Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast; Placebo; Topical or Phototherapy Therapy
Intervention description: Apremilast 30mg by mouth (PO) twice a day (BID) for 32 weeks; Identically matching placebo by mouth BID for first 16 weeks. Placebo participants will be switched to receive apremilast 30 mg BID at Week 16-32.; Topical therapies such as low-potency or weak corticosteroids or phototherapies such as light therapy are added for non-responders at Week 32, (< PASI-50) and added to their treatment regimen. The decision to add these treatments during this phase can only be made at the Week 32 visit.
Intervention MeSH terms: Apremilast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 413.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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