Moderate to Severe Plaque Psoriasis With Scalp Involvement
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Etanercept; Placebo
Intervention description: Etanercept for subcutaneous injection.; Placebo for subcutaneous injection.
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Scalp; Psoriasis; Plaque Psoriasis; Skin Diseases; Moderate to severe plaque psoriasis; etanercept

Summary:

      The purpose of this study is to determine if etanercept is effective in the treatment of
      scalp involvement in moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must provide written informed consent before any study-specific procedure

          -  Be male or female greater than or equal to 18 years of age at time of screening

          -  Has stable moderate to severe plaque psoriasis for at least 6 months

          -  Affected body surface area (BSA) greater than or equal to 10%

          -  Psoriasis Area and Severity Index (PASI) score greater than or equal to 10

          -  At least 30 percent affected scalp surface area

          -  Psoriasis Scalp Severity Index (PSSI) score greater than or equal to 15

          -  Candidate for systemic therapy or phototherapy in the opinion of the investigator

          -  Negative test for hepatitis B surface antigen, hepatitis C antibody, and Human
             Immunodeficiency Virus (HIV)

          -  Negative serum pregnancy test for female subjects (unless 3 years post menopausal or
             surgically sterile)

          -  Willing to use medically acceptable form of birth control for duration of study

          -  Negative Purified Protein Derivative (PPD) within 30 days prior to first dose of study
             drug

        Exclusion Criteria:

          -  Any active infection

          -  Significant concurrent medical conditions, including: Insulin dependent diabetes
             mellitus; Congestive heart failure; Myocardial infarction within last year; Unstable
             angina pectoris; Uncontrolled hypertension; Severe pulmonary disease [requiring oxygen
             therapy or hospitalization]; Systemic lupus erythematosus; Multiple sclerosis or any
             other demyelinating disease; Active malignancy

          -  Any condition, in opinion of study doctor, that might cause this study to be
             detrimental to subject

          -  History of cancer within 5 years before first dose of study drug

          -  Skin conditions other than psoriasis that would interfere with evaluations of the
             effect of study medications on psoriasis

          -  Presence of guttate, erythrodermic or pustular psoriasis

          -  Use of topical cyclosporine or calcineurin inhibitors within 14 days of first dose of
             study drug

          -  Use of tar shampoos within 14 days of first dose of study drug

          -  Use of following therapies within 28 days of first dose of study drug: IV or oral
             cyclosporine or calcineurin inhibitors, Ultraviolet Light A therapy, Psoralen plus
             ultraviolet A radiation, Oral retinoids, Ultraviolet Light B therapy, Topical steroids
             or steroid shampoo, Topical vitamin A or D analog preparations, Anthralin, other
             systemic psoriasis therapy, cyclophosphamide, sulfasalazine, anakinra

          -  Use of Alefacept (Amevive), Efalizumab (Raptiva), Anti-tumor necrosis factor (TNF)
             biologic therapies within 3 months of the first dose of study drug. Prior anti-TNF use
             will not be permitted if discontinued due to lack of efficacy, an adverse event, or
             non-compliance.

          -  Use of interleukin (IL)-12/IL-23 within 6 months of the first dose of study drug

          -  Participation in another clinical trial within 90 days or 5 half-lives (whichever is
             longer) of randomization

          -  Laboratory abnormalities at screening: hemoglobin less than 11 g/dL, platelet count
             less than 125,000/mm^3, white blood cell count less than 3,500 cells/mm^3, aspartate
             aminotransferase (AST)/alanine aminotransferase (ALT) greater than or equal to 1.5 x
             the upper limit of normal, any other laboratory abnormality which will prevent patient
             from completing the study or interfere with interpretation of study results

          -  Patient is pregnant or breast feeding

          -  Presence of any condition that could compromise the patient's ability to participate
             in the study, such as a history of substance abuse or psychiatric condition