A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque Psoriasis
NCT ID: NCT00674063
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
78 participants
INTERVENTIONAL
2003-07-31
2004-04-30
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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1
Dose regimen 1
alefacept
IV
2
Dose regimen 2
alefacept
IV
Interventions
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alefacept
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Chronic Plaque Psoriasis with Body Surface Area (BSA) involvement of ≥ 10%
* Candidate for phototherapy or systemic therapy for Psoriasis
* CD4 + T lymphocyte counts \> lower limit of normal
Exclusion Criteria
* ALT or AST value of ≥ 3x the upper limit of normal
* Other types of Psoriasis
* Serious infection within 3 months prior to 1st dose of study drug
* Antibody positive for HIV
* History of malignancy
* History of severe allergic or anaphylactic reactions
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease
18 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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Hot Springs, Arkansas, United States
Fridley, Minnesota, United States
Omaha, Nebraska, United States
East Windsor, New Jersey, United States
Stony Brook, New York, United States
Lake Oswego, Oregon, United States
Portland, Oregon, United States
Johnston, Rhode Island, United States
Goodlettsville, Tennessee, United States
Nashville, Tennessee, United States
Norfolk, Virginia, United States
Moncton, New Brunswick, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Waterloo, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Countries
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Other Identifiers
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C-738
Identifier Type: -
Identifier Source: org_study_id
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