Safety and Tolerability of Repeat Courses of IM Alefacept

Completed · Phase 3

Conditions studied: Chronic Plaque Psoriasis

In brief

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 dermatology treatments.

Key facts

Study ID

NCT00233662

Run by

Biogen

People needed

400

Starts

2002-12-01

Expected to finish

2005-12-01

Last updated by the study team

2023-08-23

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of California, Irvine — Irvine, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Clinical Research Specialists, Inc. — Santa Monica, California, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Central Dermatology — St Louis, Missouri, United States
• University of Medicine and Dentistry Robert Wood Jonhson Medical School — New Brunswick, New Jersey, United States
• New York University School of Medicine — New York, New York, United States
• The Mount Sinai School of Medicine — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Rivergate Dermatology — Goodlettsville, Tennessee, United States
• Baylor Dermatology Research Center — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah School of Medicine — Salt Lake City, Utah, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
• Dermatology Associates — Seattle, Washington, United States
• University of Vienna — Vienna, Austria
• Western Canada Dermatology Institute — Edmonton, Alberta, Canada
• Vancouver Hospital — Vancouver, British Columbia, Canada
• Eastern Canada Cutaneous Research Associates — Halifax, Nova Scotia, Canada
• Dermatrials Research — Hamilton, Ontario, Canada
• Royal Victoria Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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