Clinical Trial: ARTEMIS-IGAN
Omeros Corporation is sponsoring the ARTEMIS-IGAN clinical trial, a randomized, double-blind, placebo-controlled, Phase 3 study of the safety and efficacy of narsoplimab in patients with immunoglobulin A (IgA) nephropathy.
The purpose of this clinical trial is to see if the investigational drug narsoplimab is safe in people with IgA nephropathy and can help to treat IgA nephropathy.
- The primary outcome measure is the change in urine protein excretion at 36 weeks.
- This clinical trial is being conducted in patients aged 18 years and older who have a diagnosis of IgA nephropathy and meet other eligibility criteria.
- After screening and evaluation, those taking part will receive either narsoplimab or placebo for 12 weeks.
- Those who do not respond will be considered for an additional six weeks of treatment.
- Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), cytotoxic drugs, or eculizumab within 24 weeks prior to screening
- Clinical or biological evidence of systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein purpura), secondary IgA nephropathy, or other renal disease Show more
- History of renal transplantation
- History of human immunodeficiency virus (HIV), hepatitis B (HBV) infection, or hepatitis C (HCV) infection Show Less
- Age 18 years or older
- Biopsy-confirmed diagnosis of IgA nephropathy within the past 8 years Show more
- Proteinuria of >1 gram in 24-hour urine collection
- Estimated glomerular filtration rate of ≥ 30 mL/min/1.73 m2
- Currently on physician-directed, stable treatment with renin-angiotensin system (RAS) blockade of angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or direct renin inhibitors
- Systolic blood pressure of <150 mmHg and a diastolic blood pressure of <100 mmHg at rest Show Less
About Clinical Research
Omeros Corporation is a Seattle-based commercial-stage biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancer.
Narsoplimab, a MASP-2 complement inhibitor, is an investigational drug and is not yet approved by the FDA or any other regulatory agency as a treatment for any indication.