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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:9/13/2018
Start Date:May 2008
End Date:January 2010

Use our guide to learn which trials are right for you!

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.

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).

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.
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials