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)
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
OMS906 study drug dose 5mg/kg IV administration at 4-week internals
Omeros Investigational Site
Kaunas, Lithuania
RECRUITINGOmeros Investigational Site
Vilnius, Lithuania
RECRUITINGOmeros Investigational Site
Auckland, New Zealand
To assess OMS906 5mg/kg IV administration at 4-week intervals in patients with C3G and ICGN.
Number of participants with Adverse Events following dosing of OMS906.
Time frame: 48 weeks
Change in proteinuria measured by 24-hour urine protein/creatinine ratio (UPCR).
Change from baseline in proteinuria measured as 24-hour UPCR at 12, 24, and 48 weeks.
Time frame: 12, 24, 48 weeks
Change in proteinuria measured by 24-hour urine protein excretion (UPE).
Change from baseline in proteinuria measured as 24-hour UPE at 12, 24, and 48 weeks.
Time frame: 12, 24, and 48 weeks.
Change in proteinuria measured as 24-hour urine albumin excretion (UAE).
Change from baseline in proteinuria measured as 24-hour UAE at 12, 24, and 48 weeks.
Time frame: Time Frame: 12, 24, and 48 weeks.
Change in proteinuria measured as 24-hour urine albumin/creatinine ratio (UACR).
Change from baseline in proteinuria measured as 24-hour UACR at 12, 24, and 48 weeks.
Time frame: 12, 24, and 48 weeks.
Incidence of participants with a change from baseline of estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at 24 and 48 weeks.
Number and % of participants with a change from baseline of estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at 24 and 48 weeks.
Time frame: 24 and 48 weeks
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Omeros Investigational Site
Lodz, Poland
RECRUITINGOmeros Investigational Site
Leicester, United Kingdom
RECRUITINGOmeros Investigational Site
Newcastle upon Tyne, United Kingdom
RECRUITINGIncidence of participants with a change from baseline serum creatinine concentration at 24 and 48 weeks.
Number and % of participants with a change from baseline serum creatinine concentration at 24 and 48 weeks.
Time frame: 24 and 48 weeks
Pharmacodynamics (PD) of multiple-dose administration of OMS906.
Mature Complement Factor D (CFD) concentration.
Time frame: 48 weeks
Pharmacokinetics (PK) of multiple-dose administration of OMS906 - Cmax.
PK parameters including OMS906 maximum concentration - peak plasma concentration (Cmax).
Time frame: 48 weeks
Pharmacokinetics (PK) of multiple-dose administration of OMS906 - AUC.
PK parameters - Area under the plasma concentration vs time curve (AUC).
Time frame: 48 weeks
OMS906 anti-drug antibodies (ADA).
Number of patients with measurable ADA.
Time frame: 48 weeks