drugset / Trial / NCT00707070

Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis

NCT00707070

Phase 4 Unknown 100 enrolled University of Verona
RandomizedParallel-groupDouble-blindTreatment

Summary

It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.

Timeline

Start
2008-09
Primary completion
2009-10
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Acitretin Small molecule 0.4 mg/kg Oral
Background efalizumab Monoclonal antibody 1 mg/kg Subcutaneous

Indications