Psoriasis
Conditions
Keywords
psoriasis, Cyclosporine, Daclizamub, anti-TAC, dermatology, skin, lesions
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.
Interventions
DRUGDaclizumab
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.
DEVICENB-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.
Sponsors
Facet Biotech
Rockefeller University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to disease relapse | After a course of NB-UVB treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed