Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)
Condition: Psoriasis; Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast 10mg; Apremilast 20mg; Apremilast 30 mg; Placebo; Apremilast 30mg; Apremilast 20mg
Intervention MeSH terms: Thalidomide; Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 352.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: moderate-to-severe plaque-type psoriasis

Summary:

      The purpose of this study was to test if the drug apremilast was safe, if it helped improve
      psoriasis, and how well the participants tolerated it.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form

          -  ≥18 years of age at the time of signing the informed consent form

          -  Able to adhere to the study visit schedule and other protocol requirements.

          -  Diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening as
             defined by:

               1. PASI (Psoriasis Area and Severity Index) score ≥ 12

               2. Body Surface Area (BSA) ≥ 10%

          -  Candidate for photo/systemic therapy

          -  In good health as judged by the investigator, based on medical history, physical
             examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, immunology,
             and urinalysis

          -  Meet all laboratory criteria as defined per protocol

          -  Females of childbearing potential (FCBP) must have a negative urine pregnancy test at
             screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the
             following adequate forms of contraception methods. A FCBP must agree to have pregnancy
             tests every 4 weeks while on study medication

          -  Males (including those who have had a vasectomy) must agree to use barrier
             contraception (latex condoms) when engaging in reproductive sexual activity with FCBP
             while on study medication and for 84 days after taking the last dose of study
             medication

        Exclusion Criteria:

          -  History of clinically significant disease (as determined by the investigator)

          -  Pregnant or breastfeeding

          -  History of active mycobacterial infection within 3 years

          -  History of Human Immunodeficiency Virus (HIV) infection

          -  Congenital and acquired immunodeficiencies

          -  Hepatitis B surface antigen positive or Hepatitis B core antibody positive at
             screening

          -  Antibodies to Hepatitis C at screening

          -  Malignancy or history of malignancy except for treated [i.e., cured] basal-cell skin
             carcinomas

          -  Any condition, including the presence of laboratory abnormalities, that places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study

          -  Psoriasis flare within 4 weeks of screening

          -  Topical therapy within 2 weeks of randomization

          -  Systemic therapy for psoriasis within 4 weeks of randomization

          -  Use of phototherapy within 4 weeks of randomization [(i.e., Ultraviolet (UVB),
             Psoralens and long-wave ultraviolet radiation (PUVA)]

          -  Adalimumab, etanercept, efalizumab or infliximab within 12 weeks of randomization

          -  Alefacept within 24 weeks of randomization

          -  Investigational drug within 4 weeks of randomization, or 5
             pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer)

          -  Prolonged sun exposure or use of tanning booths or other ultraviolet light sources