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

Completed · Phase 3

Conditions studied: Chronic Plaque Psoriasis

In brief

Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis

Key facts

Study ID

NCT00674063

Run by

Astellas Pharma Inc

People needed

78

Starts

2003-07-01

Expected to finish

2004-04-01

Last updated by the study team

2014-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Hot Springs, Arkansas, United States
• Study site — Fridley, Minnesota, United States
• Study site — Omaha, Nebraska, United States
• Study site — East Windsor, New Jersey, United States
• Study site — Stony Brook, New York, United States
• Study site — Lake Oswego, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Johnston, Rhode Island, United States
• Study site — Goodlettsville, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Norfolk, Virginia, United States
• Study site — Moncton, New Brunswick, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — London, Ontario, Canada
• Study site — Waterloo, Ontario, Canada
• Study site — Windsor, Ontario, Canada
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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