To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris

• ClinicalTrials.gov Identifier: NCT00050648
• Recruitment Status: Completed
• First Posted: December 18, 2002
• Last Update Posted: March 13, 2009
• Sponsor: Rockefeller University
• Collaborator: Facet Biotech
• Information provided by: Rockefeller University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: Daclizumab; Drug: Cyclosporine; Drug: cyclosporine and Daclizumab	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis.
• Study Start Date: October 1997
• Actual Primary Completion Date: September 2004
• Actual Study Completion Date: April 2008

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria

1. 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.
2. Extensive skin involvement.
3. Scale, thickness, and erythema in individual psoriasis lesions of at least intensity.
4. Psoriasis treated with emollients only for 2 weeks prior to treatment
5. Patients with active psoriatic arthritis, if accompanied by psoriasis vulgaris involving more than 5% of the body surface.
6. History of psoriasis that cannot be treated with topical agents or with previous systemic/ photo(chemo)therapy agents.

Exclusion Criteria:

1. . Positive serology for HIV, Hepatitis B, or Hepatitis C.
2. . 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.
3. Guttate psoriasis, pustular psoriasis, or whole body erythroderma.
4. 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

Locations

United States, New York

Rockefeller University Hospital

New York, New York, United States, 10021

Rockefeller University

New York, New York, United States, 10021

Rockefeller University

New York, New York, United States, 10065

Sponsors and Collaborators

Rockefeller University

Facet Biotech

Investigators

• Principal Investigator: James Krueger, MD, PHD; Rockefeller University

More Information

• Responsible Party: James G. Krueger, MD, PhD, Rockefeller University
• ClinicalTrials.gov Identifier: NCT00050648
• Other Study ID Numbers: JKR-0336
• First Posted: December 18, 2002
• Last Update Posted: March 13, 2009
• Last Verified: March 2009

Keywords provided by Rockefeller University:

psoriasis; Daclizumab; Cyclosporin; anti-TAC; dermatology; skin

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Cyclosporine; Cyclosporins; Daclizumab; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antifungal Agents; Anti-Infective Agents; Dermatologic Agents; Antirheumatic Agents; Calcineurin Inhibitors