A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate

Chronic Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673556
• Other study ID #: C-740
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2008
• Last updated: August 25, 2014
• Start date: October 2003
• Est. completion date: May 2005

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 CanadaGermany: Federal Institute for Drugs and Medical DevicesBelgium: Federal Agency for Medicinal Products and Health ProductsAustria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

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
Intramuscular (IM)
• placebo
Intramuscular (IM)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Biogen

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of = 50		14 Weeks	No
Secondary	Proportion of patients achieving a PASI score of = 50 any time during study		Throughout study	No
Secondary	Proportion of patients achieving a PASI score of = 75		14 Weeks	No

External Links

•   Link to Results on JAPIC - enter 140550 in the JapicCTI-RNo. field