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

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

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.

Study Overview

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

Detailed Description

See Brief Summary

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94118
      • UCSF Psoriasis and Skin Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Amevive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Either or Both Intralesional Response and Systemic Response	Target plaque assessment completed using local Physician's Global Assessment score (PGA). Systemic response measured by comparing Psoriasis Area and Severity Index score at week 22 compared to baseline. Correlation measured using Fisher's non parametric test of association.	22 weeks

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Bhutani T, Kamangar F, Zitelli K, Chiang C, Gattu S, Nguyen T, Becker E, Koo J. Intralesional injections of alefacept may predict systemic response to intramuscular alefacept: results from a pilot study. J Dermatolog Treat. 2013 Oct;24(5):348-50. doi: 10.3109/09546634.2012.672712. Epub 2012 Jun 5.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 13, 2008
• First Submitted That Met QC Criteria: May 14, 2008
• First Posted (Estimate): May 15, 2008

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Dermatologic Agents; Alefacept
• Other Study ID Numbers: KOO-AMEVIVE-2008; CHR-H5939-31199-01 (Other Identifier: UCSF Committee for Human Research)