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

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: Epratuzumab

• Registration Number: NCT01534403
• Lead Sponsor: UCB Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-16
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-11
• Disposition First Submitted QC: 2016-04-11
• Last Update Submitted: 2016-04-11
• Disposition First Posted: 2016-05-06
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epratuzumab 4x600 mg every 12 weeks Group	Epratuzumab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Epratuzumab plasma concentration at Week 96	Week 96
Number of subjects reporting anti-Epratuzumab in plasma at Week 96	Week 96
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 total T Cells 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

Trial Locations

Locations (6)

11; 🇯🇵 Fukuoka, Japan

10; 🇯🇵 Fukuoka, Japan

9; 🇯🇵 Fukuoka, Japan

3; 🇯🇵 Kitakyusyu, Japan

1; 🇯🇵 Tokyo, Japan

8; 🇯🇵 Tokyo, Japan