NCT02682407

Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721

A Phase 2 Study to Evaluate the Safety and Effect on Proteinuria of OMS721 in Subjects With IgA Nephropathy, Lupus Nephritis, Membranous Nephropathy, or C3 Glomerulopathy Including Dense Deposit Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Omeros Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and tolerability of OMS721 (narsoplimab) in participants with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and Complement Component 3 Glomerulopathy (C3G) including Dense Deposit Disease. The study will also evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and neutralizing antibodies (NAb) of narsoplimab when administered intravenously and when administered both intravenously and subcutaneously in participants of Asian descent with IgA Nephropathy.

Conditions

• IgAN
• LN
• MN
• C3G

Interventions

Type	Name	Description
BIOLOGICAL	OMS721 (narsoplimab)	Biological: narsoplimab

Timeline

• Start date: 2016-03-10
• Primary completion: 2020-08-25
• Completion: 2020-08-25
• First posted: 2016-02-15
• Last updated: 2026-03-30
• Results posted: 2026-03-30

Locations

12 sites across 2 countries: United States, Hong Kong

Regulatory

• FDA-regulated drug study