Long-Term One Year Use of Alefacept (Amevive®) in Moderate to Severe Chronic Plaque Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Alefacept
Intervention 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).
Intervention MeSH terms: Alefacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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

        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.