drugset / Trial / NCT03373461
Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation
RandomizedParallel-groupDouble-blindTreatment
Summary
Efficacy and safety of LNP023 in IgAN patients
Timeline
- Start
- 2018-02-07
- Primary completion
- 2020-12-29
- Completion
- 2021-06-22
Outcome
Met primary endpoint
registry analysis (other test); LNP023 10 mg BID vs LNP023 50 mg BID vs LNP023 100 mg BID - Part 2 vs LNP023 200 mg BID vs Placebo; p = 0.038; Multiple Comparison Procedure-Modeling NCT03373461 ↗
registry analysis (other test); LNP023 200 mg BID vs Placebo; Ratio to placebo (of ratio to baseline) 0.77 (80% CI 0.66 to 0.92) NCT03373461 ↗
release “Iptacopan in IgA nephropathy met its primary endpoint in Ph2b enabling Ph3 initiation” novartis.com ↗
release “In the Phase II study (NCT03373461), patients (n=112) with IgAN were randomized to placebo or different doses of iptacopan 1 . The primary endpoint was met” novartis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iptacopan | Small molecule | 10 mg | — |
| Subject | Iptacopan | Small molecule | 50 mg | — |
| Subject | Iptacopan | Small molecule | 100 mg | — |
| Subject | Iptacopan | Small molecule | 200 mg | — |