A Study of Efalizumab in Participants With Moderate to Severe Chronic Psoriasis Who Have Failed, Have a Contraindication to, or Are Intolerant of Other Systemic Therapies
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Efalizumab - anti-CD11a recombinant human monoclonal antibody
Intervention description: Participants will receive efalizumab 1.0 milligram per kilogram (mg/kg) (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment [FT]). Depending on the response at Week 12, participants could receive additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Candidates for systemic therapy for psoriasis

Summary:

      This is a Phase IIIb/IV, open label, multicentre study of efalizumab (anti cluster of
      differentiation [CD] 11a recombinant human monoclonal antibody) in participants with moderate
      to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are
      intolerant to other systemic therapies including ciclosporin, methotrexate, and psoralen and
      ultraviolet A phototherapy (PUVA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe plaque psoriasis participants who have failed to respond to, or who
             have a contraindication to, or are intolerant to other systemic therapies including
             cyclosporine, methotrexate and PUVA

          -  Age at least 18 years

          -  For women of childbearing potential and for men whose partner can become pregnant, use
             of an acceptable method of contraception to prevent pregnancy and agreement to
             continue to practice an acceptable method of contraception for the duration of their
             participation in the study and up to 3 months after the last dose of efalizumab

          -  Have given written informed consent, prior to any study-related procedure not part of
             normal medical care, with the understanding that consent may be withdrawn by the
             participant at any time without prejudice to future medical care

          -  Discontinuation of any systemic psoriasis treatment prior to commencement of the study
             drug. No washout period is required for these agents prior to starting study and
             receiving first dose of study drug (efalizumab)

          -  Discontinuation of all biologic agents (other than efalizumab) 3 months prior to
             receiving first dose of study drug (efalizumab)

          -  Discontinuation of any investigational drug or treatment 3 months prior to Study Day 0
             or as per washout requirements from previous protocol

          -  No primary vaccinations (e.g., tetanus, booster, influenza vaccine) at least 14 days
             prior to first dose of study drug

          -  The participant must be willing and able to comply with the protocol requirements for
             the duration of the study

        Exclusion Criteria:

          -  Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis

          -  Participants who have previously been on efalizumab treatment who withdrew due to lack
             of efficacy or an adverse event. If withdrawal was due to another non-drug reason
             (vaccination, or infection) then the patient can be included in this study

          -  History of severe allergic or anaphylactic reactions to humanised monoclonal
             antibodies

          -  History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial
             infection

          -  History of opportunistic infections (eg, systemic fungal infections, parasites)

          -  Seropositivity for human immunodeficiency virus (HIV). Participants will undergo
             mandatory testing at screening. Participants who are positive for HIV will be excluded

          -  Pregnancy or breast feeding

          -  White Blood Cell (WBC) count less than (<) 4*10^9 per liter or greater than (>)
             14*10^9 per liter

          -  Participants with a history of clinically significant thrombocytopenia, bleeding
             disorders or a platelet count <100*10^9 per liter

          -  Seropositivity for hepatitis B or C virus. Participants will undergo testing at
             screening. Participants who are positive for hepatitis B antigen or hepatitis C
             antibody will be excluded

          -  History of active tuberculosis (TB) or currently undergoing treatment for TB within
             one year prior to Study Day 0. Chest X-ray (within 3 months prior to Study Day 0) is
             required for high-risk participants. Participants with a positive chest X-ray will be
             excluded

          -  Presence of malignancy within the past 5 years, including lymphoproliferative
             disorders. Participants with a history of fully resolved basal cell or squamous cell
             skin cancer may be enrolled

          -  Hospital admission for cardiac disease, stroke, or pulmonary disease within the last
             year

          -  Any medical condition that, in the judgment of the investigator, would jeopardize the
             participant's safety following exposure to study drug