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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534403
• Other study ID #: SL0027
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2012
• Last updated: March 7, 2015
• Start date: January 2012
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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)

Locations

Country	Name	City	State
Japan	10	Fukuoka
Japan	11	Fukuoka
Japan	9	Fukuoka
Japan	3	Kitakyusyu
Japan	1	Tokyo
Japan	8	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks)		up to Week 100	No
Primary	Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96		From Baseline (Week 0) to Week 96	No
Secondary	Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96		From Baseline (Week 0) to Week 96	No
Secondary	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	No
Secondary	Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96		From Baseline (Week 0) to Week 96	No
Secondary	Epratuzumab plasma concentration at Week 96		Week 96	No
Secondary	Number of subjects reporting anti-Epratuzumab in plasma at Week 96		Week 96	No