A Phase IV, Open Label Study of the Effects of Apremilast on Vascular Inflammation and Cardiometabolic Function in Psoriasis
The purpose of the VIP-A study is to determine the effect of apremilast on aortic vascular inflammation, cardiometabolic biomarkers and body composition in patients with moderate-severe psoriasis.
• Males and females 18 years of age and older.
• Clinical diagnosis of psoriasis for at least 6 months as determined by medical history interview 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 medical history interview.
• Moderate to severe psoriasis defined by ≥ 10 percent Body Surface Area (BSA) involvement at the baseline (Week 0) visit.
• Psoriasis Area and Severity Index (PASI) score of ≥ 12 at the Baseline (Week 0) visit.
• Participant 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:
• Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and baseline. Women of childbearing potential must undergo periodic pregnancy testing during the study and agree to use at least one of the following methods of contraception throughout the study duration and for at least 28 days after taking the last dose of investigational product:
• Oral contraceptives
• Transdermal contraceptives
• Injectable or implantable methods
• Intrauterine devices
• Vaginal ring
• Vasectomized partner
• Barrier methods (Male or female condom (latex condom or non-latex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.);
• Women who are postmenopausal (for at least one year), sterile, or hysterectomized;
• Women who have undergone tubal ligation will be required to undergo periodic pregnancy testing during the duration of the study
• Sexual abstinence, defined as total abstinence from sexual intercourse, is considered an adequate form of contraception. (Agreement to comply with sexual abstinence must be recorded in the source document).
• Participants using oral or parenteral forms of contraceptives must have been using these methods for at least 90 days prior to baseline visit.
• Men (including those who have had a vasectomy), who engage in activity in which conception is possible, are eligible to participate if they:
• Use barrier contraception (male latex condom or non-latex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]) while on investigational product and for at least 28 days after the last dose of investigational product.
• Participant is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile and physical examination performed at screening.