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

Chronic Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674063
• Other study ID #: C-738
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2008
• Last updated: August 25, 2014
• Start date: July 2003
• Est. completion date: April 2004

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• alefacept
IV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Biogen

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of =75 compared to baseline		1 Week post treatment	No
Secondary	Proportion of subjects in each dosing regimen receiving a PASI score of =75 compared to baseline		1 Week post treatment	No

External Links

•   Link to Results on JAPIC - enter 140549 in the JapicCTI-RNo. field