To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris
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Purpose
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 |
|---|---|---|
|
Psoriasis |
Drug: Daclizumab Drug: Cyclosporine Drug: cyclosporine and Daclizumab |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis. |
- clinical tolerability of DaclizumabTM and the DaclizumabTM/cyclosporine combination [ Time Frame: day 1, week 1, 2, 3, 4, 5,7,8,9,11, 12, 13, 14 ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | October 1997 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: cyclosporine
oral medication 2mg/kg/day orally from Day 0 until Day 90
|
Drug: Cyclosporine
2mg/kg/day orally from Day 0 until Day 90 or a total of 13 weeks.
Other Name: Neoral
|
|
Active Comparator: anti-TAC
1mg/kg/dose medication every other week on the odd week (week 1-13)
|
Drug: Daclizumab
1mg/kg medication every other week on the odd week (week 1-13).
|
|
Experimental: Cyclosporine and anti-TAC
DaclizumabTM at 1mg/kg plus low dose cyclosporine (2 mg/kg/day)
|
Drug: cyclosporine and Daclizumab
1mg/kg plus low dose cyclosporine (2 mg/kg/day)
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
- Male or female patients with chronic psoriasis vulgaris (disease stable or worsening for > 6 months). Patients age 16 - 21 will be considered on a case by case basis. Patients below 18 will need parental consent.
- Extensive skin involvement.
- Scale, thickness, and erythema in individual psoriasis lesions of at least intensity.
- Psoriasis treated with emollients only for 2 weeks prior to treatment
- Patients with active psoriatic arthritis, if accompanied by psoriasis vulgaris involving more than 5% of the body surface.
- History of psoriasis that cannot be treated with topical agents or with previous systemic/ photo(chemo)therapy agents.
Exclusion Criteria:
- . Positive serology for HIV, Hepatitis B, or Hepatitis C.
- . 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.
- Guttate psoriasis, pustular psoriasis, or whole body erythroderma.
- 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
Contacts and Locations| United States, New York | |
| Rockefeller University | |
| New York, New York, United States, 10021 | |
| Rockefeller University Hospital | |
| New York, New York, United States, 10021 | |
| Rockefeller University | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | James Krueger, MD, PHD | Rockefeller University |
More Information
Additional Information:
No publications provided
| Responsible Party: | James G. Krueger, MD, PhD, Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT00050648 History of Changes |
| Other Study ID Numbers: | JKR-0336 |
| Study First Received: | December 17, 2002 |
| Last Updated: | March 12, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Rockefeller University:
|
psoriasis Daclizumab Cyclosporin |
anti-TAC dermatology skin |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Cyclosporins Cyclosporine Daclizumab Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013