drugset / Trial / NCT04154787
Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy
RandomizedParallel-groupOpen-labelTreatment
Summary
This was a randomized, open-label, two arm, parallel group, proof-of-concept, nonconfirmatory study evaluating the efficacy and safety of LNP023 compared with rituximab in subjects with Idiopathic (primary) membranous nephropathy (iMN) who are at high risk of disease progression defined on the basis of anti- Phospholipase A2 Receptor (PLA2R) antibody titer ≥ 60 RU/mL and proteinuria with urine protein (UP) ≥ 3.5 g/24h.
Timeline
- Start
- 2019-11-23
- Primary completion
- 2023-01-20
- Completion
- 2023-01-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iptacopan | Small molecule | 50 mg | Oral |
| Subject | Iptacopan | Small molecule | 200 mg | Oral |
| Comparator | Rituximab | Monoclonal antibody | 1 g | Intravenous |