Overview

To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris

Status:
Completed

Trial end date:
2008-04-01

Target enrollment:
0

Participant gender:
All

Summary

This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab) and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and Cyclosporine.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rockefeller University

Collaborator:

Facet Biotech

Treatments:

Cyclosporine
Cyclosporins
Daclizumab
Immunoglobulin G

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 by case basis.
Patients below 18 will need parental consent.

2. Extensive skin involvement.

3. Scale, thickness, and erythema in individual psoriasis lesions of at least 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. History of psoriasis that cannot be treated with topical agents or with previous
systemic/ photo(chemo)therapy agents.

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 DaclizumabTM.

6) Any history of an un-treated neoplasm