Psoriasis Clinical Trial
A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
Summary
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
Full Description
Patients who completed the initial 24-week treatment course (12 weeks of weekly dosing following b y 12 weeks of follow-up) and met the eligibility criteria continued in the 24-week open label extension
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 34 Locations for this study
Irvine California, 92697, United States
Santa Monica California, 90404, United States
Omaha Nebraska, 68144, United States
New Brunswick New Jersey, 08903, United States
Winston Salem North Carolina, 27157, United States
Goodlettsville Tennessee, 37072, United States
Dallas Texas, 75246, United States
Salt Lake City Utah, 84132, United States
Norfolk Virginia, 23507, United States
Seattle Washington, 98104, United States
Vienna , 1090, Austria
Brussels , 1070, Belgium
Edegem , 2650, Belgium
Liege , 4020, Belgium
Edmonton Alberta, T5J 3, Canada
St. Johns Newfoundland and Labrador, A1B 4, Canada
Halifax Nova Scotia, B3H 1, Canada
Concord Ontario, L4K 5, Canada
Hamilton Ontario, L8N 1, Canada
London Ontario, N6K 1, Canada
Windsor Ontario, N8W 5, Canada
Montreal Quebec, H2K 4, Canada
Sainte-Foy Quebec, G1V 4, Canada
Bochum , 44791, Germany
Dresden , 01307, Germany
Duesseldorf , 40225, Germany
Essen , 45147, Germany
Frankfurt , 60596, Germany
Goettingen , 37075, Germany
Hamburg , 20246, Germany
Hannover , 30449, Germany
Homburg-Saar , 66421, Germany
Mannheim , 68135, Germany
Muenster , 48149, Germany
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