A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp

Summary

This was a Phase IV randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of subcutaneous efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis with involvement of the scalp who had no previous exposure to efalizumab. The study consisted of a screening period, a double-blind treatment period, an open-label treatment period, and an observation/follow-up period. The study enrolled 100 patients. 11 patients were excluded from all analyses because of data issues.

Timeline

Start

2008-02

Primary completion

2009-01

Completion

2009-01

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Efalizumab; p = 0.1054; Difference in proportion 0.163 (95% CI -0.063 to 0.393); Fisher Exact NCT00669214 ↗

Drugs

Indications