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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00050661
First Posted: December 18, 2002
Last Update Posted: March 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Facet Biotech
Information provided by:
Rockefeller University
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • time to disease relapse [ Time Frame: After a course of NB-UVB treatment ]

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 ]

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
Active Comparator: Narrow Band Ultraviolet B
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.
Experimental: anti-TAC or placebo 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.
Other Name: anti-TAC

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050661


Locations
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
Rockefeller University
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

Responsible Party: James Krueger, MD, PhD, Rockefeller University
ClinicalTrials.gov Identifier: NCT00050661     History of Changes
Other Study ID Numbers: JKR-0337
First Submitted: December 17, 2002
First Posted: December 18, 2002
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Rockefeller University:
psoriasis
Cyclosporine
Daclizamub
anti-TAC
dermatology
skin
lesions

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Daclizumab
Immunoglobulin G
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs