drugset / Trial / NCT02187172

Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)

NCT02187172

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The VIP-U Study is a clinical trial designed to investigate the effect of ustekinumab (Stelara) and placebo on reducing vascular inflammation and cardiometabolic risk biomarkers in patients with moderate to severe psoriasis. This study will look for systemic vascular inflammation in study participants with a test called FDG PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography). The study will also look for cardiometabolic identifiers (heart disease and metabolic factors) in blood samples, including markers of high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation. The study will also examine the effects of ustekinumab compared to placebo on psoriasis activity, severity and safety.

Timeline

Start
2014-07
Primary completion
2018-09-11
Completion
2018-09-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ustekinumab Monoclonal antibody 45 mg Subcutaneous
Comparator Ustekinumab Monoclonal antibody 90 mg Subcutaneous