Study of the Drug Efalizumab (Raptiva), for Adult Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Efalizumab
Intervention description: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: skin; psoriasis

Summary:

      Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is
      to study the action and the effects of Efalizumab, on psoriasis. This medication has been
      studied extensively and has been found to be effective and safe in the treatment of
      psoriasis. The eligible patient will have 10% of his/her body surface area involved with
      psoriasis vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

        Signed informed consent

          -  Plaque psoriasis covering >10% of total BSA

          -  Diagnosis of plaque psoriasis for at least 6 months

          -  PASI score >=12 (see Appendix A) or Linear PASI score of >= 8.0 at screening (see
             Appendix B)

          -  In the opinion of the investigator, candidate for systemic therapy for psoriasis:

               -  Who has not been previously treated (naive to systemic treatment) OR

               -  Who has had prior treatment with systemic therapy for psoriasis (e.g., PUVA,
                  cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate
                  mofetil (MMF), thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP,
                  etanercept)

          -  Body weight of <140 kg

          -  18 to 75 years old. As the risk of Efalizumab in childhood is unknown, those < 18years
             will be excluded from the study

          -  For women of childbearing potential or in men whose partners may become pregnant,
             willingness to use an acceptable method of contraception to prevent pregnancy for the
             duration of the study (while receiving study medication and 3 months following).
             Acceptable methods of contraception include use of a condom; abstinence; use by sexual
             partner of oral implantable or injectable contraceptives, IUD, female condom,
             diaphragm with spermicide, cervical cap; or a sterile sexual partner

          -  Willingness to hold sun exposure reasonably constant and to avoid use of tanning
             booths or other UV light sources during the study

        Exclusion Criteria

        Subjects who meet any of the following exclusion criteria are ineligible for study entry:

          -  Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis

          -  History of severe allergic or anaphylactic reactions to humanized monoclonal
             antibodies or fusion proteins that contain an Ig Fc region

          -  Clinically significant psoriasis flare during screening or on the first treatment day

          -  Treatment with efalizumab (anti-CD11a) within the last 12 months before enrollment

          -  Pregnancy or lactation. As the risk of Efalizumab in pregnancy is unknown, pregnant
             women will be excluded from the study

          -  History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial
             infection

          -  History of active tuberculosis (TB) or currently undergoing treatment for TB. PPD
             testing or chest X-ray is required for high-risk subjects (see Appendix D).

        Subjects with a positive PPD (not due to BCG vaccination) or chest X-ray will be excluded

          -  History of opportunistic infections (e.g., systemic fungal infections, parasites)

          -  Seropositivity for human immunodeficiency virus (HIV)

          -  Seropositivity for hepatitis B or C virus

          -  Hepatic enzymes >3 times the upper limits of normal (ULN)

          -  Diagnosis of hepatic cirrhosis, regardless of cause or severity

          -  WBC count <4000μL or >14,000/μL

          -  Serum creatinine >2 times the ULN

          -  Hospital admission for cardiac disease, stroke, or pulmonary disease within the last
             year

          -  Presence of malignancy within the past 5 years, including lymphoproliferative
             disorders. Subjects with a history of fully resolved basal cell or squamous cell skin
             cancer may be enrolled

          -  History of substance abuse within the last 5 years

          -  Any medical condition that, in the judgment of the investigator, would jeopardize the
             subject's safety following exposure to study drug Note: Certain medications and
             vaccines may not be used for specified periods of time prior to enrollment or at any
             time during the treatment period.