Status:
COMPLETED
Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Amgen
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 great...
Eligibility Criteria
Inclusion
- 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
- 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®).
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
592 Patients enrolled
Trial Details
Trial ID
NCT01235442
Start Date
September 1 2010
End Date
December 1 2011
Last Update
August 7 2018
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