Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus (EMBODY4)

UCB

Status and phase: Completed; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Epratuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01408576

SL0012

2010-020859-30 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

Full description

Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.

Enrollment: 1,250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
• Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
• Women of childbearing potential must agree to use an acceptable method of birth control

Exclusion criteria

• Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease
• Subjects with active, severe SLE disease activity which involves the renal system
• Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
• Substance abuse or dependence
• History of malignant cancer
• Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,250 participants in 2 patient groups

Epratuzumab 600 mg per week

Experimental group

Description:

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

Treatment:

Drug: Epratuzumab

Drug: Epratuzumab