An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis

Exclusion Criteria

• •Non-plaque-type psoriasis (eg, pustular, erythrodermic, and guttate psoriasis).
• •Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel blockers, or lithium).
• •Spontaneously improving or rapidly deteriorating plaque psoriasis.
• •Comorbid psoriatic arthritis that is not amenable to treatment with NSAIDs.
• •Treatment with a biologic agent for psoriasis.
• •Failed 2 or more systemic treatments for plaque psoriasis.
• •Received phototherapy or prolonged sun exposure or use of tanning booth or other ultraviolet light source within 4 weeks of initiating screening procedures.
• •Received systemic drug therapy (non-biologic) for plaque psoriasis or any systemic medication that could affect psoriasis or its evaluation (PASI or IGA), including but not limited to oral or injectable corticosteroids, retinoids, sulfasalazine, within 4 weeks of initiating screening procedures.
• •Received topical medication that could affect psoriasis or its evaluation (PASI or IGA), including but not limited to corticosteroids, retinoids, topical vitamin D derivatives, pimecrolimus, tacrolimus, calcipotriene, within 2 weeks of initiating screening procedures.
• •Received immunosuppressant agents (eg, cyclosporine, azathioprine, methotrexate) within 8 weeks of initiating screening procedures.
• •Any of the following laboratory abnormalities:
• •1. liver function tests \> 1.5 x the upper limit of normal (ULN) or direct bilirubin \> 1.5 x ULN
• •2. hemoglobin \< 8.5 g/dl (international system units \[SI\]: \< 85 g/L)
• •3. neutrophils \< 1500/mm3 (SI: \< 1.5 x 109/L)
• •4. white blood cell (WBC) count \< 3,000/mm3 (SI: \< 3.0 x 109/L)
• •5. platelets \< 80,000 mm3 (SI: 80 x 109/L)
• •6. international normalized ratio (INR) \> 1.5
• •7. serum creatinine \> 1.4 mg/dL for women or \> 1.6 mg/dL for men
• •Clinically relevant hepatic, neurological, pulmonary, dermatological, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study.
• •History of or currently active primary or secondary immunodeficiency.
• •Treatment with an investigational agent within 30 days prior to initiating screening procedures.