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

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515893-29-01
Acronym
83403
Enrollment
40
Registered
2024-11-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-19

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

Conditions

Coronary artery disease

Brief summary

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.

Detailed description

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., 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.

Interventions

DRUGZiltivekimab B 15 mg/mL DV3430-C1

Sponsors

Stichting Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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., 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.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026