NCT00050648

To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris

Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab) and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and Cyclosporine.

Detailed description

The purpose is to study the safety and effectiveness of a new drug called "anti-TAC" (anti-CD25) Monoclonal Antibody used together with low dose Cyclosporine in the treatment of psoriasis. While the exact cause of psoriasis is unknown, it is believed to involve white blood cells called lymphocytes, which become activated in the skin. It is believed that these activated cells are responsible for the changes you see as the rash of psoriasis. Anti-TAC (anti-CD25) Monoclonal Antibody is designed to block the activation of these lymphocytes. Because the anti-TAC (anti-CD25) Monoclonal Antibody targets the specific cells involved in the symptoms of psoriasis, this new drug may be a better way to treat psoriasis. The second drug, Cyclosporine, is an FDA-approved drug in the treatment of psoriasis. There is evidence in the laboratory that Cyclosporine and anti-TAC, used together, will have an additive effect. An additional benefit of this study is that we are using a lower dose of cyclosporine than is usually given when it is used alone because it is being used together with anti-TAC. This should reduce the side effects usually seen with higher doses of Cyclosporine when it is used as a single drug for psoriasis. The purpose of this study is to test the safety and effectiveness of anti-TAC (Monoclonal Antibody and low dose cyclosporine in patients with active, moderate to severe psoriasis vulgaris. We also hope to gain more information on how anti-TAC works in the body

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Daclizumab	1mg/kg medication every other week on the odd week (week 1-13).
DRUG	Cyclosporine	2mg/kg/day orally from Day 0 until Day 90 or a total of 13 weeks.
DRUG	cyclosporine and Daclizumab	1mg/kg plus low dose cyclosporine (2 mg/kg/day)

Timeline

• Start date: 1997-10-01
• Primary completion: 2004-09-01
• Completion: 2008-04-01
• First posted: 2002-12-18
• Last updated: 2009-03-13

Locations

3 sites across 1 country: United States