To Study the Use of Humanized CD25 in Preventing the Relapse of Psoriasis Vulgaris - Full Text View

Sponsors and Collaborators:	Rockefeller University Facet Biotech
Information provided by:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00050661

Purpose

This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.

Condition	Intervention	Phase
Psoriasis	Drug: Daclizumab Device: NB-UVB	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody/ Placebo to Prevent Relapse of Psoriasis Vulgaris Following NBUVB Therapy

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Dacliximab

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

time to disease relapse [ Time Frame: After a course of NB-UVB treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Histologic assessment of disease activity at relapse for measures of epidermal hyperplasia, leukocyte infiltration, and expression of cytokine-induced inflammatory proteins. [ Time Frame: before and after NB-UVB treatment ] [ Designated as safety issue: No ]

Enrollment:	6
Study Start Date:	October 1997
Study Completion Date:	April 2008
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Narrow Band Ultraviolet B: Active Comparator 312nm	Device: NB-UVB total body NB-UVB at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until for a total of 20 ± 2 treatments total.
anti-TAC or placebo: Experimental	Drug: Daclizumab Humanized anti-CD25 antibodies (anti-TAC), or placebo (saline solution), will be given as intravenous infusions on the following schedule: 2 mg/kg initially (maximum dose 200 mg) infusion given over 60 minutes, followed by a 1 mg/kg (maximum of 100 mg) infusion given over 30 minutes every two weeks thereafter for a total of 8 doses.

Detailed Description:

The first part of the study involves NB-UVB light treatment, a well-established treatment to treat psoriasis. In the second part, we are testing a drug known as Humanized CD25 Monoclonal Antibody (anti-TAC) or placebo to prevent disease relapse. Anti-TAC is an injectable medicine that is also designed to treat psoriasis by blocking a part of the immune system that we believe contributes to the disease.

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 to case basis. For those patients under the age of 18, parental consent will be obtained.
Extensive skin involvement.
Scale, thickness, and erythema in individual psoriasis lesions of at least moderate 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.
Patients that are appropriate for treatment with UVB.

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.
Major concurrent illness, which could worsen following treatment with anti-TAC.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050661

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 Krueger, MD, PhD )
Study ID Numbers:	JKR-0337
Study First Received:	December 17, 2002
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00050661 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Rockefeller University:

psoriasis
Cyclosporine
Daclizamub
anti-TAC

dermatology
skin
lesions

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Cyclosporine
Immunologic Factors
Skin Diseases
Psoriasis

Daclizumab
Immunosuppressive Agents
Cyclosporins
Skin Diseases, Papulosquamous
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Skin Diseases
Psoriasis
Daclizumab

Physiological Effects of Drugs
Immunosuppressive Agents
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009