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

Amgen

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: 2=Clobetasol propionate foam; Drug: 1=Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT01235442

20080470

Details and patient eligibility

About

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.

Enrollment: 592 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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592 participants in 2 patient groups

etanercept and clobetasol

Experimental group

Description:

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)

Treatment:

Drug: 2=Clobetasol propionate foam

etanercept

Experimental group

Description:

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

Treatment:

Drug: 1=Etanercept