Clinical trial NCT00673556: A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Keywords: Chronic Plaque Psoriasis
Alefacept
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Biogen
First posted: 2008-05-07
Enrollment: 195
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

Primary outcomes:
measure: Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50
timeFrame: 14 Weeks
Secondary outcomes:
measure: Proportion of patients achieving a PASI score of ≥ 50 any time during study
timeFrame: Throughout study
measure: Proportion of patients achieving a PASI score of ≥ 75
timeFrame: 14 Weeks
Other outcomes:
Locations:
city: Irvine
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Omaha
country: United States
state: Nebraska
city: New Brunswick
country: United States
state: New Jersey
city: Winston Salem
country: United States
state: North Carolina
city: Goodlettsville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Vienna
country: Austria
city: Brussels
country: Belgium
city: Edegem
country: Belgium
city: Liege
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: St. Johns
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Concord
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: Bochum
country: Germany
city: Dresden
country: Germany
city: Duesseldorf
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Goettingen
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Homburg-Saar
country: Germany
city: Mannheim
country: Germany
city: Muenster
country: Germany
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use central contact
role: STUDY_DIRECTOR
References: