AzTrials
AzTrials

C3 GlomerulopathyPhase 2NCT06209736

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

A Phase 2 study testing OMS906 study drug in people with C3 Glomerulopathy and Idiopathic Immune Complex-Mediated Glomerulonephritis, run by Omeros Corporation at 6 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
OMS906 study drug
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
6 sitesin 4 countries
Study dates
1 Mar 2024to 14 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • Recent surgery requiring general anesthesia within the 2 weeks prior to screening or expected to have surgery requiring general anesthesia during the treatment period.
  • 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.
  • 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.
  • Unable or unwilling to comply with the requirements of the study.

Trial locations and contacts

6 sites in 4 countries.

6 sites in 4 countries

Lithuania2 sites

  • Omeros Investigational Site

    Kaunas

  • Omeros Investigational Site

    Vilnius

Other trials in Lithuania

United Kingdom2 sites

  • Omeros Investigational Site

    Leicester

  • Omeros Investigational Site

    Newcastle upon Tyne

Other trials in United Kingdom

New Zealand1 site

  • Omeros Investigational Site

    Auckland

Other trials in New Zealand

Poland1 site

  • Omeros Investigational Site

    Lodz

Other trials in Poland

About this study

Official title: 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)

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)

Read the 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.

Being tested
OMS906 study drug
Keywords
C3G, ICGN

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMS906 study drugDrug

    Also called OMS906

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

Study groups in NCT06209736
Study groupRoleWhat they receive
Study Drug OMS906ExperimentalRepeat-dose OMS906 5 mg/kg IV administration at 4-week intervals
Receives: Drug: OMS906 study drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 48 weeks

Secondary outcomes (10)

  1. 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.

    Measured: 12, 24, 48 weeks

  2. 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.

    Measured: 12, 24, and 48 weeks.

  3. 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.

    Measured: Time Frame: 12, 24, and 48 weeks.

  4. 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.

    Measured: 12, 24, and 48 weeks.

  5. 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.

    Measured: 24 and 48 weeks

  6. Incidence 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.

    Measured: 24 and 48 weeks

  7. Pharmacodynamics (PD) of multiple-dose administration of OMS906.

    Mature Complement Factor D (CFD) concentration.

    Measured: 48 weeks

  8. Pharmacokinetics (PK) of multiple-dose administration of OMS906 - Cmax.

    PK parameters including OMS906 maximum concentration - peak plasma concentration (Cmax).

    Measured: 48 weeks

  9. Pharmacokinetics (PK) of multiple-dose administration of OMS906 - AUC.

    PK parameters - Area under the plasma concentration vs time curve (AUC).

    Measured: 48 weeks

  10. OMS906 anti-drug antibodies (ADA).

    Number of patients with measurable ADA.

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2024
  2. Study start1 Mar 2024
  3. Primary completion14 Apr 2026
  4. Study completion14 Apr 2026

Why it stopped: The study was terminated for strategic reasons related to the molecule's recent acquisition

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06209736
Sponsor's protocol ID
OMS906-C3G-001
Status last verified
Oct 2026
First submitted
4 Jan 2024
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OMS906 study drug in people with C3 Glomerulopathy and Idiopathic Immune Complex-Mediated Glomerulonephritis, run by Omeros Corporation at 6 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Lithuania, United Kingdom, New Zealand, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated for strategic reasons related to the molecule's recent acquisition). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess OMS906 5mg/kg IV administration at 4-week intervals in patients with C3G and ICGN. (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06209736.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT06209736 | AzTrials