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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Daclizumab
NB-UVB
Sponsored by
Rockefeller University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, Cyclosporine, Daclizamub, anti-TAC, dermatology, skin, lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rockefeller University Hospital
  • Rockefeller University
  • Rockefeller University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Narrow Band Ultraviolet B

anti-TAC or placebo

Arm Description

312nm

Outcomes

Primary Outcome Measures

time to disease relapse

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2002
Last Updated
March 24, 2009
Sponsor
Rockefeller University
Collaborators
Facet Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT00050661
Brief Title
To Study the Use of Humanized CD25 in Preventing the Relapse of Psoriasis Vulgaris
Official Title
Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody/ Placebo to Prevent Relapse of Psoriasis Vulgaris Following NBUVB Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rockefeller University
Collaborators
Facet Biotech

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, Cyclosporine, Daclizamub, anti-TAC, dermatology, skin, lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrow Band Ultraviolet B
Arm Type
Active Comparator
Arm Description
312nm
Arm Title
anti-TAC or placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Daclizumab
Other Intervention Name(s)
anti-TAC
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
NB-UVB
Intervention Description
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 Outcome Measure Information:
Title
time to disease relapse
Time Frame
After a course of NB-UVB treatment
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Krueger, MD, PHD
Organizational Affiliation
Rockefeller University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rockefeller University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Rockefeller University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Rockefeller University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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

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