Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab
Summary
The purpose of this study was to explore the effect of treatment with 300 mg or with 150 mg secukinumab (administered weekly for 4 weeks followed by four-weekly administration) on endothelial dysfunction and arterial stiffness after 12 weeks and for up to 52 weeks in subjects with chronic plaque-type psoriasis. Furthermore soluble biomarkers were assessed to evaluate the influence of secukinumab on cardiovascular risk. Magnetic resonance imaging (MRI) was performed in a sub-population to assess the treatment effect on arterial vessel wall morphometry in atherosclerosis prone vascular beds.
Timeline
- Start
- 2014-04
- Primary completion
- 2016-04
- Completion
- 2016-04
Outcome
Missed primary endpoint
registry analysis (superiority test); Secukinumab 300 mg vs Placebo (Pooled); p = 0.2230; Least Square (LS) mean difference 1.17 (95% CI -0.72 to 3.06); ANCOVA NCT02559622 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |