Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (EMBODY1)

UCB

Status and phase: Completed; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Placebo; Drug: Epratuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01262365

SL0009

2010-018563-41 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 793 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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793 participants in 3 patient groups, including a placebo group

Placebo (Weekly infusion)

Placebo Comparator group

Description:

Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles

Treatment:

Drug: Placebo

Epratuzumab 600 mg per week

Experimental group

Description:

600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

Treatment:

Drug: Epratuzumab

Drug: Epratuzumab

Epratuzumab 1200 mg every other week

Experimental group

Description:

1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles

Treatment:

Drug: Epratuzumab

Drug: Placebo

Drug: Epratuzumab