Overview
Sponsor-declared trial summary
Coronary artery disease
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.
Key facts
- Sponsor
- Stichting Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 19 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515893-29-01
- EudraCT number
- 2022-004078-53
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
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.
Conditions and MedDRA coding
Coronary artery disease
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-515893-29-00 | Specifying the anti-inflammatory effects of ziltivekimab with diverse imaging modalities and in-depth cellular phenotyping (SPIDER) | Stichting Amsterdam UMC |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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
Exclusion criteria 4
- Coronary stents in situ
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 7
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ziltivekimab B 15 mg/mL DV3430-C1
PRD8676484 · Product
- Active substance
- Ziltivekimab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg/ml milligram(s)/millilitre
- Max total dose
- 90 mg/ml milligram(s)/millilitre
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Amsterdam UMC
- Sponsor organisation
- Stichting Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- Prof. Dr. E.S.G. Stroes
Public contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- Prof. Dr. E.S.G. Stroes
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-11-19 | 2024-11-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | SPIDER Protocol for publication | 5.0 |
| Recruitment arrangements (for publication) | Blank document CTR transition | 1 |
| Subject information and informed consent form (for publication) | SPIDER Subject information and informed consent form REDACTED | 6.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-24 | Netherlands | Acceptable 2024-11-19
|
2024-11-19 |