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Safety and Tolerability of Repeat Courses of IM Alefacept

Primary Purpose

Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alefacept
Sponsored by
Biogen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plaque Psoriasis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Irvine
  • University of California, San Francisco
  • Clinical Research Specialists, Inc.
  • University of Connecticut Health Center
  • Loyola University Medical Center
  • Massachusetts General Hospital
  • Central Dermatology
  • University of Medicine and Dentistry Robert Wood Jonhson Medical School
  • New York University School of Medicine
  • The Mount Sinai School of Medicine
  • Duke University Medical Center
  • Wake Forest University School of Medicine
  • University Hospitals of Cleveland
  • Rivergate Dermatology
  • Baylor Dermatology Research Center
  • MD Anderson Cancer Center
  • University of Utah School of Medicine
  • Virginia Clinical Research, Inc.
  • Dermatology Associates
  • University of Vienna
  • Western Canada Dermatology Institute
  • Vancouver Hospital
  • Eastern Canada Cutaneous Research Associates
  • Dermatrials Research
  • Royal Victoria Hospital
  • Marselisborg Hospital
  • CHU Henri Mondor
  • Hopital L'Archet II
  • Hospital Saint Louis, Université Paris VII
  • Hopital Lyon Sud
  • Humboldt Universitätsklinikum Charité
  • St. Josef-Hospital
  • Universitätsklinikum Carl Gustav Carus
  • Heinrich-Heine-Universität
  • J W Goethe Universität
  • Klinikum der Albert-Ludwig-Universität
  • Universitäts Kliniken
  • Universitätskrankenhaus Eppendorf
  • Universitätskliniken des Saarlandes
  • Universität Mannhein
  • Universitätsklinikum Münster
  • AMC University of Amsterdam
  • University Hospital Nijmegen - St. Radboud
  • Hospital Cantonal
  • St. John's Institute of Dermatology
  • Academic Dermatology

Outcomes

Primary Outcome Measures

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

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).

Full Information

First Posted
October 4, 2005
Last Updated
August 21, 2023
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00233662
Brief Title
Safety and Tolerability of Repeat Courses of IM Alefacept
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2002 (Actual)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alefacept
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Ticho, MD
Organizational Affiliation
Biogen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kenneth Gordon, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Clinical Research Specialists, Inc.
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06430-6231
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Central Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
University of Medicine and Dentistry Robert Wood Jonhson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903-0019
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029-6547
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5028
Country
United States
Facility Name
Rivergate Dermatology
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072-2301
Country
United States
Facility Name
Baylor Dermatology Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Dermatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Vienna
City
Vienna
ZIP/Postal Code
A 1090
Country
Austria
Facility Name
Western Canada Dermatology Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3S9
Country
Canada
Facility Name
Vancouver Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Eastern Canada Cutaneous Research Associates
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1Z4
Country
Canada
Facility Name
Dermatrials Research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A1A1
Country
Canada
Facility Name
Marselisborg Hospital
City
Aarhus C
ZIP/Postal Code
DK-80000
Country
Denmark
Facility Name
CHU Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital L'Archet II
City
Nice
ZIP/Postal Code
6202
Country
France
Facility Name
Hospital Saint Louis, Université Paris VII
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Humboldt Universitätsklinikum Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
St. Josef-Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Heinrich-Heine-Universität
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
J W Goethe Universität
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinikum der Albert-Ludwig-Universität
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Facility Name
Universitäts Kliniken
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitätskrankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätskliniken des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universität Mannhein
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
AMC University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
University Hospital Nijmegen - St. Radboud
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Hospital Cantonal
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
St. John's Institute of Dermatology
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Academic Dermatology
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

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Safety and Tolerability of Repeat Courses of IM Alefacept

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