A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Plaque Psoriasis

In brief

To assess the efficacy and safety of Alefacept compared to placebo for the treatment of Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and inappropriate

Key facts

Study ID

NCT00673556

Run by

Astellas Pharma Inc

People needed

195

Starts

2003-10-01

Expected to finish

2005-05-01

Last updated by the study team

2014-08-26

Who can join

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

You may qualify if…

• Diagnosis of Chronic Plaque Psoriasis involving ≥ 10% body surface area
• Treatment history for Psoriasis in which 3 or more conventional anti-psoriatic therapies are inappropriate or ineffective
• CD4+ T lymphocyte counts at or above the lower limit of normal

You may not qualify if…

• Clinically significant abnormal hematology values or blood chemistry values
• AST or ALT ≥ 3x the upper limit of normal
• Other types of Psoriasis
• Serious infection within the 3 months prior to the first dose of study drug
• History of drug or alcohol abuse within the past 2 years
• Antibody positive for HIV
• History of malignancy
• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
• Exposure to psoriasis-modifying phototherapy or high-potency topical corticosteroid therapy within 2 weeks prior to the first dose of study drug
• Exposure to systemic anti-psoriatic therapy , topical immunomodulators or topical CNIs within 4 weeks prior to the first dose of study drug
• Current treatment with any therapy for tuberculosis
• Previous exposure to Alefacept
• Nursing mothers, pregnant women, and women planning to become pregnant during the study

Where it is running

• Study site — Irvine, California, United States
• Study site — Santa Monica, California, United States
• Study site — Omaha, Nebraska, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Goodlettsville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Norfolk, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Vienna, Austria
• Study site — Brussels, Belgium
• Study site — Edegem, Belgium
• Study site — Liège, Belgium
• Study site — Edmonton, Alberta, Canada
• Study site — St. John's, Newfoundland and Labrador, Canada
• Study site — Halifax, Nova Scotia, Canada
• Study site — Concord, Ontario, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — London, Ontario, Canada
• Study site — Windsor, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Sainte-Foy, Quebec, Canada
• Study site — Bochum, Germany
• Study site — Dresden, Germany

Full record on ClinicalTrials.gov

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