Vascular Inflammation in Psoriasis - Apremilast

Exclusion Criteria

• •Prior treatment with apremilast.
• •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 topical prescription medications for psoriasis for at least 14 days prior to the baseline visit (week 0) and during the study, with the exception of hydrocortisone 2.5% for the face and intertriginous areas.
• •Cannot avoid ultraviolet B (UVB) phototherapy or Excimer laser for at least 14 days prior to the Baseline (Week 0) visit and during the study.
• •Cannot avoid psoralen-ultraviolet A (UVA) phototherapy for at least 30 days prior to the Baseline (Week 0) visit and during the study.
• •Use of 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 interleukin (IL)-12/IL-23 antagonists, 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.
• •Participant is ≥ 300lbs
• •Participant is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
• •Participant is taking a medication that interferes with metabolism of apremilast, including but not limited to rifampin, phenobarbital, carbamazepine, phenytoin
• •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 participant at risk by participation in the study.
• •Prior history of suicide attempt at any time in the participant's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
• •Uncontrolled hypertension, with measured systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg
• •Participant 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;
• •Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the 30 days prior to baseline;
• •Infection requiring treatment with oral or parenteral (other than IV) antibiotics within 14 days prior to baseline;
• •Participant has received vaccination with a live viral agent within 30 days prior to screening or will require a live vaccination during study participation including up to 30 days after the last dose of study drug.
• •Participant has history of hematological or solid malignancy other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical intraepithelial neoplasia or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
• •Female participant who is pregnant or breast-feeding or considering becoming pregnant during the study.
• •Screening clinical laboratory analyses showing any of the following abnormal results:
• •White blood cell (WBC) count \<3.0 x 109/L. (Subject can be included if WBC count is \<3.0 x 109/L and absolute neutrophil count (ANC) is \>1000 cells / mm3.)
• •WBC count \> 15 x 109/L;
• •Hemoglobin (Hgb) \< 9.0 x 109/L;
• •Platelet count \< 100 x 109/L;
• •Serum creatinine \>1.5 mg/dL ;
• •Serum aspartate transaminase or alanine transaminase \>2.0 upper limits of normal
• •Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
• •History of substance abuse within 365 days of screening visit.
• •Alcohol use of more than 14 drinks per week within 14 days of the baseline visit
• •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.