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To Study the Use of Humanized CD25 in Preventing the Relapse of Psoriasis Vulgaris
This study has been completed.
Study NCT00050661   Information provided by Rockefeller University
First Received: December 17, 2002   Last Updated: March 24, 2009   History of Changes

December 17, 2002
March 24, 2009
October 1997
April 2004   (final data collection date for primary outcome measure)
time to disease relapse [ Time Frame: After a course of NB-UVB treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00050661 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
To Study the Use of Humanized CD25 in Preventing the Relapse of Psoriasis Vulgaris
Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody/ Placebo to Prevent Relapse of Psoriasis Vulgaris Following NBUVB Therapy

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

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Psoriasis
  • Drug: Daclizumab
  • Device: NB-UVB
Active Comparator: 312nm
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
6
April 2008
April 2004   (final data collection date for primary outcome measure)

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 to case basis.

    For those patients under the age of 18, parental consent will be obtained.

  2. Extensive skin involvement.
  3. Scale, thickness, and erythema in individual psoriasis lesions of at least moderate 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. Patients that are appropriate for treatment with UVB.

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 anti-TAC.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00050661
James Krueger, MD, PhD, Rockefeller University
JKR-0337
Rockefeller University
Facet Biotech
Principal Investigator: James Krueger, MD, PHD Rockefeller University
Rockefeller University
March 2009

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