A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Plaque Psoriasis Involving the Hands and/or Feet
This is a Phase IV randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of SC efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis involving the hands and/or feet who have had no previous exposure to efalizumab. The study will consist of a screening period, a treatment period, and an observation period.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase IV Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 1.0 mg/kg Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis Involving the Hands and/or Feet|
- The primary efficacy outcome measure is the proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 84.
- The proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 42
- The proportion of patients who achieve a PGA rating of clear (0) or almost clear (1) at Day 84
- The change from Day 0 to Day 84 in the following PRO measures: SF 36, PDS, Work Loss Questionnaire
- The change from Day 0 in PGA rating (i.e., the number of categories changed) at Day 84
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||November 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312026
|Study Director:||Ivor Caro, M.D.||Genentech|