Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Winston-Salem, North Carolina 27157


Purpose:

The purpose of this research study is to see how well the medication Alefacept (Amevive®) works for continuous treatment of chronic plaque psoriasis. The US Food and Drug Administration (FDA) has approved Alefacept in an intermittent dosage schedule of 15 mg weekly injection for 12 weeks followed by 12 weeks off treatment.


Study summary:

To estimate the efficacy of continuous use of alefacept (15mg IM/week) in the treatment of moderate to severe chronic plaque type psoriasis as defined as Investigator Global Assessment (IGA) of 0 or 1 (clear or almost clear) or as a 75% reduction in Psoriasis Area and Severity Index (PASI).


Criteria:

Inclusion Criteria: - Must give written informed consent. - Subjects must be 18 years of age or older. - Subject must be adult males or non-pregnant, non-lactating females. - Female subjects of childbearing potential must state that they are using measures to avoid conception through active means including hormone replacement, intrauterine device, or abstinence. - Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of psoriasis or which would increase their health risk by study participation. - Subjects must be willing to receive an IM injection per protocol for 1 year. - Must require systemic therapy or phototherapy for their psoriasis, as determined by the investigator prior to Visit 1. Objectively this equates to Inclusion criteria of either: - IGA≥3 on a 0-5 scale and BSA≥10% - PASI ≥12 - Subjects may not be taking any other systemic therapies or receiving phototherapy during the duration of the study. Subjects are required a 4 week washout period from any systemic medication or phototherapy prior to enrolling in the study and starting treatment with alefacept. - There is no washout for topical corticosteroid medications. Stable dosing of topical corticosteroids may be used up until the first dosing visit. Exclusion Criteria: - 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. - Subjects have guttate, pustular, erythrodermic or rapidly flaring psoriasis. - Current enrollment in any research study. - 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. - Any subject who has a CD4<250 cells/µL at study entry. - Treatment with another investigational drug or approved therapy within 28 days prior to study drug administration. - Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mofetil or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration. - Phototherapy, including Ultraviolet B (UVB) and Psoralen + Ultraviolet A (PUVA), within 28 days prior to investigational drug administration. - Known HIV+, known viral Hepatitis infection, known tuberculosis infection. - History of systemic malignancy.


Study is Available At:


Original ID:

IRB00004816


NCT ID:

NCT00655564


Secondary ID:

32547 Contract number


Study Acronym:


Brief Title:

Long-Term One Year Use of Alefacept (Amevive®) in Moderate to Severe Chronic Plaque Type Psoriasis


Official Title:

Long-Term One Year Use of Alefacept (Amevive®) in Moderate to Severe Chronic Plaque Type Psoriasis


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wake Forest University Health Sciences


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Actual


Overall Contact Information

Official Name:Steven Feldman, MD
Principal Investigator
Wake Forest University

Study Dates

Start Date:May 2008
Completion Date:January 2010
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:August 2018
Last Changed Date:August 13, 2018
First Received Date:April 4, 2008
First Results Date:June 27, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Safety of Alefacept Using CD4 Counts
Time Frame:52 weeks
Safety Issues:False
Description:Number of participants experiencing CD4 cell counts below 250/uL
Outcome Type:Primary Outcome
Measure:Efficacy
Time Frame:52 weeks
Safety Issues:False
Description:Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52

Study Interventions

Intervention Type:Drug
Name:Alefacept
Description:Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks. Alefacept is supplied as a lyophilized powder. Alefacept contains LFA3-IgG1 Fusion Protein and excipient materials (citrate, glycine and sucrose).
Arm Name:Alefacept
Other Name:Amevive®

Study Arms

Study Arm Type:Experimental
Arm Name:Alefacept
Description:Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wake Forest University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.