Vascular Inflammation in Psoriasis - Ustekinumab Trial (VIP-U Trial)
Brief Description Of Study
Psoriasis is a systemic (affecting the entire body) inflammatory (causing redness, swelling, and pain) disorder, not just a disorder of the skin. Evidence has shown that psoriasis is a risk factor for developing high blood pressure, diabetes, obesity, high cholesterol, heart attack, and stroke. The purpose of this study is to assess the effect of the ustekinumab (Stelara) injection when compared to placebo (an inactive substance that may resemble an active substance but has no medical value). The study will compare the effects of each on systemic inflammation and cardiovascular disease risk factors in participants diagnosed with moderate to severe psoriasis.
Detailed Study Description
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. All eligible participants will be randomized to ustekinumab (Stelara) or placebo for a treatment period of 12 weeks. After completion of the 12 weeks, all patients will be treated with ustekinumab for a period of up to 52 weeks.
Additional Information About The Study
Eligibility Criteria: Psoriasis for at least 6 months as diagnosed by a doctor; moderate to severe psoriasis at initial visit; no history of diabetes mellitus type 1 (if history of diabetes mellitus type 2, duration must be less than 10 years and HbA1c under 7.0%); systolic blood pressure less than 180 mmHg and diastolic blood pressure less than 90 mmHg