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

This study has been completed.
Sponsor:
Collaborator:
Facet Biotech
Information provided by:
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00050661
First received: December 17, 2002
Last updated: March 24, 2009
Last verified: March 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Daclizumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 01, 2014