Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263244
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2023-08-03
Brief Title:
Specifying the Anti-inflammatory Effects of Ziltivekimab
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Specifying the Anti-inflammatory Effects of Ziltivekimab With Diverse Imaging Modalities and In-depth Cellular Phenotyping
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIDER
Brief Summary:
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
Detailed Description:
Considering that ziltivekimab is currently undergoing a phase 3 CVOT trial it is of great importance to elucidate its mechanistic effects 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 The imaging modalities used in this study are 68Ga-DOTATATE PETCT and CCTA This study is designed as a single center randomized double-blinded placebo-controlled intervention study in 40 atherosclerotic patients of 50 years and older with hsCRP levels of 2 mgL and above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None