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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: cyclosporine and Daclizumab; Drug: Cyclosporine; Drug: Daclizumab

• Registration Number: NCT00050648
• Lead Sponsor: Rockefeller University

Brief 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

Study Timeline

• Study Start: 1997-10
• Study First Submitted: 2002-12-17
• Study First Submitted QC: 2002-12-17
• Study First Posted: 2002-12-18
• Primary Completion: 2004-09
• Study Completion: 2008-04
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-12
• Last Update Posted: 2009-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1. . Positive serology for HIV, Hepatitis B, or Hepatitis C.
2. . Positive β-HCG titer. For women of childbearing potential, unwillingness or inability to use a contraceptive device during this study if negative for β-HCG.
3. Guttate psoriasis, pustular psoriasis, or whole body erythroderma.
4. Active infection or persistent fever of unknown origin. 5.) Major concurrent illness, which could worsen following treatment with DaclizumabTM.

6. Any history of an un-treated neoplasm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclosporine and anti-TAC	cyclosporine and Daclizumab	DaclizumabTM at 1mg/kg plus low dose cyclosporine (2 mg/kg/day)
cyclosporine	Cyclosporine	oral medication 2mg/kg/day orally from Day 0 until Day 90
anti-TAC	Daclizumab	1mg/kg/dose medication every other week on the odd week (week 1-13)

Primary Outcome Measures

Name	Time	Method
clinical tolerability of DaclizumabTM and the DaclizumabTM/cyclosporine combination	day 1, week 1, 2, 3, 4, 5,7,8,9,11, 12, 13, 14

Trial Locations

Locations (2)

Rockefeller University Hospital; 🇺🇸 New York, New York, United States

Rockefeller University; 🇺🇸 New York, New York, United States