A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
NCT ID: NCT00673556
Last Updated: 2014-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
195 participants
INTERVENTIONAL
2003-10-31
2005-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Course A1
alefacept
Intramuscular (IM)
Course A2
placebo
Intramuscular (IM)
Course B
Open label extension
alefacept
Intramuscular (IM)
Interventions
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alefacept
Intramuscular (IM)
placebo
Intramuscular (IM)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use central contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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Irvine, California, United States
Santa Monica, California, United States
Omaha, Nebraska, United States
New Brunswick, New Jersey, United States
Winston-Salem, North Carolina, United States
Goodlettsville, Tennessee, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Vienna, , Austria
Brussels, , Belgium
Edegem, , Belgium
Liège, , Belgium
Edmonton, Alberta, Canada
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Concord, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
Bochum, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Essen, , Germany
Frankfurt, , Germany
Göttingen, , Germany
Hamburg, , Germany
Hanover, , Germany
Homburg-Saar, , Germany
Mannheim, , Germany
Münster, , Germany
Countries
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Other Identifiers
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C-740
Identifier Type: -
Identifier Source: org_study_id
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