A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis

Exclusion Criteria

• •Participated in a clinical study within last 30 days
• •Present with pustular, erythrodermic psoriasis, generalized pustular psoriasis, or acute guttate psoriasis
• •Have current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including a history of ischemic or structural heart disease, conduction system disease or history of clinically significant arrhythmia), endocrinologic, neurologic, psychiatric, immunologic, hematologic, or dermatologic disease
• •Have a history of clinically significant severe drug allergies or severe post treatment hypersensitivity reactions
• •Have received inactivated vaccine within 4 weeks prior to dosing in this study, or a live vaccine within the last 3 months
• •A history of clinically significant opportunistic infection (for example, invasive candidiasis or Pneumocystis pneumonia)
• •Had symptomatic herpes zoster within last 3 months or other recent or ongoing infection
• •Present with any of the following laboratory test results:
• •* Positive QuantiFERON®-tuberculosis test
• •* For women, positive serum pregnancy test
• •* Evidence of Human Immunodeficiency Virus (HIV) infection or are positive for HIV antibodies
• •* Positive test for active hepatitis B
• •* Positive of anti-hepatitis C antibody with confirmed presence of hepatitis C virus, or chronic liver disease
• •Evidence of clinically significant hepatic or renal impairment
• •Clinically significant ECG (electrocardiogram) abnormalities or personal or family history of heart disease, including:
• •* Confirmed corrected QT interval with Frederica's correction (QTcF) \>450 milliseconds (msec) for both men and women
• •* Specific bundle branch blocks, irregular rhythms, history of unexplained syncope, or family history of unexplained death
• •Are receiving any of the following therapies for psoriasis:
• •* Systemic retinoids within last 12 weeks
• •* Systemic psoriasis therapy, such as psoralen and ultraviolet A (PUVA) light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine, or phototherapy (including ultraviolet B or self-treatment with tanning beds or therapeutic sunbathing) within last 4 weeks
• •* Topical psoriasis treatment within last 2 weeks; or
• •* Any biologic agent within the following washout periods: 30 days for anti-tumor necrosis factor (TNF) inhibitors, and 90 days for other agents