Safety and Tolerability of Repeat Courses of IM Alefacept

August 21, 2023 updated by: Biogen

An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Repeat Courses of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Patients With Chronic Plaque Psoriasis

The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

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, A 1090
        • University of Vienna
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3S9
        • Western Canada Dermatology Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • Vancouver Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1Z4
        • Eastern Canada Cutaneous Research Associates
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1V6
        • Dermatrials Research
    • Quebec
      • Montreal, Quebec, Canada, H3A1A1
        • Royal Victoria Hospital
  • Denmark
      • Aarhus C, Denmark, DK-80000
        • Marselisborg Hospital
  • France
      • Creteil, France, 94010
        • CHU Henri Mondor
      • Nice, France, 6202
        • Hopital L'Archet II
      • Paris, France, 75475
        • Hospital Saint Louis, Université Paris VII
      • Pierre Benite, France, 69495
        • Hopital Lyon Sud
  • Germany
      • Berlin, Germany, 10117
        • Humboldt Universitätsklinikum Charité
      • Bochum, Germany, 44791
        • St. Josef-Hospital
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus
      • Düsseldorf, Germany, 40225
        • Heinrich-Heine-Universität
      • Frankfurt, Germany, 60590
        • J W Goethe Universität
      • Freiburg, Germany, 79104
        • Klinikum der Albert-Ludwig-Universität
      • Göttingen, Germany, 37075
        • Universitäts Kliniken
      • Hamburg, Germany, 20246
        • Universitätskrankenhaus Eppendorf
      • Homburg/Saar, Germany, 66421
        • Universitätskliniken des Saarlandes
      • Mannheim, Germany, 68167
        • Universität Mannhein
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • AMC University of Amsterdam
      • Nijmegen, Netherlands, 6500 HB
        • University Hospital Nijmegen - St. Radboud
  • Switzerland
      • Geneva, Switzerland, 1211
        • Hospital Cantonal
  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • St. John's Institute of Dermatology
      • Salford, United Kingdom, M6 8HD
        • Academic Dermatology
  • United States
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine
      • San Francisco, California, United States, 94118
        • University of California, San Francisco
      • Santa Monica, California, United States, 90404
        • Clinical Research Specialists, Inc.
    • Connecticut
      • Farmington, Connecticut, United States, 06430-6231
        • University of Connecticut Health Center
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Central Dermatology
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903-0019
        • University of Medicine and Dentistry Robert Wood Jonhson Medical School
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine
      • New York, New York, United States, 10029-6547
        • The Mount Sinai School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44106-5028
        • University Hospitals of Cleveland
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072-2301
        • Rivergate Dermatology
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Dermatology Research Center
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah School of Medicine
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research, Inc.
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates

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

Description

Inclusion Criteria:

  • Written informed consent.
  • At least 16 years of age.
  • Diagnosed with chronic plaque psoriasis and require systemic therapy.
  • CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).

Exclusion Criteria:

  • Unstable erthrodermic or pustular psoriasis.
  • Diagnosis of guttate psoriasis.
  • Serious local infection or systemic infection within 3 months prior to first dose of alefacept.
  • Positive for HIV antibody.
  • Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.
  • Evidence of active tuberculosis.
  • Current treatment for active tuberculosis or tuberculosis prophylaxis.
  • Female patients unwilling to practice effective contraception as defined by the investigator.
  • Female patients who are pregnant or breast-feeding.
  • Current enrollment in any other investigational drug study.
  • Previous participation in this study or previous alefacept studies.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time.

Secondary Outcome Measures

Outcome Measure
Patients who achieve a Physician Global Assessment (PGA) of "almost clear" or "clear" over time; the duration of the response to alefacept (the amount of time after alefacept treament before re-treatment with alefacept is necessary).

Collaborators and Investigators

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

Sponsor

Biogen

Investigators

  • Study Director: Barry Ticho, MD, Biogen
  • Principal Investigator: Kenneth Gordon, MD, Loyola University

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 (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 4, 2005

First Posted (Estimated)

October 6, 2005

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-733

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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