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
  Purpose

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 Intervention Phase
Chronic Plaque Psoriasis
Drug: alefacept
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50 [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 195
Study Start Date: October 2003
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673556

  Show 34 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Biogen Idec
Investigators
Study Director: Use central contact Astellas Pharma US, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00673556     History of Changes
Other Study ID Numbers: C-740
Study First Received: May 6, 2008
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Austria: Federal Office for Safety in Health Care

Keywords provided by Astellas Pharma Inc:
Chronic Plaque Psoriasis
Alefacept

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014