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

Psoriasis Clinical Trial

Official title:

Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody/ Placebo to Prevent Relapse of Psoriasis Vulgaris Following NBUVB Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050661
• Other study ID #: JKR-0337
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 17, 2002
• Last updated: March 24, 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 is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2008
• Est. primary completion date: April 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 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 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 anti-TAC.

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
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.

Device:
• 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.

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	time to disease relapse		After a course of NB-UVB treatment	No
Secondary	Histologic assessment of disease activity at relapse for measures of epidermal hyperplasia, leukocyte infiltration, and expression of cytokine-induced inflammatory proteins.		before and after NB-UVB treatment	No