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

Psoriasis Clinical Trial

Official title:

Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050648
• Other study ID #: JKR-0336
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 17, 2002
• Last updated: March 12, 2009
• Start date: October 1997
• Est. completion date: April 2008

Study information

• Verified date: March 2009
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose is to study the safety and effectiveness of a new drug called "anti-TAC" (anti-CD25) Monoclonal Antibody used together with low dose Cyclosporine in the treatment of psoriasis. While the exact cause of psoriasis is unknown, it is believed to involve white blood cells called lymphocytes, which become activated in the skin. It is believed that these activated cells are responsible for the changes you see as the rash of psoriasis. Anti-TAC (anti-CD25) Monoclonal Antibody is designed to block the activation of these lymphocytes. Because the anti-TAC (anti-CD25) Monoclonal Antibody targets the specific cells involved in the symptoms of psoriasis, this new drug may be a better way to treat psoriasis. The second drug, Cyclosporine, is an FDA-approved drug in the treatment of psoriasis. There is evidence in the laboratory that Cyclosporine and anti-TAC, used together, will have an additive effect. An additional benefit of this study is that we are using a lower dose of cyclosporine than is usually given when it is used alone because it is being used together with anti-TAC. This should reduce the side effects usually seen with higher doses of Cyclosporine when it is used as a single drug for psoriasis. The purpose of this study is to test the safety and effectiveness of anti-TAC (Monoclonal Antibody and low dose cyclosporine in patients with active, moderate to severe psoriasis vulgaris. We also hope to gain more information on how anti-TAC works in the body

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2008
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß-HCG titer. For women of childbearing potential, unwillingness or inability to use a contraceptive device during this study if negative for ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Daclizumab
1mg/kg medication every other week on the odd week (week 1-13).
• Cyclosporine
2mg/kg/day orally from Day 0 until Day 90 or a total of 13 weeks.
• cyclosporine and Daclizumab
1mg/kg plus low dose cyclosporine (2 mg/kg/day)

Locations

Country	Name	City	State
United States	Rockefeller University	New York	New York
United States	Rockefeller University	New York	New York
United States	Rockefeller University Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rockefeller University	Facet Biotech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical tolerability of DaclizumabTM and the DaclizumabTM/cyclosporine combination		day 1, week 1, 2, 3, 4, 5,7,8,9,11, 12, 13, 14	No