Community Based Trial for AMEVIVE®

An Open-Label Community-Based Study to Determine the Safety and Efficacy of an Extended Course of Alefacept, Following a Standard 12-Week Course of Amevive®, With Commonly Used Clinical Assessment Tools

To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Chronic Plaque Psoriasis
• Intervention / Treatment: Drug: Alefacept

Detailed Description

Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response.

Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM. Determination of number of doses will be based on physician qualitative assessment at weeks 4 and 8.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35203
      • Monheit Dermatology Associates
    • Fairhope, Alabama, United States, 36532
      • Bayshore Dermatology
  • Alaska
    • Anchorage, Alaska, United States, 99501
      • Jayne Fortson
  • California
    • Bakersfield, California, United States, 93301
      • Bakersfield Dermatology & Skin Cancer Medical Group
    • Riverside, California, United States, 92501
      • Integrated Research Group
    • San Ramon, California, United States, 94582
      • Robert Greenberg
  • Colorado
    • Denver, Colorado, United States, 80014
      • Front Dermatology
  • Florida
    • Tamarac, Florida, United States, 33309
      • Skin and Cancer Associates
    • Tampa, Florida, United States, 33602
      • Michael Scannon
  • Georgia
    • Alpharetta, Georgia, United States, 30004
      • Atlanta Derm, Vein & Research Center
  • Hawaii
    • Aiea, Hawaii, United States, 96701
      • Pearlridge Dermatology
  • Illinois
    • Arlington Heights, Illinois, United States, 60004
      • Altman Dermatology Associates
    • Calumet City, Illinois, United States, 60477
      • Calumet Dermatology Associates
    • Elk Grove Village, Illinois, United States, 60007
      • Michael Greenberg
    • Peru, Illinois, United States, 61354
      • David J. Coynik
  • Kentucky
    • Corbin, Kentucky, United States, 40701
      • Melissa Knuckles
  • Massachusetts
    • Plymouth, Massachusetts, United States, 02360
      • Richard Eisen
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Psoriasis Treatment Center
  • Nevada
    • Las Vegas, Nevada, United States, 89101
      • Woodson Clinical Studies Group, Inc.
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Nashua Dermatology
  • New Jersey
    • East Windsor, New Jersey, United States, 08512
      • Jerry Bagel
  • New York
    • Monticello, New York, United States, 12701
      • Catskill Dermatology
    • Smithtown, New York, United States, 11787
      • Marina I Peredo
    • Williamsville, New York, United States, 14221
      • Buffalo Medical Group
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Wilmington Health Associates Dermatology
  • Ohio
    • Warren, Ohio, United States, 44481
      • Robert Brodell
  • Oregon
    • Roseburg, Oregon, United States, 97470
      • Dermatology & Laser Center of Roseberg
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Dermatology Assoc of Plymouth Meeting
  • Tennessee
    • Knoxville, Tennessee, United States, 37902
      • Dermatology Associates of Knoxville
    • Nashville, Tennessee, United States, 37201
      • Gold Skin Care
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates
    • Dallas, Texas, United States, 75201
      • Texas Dermatology Research
    • Longview, Texas, United States, 75601
      • Mark Wallis
    • San Antonio, Texas, United States, 78201
      • Stephen Miller
  • Virginia
    • Winchester, Virginia, United States, 22601
      • Stephen Flax
  • Washington
    • Bellingham, Washington, United States, 98225
      • Dermatology & Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Must give written informed consent.
2. Must have had moderate, moderately severe or severe chronic plaque psoriasis as determined by the investigator prior to initial treatment (baseline) with AMEVIVE.
3. Must be 18 years of age or older.
4. Must have completed a standard 12-week course of AMEVIVE and have received at least 10 doses.
5. Response to current AMEVIVE therapy must be less than a desired response as determined by the physician, and subject and some residual psoriasis must be present.

Exclusion Criteria:

1. Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or not willing to practice effective contraception during the study.
2. Nursing mothers, pregnant women, and women planning to become pregnant
3. Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
4. Treatment with another investigational drug, or approved therapy for investigational use, within 3 months of investigational drug administration.
5. Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mycophenolate mofetil or other systemic immunosuppressant agents within 4 weeks of investigational drug administration.
6. Treatment with Ultraviolet B (UVB) phototherapy or Psoralen + Ultraviolet A (PUVA), within 4 weeks of investigational drug administration.
7. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
8. History of >3 cutaneous squamous cell carcinomas or any systemic malignancy.
9. Skin lesions suspicious for malignancy.
10. Known HIV, viral hepatitis, or tuberculosis infection.
11. History of severe allergic or anaphylactic reactions.
12. ALT or AST greater than three times the upper limit of normal.
13. Significantly abnormal hematology (hemoglobin, hematocrit, platelets, white blood cells), as determined by the investigator.
14. CD4+ T lymphocyte count at screening visit less than 250 cells/mm3.
15. Known hypersensitivity to AMEVIVE or any of its components.
16. Subject's inability to comply with study requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Alefacept; IM; Other Names: Amevive; ASP0485

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE.	16 weeks, 20 weeks or 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,	End of study
The cumulative change in PQA score from screening visit to best PQA score at any time in the study,	End of study
Association of the total number of doses received with the best efficacy reached, as assessed by PQA score, at any time during the study,	End of study
Time to re-treatment for subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,	End of study
The cumulative change in SSA score from screening visit to best SSA score at any time in the study,	End of study
Association of the total number of doses received with the best efficacy reached, as assessed by SSA score, at any time during the study, and	End of study
Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively.	End of study

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Biogen
• Investigators: Principal Investigator: Michael Gold, GoldSkin Care

Publications and helpful links

Helpful Links

• Link to Results on JAPIC - enter 140573 in the JapicCTI-RNo. field

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): March 1, 2005
• Study Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: September 5, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Extended dosing; alefacept
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Dermatologic Agents; Alefacept
• Other Study ID Numbers: IST-US-064-04-AME; CBT/IST 64