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

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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

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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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

195

Study ID:

NCT00673556

Recruitment Status:

Completed

Sponsor:

Astellas Pharma Inc

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There are 34 Locations for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

195

Study ID:

NCT00673556

Recruitment Status:

Completed

Sponsor:


Astellas Pharma Inc

How clear is this clinincal trial information?

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