Open Label Study of Alefacept Injections to Patients With Moderate to Severe Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Koo, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00678470
First received: May 13, 2008
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in this 6 month study to evaluate whether the response to intralesional alefacept injections prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes in psoriasis patients. One lesion with a psoriasis severity assessment score greater than 3 and an induration score greater than 1 will be identified on each patient. Each lesion will receive only one intralesional alefacept injection during the first three weeks of the study (1 lesion per week). Following a 2 week observation period, subjects will undergo a standard 12 week course of weekly intramuscular alefacept injections. The Psoriasis Area Severity Index (PASI) score will be used to determine the effectiveness of the intramuscular alefacept treatments. An 8 week follow-up period will begin after the last dose of alefacept is administered where safety and efficacy measures will continue to be monitored as outlined in the study procedures. The hypothesis is that the response to intralesional alefacept injections, whether it is positive or no benefit, will predict the clinical response to intramuscular alefacept administration.


Condition Intervention
Moderate to Severe Psoriasis
Drug: Intralesional Alefacept

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Open Label Study to Explore if Response to Intralesional Alefacept Injections Prior to the Standard Course of Intramuscular Treatment Can Predict Clinical Outcomes in Patients With Moderate to Severe Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • To Evaluate the Effectiveness of Intralesional Alefacept Administration as Defined by the Psoriasis Severity Assessment Score Followed by the Evaluation of the Effectiveness of Intramuscular Alefacept Administration. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of Patients Who Were Both Intralesional and Intramuscular Responders. [ Time Frame: 12 weeks after intramuscular injection of alefacept. ] [ Designated as safety issue: No ]
    Patients were first injected with alefacept into a single "target" plaque. Those who had improvement in the plaque from baseline were deemed "intralesional responders". All the patients then were injected with alefacept intramuscularly. The patients who had a 70% or greater improvement in their psoriasis severity score (includes assessment of entire body) were systemic responders to alefacept. The number of patients who were both intralesional and systemic responders was measured.


Enrollment: 18
Study Start Date: September 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Investigational intervention without random assignment
Drug: Intralesional Alefacept
Patients enrolled in this study will receive intralesional alefacept injections to a single psoriatic plaque at week 0. After a two week observation period, patients will receive 15 mg intramuscular alefacept for 12 weeks.
Other Name: Amevive

Detailed Description:

See Brief Summary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects are nonimmunocompromised males or females 18 years of age or older
  2. Subjects have moderate to severe plaque-type psoriasis.
  3. Subjects have a Body Surface Area (BSA) involvement of greater than 5%.
  4. Subjects have a Psoriasis Area and Severity Index (PASI) greater than 10.
  5. Subjects have three psoriatic lesions with psoriasis severity score greater than or equal to 6 and an induration score greater than or equal to 2.
  6. Subjects' target lesions are greater than 2 cm2 preferably on similar anatomical regions.
  7. Subjects are eligible for systemic therapy, particularly alefacept, in the opinion of the investigator.
  8. Before any study-specific procedure, subject must sign/date the appropriate written informed consent, HIPAA authorization, and a photography consent form.
  9. Negative urine pregnancy test within 7 days before the first dose of alefacept in all women (except those surgically sterile or at least 1 years postmenopausal)
  10. Subjects must be in general good health with no other skin disease, state of physical condition which would impair evaluation of psoriasis or which would increase their health risk by study participation.
  11. Subject agrees to comply with protocol requirements, attend all regularly study visits and is considered to be a good study subject.
  12. Subject meets concomitant medication washout requirements.

Exclusion Criteria:

  1. Subjects with erythrodermic, pustular, or guttate psoriasis.
  2. Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
  3. Subject has a known sensitivity to any component of the study medications.
  4. Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits.
  5. Subjects whose CD4+ T-lymphocyte count at study entry is less than the lower limit of normal per reference laboratory.
  6. History of immune compromised status [e.g. human immunodeficiency virus (HIV) positive status or other immune suppressing drug] or a congenital or acquired immunodeficiency.
  7. Subject has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk.
  8. Subject has a history of or ongoing drug or alcohol abuse.
  9. Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
  10. Subject plans to receive any live vaccines during the study.
  11. Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to Week 0.
  12. Subjects that cannot commit to all the assessments required by the protocol.
  13. Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
  14. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for study participation.
  15. Subjects that cannot or do not wish to comply with the protocol
  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: NCT00678470

Locations
United States, California
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: John Koo, MD UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco
  More Information

Publications:
Responsible Party: John Koo, Principle Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00678470     History of Changes
Other Study ID Numbers: KOO-AMEVIVE-2008, CHR-H5939-31199-01
Study First Received: May 13, 2008
Results First Received: November 20, 2012
Last Updated: February 19, 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 September 22, 2014