A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Comparison Study of CC-10004 in Subjects with Moderate-to-severe Plaque-Type Psoriasis

INTERVENTION: Product Name: CC‐10004 Product Code: CC‐10004 Pharmaceutical Form: Capsule* Current Sponsor code: CC‐10004 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Moderate to severe plaque‐type psoriasis PRIMARY OUTCOME: Main Objective: To compare the clinical efficacy of 2 oral (PO) doses of CC‐10004 (20 mg once daily (QD) and 20 mg twice daily (BID)) with placebo when taken for 12 weeks in subjects with moderate‐to‐severe plaque‐type psoriasis Primary end point(s): Proportion of subjects treated with CC‐10004 (20 mg QD and 20 mg BID PO) who achieve a Psoriasis Area and Severity Index reduction of 75% (PASI‐75) at Day 84 (Week 12/Final Visit) in reference to the baseline visit compared with placebo Secondary Objective: To evaluate the safety of CC‐10004 (20 mg QD and 20 mg BID PO) compared with placebo in subjects with moderate‐to‐severe plaque‐type psoriasis; ; To evaluate the effects of CC‐10004 (20 mg QD and 20 mg BID PO) compared with placebo on the quality of life in subjects with moderate‐to‐severe plaque‐type psoriasis INCLUSION CRITERIA: 1. Must understand and voluntarily sign an informed consent form 2. Must be a male or female of any ethnic origin or race, aged 18 years or older at time of consent 3. Must be in good health as judged by the investigator, based on medical history, physical examination, 12‐lead ECG, serum chemistry, hematology, and urinalysis 4. Must be able to adhere to the study visit schedule and other protocol requirements 5. Must have a =6‐month history of moderate‐to‐severe plaque‐type psoriasis immediately prior to enrollment. Note that the severity must have been moderate‐to‐severe during the entire 6‐month period before screening 6. Must have a PASI score =10 and BSA =10% 7. Must meet the following laboratory criteria: a. White blood cell count =3000/mm3 (=3.0 X 10^9/L) and < 20,000/mm3 (<20 X 10^9/L) b. Platelet count =100,000/µL (=100 X 10^9/L) c. Serum creatinine =1.5 mg/dl (=132.6 µmol/L) d. AST (SGOT) and ALT (SGPT) =1.5 X uppe