- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00050661
To Study the Use of Humanized CD25 in Preventing the Relapse of Psoriasis Vulgaris
March 24, 2009 updated by: Rockefeller University
Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody/ Placebo to Prevent Relapse of Psoriasis Vulgaris Following NBUVB Therapy
This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Rockefeller University
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New York, New York, United States, 10021
- Rockefeller University Hospital
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New York, New York, United States, 10021
- Rockefeller University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Narrow Band Ultraviolet B
312nm
|
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.
|
Experimental: anti-TAC or placebo
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to disease relapse
Time Frame: After a course of NB-UVB treatment
|
After a course of NB-UVB treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
before and after NB-UVB treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1997
Primary Completion (Actual)
April 1, 2004
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
December 17, 2002
First Submitted That Met QC Criteria
December 17, 2002
First Posted (Estimate)
December 18, 2002
Study Record Updates
Last Update Posted (Estimate)
March 25, 2009
Last Update Submitted That Met QC Criteria
March 24, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JKR-0337
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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