We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00673556
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : August 26, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
To assess the efficacy and safety of Alefacept compared to placebo for the treatment of Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and inappropriate

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: alefacept Drug: placebo Phase 3

Detailed Description:
Patients who completed the initial 24-week treatment course (12 weeks of weekly dosing following b y 12 weeks of follow-up) and met the eligibility criteria continued in the 24-week open label extension

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study Examining the Efficacy and Safety of Weekly Intramuscular Administration of 15mg Alefacept Over 12 Weeks in a Population of Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
Study Start Date : October 2003
Primary Completion Date : May 2005
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Course A1 Drug: alefacept
Intramuscular (IM)
Other Names:
  • Amevive
  • ASP0485
Placebo Comparator: Course A2 Drug: placebo
Intramuscular (IM)
Experimental: Course B
Open label extension
Drug: alefacept
Intramuscular (IM)
Other Names:
  • Amevive
  • ASP0485

Primary Outcome Measures :
  1. Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50 [ Time Frame: 14 Weeks ]

Secondary Outcome Measures :
  1. Proportion of patients achieving a PASI score of ≥ 50 any time during study [ Time Frame: Throughout study ]
  2. Proportion of patients achieving a PASI score of ≥ 75 [ Time Frame: 14 Weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Diagnosis of Chronic Plaque Psoriasis involving ≥ 10% body surface area
  • Treatment history for Psoriasis in which 3 or more conventional anti-psoriatic therapies are inappropriate or ineffective
  • CD4+ T lymphocyte counts at or above the lower limit of normal

Exclusion Criteria:

  • Clinically significant abnormal hematology values or blood chemistry values
  • AST or ALT ≥ 3x the upper limit of normal
  • Other types of Psoriasis
  • Serious infection within the 3 months prior to the first dose of study drug
  • History of drug or alcohol abuse within the past 2 years
  • Antibody positive for HIV
  • History of malignancy
  • History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
  • Exposure to psoriasis-modifying phototherapy or high-potency topical corticosteroid therapy within 2 weeks prior to the first dose of study drug
  • Exposure to systemic anti-psoriatic therapy , topical immunomodulators or topical CNIs within 4 weeks prior to the first dose of study drug
  • Current treatment with any therapy for tuberculosis
  • Previous exposure to Alefacept
  • Nursing mothers, pregnant women, and women planning to become pregnant during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673556

  Hide Study Locations
United States, California
Irvine, California, United States, 92697
Santa Monica, California, United States, 90404
United States, Nebraska
Omaha, Nebraska, United States, 68144
United States, New Jersey
New Brunswick, New Jersey, United States, 08903
United States, North Carolina
Winston Salem, North Carolina, United States, 27157
United States, Tennessee
Goodlettsville, Tennessee, United States, 37072
United States, Texas
Dallas, Texas, United States, 75246
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Norfolk, Virginia, United States, 23507
United States, Washington
Seattle, Washington, United States, 98104
Vienna, Austria, 1090
Brussels, Belgium, 1070
Edegem, Belgium, 2650
Liege, Belgium, 4020
Canada, Alberta
Edmonton, Alberta, Canada, T5J 3S9
Canada, Newfoundland and Labrador
St. Johns, Newfoundland and Labrador, Canada, A1B 4S8
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Concord, Ontario, Canada, L4K 5V2
Hamilton, Ontario, Canada, L8N 1V6
London, Ontario, Canada, N6K 1L6
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Montreal, Quebec, Canada, H2K 4L5
Sainte-Foy, Quebec, Canada, G1V 4X7
Bochum, Germany, 44791
Dresden, Germany, 01307
Duesseldorf, Germany, 40225
Essen, Germany, 45147
Frankfurt, Germany, 60596
Goettingen, Germany, 37075
Hamburg, Germany, 20246
Hannover, Germany, 30449
Homburg-Saar, Germany, 66421
Mannheim, Germany, 68135
Muenster, Germany, 48149
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use central contact Astellas Pharma US, Inc.

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00673556     History of Changes
Other Study ID Numbers: C-740
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc:
Chronic Plaque Psoriasis

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents