NCT00707070

Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universita di Verona · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	efalizumab plus placebo	1 mg/kg/week subcutaneous for 24 weeks
DRUG	efalizumab plus acitretin	1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-06-30
• Last updated: 2008-06-30

Locations

1 site across 1 country: Italy