NCT00794807

Safety and Tolerability of Repeat Courses of IM Alefacept

A 12-Week Open-Label Followed by 4-Week Double-Blind Study to Determine the Safety and Efficacy of an Extended Course of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Previous Biogen studies have provided experience with the tolerability, immunogenicity, and efficacy of a single and multiple 12-week courses of therapy of alefacept. At this stage, experience in larger studies, as well as the FDA-approved labeling, is confined to treatment courses of 12 weeks. The purpose of the present study is to offer an extended course of therapy with alefacept.

Detailed description

Twenty statistically matched patients (15 males, 5 females, aged between 28 and 70 years, median 50 years) with moderate to severe psoriasis (PASI: 7-36) were included in this study. They were treated with 15 mg alefacept i.m. weekly. Peripheral blood was taken prior to first alefacept application and then weekly until week five and thereafter every second week, until the end of treatment at week 13. At the same time points severity of disease and thereby possible reduction of symptoms was evaluated applying the PASI. Investigators analysing the samples were blinded to the outcome of the study. The protocol concerning human subjects was approved by the ethics commission of the Charité University Medicine Berlin Campus Mitte, Germany .

Conditions

• Chronic Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Alefacept	Alefacept=LFA-3/IgG1 fusion protein, once weekly, 15mg i.m.

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2008-11-20
• Last updated: 2008-11-20

Locations

1 site across 1 country: Germany