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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53495

Enrollment

Registered

2023-07-27

Start date

2023-11-09

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis low-grade inflammation

Interventions

Ziltivekimab 15 mg or placebo, subcutaneously delivered using a manual syringe, once per every four weeks, for a total of 20 weeks (6 administrations).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Aged 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.

Exclusion criteria

Exclusion criteria: - Coronary stents in situ. - Chronic or recent (

Design outcomes

Primary

Measure	Time frame
The main outcome is the mean percentage change in coronary arteries target to background ratio (TBRmax) and monocyte activation marker protein expression between the treatment and placebo group, at the primary analysis time point of 20 weeks, compared to baseline.	—

Secondary

Measure	Time frame
Imaging: • Difference in PCAT (CCTA derived) after ziltivekimab treatment. • Correlation between changes in coronary 68Ga-DOTATATE uptake and anatomical plaque changes on CCTA. • Difference in 68Ga-DOTATATE SUVmax of bone marrow and spleen after treatment. • Difference in 68Ga-DOTATATE TBRmax of ascending aorta after treatment. Inflammation and proteomics: • The impact of ziltivekimab on monocyte phenotype in transendothelial migration (TEM) capacity and transcriptome profile. • The mean percentage change in plasmatic proteins before and after ziltivekimab treatment. • The impact of ziltivekimab on inflammation in plasma cytokine and chemokine levels.	—

Measure

Time frame

Imaging: • Difference in PCAT (CCTA derived) after ziltivekimab treatment. • Correlation between changes in coronary 68Ga-DOTATATE uptake and anatomical plaque changes on CCTA. • Difference in 68Ga-DOTATATE SUVmax of bone marrow and spleen after treatment. • Difference in 68Ga-DOTATATE TBRmax of ascending aorta after treatment. Inflammation and proteomics: • The impact of ziltivekimab on monocyte phenotype in transendothelial migration (TEM) capacity and transcriptome profile. • The mean percentage change in plasmatic proteins before and after ziltivekimab treatment. • The impact of ziltivekimab on inflammation in plasma cytokine and chemokine levels.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)