To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris - Full Text View

Sponsor:	Rockefeller University
Collaborator:	Facet Biotech
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 Drug: cyclosporine and Daclizumab	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis.

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Cyclosporine Cyclosporin Dacliximab

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

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
cyclosporine: Active Comparator 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.
anti-TAC: Active Comparator 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).
Cyclosporine and anti-TAC: Experimental 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

Criteria

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

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
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

Additional Information:

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

No publications provided

Responsible Party:	Rockefeller University ( James G. Krueger, MD, PhD )
Study ID Numbers:	JKR-0336
Study First Received:	December 17, 2002
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00050648 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Rockefeller University:

psoriasis
Daclizumab
Cyclosporin

anti-TAC
dermatology
skin

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Daclizumab
Physiological Effects of Drugs
Enzyme Inhibitors
Cyclosporins

Immunosuppressive Agents
Pharmacologic Actions
Psoriasis
Therapeutic Uses
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 09, 2009