Clinical trial NCT01235442: Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Topical
etanercept
clobetasol propionate
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2010-11-05
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 greater efficacy compared with etanercept monotherapy, as measured by PASI 75 at Week 12.


Eligibility 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®).

Primary outcomes:
measure: PASI 75 at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: sPGA (0,1) at Week 12
timeFrame: Week 12
measure: PASI 90 at Week 12
timeFrame: Week 12
measure: Patient Satisfaction at Week 12
timeFrame: Week 12
measure: Percent PASI Improvement From Baseline at Week 12
timeFrame: Week 12
measure: PASI 75 at Week 24
timeFrame: Week 24
measure: sPGA (0,1) at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.