NCT06209736

Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN

A Phase 2 Proof of Concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of OMS906 in Patients With C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Omeros Corporation · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OMS906 in patients with C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)

Detailed description

This is a multicenter, open-label, uncontrolled, non-comparative, fixed-dose study. The primary objective is to assess safety and tolerability of OMS906 in patients with C3G or idiopathic ICGN, both complement-mediated disorders. Patients will receive 5 mg/kg administered as intravenous (IV) infusions at 4-week intervals. The study will enroll up to approximately 20 patients with C3G or ICGN. Safety will be evaluated in all patients and by disease cohort. Preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) will be evaluated by disease cohort.

Conditions

• C3 Glomerulopathy
• Idiopathic Immune Complex-Mediated Glomerulonephritis

Interventions

Type	Name	Description
DRUG	OMS906 study drug	OMS906 study drug dose 5mg/kg IV administration at 4-week internals

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-01-01
• Completion: 2026-04-01
• First posted: 2024-01-17
• Last updated: 2025-07-15

Locations

6 sites across 4 countries: Lithuania, New Zealand, Poland, United Kingdom

Regulatory

• FDA-regulated drug study