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

Sponsor

UCB Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01534403

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Biological: Epratuzumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epratuzumab 4x600 mg every 12 weeks Group	Biological: Epratuzumab 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)

Arm

Intervention/Treatment

Experimental: Epratuzumab 4x600 mg every 12 weeks Group

Biological: Epratuzumab

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)

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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