Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050648
Status:
COMPLETED
Last Update Posted:
2009-03-13
First Post:
2002-12-17
Brief Title:
To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris
Sponsor:
Rockefeller University
Organization:
Rockefeller University
Study Overview
Official Title:
Use of Humanized CD25 Anti-TAC Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None