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

NCT ID: NCT00655564

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-01-31

Brief Summary

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.

Detailed Description

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).

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alefacept

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.

Group Type: EXPERIMENTAL

Alefacept

Intervention Type: DRUG

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).

Interventions

Alefacept

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).

Intervention Type: DRUG

Other Intervention Names

Amevive®

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

32547 Contract number

Identifier Type: -

Identifier Source: secondary_id

IRB00004816

Identifier Type: -

Identifier Source: org_study_id