Status:
COMPLETED
A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque Psoriasis
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Biogen
Conditions:
Chronic Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis
Eligibility Criteria
Inclusion
- Body weight between 100kg and 150kg
- Diagnosis of Chronic Plaque Psoriasis with Body Surface Area (BSA) involvement of ≥ 10%
- Candidate for phototherapy or systemic therapy for Psoriasis
- CD4 + T lymphocyte counts \> lower limit of normal
Exclusion
- Clinically significant abnormal hematology values or blood chemistry values
- ALT or AST value of ≥ 3x the upper limit of normal
- Other types of Psoriasis
- Serious infection within 3 months prior to 1st dose of study drug
- Antibody positive for HIV
- History of malignancy
- History of severe allergic or anaphylactic reactions
- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00674063
Start Date
July 1 2003
End Date
April 1 2004
Last Update
August 26 2014
Active Locations (17)
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1
Hot Springs, Arkansas, United States, 71913
2
Fridley, Minnesota, United States, 55432
3
Omaha, Nebraska, United States, 68144
4
East Windsor, New Jersey, United States, 08520