To Study the Use of Humanized CD25 in Preventing the Relapse of Psoriasis Vulgaris
- Registration Number
- NCT00050661
- Lead Sponsor
- Rockefeller University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Narrow Band Ultraviolet B NB-UVB 312nm anti-TAC or placebo Daclizumab -
- Primary Outcome Measures
Name Time Method time to disease relapse After a course of NB-UVB treatment
- Secondary Outcome Measures
Name Time Method Histologic assessment of disease activity at relapse for measures of epidermal hyperplasia, leukocyte infiltration, and expression of cytokine-induced inflammatory proteins. before and after NB-UVB treatment
Trial Locations
- Locations (2)
Rockefeller University
🇺🇸New York, New York, United States
Rockefeller University Hospital
🇺🇸New York, New York, United States