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| Name | Class |
|---|---|
| Facet Biotech | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cyclosporine | Active Comparator | oral medication 2mg/kg/day orally from Day 0 until Day 90 |
|
| anti-TAC | Active Comparator | 1mg/kg/dose medication every other week on the odd week (week 1-13) |
|
| Cyclosporine and anti-TAC | Experimental | DaclizumabTM at 1mg/kg plus low dose cyclosporine (2 mg/kg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclizumab | Drug | 1mg/kg medication every other week on the odd week (week 1-13). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| clinical tolerability of DaclizumabTM and the DaclizumabTM/cyclosporine combination | day 1, week 1, 2, 3, 4, 5,7,8,9,11, 12, 13, 14 |
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Inclusion criteria
Exclusion Criteria:
6) Any history of an un-treated neoplasm
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| Name | Affiliation | Role |
|---|---|---|
| James Krueger, MD, PHD | Rockefeller University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockefeller University Hospital | New York | New York | 10021 | United States | ||
| Rockefeller University |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077561 | Daclizumab |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Cyclosporine |
| Drug |
2mg/kg/day orally from Day 0 until Day 90 or a total of 13 weeks. |
|
|
| cyclosporine and Daclizumab | Drug | 1mg/kg plus low dose cyclosporine (2 mg/kg/day) |
|
| New York |
| New York |
| 10021 |
| United States |
| Rockefeller University | New York | New York | 10065 | United States |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |