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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508669-33-00

Acronym

OMS906-C3G-001

Enrollment

Registered

2024-08-04

Start date

2024-01-29

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C3 Glomerulopathy and Idiopathic Immune Complex-Mediated Glomerulonephritis

Brief summary

Safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory tests.

Detailed description

Change from baseline in proteinuria measured as 24-hour UPCR at 12, 24, and 48 weeks., Change from baseline in proteinuria measured as 24-hour UPE at 12, 24, and 48 weeks., Change from baseline in proteinuria measured as 24-hour UACR at 12, 24, and 48 weeks., Change from baseline in proteinuria measured as 24-hour urine UAE at 12, 24, and 48 weeks., Change from baseline of eGFR calculated by the CKD-EPI formula at 24 and 48 weeks., Change from baseline in serum creatinine at 24 and 48 weeks., Key OMS906 PK parameters estimated using appropriate population PK methods based on sparse sampling., Serum/plasma PD parameters, including mature FD, measured as changes from baseline., Incidence of ADAs in serum.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory tests.	—

Secondary

Measure	Time frame
Change from baseline in proteinuria measured as 24-hour UPCR at 12, 24, and 48 weeks., Change from baseline in proteinuria measured as 24-hour UPE at 12, 24, and 48 weeks., Change from baseline in proteinuria measured as 24-hour UACR at 12, 24, and 48 weeks., Change from baseline in proteinuria measured as 24-hour urine UAE at 12, 24, and 48 weeks., Change from baseline of eGFR calculated by the CKD-EPI formula at 24 and 48 weeks., Change from baseline in serum creatinine at 24 and 48 weeks., Key OMS906 PK parameters estimated using appropriate population PK methods based on sparse sampling., Serum/plasma PD parameters, including mature FD, measured as changes from baseline., Incidence of ADAs in serum.	—

Measure

Time frame

—

Countries

Lithuania, Poland

Outcome results