drugset / Trial / NCT01499355
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.
Timeline
- Start
- 2012-07
- Primary completion
- 2015-12
- Completion
- 2015-12
Outcome
Outcome not reported
Stopped: “Results from pre-specified criteria 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 | 1 g | — |