BridgeMD
This study will use a new investigation study drug called OMS906 in peoplewith C3 Glomerulopathy (C3G) or Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN). The purpose of this study is to test the safety and describe the effect of OMS906 study drug in people with these diseases.
EU CTIS ID: 2023-508669-33-00
What this study is testing
To assess overall safety and tolerability of 5 mg/kg repeat-dose OMS906 IV administration at 4-week intervals in patients with C3G and ICGN.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female adults 18 years and older.
- 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.
- Competent to provide informed consent and has completed informed consent procedures.
You likely can't join if
- History of major organ transplant or hematopoietic stem cell/marrow transplant.
- 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.
See the full eligibility criteria
Who can join
- Male or female adults 18 years and older.
- 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.
- 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 ≥ 30 mL/min/1.73m2.
- Serum C3 concentration less than the lower limit of laboratory normal during the 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.
What rules you out
- History of major organ transplant or hematopoietic stem cell/marrow transplant.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Turkey
- Tunisia
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Turkey; Tunisia; New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.