Alefacept in Subjects With Chronic Plaque Psoriasis Who Failed to Respond to Anti-TNF Therapy

This study has been terminated.
(Subjects declined enrollment; sponsor/PI elected to close study.)
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
John Murray, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00953329
First received: July 22, 2009
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

Study Status:

Duke University Health System Institutional Review Board has received notification of study termination; final IRB closure date is 12/12/2008. Study enrollment is now closed.

Enrollment Update:

Only one subject was entered into this study out of an expected enrollment of 15 patients in this single site clinical trial. With no recruitment interest, the financial sponsor and Sponsor-PI chose to close the clinical trial.


Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: alefacept
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Determine the Safety and Efficacy of Alefacept as Monotherapy in Subjects With Chronic Plaque Psoriasis Who Have Failed to Respond to Anti-TNF Therapy

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Treatment Alefacept [ Time Frame: 12 weeks (study terminated) ] [ Designated as safety issue: No ]
    Terminated study


Enrollment: 1
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alefacept 15 mg IM qweek
Alefacept will be given to subjects with plaque psoriasis who have failed treatment with Fnbrel.
Drug: alefacept
Alefacept 15 mg IM once a week were to be administered for 12 weeks, which is the FDA approved dosage, duration, and frequency. This study allowed an additional 8 doses if subject did not achieve a 'clear' response with the original 12 weeks of treatment. Each enrolled subject must have failed a response to anti-TNF therapy prior to entering this study.
Other Name: Amevive

Detailed Description:

This is an open-label study using alefacept in the treatment of patients with chronic plaque psoriasis who have not responded to treatment with an anti-TNF agent. Patients not responding to Enbrel® 50 mg weekly with a 75% reduction of Psoriasis Area and Severity Index (PASI) Score or a Physician Global Assessment (PGA) score of 'almost clear' or 'clear', will be treated with 15 mg alefacept intramuscularly (IM) once weekly for up to 20 weeks. Patients who have 'cleared' or 'almost cleared' at the end of 12 weeks of treatment with alefacept will have completed the 'standard treatment' phase of the study. Study subjects who have not responded to treatment during the initial 12 weeks will continue with alefacept therapy for an additional 8 weekly doses or until the subject has reached a PGA of 'almost clear' or 'clear'. Alefacept is FDA approved for this indication for 12 weeks of treatment and this clinical trial is extending the treatment window for up to 8 additional weeks. Because of this increased exposure to alefacept, all subjects will be carefully monitored while on treatment and followed post-treatment at 3, 4, 6, 9 and 12 months after the last dose of alefacept is given.

Purpose:

This open-label study will determine the safety and efficacy of Amevive® 15 mg IM weekly in subjects with chronic plaque psoriasis who have not sufficiently responded to etanercept, an anti-TNF agent. The plan also is to determine the length of response time to point of relapse and to determine the length of time before retreatment with alefacept is necessary.

Patient Population:

This study is for adult men and women, ages 18 to 80, with chronic plaque psoriasis. At the time of enrollment, the subject must have received 50 mg per week of Enbrel without achieving a response of 'almost clear' or 'clear' according to PGA or has not responded with a 75% reduction of PASI Score.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women between ages of 18 and 80 years
  • Subjects diagnosed with chronic plaque psoriasis who require systemic therapy.
  • Must be receiving anti-TNF treatment without achieving response of 'almost clear' or 'clear' according to PGA or has not responded with 75% reduction PASI score.
  • Must be willing to receive up to 20 weeks of IM injections weekly
  • CD4 counts must be above 250 cells/mm3 at screening

Exclusion Criteria:

  • Diagnosis of unstable erythroderma or pustular psoriasis or guttate psoriasis
  • Serious local infection or systemic infection 3 months prior to receiving study drug.
  • Subjects with CD4 lymphocyte count less than 250 cells/mm3 at study entry
  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: NCT00953329

Sponsors and Collaborators
John Murray
Astellas Pharma US, Inc.
Investigators
Principal Investigator: John C Murray, MD Duke University
  More Information

No publications provided

Responsible Party: John Murray, Professor of Dermatology, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00953329     History of Changes
Other Study ID Numbers: Pro00002474, Funding Agency # ER-07-001, IND # 100770
Study First Received: July 22, 2009
Results First Received: October 18, 2012
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 20, 2014