Safety and Tolerability of Repeat Courses of IM Alefacept

Chronic Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233662
• Other study ID #: C-733
• Status: Completed
• Phase: Phase 3
• Start date: December 1, 2002
• Est. completion date: December 1, 2005

Study information

• Verified date: August 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Alefacept

Locations

Country	Name	City	State
Austria	University of Vienna	Vienna
Canada	Western Canada Dermatology Institute	Edmonton	Alberta
Canada	Eastern Canada Cutaneous Research Associates	Halifax	Nova Scotia
Canada	Dermatrials Research	Hamilton	Ontario
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Vancouver Hospital	Vancouver	British Columbia
Denmark	Marselisborg Hospital	Aarhus C
France	CHU Henri Mondor	Creteil
France	Hopital L'Archet II	Nice
France	Hospital Saint Louis, Université Paris VII	Paris
France	Hopital Lyon Sud	Pierre Benite
Germany	Humboldt Universitätsklinikum Charité	Berlin
Germany	St. Josef-Hospital	Bochum
Germany	Universitätsklinikum Carl Gustav Carus	Dresden
Germany	Heinrich-Heine-Universität	Düsseldorf
Germany	J W Goethe Universität	Frankfurt
Germany	Klinikum der Albert-Ludwig-Universität	Freiburg
Germany	Universitäts Kliniken	Göttingen
Germany	Universitätskrankenhaus Eppendorf	Hamburg
Germany	Universitätskliniken des Saarlandes	Homburg/Saar
Germany	Universität Mannhein	Mannheim
Germany	Universitätsklinikum Münster	Münster
Netherlands	AMC University of Amsterdam	Amsterdam
Netherlands	University Hospital Nijmegen - St. Radboud	Nijmegen
Switzerland	Hospital Cantonal	Geneva
United Kingdom	St. John's Institute of Dermatology	London
United Kingdom	Academic Dermatology	Salford
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Baylor Dermatology Research Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Rivergate Dermatology	Goodlettsville	Tennessee
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of California, Irvine	Irvine	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Medicine and Dentistry Robert Wood Jonhson Medical School	New Brunswick	New Jersey
United States	New York University School of Medicine	New York	New York
United States	The Mount Sinai School of Medicine	New York	New York
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Central Dermatology	Saint Louis	Missouri
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	University of California, San Francisco	San Francisco	California
United States	Clinical Research Specialists, Inc.	Santa Monica	California
United States	Dermatology Associates	Seattle	Washington
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  France,  Germany,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).