in depth phenotyping of circulating monocytes, inflammatory biomarkers and proteomics.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
40 (estimated)
First submitted
24 Oct 2024
Start date
19 Nov 2024
Lead sponsor
Stichting Amsterdam UMC
EU CT number
2024-515893-29-01
EudraCT number
2022-004078-53

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 40
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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
  • 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

Other

  • Coronary stents in situ

Who the study is looking for

  • Age 50 years and older
  • Multi-vessel coronary artery disease (defined as CAD-RADS ≥2 and/or PAV/NCPV stage ≥2)
  • Serum hsCRP level ≥2 mg/L

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC StichtingAmsterdamNetherlandsActive, not recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.