Status:
COMPLETED
Safety and Tolerability of Repeat Courses of IM Alefacept
Lead Sponsor:
Biogen
Conditions:
Chronic Plaque Psoriasis
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermato...
Eligibility Criteria
Inclusion
- Written informed consent.
- At least 16 years of age.
- Diagnosed with chronic plaque psoriasis and require systemic therapy.
- CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).
Exclusion
- Unstable erthrodermic or pustular psoriasis.
- Diagnosis of guttate psoriasis.
- Serious local infection or systemic infection within 3 months prior to first dose of alefacept.
- Positive for HIV antibody.
- Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.
- Evidence of active tuberculosis.
- Current treatment for active tuberculosis or tuberculosis prophylaxis.
- Female patients unwilling to practice effective contraception as defined by the investigator.
- Female patients who are pregnant or breast-feeding.
- Current enrollment in any other investigational drug study.
- Previous participation in this study or previous alefacept studies.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00233662
Start Date
December 1 2002
End Date
December 1 2005
Last Update
August 23 2023
Active Locations (46)
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1
University of California, Irvine
Irvine, California, United States, 92697
2
University of California, San Francisco
San Francisco, California, United States, 94118
3
Clinical Research Specialists, Inc.
Santa Monica, California, United States, 90404
4
University of Connecticut Health Center
Farmington, Connecticut, United States, 06430-6231