Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U) (VIP-U)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02187172|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2014
Last Update Posted : June 16, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Cardiovascular Disease||Drug: Ustekinumab Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A PHASE IV, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF USTEKINUMAB ON VASCULAR INFLAMMATION IN PSORIASIS|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Active Comparator: Ustekinumab (Stelara)
Ustekinumab (Stelara) subcutaneous injection 45mg (if person's weight is 100kg or less) or 90mg (if person's weight is greater than 100kg) at day 0 and week 4 followed by every 12-week dosing thereafter.
Placebo Comparator: Placebo
Placebo subcutaneous injection will be given according to the same dose and schedule as the active comparator.
|Drug: Ustekinumab Drug: Placebo|
- Vascular Inflammation and Biomarkers [ Time Frame: Baseline - End of Study Visit (Week 52 or Week 64) ]Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT and change in metabolic, lipid, and inflammatory biomarker levels.
- Change in Psoriasis Activity [ Time Frame: Baseline, week 4, 8, 12, and then every 12 weeks throughout the study. ]Change in psoriasis activity throughout the study.
- Change in Patient-Reported Outcomes [ Time Frame: Baseline, week 4, 8, 12, and then every 12 weeks throughout the study. ]Change in patient-reported dietary and physical activity assessments (i.e. MEDFICTS and IPAQ).
- Number of Patients with Adverse Events [ Time Frame: Per patient report throughout the study. ]Safety will be assessed by evaluating all reported adverse events and comparing the reports of study participants on ustekinumab vs. placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187172
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Joel M Gelfand, MD, MSCE||University of Pennsylvania|