Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: 1=Etanercept (Drug); 2=Clobetasol propionate foam (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
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 greater efficacy compared with etanercept monotherapy, as measured by
PASI 75 at Week 12.
Clinical Details
Official title: A Randomized Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: PASI 75 at Week 12
Secondary outcome: sPGA (0,1) at Week 12PASI 90 at Week 12 Patient Satisfaction at Week 12 Percent PASI Improvement From Baseline at Week 12 PASI 75 at Week 24 sPGA (0,1) at Week 24
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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®).
Locations and Contacts
Additional Information
AmgenTrials clinical trials website
Related publications: Lebwohl MG, Kircik L, Callis Duffin K, Pariser D, Hooper M, Wenkert D, Thompson EH, Yang J, Kricorian G, Koo J. A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2013 Sep;69(3):385-92. doi: 10.1016/j.jaad.2013.03.031. Epub 2013 May 1.
Starting date: September 2010
Last updated: July 18, 2014
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