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

To Study the Use of Humanized CD25 in Preventing the Relapse of 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:	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	Phase I Phase II

MedlinePlus related topics:

Psoriasis

Drug Information available for:

Cyclosporine Cyclosporin Dacliximab

U.S. FDA Resources

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

Further study details as provided by Rockefeller University:

Estimated Enrollment:	30
Study Start Date:	October 1997
Estimated Study Completion Date:	December 2004

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

extensive active psoriasis vulgaris, body surface area more than 10% if accompanied by psoriatic arthritis
negative hepatitis and HIV
no treatment with systemic drugs for 1 month prior to the start of a study
no treatment with topical medications for 2 weeks prior to the start of a study

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

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-0337
First Received:	December 17, 2002
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00050661
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

Skin Diseases

Psoriasis

Daclizumab

Cyclosporins

Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008