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

NCT06209736 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: OMS906-C3G-001
• Study Type: interventional
• Target: 20
• Locations: 4 countries
• Sites: 6

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)

Conditions

C3 Glomerulopathy; Idiopathic Immune Complex-Mediated Glomerulonephritis

Keywords

C3G; ICGN

Outcome Measures

Primary Outcomes (1)

• 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.

  48 weeks

Secondary Outcomes (10)

• Change in proteinuria measured by 24-hour urine protein/creatinine ratio (UPCR).

  12, 24, 48 weeks

• Change in proteinuria measured by 24-hour urine protein excretion (UPE).

  12, 24, and 48 weeks.

• Change in proteinuria measured as 24-hour urine albumin excretion (UAE).

  Time Frame: 12, 24, and 48 weeks.

• Change in proteinuria measured as 24-hour urine albumin/creatinine ratio (UACR).

  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

Study Arms (1)

Study Drug OMS906

EXPERIMENTAL

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

Drug: OMS906 study drug

Interventions

OMS906 study drug DRUG

OMS906 study drug dose 5mg/kg IV administration at 4-week internals

Also known as: OMS906

Study Drug OMS906

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 m2.
• 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.
• Patients who have not received these vaccinations at the time of screening may be vaccinated at any time prior to 2 weeks before the first study drug administration. Vaccine serotypes will be chosen by the local standard of care and serotype prevalence.
• Female patients of child-bearing potential must have a negative highly sensitive pregnancy test at screening and prior to each dose of OMS906.
• Females must use highly effective birth control\* to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug.
• Males must use highly effective birth control\* with a female partner to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug.

You may not qualify if:

• 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 C4.
• 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.
• History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation.
• Significant active bacterial or viral infection within the 2 weeks prior to screening including Covid-19 infection.
• Use of any other complement inhibitor within 6 months prior to the screening visit.
• Have human immunodeficiency virus, hepatitis B, or untreated hepatitis C infection.
• Pregnant, planning to become pregnant, or nursing female patient.

Sponsors & Collaborators

• Omeros Corporation: lead

Study Sites (6)

Omeros Investigational Site

Kaunas, Lithuania

RECRUITING

Omeros Investigational Site

Vilnius, Lithuania

RECRUITING

Omeros Investigational Site

Auckland, New Zealand

RECRUITING

Omeros Investigational Site

Lodz, Poland

RECRUITING

Omeros Investigational Site

Leicester, United Kingdom

RECRUITING

Omeros Investigational Site

Newcastle upon Tyne, United Kingdom

RECRUITING

Study Officials

• Steve Whitaker, MD

  Omeros Corporation

  STUDY DIRECTOR

Central Study Contacts

Omeros Clinical Trial Information

CONTACT

206-676-5000; ctinfo@omeros.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 17, 2024
• Study Start: March 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); GB (2); LI (2); PL (1)