Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects

UCB

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: Epratuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01534403

SL0027

Details and patient eligibility

About

The study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 [NCT01449071] phase I/II trial.

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has completed the double-blind study SL0026 [NCT01449071] or terminated prematurely at Week 8 or later in SL0026 [NCT01449071] due to lack of efficacy
• Women of childbearing potential must agree to use an acceptable method of birth control/Written Informed Consent

Exclusion criteria

• Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A
• Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
• Substance abuse or dependence
• Significant hematologic abnormalities
• 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Epratuzumab 4x600 mg every 12 weeks Group

Experimental group

Treatment:

Biological: Epratuzumab