Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

UCB

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: Epratuzumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00624351

SL0007

2007-002566-35 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive ANA result at visit 1
• Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met
• Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present
• If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.

Exclusion criteria

• Patients receiving any live vaccination within 2 weeks prior to visit 1 or during the course of the study
• Active severe SLE disease activity which involves the central nervous system (CNS) (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
• Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher World Health Organization (WHO) nephritis) or serum creatinine >2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria >3.5gm/day
• Patients with a history of anti-phospholipid antibody syndrome AND use of oral anticoagulants or anti-platelet treatment
• Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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227 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Phosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3.

Treatment:

Other: Placebo

EMAB 600mg

Experimental group

Description:

600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3.

Treatment:

Biological: Epratuzumab

EMAB 100mg

Experimental group

Description:

100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.

Treatment:

Biological: Epratuzumab

Other: Placebo

EMAB 400mg

Experimental group

Description:

400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.

Treatment:

Biological: Epratuzumab

Other: Placebo

EMAB 1200mg

Experimental group

Description:

1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.

Treatment:

Biological: Epratuzumab

Other: Placebo

EMAB 1800mg

Experimental group

Description:

1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.

Treatment:

Biological: Epratuzumab

Other: Placebo