A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: efalizumab; placebo
Intervention description: All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).; All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Raptiva; Moderate plaque psoriasis; Severe plaque psoriasis; Scalp

Summary:

      This was a Phase IV randomized, double-blind, placebo-controlled study designed to evaluate
      the safety and efficacy of subcutaneous efalizumab in adult patients (18 years of age and
      older) with chronic moderate to severe plaque psoriasis with involvement of the scalp who had
      no previous exposure to efalizumab. The study consisted of a screening period, a double-blind
      treatment period, an open-label treatment period, and an observation/follow-up period. The
      study enrolled 100 patients. 11 patients were excluded from all analyses because of data
      issues.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent and Health Insurance Portability and Accountability
             Act of 1996 (HIPAA) documents

          -  Be aged 18 years or older

          -  Have chronic (6 months or greater) moderate to severe plaque psoriasis with
             involvement of the scalp

          -  Have a whole body Physician's Global Assessment (PGA) rating of moderate (3) or severe
             (4) for psoriasis

          -  Have a scalp surface area affected by plaque psoriasis of 30% or more, assessed using
             Psoriasis Scalp Severity Index (PSSI)

          -  Have at least one of three clinical signs involving the scalp (erythema, induration,
             and desquamation) be rated as at least moderate (2) with the other two rated as at
             least slight (1) using PSSI

          -  Be a candidate for systemic therapy in the opinion of the investigator

          -  Be naive to efalizumab treatment

          -  For women of childbearing potential, must be willing to use a method of contraception
             acceptable to the investigator to prevent pregnancy and agree to continue to practice
             an acceptable method of contraception for the duration of their participation in the
             study and for 6 weeks after the last dose of efalizumab

        Exclusion Criteria:

          -  Have had previous exposure to efalizumab or a history of hypersensitivity to any of
             its components

          -  Are using any excluded therapy

          -  Have a history of drug or alcohol abuse in the past five years

          -  Have a history in the past 5 years of a serious infection or currently have an ongoing
             uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection

          -  Have any history of opportunistic infections (e.g., systemic fungal infections,
             parasites)

          -  Are seropositive for hepatitis B antigen, hepatitis C antibody, or human
             immunodeficiency virus (HIV)

          -  Have a history of active tuberculosis or are currently undergoing treatment for
             tuberculosis, including latent tuberculosis with isoniazid

          -  Have the presence or history of malignancy within the past 5 years, including
             lymphoproliferative disorders

          -  Are pregnant or breastfeeding

          -  Have a diagnosis of hepatic cirrhosis, regardless of cause or severity

          -  Have a history in the last 5 years of thrombocytopenia

          -  Have a history in the last 5 years of hemolytic anemia or any other clinically
             significant anemia

          -  Have been exposed to any experimental and/or unapproved drugs or treatments within 30
             days or 5 half-lives, whichever is longer, before the screening visit

          -  Have been vaccinated with a live virus or live bacteria within the 14 days before the
             first dose of efalizumab

          -  Have any medical condition that, in the judgment of the investigator, would jeopardize
             the patient's safety following exposure to study drug (efalizumab or placebo
             equivalent) or would significantly interfere with the patient's ability to comply with
             the provisions of this protocol