Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

592 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-12-31

Brief Summary

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The primary hypothesis of this trial is that the addition of short courses of clobetasol propionate foam to etanercept monotherapy in subjects with moderate to severe plaque psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by PASI 75 at Week 12.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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etanercept and clobetasol

Etanercept 50 mg twice weekly x 12 weeks + clobetasol propionate foam (weeks 11 and 12) then Etanercept 50 mg once weekly x 12 weeks + clobetasol propionate foam (weeks 23 and 24)

Group Type EXPERIMENTAL

2=Clobetasol propionate foam

Intervention Type DRUG

0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses

etanercept

Etanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks

Group Type EXPERIMENTAL

1=Etanercept

Intervention Type DRUG

50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks.

Interventions

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1=Etanercept

50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks.

Intervention Type DRUG

2=Clobetasol propionate foam

0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* Subject has involved BSA ≥ 10% and PASI ≥ 10 at screening and at baseline.
* Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator

Exclusion Criteria

* Subject has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
* Subject has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept and/orclobetasol propionate foam on psoriasis.
* Subject diagnosed with medication-induced or medication exacerbated psoriasis
* Subject has any active Common Toxicity Criteria (CTC) grade 2 or higher infection
* Subject has a significant concurrent medical condition or laboratory abnormalities as defined in the study protocol.
* Subject has used any of the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids.
* Subject has used any of the following therapies within 28 days of the first dose: Class I or II topical steriods, UVA therapy (with or without psoralen), or systemic psoriasis therapies
* Subject has used one or more biologic therapies (other than interleukin (IL)12/IL23 inhibitors) within 3 months of the first dose
* Subject has used an IL-12/IL-23 inhibitor within 6 months of the first dose of etanercept
* Subject has ever used efalizumab (Raptiva®).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No