Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo; Epratuzumab; Epratuzumab
Intervention description: Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles; 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles; 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
Intervention MeSH terms: Epratuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 791.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lupus; Monoclonal antibody; B-Cell immunotherapy; Epratuzumab

Summary:

      The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the
      treatment of subjects with Systemic Lupus Erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive antinuclear antibodies (ANA) at Screening (Visit 1)

          -  Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College
             of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met

          -  Active moderate to severe SLE activity as demonstrated by the British Isles Lupus
             Assessment Group Index (BILAG)

          -  Active moderate to severe SLE disease as demonstrated by SLE disease activity index
             (SLEDAI) total score

          -  On stable SLE treatment regimen, including mandatory corticosteroids and
             immunosuppressants or antimalarials

        Exclusion Criteria:

          -  Subjects who are breastfeeding, pregnant, or plan to become pregnant

          -  Subjects with active, severe SLE disease activity which involves the renal system

          -  Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric
             element scoring BILAG level A disease.

          -  Subjects with the evidence of an immunosuppressive state

          -  Subjects who, in the opinion of the investigator, are at a particularly high risk of
             significant infection

          -  History of malignant cancer, except the following treated cancers: cervical carcinoma
             in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.

          -  Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit
             1).

          -  Subjects with history of infections, including but not limited to concurrent acute or
             chronic viral hepatitis B or C

          -  Subjects with substance abuse or dependence or other relevant concurrent medical
             condition

          -  Subjects with history of thromboembolic events within 1 year of screening Visit.

          -  Subjects with significant hematologic abnormalities

          -  Subject has received treatment with other anti- B cell antibodies within 12 months
             prior to screening (visit 1)

          -  Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs
             (NSAIDs) within 12 weeks prior to screening (Visit 1)

          -  Subject has previously participated in this study or has previously received
             epratuzumab treatment.