Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis

This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study will test efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

Inclusion Criteria:

1. Males or females, ≥ 18 years of age at the time of signing the informed consent document

2. Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening

   a. Have moderate to severe plaque psoriasis at Screening and Baseline

3. Must meet all laboratory criteria

4. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication

5. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.

Exclusion Criteria:

1. Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
2. Pregnant or breast feeding
3. History of allergy to any component of the study drug
4. Hepatitis B surface antigen positive at Screening
5. Anti-hepatitis C antibody positive at Screening
6. Active tuberculosis (TB) or a history of incompletely treated TB
7. Clinically significant abnormality on 12-Lead ECG at Screening
8. Clinically significant abnormal chest x-ray
9. History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
10. Active substance abuse or a history of substance abuse within 6 months prior to Screening
11. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
12. Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years)
13. Psoriasis flare or rebound within 4 weeks prior to Screening
14. Evidence of skin conditions that would interfere with clinical assessments
15. Topical therapy within 2 weeks of randomization
16. Systemic therapy for psoriasis within 4 weeks prior to randomization
17. Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
18. Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
19. Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
20. Use of any investigational drug within 4 weeks prior to randomization
21. Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
22. Prior treatment with apremilast