drugset / Trial / NCT01930890
BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).
Timeline
- Start
- 2013-11
- Primary completion
- 2016-01
- Completion
- 2016-01
Outcome
Outcome not reported
Stopped: “Results from pre-specified criteria in study NCT01499355 (211LE201) did not demonstrate sufficient efficacy to warrant continuation of the study”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIIB023 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | BIIB023 | Monoclonal antibody | 20 mg/kg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 2 g | — |
| Background | Prednisone | Other / unclassified | 10 mg | Oral |