CClinicalTrials.gg
CompletedNCT00168753Updated Sep 8, 2014

Community Based Trial for AMEVIVE®

A Phase 4 interventional study of Alefacept in Moderate to Severe Chronic Plaque Psoriasis, sponsored by Astellas Pharma Inc. Completed at 36 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-08.

Sponsored by Astellas Pharma Inc · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
114
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Moderate to Severe Chronic Plaque Psoriasis

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Keywords

  • Extended dosing
  • alefacept
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 114 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
114 participants (actual)

Study arms

  • Experimental
    1

    Drug: Alefacept

Interventions

  • DrugAlefacept

    IM

    Also known as: Amevive, ASP0485

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 16 weeks, 20 weeks or 24 weeks

Secondary outcomes

  1. The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,

    Time frame: End of study

  2. The cumulative change in PQA score from screening visit to best PQA score at any time in the study,

    Time frame: End of study

  3. Association of the total number of doses received with the best efficacy reached, as assessed by PQA score, at any time during the study,

    Time frame: End of study

  4. 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,

    Time frame: End of study

  5. The cumulative change in SSA score from screening visit to best SSA score at any time in the study,

    Time frame: End of study

  6. 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

    Time frame: End of study

  7. Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively.

    Time frame: End of study

07

Study locations

36 sites
  • Monheit Dermatology Associates
    Birmingham, Alabama 35203, United States
  • Bayshore Dermatology
    Fairhope, Alabama 36532, United States
  • Jayne Fortson
    Anchorage, Alaska 99501, United States
  • Bakersfield Dermatology & Skin Cancer Medical Group
    Bakersfield, California 93301, United States
  • Integrated Research Group
    Riverside, California 92501, United States
  • Robert Greenberg
    San Ramon, California 94582, United States
  • Front Dermatology
    Denver, Colorado 80014, United States
  • Skin and Cancer Associates
    Tamarac, Florida 33309, United States
  • Michael Scannon
    Tampa, Florida 33602, United States
  • Atlanta Derm, Vein & Research Center
    Alpharetta, Georgia 30004, United States
  • Pearlridge Dermatology
    Aiea, Hawaii 96701, United States
  • Altman Dermatology Associates
    Arlington Heights, Illinois 60004, United States
  • Calumet Dermatology Associates
    Calumet City, Illinois 60477, United States
  • Michael Greenberg
    Elk Grove Village, Illinois 60007, United States
  • David J. Coynik
    Peru, Illinois 61354, United States
  • Melissa Knuckles
    Corbin, Kentucky 40701, United States
  • Richard Eisen
    Plymouth, Massachusetts 02360, United States
  • Psoriasis Treatment Center
    Grand Rapids, Michigan 49503, United States
  • Woodson Clinical Studies Group, Inc.
    Las Vegas, Nevada 89101, United States
  • Nashua Dermatology
    Nashua, New Hampshire 03060, United States
  • Jerry Bagel
    East Windsor, New Jersey 08512, United States
  • Catskill Dermatology
    Monticello, New York 12701, United States
  • Marina I Peredo
    Smithtown, New York 11787, United States
  • Buffalo Medical Group
    Williamsville, New York 14221, United States
  • Wilmington Health Associates Dermatology
    Wilmington, North Carolina 28401, United States
  • Robert Brodell
    Warren, Ohio 44481, United States
  • Dermatology & Laser Center of Roseberg
    Roseburg, Oregon 97470, United States
  • Dermatology Assoc of Plymouth Meeting
    Plymouth Meeting, Pennsylvania 19462, United States
  • Dermatology Associates of Knoxville
    Knoxville, Tennessee 37902, United States
  • Gold Skin Care
    Nashville, Tennessee 37201, United States
  • Bellaire Dermatology Associates
    Bellaire, Texas 77401, United States
  • Texas Dermatology Research
    Dallas, Texas 75201, United States
  • Mark Wallis
    Longview, Texas 75601, United States
  • Stephen Miller
    San Antonio, Texas 78201, United States
  • Stephen Flax
    Winchester, Virginia 22601, United States
  • Dermatology & Laser Center
    Bellingham, Washington 98225, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00168753
Lead sponsor
Astellas Pharma Inc
Collaborators
Biogen
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Jul 2004
Primary completion
Mar 2005
Completion
Mar 2005
Last update
Sep 8, 2014

Study contacts

Michael Gold
principal investigator · GoldSkin Care

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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