Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.

Official Title
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A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Etanercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Etanercept|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Live Quality Index (DLQI) response at week 12 |  |  | 
| Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12 |  |  | 
| Psoriasis pain (VAS) at week 12 |  |  | 
| Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12 |  |  | 
| PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy |  |  | 
| Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy |  |  | 
| Adverse events, infections injection site reactions during long-term therapy |  |  | 
| Serious adverse events and infections during long-term therapy |  |  | 
| Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, adults, skin, Phase 3, clinical trial, Amgen, etanercept, Enbrel®, moderate, severe