Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Epratuzumab

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 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.