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

Primary Purpose

Systemic Lupus Erythematosus

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Epratuzumab

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus, Monoclonal antibody, B-cell immunotherapy, Epratuzumab

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epratuzumab 4x600 mg every 12 weeks Group

Arm Description

Outcomes

Primary Outcome Measures

Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks)

Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96

Secondary Outcome Measures

Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96

Change from Baseline in levels of NK-Cells (Natural Killer-Cells) in the peripheral blood circulation at Week 96

Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96

Epratuzumab plasma concentration at Week 96

Number of subjects reporting anti-Epratuzumab in plasma at Week 96

Full Information

NCT ID

NCT01534403

First Posted

February 13, 2012

Last Updated

April 11, 2016

Sponsor

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01534403

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCB Pharma

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

Lupus, Monoclonal antibody, B-cell immunotherapy, Epratuzumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epratuzumab 4x600 mg every 12 weeks Group

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Epratuzumab

Intervention Description

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)

Primary Outcome Measure Information:

Title

Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks)

Time Frame

up to Week 100

Title

Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96

Time Frame

From Baseline (Week 0) to Week 96

Secondary Outcome Measure Information:

Title

Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96

Time Frame

From Baseline (Week 0) to Week 96

Title

Change from Baseline in levels of NK-Cells (Natural Killer-Cells) in the peripheral blood circulation at Week 96

Time Frame

From Baseline (Week 0) to Week 96

Title

Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96

Time Frame

From Baseline (Week 0) to Week 96

Title

Epratuzumab plasma concentration at Week 96

Time Frame

Week 96

Title

Number of subjects reporting anti-Epratuzumab in plasma at Week 96

Time Frame

Week 96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

UCB Clinical Trial Call Center

Organizational Affiliation

+1 877 822 9493 (UCB)

Official's Role

Study Director

Facility Information:

Facility Name

City

Fukuoka

Country

Japan

Facility Name

City

Fukuoka

Country

Japan

Facility Name

City

Fukuoka

Country

Japan

Facility Name

City

Kitakyusyu

Country

Japan

Facility Name

City

Tokyo

Country

Japan

Facility Name

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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