Systemic Lupus Erythematosus
Conditions
Keywords
Lupus, Monoclonal antibody, B-cell immunotherapy, Epratuzumab
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.
Interventions
BIOLOGICALEpratuzumab
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)
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Monocyte in the peripheral blood circulation at Week 96 | From Baseline (Week 0) to Week 96 |
| Number of subjects reporting anti-Epratuzumab in plasma at Week 96 | Week 96 |
| Epratuzumab plasma concentration at Week 96 | 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 |
Countries
Japan
Outcome results
None listed