Moderate to Severe Plaque Psoriasis With Scalp Involvement

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

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Treating Scalp Involvement in Subjects With Moderate to Severe Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Biological: Etanercept
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo BIW/Etanercept 50 mg BIW<br>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. | Biological: Etanercept<br>* Etanercept for subcutaneous injection.<br>* Other names: Enbrel®;Biological: Placebo<br>* Placebo for subcutaneous injection.<br>|
| Experimental: Etanercept 50 mg BIW/Etanercept 50 mg QW<br>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. | Biological: Etanercept<br>* Etanercept for subcutaneous injection.<br>* Other names: Enbrel®;Biological: Placebo<br>* Placebo for subcutaneous injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12 | The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With PSSI 75% Response at Week 12 | Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline. | Baseline and Week 12 | 
| Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12 | Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area. | Baseline and Week 24 | 
| Patient Satisfaction With Treatment at Week 12 | This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from very dissatisfied to very satisfied) to indicate his or her level of satisfaction with the medication's control of psoriasis. | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scalp, Psoriasis, Plaque Psoriasis, Skin Diseases, Moderate to severe plaque psoriasis, etanercept