Safety and Tolerability of Repeat Courses of IM Alefacept

NCT00233662 | Completed Phase 3

• 1 other identifier: C-733
• Study Type: interventional
• Target: 400
• Locations: 9 countries
• Sites: 46

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.

Conditions

Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Interventions

Alefacept DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (46)

University of California, Irvine

Irvine, California, 92697, United States

Location

University of California, San Francisco

San Francisco, California, 94118, United States

Location

Clinical Research Specialists, Inc.

Santa Monica, California, 90404, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06430-6231, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Central Dermatology

St Louis, Missouri, 63117, United States

Location

University of Medicine and Dentistry Robert Wood Jonhson Medical School

New Brunswick, New Jersey, 08903-0019, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

The Mount Sinai School of Medicine

New York, New York, 10029-6547, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106-5028, United States

Location

Rivergate Dermatology

Goodlettsville, Tennessee, 37072-2301, United States

Location

Baylor Dermatology Research Center

Dallas, Texas, 75246, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

Dermatology Associates

Seattle, Washington, 98101, United States

Location

University of Vienna

Vienna, A 1090, Austria

Location

Western Canada Dermatology Institute

Edmonton, Alberta, T5J 3S9, Canada

Location

Vancouver Hospital

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Eastern Canada Cutaneous Research Associates

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1V6, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A1A1, Canada

Location

Marselisborg Hospital

Aarhus C, DK-80000, Denmark

Location

CHU Henri Mondor

Créteil, 94010, France

Location

Hopital L'Archet II

Nice, 6202, France

Location

Hospital Saint Louis, Université Paris VII

Paris, 75475, France

Location

Hopital Lyon Sud

Pierre-Bénite, 69495, France

Location

Humboldt Universitätsklinikum Charité

Berlin, 10117, Germany

Location

St. Josef-Hospital

Bochum, 44791, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Heinrich-Heine-Universität

Düsseldorf, 40225, Germany

Location

J W Goethe Universität

Frankfurt, 60590, Germany

Location

Klinikum der Albert-Ludwig-Universität

Freiburg im Breisgau, 79104, Germany

Location

Universitäts Kliniken

Göttingen, 37075, Germany

Location

Universitätskrankenhaus Eppendorf

Hamburg, 20246, Germany

Location

Universitätskliniken des Saarlandes

Homburg/Saar, 66421, Germany

Location

Universität Mannhein

Mannheim, 68167, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

AMC University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

University Hospital Nijmegen - St. Radboud

Nijmegen, 6500 HB, Netherlands

Location

Hospital Cantonal

Geneva, 1211, Switzerland

Location

St. John's Institute of Dermatology

London, SE1 7EH, United Kingdom

Location

Academic Dermatology

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Interventions

Alefacept

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Study Officials

• Barry Ticho, MD

  Biogen

  STUDY DIRECTOR

• Kenneth Gordon, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 6, 2005
• Study Start: December 1, 2002
• Study Completion: December 1, 2005
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

CA (5); CH (1); NL (2); US (19); DE (11); FR (4); DK (1); AU (1); GB (2)