Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis

September 17, 2014 updated by: Astellas Pharma Inc

An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712

An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

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

  • Belgium
      • Brussels, Belgium, B-1070
      • Edegem, Belgium, B-2650
      • Liege, Belgium, 4000
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2S 3B3
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C ON2
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 4S8
    • Ontario
      • London, Ontario, Canada, N6A 3H7
      • Waterloo, Ontario, Canada, N2J 1C
      • Windsor, Ontario, Canada, N8W 5L7
    • Quebec
      • Sainte-Foy, Quebec, Canada, G1V 4X7
  • Denmark
      • Copenhagen, Denmark, DK-2400
  • France
      • Besancon, France, 25030
      • Brest, France, 29279
      • Nice, France, 06202
      • Paris, France, 75475
      • Tours, France, 37044
  • Germany
      • Bochum, Germany, 44791
      • Dresden, Germany, 01307
      • Munich, Germany, 80337
  • Netherlands
      • Amsterdam, Netherlands, 1100 DE
  • Spain
      • Madrid, Spain, 28006
      • Valencia, Spain, 46014
  • United Kingdom
      • Liverpool, United Kingdom, L14 3LB
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • California
      • Fresno, California, United States, 93710
      • La Jolla, California, United States, 92037
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Jacksonville, Florida, United States, 32204
      • Pinellas Park, Florida, United States, 33781
    • Georgia
      • Newnan, Georgia, United States, 30263
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Michigan
      • Clinton Township, Michigan, United States, 48038
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New Jersey
      • Berlin, New Jersey, United States, 08009
    • Oregon
      • Lake Oswego, Oregon, United States, 79035
      • Portland, Oregon, United States, 97210
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
    • Texas
      • Austin, Texas, United States, 78759
      • San Antonio, Texas, United States, 78229

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:

  • Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR,
  • Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728

Exclusion Criteria:

  • Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study
  • Clinically significant abnormal hematology values or history of an immunosuppressive disorder
  • Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
  • A significant change in the subject's medical history from their previous alefacept study
  • Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717
  • Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed)

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Alefacept
intramuscular injection (IM)
Other Names:
  • Amevive
  • ASP0485

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring
Time Frame: Throughout treatment course
Throughout treatment course

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment
Time Frame: Every 2 weeks throughout treamtent course
Every 2 weeks throughout treamtent course

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Collaborators

Biogen

Investigators

  • Study Director: Central Contact, Astellas Pharma US, Inc.

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.

General Publications

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

December 1, 2001

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-728

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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