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Sponsors and Collaborators: |
Rockefeller University PDL BioPharma, Inc. |
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Information provided by: | Rockefeller University |
ClinicalTrials.gov Identifier: | NCT00050648 |
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.
Condition | Intervention | Phase |
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Psoriasis |
Drug: Daclizumab Drug: Cyclosporine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis. |
Estimated Enrollment: | 30 |
Study Start Date: | October 1997 |
Estimated Study Completion Date: | September 2005 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
United States, New York | |
Rockefeller University | |
New York, New York, United States, 10021 | |
Rockefeller University Hospital | |
New York, New York, United States, 10021 |
Principal Investigator: | James Krueger, MD, PHD | Rockefeller University |
Study ID Numbers: | JKR-0336 |
Study First Received: | December 17, 2002 |
Last Updated: | September 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00050648 |
Health Authority: | United States: Food and Drug Administration |
psoriasis Daclizumab Cyclosporin |
anti-TAC dermatology skin |
Antibodies, Monoclonal Antibodies Cyclosporine Skin Diseases Clotrimazole Psoriasis |
Miconazole Daclizumab Tioconazole Cyclosporins Skin Diseases, Papulosquamous Immunoglobulins |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antifungal Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Pharmacologic Actions |