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To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Rockefeller University
PDL BioPharma, Inc.
Information provided by: Rockefeller University
ClinicalTrials.gov Identifier: NCT00050648
  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
Phase I
Phase II

MedlinePlus related topics: Psoriasis
Drug Information available for: Cyclosporin Cyclosporine Immunoglobulins Globulin, Immune Dacliximab
U.S. FDA Resources
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.

Further study details as provided by Rockefeller University:

Estimated Enrollment: 30
Study Start Date: October 1997
Estimated Study Completion Date: September 2005
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
Criteria
  • extensive active psoriasis vulgaris, body surface area more than 10% if accompanied by psoriatic arthritis,
  • negative hepatitis and HIV,
  • no treatment with topical medications for 2 weeks prior to the start of the study,
  • no treatment with systemic drugs for 1 month prior to the start of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050648

Locations
United States, New York
Rockefeller University
New York, New York, United States, 10021
Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
PDL BioPharma, Inc.
Investigators
Principal Investigator: James Krueger, MD, PHD Rockefeller University
  More Information

Rockefeller University Hospital Clinical Studies  This link exits the ClinicalTrials.gov site

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

Keywords provided by Rockefeller University:
psoriasis
Daclizumab
Cyclosporin
anti-TAC
dermatology
skin

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Cyclosporine
Skin Diseases
Clotrimazole
Psoriasis
Miconazole
Daclizumab
Tioconazole
Cyclosporins
Skin Diseases, Papulosquamous
Immunoglobulins

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 15, 2009