NCT00673556

A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study Examining the Efficacy and Safety of Weekly Intramuscular Administration of 15mg Alefacept Over 12 Weeks in a Population of Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of Alefacept compared to placebo for the treatment of Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and inappropriate

Detailed description

Patients who completed the initial 24-week treatment course (12 weeks of weekly dosing following b y 12 weeks of follow-up) and met the eligibility criteria continued in the 24-week open label extension

Conditions

• Chronic Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	alefacept	Intramuscular (IM)
DRUG	placebo	Intramuscular (IM)

Timeline

• Start date: 2003-10-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2008-05-07
• Last updated: 2014-08-26

Locations

34 sites across 5 countries: United States, Austria, Belgium, Canada, Germany