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

Tracking Information

First Received Date ^ICMJE

December 17, 2002

Last Updated Date

March 24, 2009

Start Date ^ICMJE

October 1997

Primary Completion Date

April 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00050661 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

To Study the Use of Humanized CD25 in Preventing the Relapse of Psoriasis Vulgaris

Official Title ^ICMJE

Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody/ Placebo to Prevent Relapse of Psoriasis Vulgaris Following NBUVB Therapy

Brief Summary

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

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.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: Daclizumab
Device: NB-UVB

Study Arms / Comparison Groups

Active Comparator: 312nm

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2008

Primary Completion Date

April 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00050661

Responsible Party

James Krueger, MD, PhD, Rockefeller University

Study ID Numbers ^ICMJE

JKR-0337

Study Sponsor ^ICMJE

Rockefeller University

Collaborators ^ICMJE

Facet Biotech

Investigators ^ICMJE

Principal Investigator:

James Krueger, MD, PHD

Rockefeller University

Information Provided By

Rockefeller University

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP