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Completed

NCT Number: NCT00050661

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

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rockefeller University, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

  • Extensive skin involvement.
  • Scale, thickness, and erythema in individual psoriasis lesions of at least moderate intensity.
  • Psoriasis treated with emollients only for 2 weeks prior to treatment
  • Patients with active psoriatic arthritis, if accompanied by psoriasis vulgaris involving more than 5% of the body surface.
  • Patients that are appropriate for treatment with UVB.

Exclusion criteria

  • Positive serology for HIV, Hepatitis B, or Hepatitis C.
  • 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.
  • Guttate psoriasis, pustular psoriasis, or whole body erythroderma.
  • Active infection or persistent fever of unknown origin.
  • Major concurrent illness, which could worsen following treatment with anti-TAC.

Treatment and study plan

Daclizumab

Drug

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.

Other names: anti-TAC

NB-UVB

Device

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.

Primary outcomes

  1. time to disease relapse

    Time frame: After a course of NB-UVB treatment

Secondary outcomes

  1. Histologic assessment of disease activity at relapse for measures of epidermal hyperplasia, leukocyte infiltration, and expression of cytokine-induced inflammatory proteins.

    Time frame: before and after NB-UVB treatment

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Collaborators

  • Facet Biotech

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2004
Study completion
2008
First posted
Dec 18, 2002
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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