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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


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 12

PASI 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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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