Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)

Inclusion Criteria

• 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;
• 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.

Exclusion Criteria

• 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 d