Moderate to Severe Plaque Psoriasis With Scalp Involvement

Amgen

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Biological: Etanercept; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00791765

20080014

Details and patient eligibility

About

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

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups

Placebo BIW/Etanercept 50 mg BIW

Experimental group

Description:

Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.

Treatment:

Biological: Placebo

Biological: Etanercept

Etanercept 50 mg BIW/Etanercept 50 mg QW

Experimental group

Description:

Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.

Treatment:

Biological: Placebo

Biological: Etanercept