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

August 25, 2014 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

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

  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1V6
      • London, Ontario, Canada, N6K 1L6
      • Waterloo, Ontario, Canada, N2J 1C4
      • Windsor, Ontario, Canada, N8W 5L7
    • Quebec
      • Montreal, Quebec, Canada, H3H 1V4
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • Minnesota
      • Fridley, Minnesota, United States, 55432
    • Nebraska
      • Omaha, Nebraska, United States, 68144
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
    • New York
      • Stony Brook, New York, United States, 11790
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
      • Portland, Oregon, United States, 97210
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
      • Nashville, Tennessee, United States, 37215
    • Virginia
      • Norfolk, Virginia, United States, 23507

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: 1
Dose regimen 1
Drug: alefacept
IV
Other Names:
  • Amevive
  • ASP0485
Experimental: 2
Dose regimen 2
Drug: alefacept
IV
Other Names:
  • Amevive
  • ASP0485

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baseline
Time Frame: 1 Week post treatment
1 Week post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects in each dosing regimen receiving a PASI score of ≥75 compared to baseline
Time Frame: 1 Week post treatment
1 Week post treatment

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

July 1, 2003

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2004

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-738

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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