NCT00150982

Alefacept Mechanism of Action in Psoriasis

In Vivo Induction of T Cell Apoptosis by Alefacept (LFA-3/IgG1 Fusion Protein, Amevive) in Patients With Psoriasis: An Investigator-Initiated, Open-Label, Mechanism of Action Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (planned)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the mechanism of action of alefacept in patients with psoriasis.

Detailed description

The purpose of the study is to better understand the mechanism of action of an FDA approved drug (alefacept). Subjects enrolled will be given alefacept 7.5 mg intravenously on a weekly basis for 12 weeks. Response is assessed by improvement in the PASI score. The responders will get no further treatment and the nonresponders will receive additional 4 weeks of therapy. Skin biopsies will be obtained throughout the study and T-cell apoptosis will be correlated to clinical response. There is no placebo group. The duration of the study is approximately 1 year.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Mechanism of action of alefacept

Timeline

• Start date: 2003-09-01
• Completion: 2005-02-01
• First posted: 2005-09-08
• Last updated: 2008-08-07

Locations

1 site across 1 country: United States