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Safety and Tolerability of Repeat Courses of IM Alefacept

This study has been completed.
Information provided by:
Biogen Identifier:
First received: October 4, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
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.

Condition Intervention Phase
Chronic Plaque Psoriasis Drug: Alefacept Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Biogen:

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).

Estimated Enrollment: 400
Study Start Date: December 2002
Estimated Study Completion Date: June 2005

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00233662

  Show 46 Study Locations
Sponsors and Collaborators
Study Director: Barry Ticho, MD Biogen
Principal Investigator: Kenneth Gordon, MD Loyola University
  More Information Identifier: NCT00233662     History of Changes
Other Study ID Numbers: C-733
Study First Received: October 4, 2005
Last Updated: October 4, 2005

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents processed this record on August 17, 2017