Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis (CobAcE)

NCT00707070 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Universita di Verona
Phase	Phase 4
Status	UNKNOWN
Enrolment	100
Start date	2008-09
Completion	2009-10

Conditions

• Chronic Plaque Psoriasis

Interventions

• efalizumab plus placebo
• efalizumab plus acitretin

Primary outcomes

• PASI 75 and PASI 50 at week 24 Physician Global Assessment — week 12 and 24

Countries

Italy