A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study Examining the Efficacy and Safety of Weekly Intramuscular Administration of 15mg Alefacept Over 12 Weeks in a Population of Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
1 other identifier
interventional
195
5 countries
34
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2003
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 6, 2008
CompletedFirst Posted
Study publicly available on registry
May 7, 2008
CompletedAugust 26, 2014
August 1, 2014
1.6 years
May 6, 2008
August 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50
14 Weeks
Secondary Outcomes (2)
Proportion of patients achieving a PASI score of ≥ 50 any time during study
Throughout study
Proportion of patients achieving a PASI score of ≥ 75
14 Weeks
Study Arms (3)
Course A1
EXPERIMENTALCourse A2
PLACEBO COMPARATORCourse B
EXPERIMENTALOpen label extension
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Biogencollaborator
Study Sites (34)
Unknown Facility
Irvine, California, 92697, United States
Unknown Facility
Santa Monica, California, 90404, United States
Unknown Facility
Omaha, Nebraska, 68144, United States
Unknown Facility
New Brunswick, New Jersey, 08903, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Goodlettsville, Tennessee, 37072, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Seattle, Washington, 98104, United States
Unknown Facility
Vienna, 1090, Austria
Unknown Facility
Brussels, 1070, Belgium
Unknown Facility
Edegem, 2650, Belgium
Unknown Facility
Liège, 4020, Belgium
Unknown Facility
Edmonton, Alberta, T5J 3S9, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1B 4S8, Canada
Unknown Facility
Halifax, Nova Scotia, B3H 1Z4, Canada
Unknown Facility
Concord, Ontario, L4K 5V2, Canada
Unknown Facility
Hamilton, Ontario, L8N 1V6, Canada
Unknown Facility
London, Ontario, N6K 1L6, Canada
Unknown Facility
Windsor, Ontario, N8W 5L7, Canada
Unknown Facility
Montreal, Quebec, H2K 4L5, Canada
Unknown Facility
Sainte-Foy, Quebec, G1V 4X7, Canada
Unknown Facility
Bochum, 44791, Germany
Unknown Facility
Dresden, 01307, Germany
Unknown Facility
Düsseldorf, 40225, Germany
Unknown Facility
Essen, 45147, Germany
Unknown Facility
Frankfurt, 60596, Germany
Unknown Facility
Göttingen, 37075, Germany
Unknown Facility
Hamburg, 20246, Germany
Unknown Facility
Hanover, 30449, Germany
Unknown Facility
Homburg-Saar, 66421, Germany
Unknown Facility
Mannheim, 68135, Germany
Unknown Facility
Münster, 48149, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use central contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2008
First Posted
May 7, 2008
Study Start
October 1, 2003
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
August 26, 2014
Record last verified: 2014-08