A Phase 1/2 interventional study of Daclizumab and NB-UVB in Psoriasis, sponsored by Rockefeller University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-25.
Sponsored by Rockefeller University · Phase 1/2, Interventional, and Treatment
This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 6 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Rockefeller University is the lead sponsor of 120 studies on the registry; 3 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
312nm
Device: NB-UVB
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.
Also known as: anti-TAC
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.
time to disease relapse
Time frame: After a course of NB-UVB treatment
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
This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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Rockefeller University