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

Rockefeller University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Psoriasis

Treatments: Device: NB-UVB; Drug: Daclizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00050661

JKR-0337

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

6 participants in 2 patient groups

Narrow Band Ultraviolet B

Active Comparator group

Description:

312nm

Treatment:

Device: NB-UVB

anti-TAC or placebo

Experimental group

Treatment:

Drug: Daclizumab