5082W-11: Mease UCB EMBODY 2

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE) (EMBODY 2)

Type of Study
Rheumatology - Systemic Lupus Erythematosis (SLE)
Short Description

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


Status
Open
Principal Investigator
Philip J. Mease, MD
Eligibility Notes

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.
Start Date
4/18/2014
Contact Name
Sephren Barrow
Phone
206-386-6248
Alternate Phone
206-386-3201
Email
Sephren.Barrow@swedish.org
Alternate Email
Allison.Everett@swedish.org