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)

Omeros Corporation1 site in 1 country20 target enrollmentMarch 1, 2024

ConditionsC3 Glomerulopathy Idiopathic Immune Complex-Mediated Glomerulonephritis

InterventionsOMS906 study drug

DrugsOMS906 study drug

Overview

Phase: Phase 2
Intervention: OMS906 study drug
Conditions: C3 Glomerulopathy
Sponsor: Omeros Corporation
Enrollment: 20
Locations: 1
Primary Endpoint: To assess OMS906 5mg/kg IV administration at 4-week intervals in patients with C3G and ICGN.
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 1, 2024

End Date

April 1, 2026

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Omeros Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female adults 18 years and older.
•Competent to provide informed consent and has completed informed consent procedures.
•Diagnosis of C3G, including dense deposit disease, or ICGN confirmed by biopsy within 36 months of screening.
•Two 24-hour UPCR ≥ 0.8 gm/gm with the 2 collections separated by 14 - 28 days.
•GFR estimated by the CKD-EPI equation ≥ 45 mL/min/1.73 m
•Serum C3 concentration less than the lower limit of laboratory normal during screening.
•Must be on stable maximally tolerated or allowed dose of ACE inhibitor or ARB for at least 90 days.
•If receiving a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, must be on a stable dose for at least 90 days.
•If receiving mycophenolate mofetil, a mineralocorticoid receptor antagonist, or a corticosteroid, must be on stable dose for at least 90 days.
•Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Haemophilus influenza (where available) and agree to maintain vaccination throughout the study.

Exclusion Criteria

•History of major organ transplant or hematopoietic stem cell/marrow transplant.
•Have known congenital deficiency of any of complement factors C1q, C1r, C1s, C2 or C
•Have rapidly progressing glomerulonephritis defined as a 50% or greater decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
•Have renal biopsy findings showing interstitial fibrosis/tubular atrophy of more than 50%.
•Immunodeficiency or treatment with immunosuppressive agents (except mycophenolate mofetil or corticosteroids at the prednisone equivalent of ≤ 7.5 mg/day in patients with C3G only) within 90 days of screening.
•Treatment with rituximab within 6 months of screening.
•Resting blood pressure \> 140/90 mmHg during screening.
•History of any active malignancy within 5 years of screening except non-melanoma skin cancers.
•History of monoclonal gammopathy of unknown significance or any autoimmune disorder.
•Elevation of liver function tests, defined as total bilirubin \> 2 × upper limit of normal (ULN), direct bilirubin \> 1.5 × ULN, and elevated transaminases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 × ULN.

Arms & Interventions

Study Drug OMS906

Repeat-dose OMS906 5 mg/kg IV administration at 4-week intervals

Intervention: OMS906 study drug

Outcomes

Primary Outcomes

To assess OMS906 5mg/kg IV administration at 4-week intervals in patients with C3G and ICGN.

Time Frame: 48 weeks

Number of participants with Adverse Events following dosing of OMS906.

Secondary Outcomes

Change in proteinuria measured by 24-hour urine protein excretion (UPE).(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.(24 and 48 weeks)
Incidence of participants with a change from baseline serum creatinine concentration at 24 and 48 weeks.(24 and 48 weeks)
Pharmacokinetics (PK) of multiple-dose administration of OMS906 - Cmax.(48 weeks)
Pharmacodynamics (PD) of multiple-dose administration of OMS906.(48 weeks)
OMS906 anti-drug antibodies (ADA).(48 weeks)
Change in proteinuria measured as 24-hour urine albumin/creatinine ratio (UACR).(12, 24, and 48 weeks.)
Change in proteinuria measured by 24-hour urine protein/creatinine ratio (UPCR).(12, 24, 48 weeks)
Change in proteinuria measured as 24-hour urine albumin excretion (UAE).(Time Frame: 12, 24, and 48 weeks.)
Pharmacokinetics (PK) of multiple-dose administration of OMS906 - AUC.(48 weeks)