Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
Condition: Psoriasis; Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis
Intervention: Apremilast; Etanercept; Placebo tablet; Placebo injection
Intervention description: Apremilast 30 mg tablet orally BID; Etanercept 50 mg evaluator/subject-blinded SC QW injection; Placebo tablets BID; Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)
Intervention MeSH terms: Etanercept; 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: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; arthritis; psoriatic; palmoplantar; scalp; psoriasis pill; psoriasis tablet; plaque psoriasis; plaque type psoriasis; moderate to severe plaque type psoriasis; psoriatic arthritis

Summary:

      This study will test the clinical effectiveness and safety of apremilast compared with
      placebo as well as etanercept compared with placebo in the same group of patients with
      moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, ≥ 18 years of age

          -  Diagnosis of chronic, moderate to severe plaque psoriasis for at least 12 months prior
             to Screening, and a candidate for phototherapy and/or systemic (including etanercept)
             therapy

          -  Had an inadequate response, intolerance, or contraindication to at least 1
             conventional systemic agent for the treatment of psoriasis.

          -  No prior exposure to biologics for treatment of psoriatic arthritis or psoriasis

        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 subject at unacceptable risk if he/she were to participate in the
             study.

          -  Pregnant or breast feeding.

          -  Have failed more than 3 systemic agents for treatment of psoriasis.

          -  History of allergy to any component of the investigational product (IP), including
             human immunoglobulin (Ig) proteins or allergy to etanercept.

          -  Hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.

          -  Latent, active tuberculosis (TB) or inadequately treated TB; nontuberculous
             mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis
             carinii, aspergillosis, Clostridium difficile).

          -  Have a history of, or ongoing, chronic or recurrent infectious disease

          -  Have received, or are expected to receive, any live virus or bacterial vaccination
             within 3 months before first administration of IP, or through Week 20 during the
             study.

          -  Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.

          -  History of positive human immunodeficiency virus (HIV), or have congenital or acquired
             immunodeficiency (eg, common variable immunodeficiency disease).

          -  Active substance abuse or a history of substance abuse within 6 months prior to
             Screening.

          -  Malignancy or history of malignancy, except for treated [ie, cured] basal cell or
             squamous cell in situ skin carcinomas and cervical intraepithelial neoplasia [CIN] or
             carcinoma in situ of the cervix with no evidence of recurrence within the previous 5
             years.

          -  Psoriasis flare or rebound within 4 weeks prior to Screening.

          -  Topical therapy within 2 weeks of randomization or systemic therapy for psoriasis
             within 4 weeks prior to randomization

          -  Use of phototherapy within 4 weeks prior to randomization or prolonged sun exposure or
             use of tanning booths or other ultraviolet (UV) light sources.

          -  Any investigational drug within 4 weeks prior to randomization, or 5
             pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).

          -  Prior treatment with apremilast or etanercept.