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

Phase 3 Completed 592 enrolled Amgen Wyeth is now a wholly owned subsidiary of Pfizer · collab

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2010-09
Primary completion: 2011-10
Completion: 2011-12

Outcome

Met primary endpoint

registry NUMBER Etanercept Monotherapy: 48.3 Percentage of participants NUMBER Etanercept + Clobetasol Propionate Foam: 65.2 Percentage of participants NCT01235442 ↗

registry analysis (superiority or other test); Etanercept Monotherapy vs Etanercept + Clobetasol Propionate Foam; p <0.001; Odds Ratio (OR) 2.05 (95% CI 1.46 to 2.87) NCT01235442 ↗

Publications

Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etanercept	Protein / enzyme biologic	50 mg	Subcutaneous
Subject	clobetasol propionate	Small molecule	0.05 %	Topical