Epratuzumab

A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (Embody 2)

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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 of >6
  • 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.