Clinical trial NCT00674063: 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
Official title: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Weekly Intravenous Administration of 7.5mg and 0.075mg/kg Alefacept in Subjects Weighing Between 100kg and 150kg, With Moderate to Severe Chronic Plaque Psoriasis
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: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis


Eligibility criteria: Inclusion Criteria:

* Body weight between 100kg and 150kg
* 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:

* Clinically significant abnormal hematology values or blood chemistry values
* 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

Primary outcomes:
measure: Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baseline
timeFrame: 1 Week post treatment
Secondary outcomes:
measure: Proportion of subjects in each dosing regimen receiving a PASI score of ≥75 compared to baseline
timeFrame: 1 Week post treatment
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Fridley
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: East Windsor
country: United States
state: New Jersey
city: Stony Brook
country: United States
state: New York
city: Lake Oswego
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Johnston
country: United States
state: Rhode Island
city: Goodlettsville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
city: Moncton
country: Canada
state: New Brunswick
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use central contact
role: STUDY_DIRECTOR
References: