Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis
Condition: Psoriasis; Psoriatic Arthritis; Psoriasis Arthropatica
MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis
Intervention: Apremilast; Apremilast; Placebo
Intervention description: 20 mg tablet BID for 68 weeks; 20 mg tablet BID for 68 weeks; Placebo tablet BID for 16 weeks
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: 254.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Psoriasis; Psoriatic Arthritis

Summary:

      This study will test the clinical effectiveness and safety of two orally administered doses
      of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type
      psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Japanese participants greater than or equal to 20 years of age.

          -  Diagnosis of chronic, stable plaque psoriasis for at least 6 months prior to screening
             as defined by: Psoriasis Area Severity Index (PASI) score ≥ 12 and BSA ≥ 10%.

          -  Psoriasis which is considered inappropriate for topical therapy (based on severity of
             disease and extent of affected area) or has not been adequately controlled or treated
             by topical therapy in spite of at least 4 weeks of prior therapy with at least one
             topical medication for psoriasis or per label.

          -  In otherwise good health based on medical history, physical examination, 12-lead
             electrocardiogram (ECG), serum chemistry, hematology, immunology, and urinalysis.

        Exclusion Criteria:

          -  Other than psoriasis, history of any clinically significant and uncontrolled systemic
             diseases; any condition, including the presence of laboratory abnormalities, which
             would place the participant at unacceptable risk or confound the ability to interpret
             the data in the study.

        Prior medical history of suicide attempt or major psychiatric illness requiring
        hospitalization within the last 3 years

          -  Pregnant or breastfeeding.

          -  History of or ongoing chronic or recurrent infectious disease.

          -  Active tuberculosis (TB) or a history of incompletely treated TB.

          -  Clinically significant abnormality on 12-lead ECG or on chest radiograph at screening.

          -  History of human immunodeficiency virus (HIV) infection or have congenital or acquired
             immunodeficiencies (eg, Common Variable Immunodeficiency).

          -  Hepatitis B surface antigen or hepatitis B core antibody positive at screening;
             positive for antibodies to hepatitis C at screening.

          -  Malignancy or history of malignancy, except for treated (ie, cured) basal cell or
             squamous cell in situ skin carcinomas or treated (ie, cured) cervical intraepithelial
             neoplasia or carcinoma in situ (CIN) of the cervix with no evidence of recurrence
             within previous 5 years.

          -  Psoriasis flare within 4 weeks of screening.

          -  Topical therapy within 2 weeks prior to randomization or systemic therapy for
             psoriasis or psoriatic arthritis within 4 weeks prior to randomization.

          -  Use of etretinate within 2 years prior to randomization for females of child bearing
             potential (FCBP) or within 6 months for males, and within 4 weeks prior to
             randomization for non-FCBP.

          -  Use of phototherapy: Ultraviolet light B (UVB), Psoralens and long-wave ultraviolet
             radiation (PUVA) within 4 weeks prior to randomization or prolonged sun exposure or
             use of tanning booths or other ultraviolet light sources.

          -  Use of adalimumab, etanercept, certolizumab pegol, abatacept, tocilizumab, golimumab
             or infliximab within 12 weeks prior to randomization; use of ustekinumab, alefacept or
             briakinumab within 24 weeks prior to randomization.

          -  Any investigational drug within 4 weeks prior to randomization.