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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Biological: Epratuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epratuzumab 4x600 mg every 12 weeks Group<br> | Biological: Epratuzumab<br>* Epratuzumab 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, 39, 48, 49, 50, 51, 60, 61, 62, 63, 72, 73, 74, 75, 84, 85, 86, and 87)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks) |  | up to Week 100 | 
| Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96 |  | From Baseline (Week 0) to Week 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96 |  | From Baseline (Week 0) to Week 96 | 
| Change from Baseline in levels of NK-Cells (Natural Killer-Cells) in the peripheral blood circulation at Week 96 |  | From Baseline (Week 0) to Week 96 | 
| Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96 |  | From Baseline (Week 0) to Week 96 | 
| Epratuzumab plasma concentration at Week 96 |  | Week 96 | 
| Number of subjects reporting anti-Epratuzumab in plasma at Week 96 |  | Week 96 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus, Monoclonal antibody, B-cell immunotherapy, Epratuzumab