Clinical trial NCT00050661: To Study the Use of Humanized CD25 in Preventing the Relapse of Psoriasis Vulgaris
Official title: Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody/ Placebo to Prevent Relapse of Psoriasis Vulgaris Following NBUVB Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psoriasis
Keywords: psoriasis
Cyclosporine
Daclizamub
anti-TAC
dermatology
skin
lesions
Lead sponsor: Rockefeller University
Sponsor class: OTHER
Collaborators: name: Facet Biotech
First posted: 2002-12-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: time to disease relapse
timeFrame: After a course of NB-UVB treatment
Secondary outcomes:
measure: Histologic assessment of disease activity at relapse for measures of epidermal hyperplasia, leukocyte infiltration, and expression of cytokine-induced inflammatory proteins.
timeFrame: before and after NB-UVB treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University Hospital
state: New York
city: New York
country: United States
facility: Rockefeller University
state: New York
city: New York
country: United States
facility: Rockefeller University
state: New York
Study officials:
affiliation: Rockefeller University
name: James Krueger, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: