Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects
This study is ongoing, but not recruiting participants.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01534403
First received: February 13, 2012
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Systemic Lupus Erythematosus |
Biological: Epratuzumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks) [ Time Frame: up to Week 100 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96 [ Time Frame: From Baseline (Week 0) to Week 96 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Epratuzumab plasma concentration at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
- Number of subjects reporting anti-Epratuzumab in plasma at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534403
Locations
| Japan | |
| 10 | |
| Fukuoka, Japan | |
| 11 | |
| Fukuoka, Japan | |
| 9 | |
| Fukuoka, Japan | |
| 3 | |
| Kitakyusyu, Japan | |
| 2 | |
| Tokyo, Japan | |
| 1 | |
| Tokyo, Japan | |
| 8 | |
| Tokyo, Japan | |
| 4 | |
| Tokyo, Japan | |
| 5 | |
| Tokyo, Japan | |
| 6 | |
| Tokyo, Japan | |
| 12 | |
| Urayasu, Japan | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT01534403 History of Changes |
| Other Study ID Numbers: | SL0027 |
| Study First Received: | February 13, 2012 |
| Last Updated: | May 2, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by UCB, Inc.:
|
Lupus Monoclonal antibody B-cell immunotherapy Epratuzumab |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013