Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase2

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

Sponsor: Omeros Corporation

NCT ID: NCT06209736

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
OMS906 study drug (drug)
How long the study runs
Study runs about 25 months (dates as stated)
About the drug or intervention
OMS906 study drug — drug: OMS906 study drug dose 5mg/kg IV administration at 4-week internals
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at how safe and effective a medicine called OMS906 is for adults with two rare kidney conditions: C3 glomerulopathy (C3G, including dense deposit disease) and idiopathic immune complex-mediated glomerulonephritis (ICGN). Both conditions affect the kidneys' filtering units. The study is run by Omeros Corporation.

Who can take part

  • Adults aged 18 or over, male or female
  • Diagnosis of C3G (including dense deposit disease) or ICGN confirmed by a kidney biopsy within the last 36 months
  • Two urine tests (24-hour collections) at least 14 to 28 days apart showing raised protein levels
  • Kidney function (GFR) of at least 45 mL/min/1.73 m2
  • Low levels of a blood protein called C3 during screening
  • Already taking a stable dose of an ACE inhibitor or ARB blood pressure medicine for at least 90 days (and other medicines, if used, at a stable dose for at least 90 days)
  • Up to date with certain vaccinations (against meningococcal disease, pneumococcal disease and Haemophilus influenzae, where available) and willing to keep these up to date during the study
  • Women who can become pregnant must have a negative pregnancy test and use highly effective birth control during the study and for 20 weeks (140 days) after the last dose; men must also use highly effective birth control with a female partner during the study and for 20 weeks after the last dose

Who may not be able to

  • People who have had a major organ transplant or a stem cell or bone marrow transplant
  • People born without certain complement proteins (C1q, C1r, C1s, C2 or C4)
  • People with rapidly worsening kidney disease (a 50% or bigger drop in kidney function within 3 months, with certain biopsy findings)
  • Biopsy results showing more than 50% scarring of the kidney
  • Weakened immune system or certain immunosuppressive medicines within 90 days (some exceptions apply for people with C3G)
  • Treatment with rituximab within the last 6 months
  • Blood pressure above 140/90 mmHg at screening
  • Cancer within the last 5 years (except non-melanoma skin cancer)
  • A history of monoclonal gammopathy of unknown significance or any autoimmune disorder
  • Certain abnormal liver blood tests
  • Past severe allergic reactions to monoclonal antibodies or to ingredients in OMS906
  • A significant infection (including COVID-19) in the 2 weeks before screening
  • Use of any other complement inhibitor within the last 6 months
  • HIV, hepatitis B, or untreated hepatitis C infection
  • Women who are pregnant, planning to become pregnant, or breastfeeding
  • Recent or planned surgery needing a general anaesthetic (within 2 weeks before screening or during treatment)
  • Any other significant medical, neurological or psychiatric condition that the study doctor thinks would make taking part unsuitable
  • Taking another investigational medicine or device within the last 30 days, or taking part in another clinical trial of a treatment (observational or registry studies are allowed)
  • Unable or unwilling to follow the study requirements

What taking part involves

  • • Taking the study medicine OMS906 (how it is given and how often is not stated — ask the trial team)
  • • Two 24-hour urine collections before joining
  • • Vaccinations kept up to date throughout the study
  • • Highly effective birth control during the study and for 20 weeks after the last dose

Time commitment: Number of visits, study duration and how long treatment lasts are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 99 Years
Who
All
Number of participants
20
Started
2024-03-01
Last checked
2025-07

Plain English Summary

What is this study?

  • • Testing a new treatment for c3 glomerulopathy
  • • Phase2 - 20 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 99 Years
  • • Diagnosed with c3 glomerulopathy

Where?

  • • Leicester - Omeros Investigational Site
  • • Newcastle upon Tyne - Omeros Investigational Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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)

More detail

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.

C3 GlomerulopathyIdiopathic Immune Complex-Mediated Glomerulonephritis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 99 Years
  • Who can join: All genders

Biomarkers mentioned

have a negativeeGFR

Treatment history

Treatments you must have had:

  • ✓ a negative highly sensitive pregnancy test at screening and

What the study is looking for

  • ✓Male or female adults 18 years and older.
  • ✓Competent to provide agreement to take part and has completed agreement to take part 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.

Who cannot take part

  • ✗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 kidney biopsy findings showing interstitial fibrosis/tubular atrophy of more than 50%.
  • ✗Treatment with rituximab within 6 months of screening.
  • ✗Resting blood pressure \> 140/90 mmHg during screening.
See the full criteria
Inclusion Criteria: 1. Male or female adults 18 years and older. 2. Competent to provide informed consent and has completed informed consent procedures. 3. Diagnosis of C3G, including dense deposit disease, or ICGN confirmed by biopsy within 36 months of screening. 4. Two 24-hour UPCR ≥ 0.8 gm/gm with the 2 collections separated by 14 - 28 days. 5. GFR estimated by the CKD-EPI equation ≥ 45 mL/min/1.73 m2. 6. Serum C3 concentration less than the lower limit of laboratory normal during screening. 7. Must be on stable maximally tolerated or allowed dose of ACE inhibitor or ARB for at least 90 days. 8. If receiving a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, must be on a stable dose for at least 90 days. 9. If receiving mycophenolate mofetil, a mineralocorticoid receptor antagonist, or a corticosteroid, must be on stable dose for at least 90 days. 10. 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. 11. Female patients of child-bearing potential must have a negative highly sensitive pregnancy test at screening and prior to each dose of OMS906. 12. 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. 13. 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. Exclusion Criteria: 1. History of major organ transplant or hematopoietic stem cell/marrow transplant. 2. Have known congenital deficiency of any of complement factors C1q, C1r, C1s, C2 or C4. 3. 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. 4. Have renal biopsy findings showing interstitial fibrosis/tubular atrophy of more than 50%. 5. 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. 6. Treatment with rituximab within 6 months of screening. 7. Resting blood pressure \> 140/90 mmHg during screening. 8. History of any active malignancy within 5 years of screening except non-melanoma skin cancers. 9. History of monoclonal gammopathy of unknown significance or any autoimmune disorder. 10. 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. 11. History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation. 12. Significant active bacterial or viral infection within the 2 weeks prior to screening including Covid-19 infection. 13. Use of any other complement inhibitor within 6 months prior to the screening visit. 14. Have human immunodeficiency virus, hepatitis B, or untreated hepatitis C infection. 15. Pregnant, planning to become pregnant, or nursing female patient. 16. Recent surgery requiring general anesthesia within the 2 weeks prior to screening or expected to have surgery requiring general anesthesia during the treatment period. 17. History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the study. 18. Treatment with any investigational medicinal product or investigational device within 30 days (or within 5 × its half-life in days, whichever is the longer period) prior to screening, or participation in another concurrent clinical trial involving a therapeutic intervention. Participation in observational and/or registry studies is permitted. 19. Unable or unwilling to comply with the requirements of the study.

Where Is This Study? (2 UK sites)

Omeros Investigational Site

Leicester, United Kingdom

Recruiting

Omeros Investigational Site

Newcastle upon Tyne, United Kingdom

Recruiting

How to Get in Touch

Omeros Clinical Trial Information

Sponsor contact

CONTACT

206-676-5000 ctinfo@omeros.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-07