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

August 25, 2014 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
  • Belgium
      • Brussels, Belgium, 1070
      • Edegem, Belgium, 2650
      • Liege, Belgium, 4020
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3S9
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 4S8
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1Z4
    • Ontario
      • Concord, Ontario, Canada, L4K 5V2
      • Hamilton, Ontario, Canada, L8N 1V6
      • London, Ontario, Canada, N6K 1L6
      • Windsor, Ontario, Canada, N8W 5L7
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
      • Sainte-Foy, Quebec, Canada, G1V 4X7
  • Germany
      • Bochum, Germany, 44791
      • Dresden, Germany, 01307
      • Duesseldorf, Germany, 40225
      • Essen, Germany, 45147
      • Frankfurt, Germany, 60596
      • Goettingen, Germany, 37075
      • Hamburg, Germany, 20246
      • Hannover, Germany, 30449
      • Homburg-Saar, Germany, 66421
      • Mannheim, Germany, 68135
      • Muenster, Germany, 48149
  • United States
    • California
      • Irvine, California, United States, 92697
      • Santa Monica, California, United States, 90404
    • Nebraska
      • Omaha, Nebraska, United States, 68144
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
    • Texas
      • Dallas, Texas, United States, 75246
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Virginia
      • Norfolk, Virginia, United States, 23507
    • Washington
      • Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Course A1
Drug: alefacept
Intramuscular (IM)
Other Names:
  • Amevive
  • ASP0485
Placebo Comparator: Course A2
Drug: placebo
Intramuscular (IM)
Experimental: Course B
Open label extension
Drug: alefacept
Intramuscular (IM)
Other Names:
  • Amevive
  • ASP0485

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50
Time Frame: 14 Weeks
14 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients achieving a PASI score of ≥ 50 any time during study
Time Frame: Throughout study
Throughout study
Proportion of patients achieving a PASI score of ≥ 75
Time Frame: 14 Weeks
14 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

May 6, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2014

Last Update Submitted That Met QC Criteria

August 25, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-740

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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