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

C3 Glomerulopathy Clinical Trial

Official title:
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)

Clinical Trial 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)

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06209736
Study type Interventional
Source Omeros Corporation
Contact Omeros Clinical Trial Information
Phone 206-676-5000
Email ctinfo@omeros.com
Status Recruiting
Phase Phase 2
Start date March 1, 2024
Completion date April 2026
View Details
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