NCT03373461

Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation

An Adaptive Seamless Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Efficacy and safety of LNP023 in IgAN patients

Detailed description

This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study with an adaptive design (Part 1 informed the design adaptations for Part 2). In Part 1, three doses of LNP023 (10 mg, 50 mg, and 200 mg) vs. placebo control were compared; In Part 2, four doses of LNP023 (10 mg, 50 mg, 100 mg, and 200 mg) vs. placebo control were compared. The study comprised a run-in phase in order that patients were on stable and maximally tolerated dose of Angiotensin-converting-enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) for at least 90 days, a 90 days treatment phase in Part 1; a 180 days treatment phase in Part 2 and a 90 days follow-up phase in both Parts 1 and 2.

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
DRUG	LNP023	LNP023 5, 25, 100 mg capsles
OTHER	Placebo	Matching placebo to LNP023

Timeline

• Start date: 2018-02-07
• Primary completion: 2020-12-29
• Completion: 2021-06-22
• First posted: 2017-12-14
• Last updated: 2023-01-30
• Results posted: 2022-10-07

Locations

56 sites across 25 countries: Argentina, Australia, Belgium, Brazil, China, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Japan, Malaysia, Netherlands, Norway, Singapore, South Korea, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study