PsoriasisPhase 4VIP-UNCT02187172

Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)

A Phase 4 study testing Ustekinumab in people with Psoriasis and Cardiovascular Disease, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis, Cardiovascular Disease
What is being tested?: Ustekinumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Jul 2014to 11 Sep 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females 18 years of age and older.
Clinical diagnosis of psoriasis for at least 6 months as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by Investigator.
Stable plaque psoriasis for at least 2 months before Screening and at Baseline (Week 0) as determined by subject interview of his/her medical history.
Moderate to severe psoriasis defined by ≥ 10 percent Body Surface Area (BSA) involvement at the Baseline (Week 0) visit.
PASI score of ≥ 12 at the Baseline (Week 0) visit.
Subject is a candidate for systemic therapy and has active psoriasis despite prior treatment with topical agents.

Show all 19Show fewer

Women are eligible to participate in the study if they meet one of the following criteria:
Women of childbearing potential who are willing to undergo periodic pregnancy testing during the study and agree to use at least one method of contraception throughout the study duration and for at least 15 weeks after the last dose of the study drug are eligible to participate.
Women who are postmenopausal (for at least one year), sterile, or hysterectomized are eligible to participate.
Women who have undergone tubal ligation are eligible to participate.
Women who agree to be sexually abstinent, defined as total abstinence from sexual intercourse, as a form of contraception, are eligible to participate.
Men are eligible to participate in the study if they meet one of the following criteria:
Agree to use a proven birth control method during the study and for at least 15 weeks after the last dose of the study drug.
Have a female partner who agrees to use at least one method of contraception throughout the study duration and for at least 15 weeks after the last dose of the study drug.
Have a female partner who is postmenopausal (for at least one year), sterile, or hysterectomized;
Have a female partner who has undergone tubal ligation,
Agree to be sexually abstinent, defined as total abstinence from sexual intercourse, as a form of contraception.
Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, and 12-lead electrocardiogram (ECG) performed at screening.
Able and willing to give written informed consent and to comply with requirements of this study protocol.

Who cannot join

Previous adverse event following exposure to an IL-12/IL-23 antagonist that led to discontinuation of therapy and contraindicates future treatment.
Previous lack of response to an IL-12/IL-23 antagonist that led to discontinuation of therapy.
Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
Cannot avoid UVB phototherapy or Excimer laser for at least 14 days prior to the Baseline (Week 0) visit and during the study.
Cannot avoid psoralen-UVA phototherapy for at least 30 days prior to the Baseline (Week 0) visit and during the study.

Show all 40Show fewer

Cannot discontinue systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis, during the study:
Systemic therapies must be discontinued at least 30 days prior to the Baseline (Week 0) visit except for biologics.
All biologics, except ustekinumab, must be discontinued for at least 90 days prior to Baseline (Week 0).
Any IL-12/IL-23 antagonist (e.g., ustekinumab, briakinumab) must be discontinued for at least 180 days prior to Baseline (Week 0).
Investigational agents must be discontinued at least 30 days or 5 half-lives (whichever is longer) prior to the Baseline (Week 0) visit.
Subject is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
Poorly controlled medical condition, such as unstable ischemic heart disease, cerebrovascular accident or myocardial infarction within the prior 6 months, psychiatric disease requiring frequent hospitalization, and any other condition, which, in the opinion of the Investigator, would put the subject at risk by participation in the study.
History of diabetes mellitus, type 1 or type 2 with the exception that patients with type 2 diabetes may be enrolled if the duration of diabetes is <10 years and HbA1c is <7.0%.
Uncontrolled hypertension, with measured systolic blood pressure >180 mmHg or diastolic blood pressure >90 mmHg
Subject has infection or risk factors for severe infections, for example:
Positive serology or known history of HIV, hepatitis B or C, or other severe, recurrent, or persistent infections;
Excessive immunosuppression or other factors associated with it, including human immunodeficiency virus infection;
Active tuberculosis (TB) disease;
Evidence of latent TB infection demonstrated by positive Quantiferon-GOLD result; except if prophylactic treatment for TB, as recommended by local guidelines, is initiated prior to administration of study drug or if there is documentation that the subject has received prophylactic treatment for TB within 3 years prior to the first administration of study agent.
Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the month prior to Baseline;
Infection requiring treatment with oral or parenteral (other than IV) antibiotics within 14 days prior to Baseline;
Subject has received vaccination with Bacille Calmette-Guerin (BCG) within 365 days prior to Screening or will receive BCG vaccination during study participation including up to 12 months after the last dose of the study drug;
Subject has received vaccination with a live viral agent 30 days prior to Screening or will require a live vaccination during study participation including up to 3 months after the last dose of study drug.
Subject has history of hematological or solid malignancy within the past five years other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical carcinoma in situ.
Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.
Male subject who is considering fathering a child during the study.
Screening clinical laboratory analyses showing any of the following abnormal results:
Hemoglobin (Hgb) < 10 g/dL in females or <12 g/dL in males;
White blood cell (WBC) count <2.5 x 109/L
o Subject can be included if WBC count is <2.5 x 109/L and absolute neutrophil count (ANC) is >1000 cells / mm3.
WBC count > 15 x 109/L;
Platelet count < 100 x 109/L;
Serum creatinine >1.6 mg/dL (>141 µmol/L);
Serum aspartate transaminase (AST) or alanine transaminase (ALT) >2.5 upper limits of normal (ULN);
Serum total bilirubin ≥2 mg/dL (≥26 µmol/L)
Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
History of any substance abuse within 365 days of screening visit
Alcohol use >14 drinks per week at the screening visit or within 30 days of the screening period
If subject is on cholesterol-lowering medication (e.g. statin), dose and form of medication must be stable for 90 days prior to week 0 and remain stable throughout the duration of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A PHASE IV, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF USTEKINUMAB ON VASCULAR INFLAMMATION IN 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.

Conditions: Psoriasis, Cardiovascular Disease
Being tested: Ustekinumab, Placebo
Keywords: Psoriasis, Cardiovascular Disease, Vascular Inflammation, Lipid Biomarkers, FDG-PET/CT
Medical subject headings: Psoriasis, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UstekinumabDrug
PlaceboDrug

Study groups in NCT02187172
Study group	Role	What they receive
Ustekinumab (Stelara)	Active comparator	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. Patient will receive total of 52 weeks of ustekinumab (12 weeks during RCT phase, 40 weeks post RCT phase). The end of study is at Week 52 for this arm. Receives: Drug: Ustekinumab
Placebo	Placebo comparator	Placebo subcutaneous injection will be given according to the same dose and schedule as the active comparator until week 12 (end of RCT phase). At week 12, ustekinumab will be administered according according to the same injection schedule as the active comparator arm for 52 weeks. Patient will receive total of 52 weeks of ustekinumab (0 weeks during RCT phase, 52 weeks post RCT phase). The end of study is at Week 64 for this arm. Receives: Drug: Ustekinumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Vascular Inflammation
Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12 (RCT period) or end of study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: Intercellular Adhesion Molecule-1 (ICAM-1)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on ICAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: Vascular Cell Adhesion Molecule-1 (VCAM-1)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VCAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: C-reactive Protein (CRP)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on CRP, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: Ferritin
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Ferritin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: Serum Amyloid A (SAA)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on SAA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: Interferon-gamma (INF-g)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on INF-g,, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: Monocyte Chemoattractant Protein-1 (MCP-1)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MCP-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: Tumor Necrosis Factor-alpha (TNF-a)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on TNF-a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: GlycA
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on GlycA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: Interleukin (IL)-1b
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-1b, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: IL-2ra
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-2ra, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: IL-12/23
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-12/23, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: IL-17a
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-17a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: IL-18
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-18, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: IL-6
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-6, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Inflammatory Biomarker Levels: IL-8
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-8, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Triglycerides
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Total Cholesterol
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Total cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: High-density Lipoprotein (HDL) Cholesterol
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: HDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: HDL Particle Size
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Large-HDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Small-HDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Medium-HDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Large Medium-HDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Low-density Lipoprotein (LDL) Cholesterol
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: LDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: LDL Particle Size
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Small-LDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Large-LDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Very Large-LDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Very large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Very Low-density Lipoprotein (VLDL) Particle Size
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: VLDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: VLDL Triglycerides
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Small-VLDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Medium-VLDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Large Medium-VLDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Large-VLDL Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Intermediate-density Lipoprotein (IDL) Particle Number
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Cholesterol Efflux Capacity
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Cholesterol efflux capacity, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)].
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Apolipoprotein-B
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Apolipoprotein-B, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Lipid Biomarker Levels: Fetuin-A
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Fetuin-A, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Metabolic Biomarker Levels: Adiponectin
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Adiponectin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Metabolic Biomarker Levels: Leptin
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Leptin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Metabolic Biomarker Levels: Insulin
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Insulin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Metabolic Biomarker Levels: Glucose
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Glucose, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Metabolic Biomarker Levels: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HOMA-IR, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose [mg/dl] * fasting insulin [mU/ml]/405).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Secondary outcomes (5)

Number of Participants Achieving PASI75 (75% or Greater Reduction in PASI Score)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI75, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Binary measure of change in psoriasis activity; 75% or greater reduction in PASI score compared to baseline.
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Number of Participants Achieving PASI90 (90% or Greater Reduction in PASI Score)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI90, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Binary measure of change in psoriasis activity; 90% or greater reduction in PASI score compared to baseline.
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Number of Participants Achieving Physician Global Assessment (PGA) Clear/Almost Clear
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PGA clear/almost clear, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Binary measure of psoriasis disease activity at measurement time points; Physician Global Assessment score <1.5 (clear/almost clear)
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Patient-Reported Outcomes: MEDFICTS
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MEDFICTS, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument, has been provided as part of the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) guidelines as a free tool to use for proper cardiovascular diet assessment. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of <40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day).
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Patient-reported Physical Activity Assessments: IPAQ
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IPAQ, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.
Measured: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201411 Sep 2018

First posted10 Jul 2014 (estimated)
Study startJul 2014
Primary completion11 Sep 2018
Study completion11 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A hybrid RCT (randomized controlled trial) crossover trial where all patients receive total of 52 weeks of active treatment following an RCT phase of 12 weeks (active treatment or placebo). Patients randomized to active treatment will receive additional 40 weeks of active treatment at end of RCT phase; patients randomized to placebo will receive 52 weeks of active treatment at end of RCT phase. Primary outcomes are assessed at end of the RCT phase (comparison of interventions in change from start of treatment) and at end of 52 weeks of active treatment (change from start of treatment).
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02187172
Sponsor's protocol ID: 820124
Acronym: VIP-U
Status last verified: Aug 2019
First submitted: 8 Jul 2014
Last updated: 15 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE IV, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF USTEKINUMAB ON VASCULAR INFLAMMATION IN PSORIASIS
ClinicalTrials.gov ID: NCT02187172
Acronym / sponsor ID: VIP-U / 820124
Conditions: Psoriasis, Cardiovascular Disease
Keywords: Psoriasis, Cardiovascular Disease, Vascular Inflammation, Lipid Biomarkers, FDG-PET/CT
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Janssen Scientific Affairs, LLC
Study start: Jul 2014
Primary completion: 11 Sep 2018 (actual)
Study completion: 11 Sep 2018 (actual)
First posted: 10 Jul 2014 (estimated)
Results: Posted 15 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will also examine the effects of ustekinumab compared to placebo on psoriasis activity, severity and safety.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: A hybrid RCT (randomized controlled trial) crossover trial where all patients receive total of 52 weeks of active treatment following an RCT phase of 12 weeks (active treatment or placebo). Patients randomized to active treatment will receive additional 40 weeks of active treatment at end of RCT phase; patients randomized to placebo will receive 52 weeks of active treatment at end of RCT phase. Primary outcomes are assessed at end of the RCT phase (comparison of interventions in change from start of treatment) and at end of 52 weeks of active treatment (change from start of treatment).

Arm	Type	Receives
Ustekinumab (Stelara)	Active comparator	Drug: UstekinumabUstekinumab (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. Patient will receive total of 52 weeks of ustekinumab (12 weeks during RCT phase, 40 weeks post RCT phase). The end of study is at Week 52 for this arm.
Placebo	Placebo comparator	Drug: Ustekinumab, Drug: PlaceboPlacebo subcutaneous injection will be given according to the same dose and schedule as the active comparator until week 12 (end of RCT phase). At week 12, ustekinumab will be administered according according to the same injection schedule as the active comparator arm for 52 weeks. Patient will receive total of 52 weeks of ustekinumab (0 weeks during RCT phase, 52 weeks post RCT phase). The end of study is at Week 64 for this arm.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Males and females 18 years of age and older.
Clinical diagnosis of psoriasis for at least 6 months as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by Investigator.
Stable plaque psoriasis for at least 2 months before Screening and at Baseline (Week 0) as determined by subject interview of his/her medical history.
Moderate to severe psoriasis defined by ≥ 10 percent Body Surface Area (BSA) involvement at the Baseline (Week 0) visit.
PASI score of ≥ 12 at the Baseline (Week 0) visit.

Key exclusion criteria (40 listed)

Previous adverse event following exposure to an IL-12/IL-23 antagonist that led to discontinuation of therapy and contraindicates future treatment.
Previous lack of response to an IL-12/IL-23 antagonist that led to discontinuation of therapy.
Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
Cannot avoid UVB phototherapy or Excimer laser for at least 14 days prior to the Baseline (Week 0) visit and during the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ustekinumab	Drug	Placebo, Ustekinumab (Stelara)
Placebo	Drug	Placebo

Primary outcome

Change in Vascular Inflammation
Time frame: Baseline - Week 12; 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 between baseline and week 12 (RCT period) or end of study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).
Change in Inflammatory Biomarker Levels: Intercellular Adhesion Molecule-1 (ICAM-1)
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on ICAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: Vascular Cell Adhesion Molecule-1 (VCAM-1)
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VCAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: C-reactive Protein (CRP)
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on CRP, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: Ferritin
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Ferritin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: Serum Amyloid A (SAA)
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on SAA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: Interferon-gamma (INF-g)
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on INF-g,, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: Monocyte Chemoattractant Protein-1 (MCP-1)
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MCP-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: Tumor Necrosis Factor-alpha (TNF-a)
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on TNF-a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: GlycA
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on GlycA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: Interleukin (IL)-1b
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-1b, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: IL-2ra
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-2ra, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: IL-12/23
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-12/23, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: IL-17a
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-17a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: IL-18
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-18, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: IL-6
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-6, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Inflammatory Biomarker Levels: IL-8
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-8, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Triglycerides
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Total Cholesterol
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Total cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: High-density Lipoprotein (HDL) Cholesterol
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: HDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: HDL Particle Size
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Large-HDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Small-HDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Medium-HDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Large Medium-HDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Low-density Lipoprotein (LDL) Cholesterol
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: LDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: LDL Particle Size
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Small-LDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Large-LDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Very Large-LDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Very large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Very Low-density Lipoprotein (VLDL) Particle Size
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: VLDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: VLDL Triglycerides
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Small-VLDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Medium-VLDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Large Medium-VLDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Large-VLDL Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Intermediate-density Lipoprotein (IDL) Particle Number
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Cholesterol Efflux Capacity
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Cholesterol efflux capacity, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period). The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)].
Change in Lipid Biomarker Levels: Apolipoprotein-B
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Apolipoprotein-B, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Lipid Biomarker Levels: Fetuin-A
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Fetuin-A, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Metabolic Biomarker Levels: Adiponectin
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Adiponectin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Metabolic Biomarker Levels: Leptin
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Leptin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Metabolic Biomarker Levels: Insulin
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Insulin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Metabolic Biomarker Levels: Glucose
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Glucose, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Change in Metabolic Biomarker Levels: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HOMA-IR, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period). HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose [mg/dl] * fasting insulin [mU/ml]/405).

5 secondary outcomes

Number of Participants Achieving PASI75 (75% or Greater Reduction in PASI Score)
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Number of Participants Achieving PASI90 (90% or Greater Reduction in PASI Score)
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Number of Participants Achieving Physician Global Assessment (PGA) Clear/Almost Clear
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Patient-Reported Outcomes: MEDFICTS
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
Change in Patient-reported Physical Activity Assessments: IPAQ
Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Results and safety

Results posted to the registry on 15 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ustekinumab	22	19
Placebo	21	15

Primary outcome: Change in Vascular Inflammation

Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64). Mean (Standard Error). Unit: TBR max

Measure	Ustekinumab (RCT Period) n = 22	Placebo (RCT Period) n = 19	Total (Active Treatment Period) n = 38
Value	-0.1015 (0.0465)	0.1442 (0.0137)	-0.0151 (0.0353)

Ustekinumab (RCT Period) vs Placebo (RCT Period): Mean Difference (Final Values): -0.2456 (95% CI -0.3873 to -0.1040), p = 0.0012, Regression, Linear
Total (Active Treatment Period): Mean Difference (Final Values): -0.0151 (95% CI -0.0867 to 0.0565), p = 0.6718, Regression, Linear

Population analysed: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

Primary outcome: Change in Inflammatory Biomarker Levels: Intercellular Adhesion Molecule-1 (ICAM-1)

Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64). Mean (Standard Error). Unit: ng/mL

Measure	Ustekinumab (RCT Period) n = 21	Placebo (RCT Period) n = 19	Total (Active Treatment Period) n = 38
Value	10.83 (26.30)	75.80 (37.19)	6.65 (22.24)

Ustekinumab (RCT Period) vs Placebo (RCT Period): Mean Difference (Final Values): -64.97 (95% CI -115.83 to 25.89), p = 0.1159, Regression, Linear
Total (Active Treatment Period): Mean Difference (Final Values): 6.65 (95% CI -38.41 to 51.72), p = 0.7666, Regression, Linear

Primary outcome: Change in Inflammatory Biomarker Levels: Vascular Cell Adhesion Molecule-1 (VCAM-1)

Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64). Mean (Standard Error). Unit: ng/mL

Measure	Ustekinumab (RCT Period) n = 21	Placebo (RCT Period) n = 19	Total (Active Treatment Period) n = 38
Value	-20.36 (18.39)	60.53 (24.76)	-1.99 (14.11)

Ustekinumab (RCT Period) vs Placebo (RCT Period): Mean Difference (Final Values): -80.89 (95% CI -142.55 to -19.23), p = 0.0115, Regression, Linear
Total (Active Treatment Period): Mean Difference (Final Values): -1.99 (95% CI -30.58 to 26.59), p = 0.8883, Regression, Linear

Primary outcome: Change in Inflammatory Biomarker Levels: C-reactive Protein (CRP)

Time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64). Mean (Standard Error). Unit: ng/mL

Measure	Ustekinumab (RCT Period) n = 21	Placebo (RCT Period) n = 19	Total (Active Treatment Period) n = 38
Value	-2886.57 (2851.16)	140.64 (1108.54)	-1974.63 (1659.11)

Ustekinumab (RCT Period) vs Placebo (RCT Period): Mean Difference (Final Values): -3027.21 (95% CI -9465.95 to 3411.54), p = 0.3472, Regression, Linear
Total (Active Treatment Period): Mean Difference (Final Values): -1974.63 (95% CI -5336.30 to 1387.04), p = 0.2416, Regression, Linear

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ustekinumab (Stelara)	0 of 22 (0%)	14 of 22 (63.6%)	0 of 22
Placebo (RCT Period)	0 of 21 (0%)	3 of 21 (14.3%)	0 of 21
Placebo (Active Treatment Period)	3 of 19 (15.8%)	16 of 19 (84.2%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joel M Gelfand, MD, MSCE principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ustekinumab in people with Psoriasis and Cardiovascular Disease, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Vascular Inflammation (time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02187172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.