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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-10-31

Study Completion Date

2008-04-30

Brief Summary

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This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.

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Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Narrow Band Ultraviolet B

312nm

Group Type ACTIVE_COMPARATOR

NB-UVB

Intervention Type DEVICE

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.

anti-TAC or placebo

Group Type EXPERIMENTAL

Daclizumab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DEVICE

Other Intervention Names

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anti-TAC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No