Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)

NCT02187172 | Completed Phase 4 Results

• 1 other identifier: 820124
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis; Cardiovascular Disease

Keywords

Psoriasis; Cardiovascular Disease; Vascular Inflammation; Lipid Biomarkers; FDG-PET/CT

Outcome Measures

Primary Outcomes (48)

• 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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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: \[(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)\].

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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)

  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)

  Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

• Number of Participants Achieving Physician Global Assessment (PGA) Clear/Almost Clear

  Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

• Change in Patient-Reported Outcomes: MEDFICTS

  Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

• Change in Patient-reported Physical Activity Assessments: IPAQ

  Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Study Arms (2)

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.

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.

Drug: Ustekinumab; Drug: Placebo

Interventions

Ustekinumab DRUG

Placebo; Ustekinumab (Stelara)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Psoriasis; Cardiovascular Diseases

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Joel Gelfand
• Organization: University of Pennsylvania

joel.gelfand@pennmedicine.upenn.edu

215-662-3514

Study Officials

• Joel M Gelfand, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 10, 2014
• Study Start: July 1, 2014
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: August 15, 2019
• Results First Posted: August 15, 2019

Record last verified: 2019-08

Locations

US (1)