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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00673556
First received: May 6, 2008
Last updated: August 25, 2014
Last verified: August 2014

May 6, 2008
August 25, 2014
October 2003
May 2005   (final data collection date for primary outcome measure)
Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50 [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00673556 on ClinicalTrials.gov Archive Site
  • Proportion of patients achieving a PASI score of ≥ 50 any time during study [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Proportion of patients achieving a PASI score of ≥ 75 [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
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

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Plaque Psoriasis
  • Drug: alefacept
    Intramuscular (IM)
    Other Names:
    • Amevive
    • ASP0485
  • Drug: placebo
    Intramuscular (IM)
  • Experimental: Course A1
    Intervention: Drug: alefacept
  • Placebo Comparator: Course A2
    Intervention: Drug: placebo
  • Experimental: Course B
    Open label extension
    Intervention: Drug: alefacept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
May 2005
May 2005   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   Germany
 
NCT00673556
C-740
No
Astellas Pharma Inc
Astellas Pharma Inc
Biogen Idec
Study Director: Use central contact Astellas Pharma US, Inc.
Astellas Pharma Inc
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP