NCT00050661

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1997-10-01
• Primary completion: 2004-04-01
• Completion: 2008-04-01
• First posted: 2002-12-18
• Last updated: 2009-03-25

Locations

3 sites across 1 country: United States