Artemis-IGAN Clinical Trial

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 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 week of treatment.

Key Exclusion Criteria

• Treatment with immunosuppressants (e.g. azathioprine, 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
• History of renal transplantation
• History of human immunodeficiency virus (HIV), hepatitis B (HBV) infection, or hepatitis C (HCV) infection  

Key Inclusion Criteria

• Age 18 years or older
• Biopsy-confirmed diagnosis of IgA nephropathy within the past 8 years
• Protein of > 1 gram in 24-hour urine collection
• Estimated glomerular filtration rate of ≥ 30mL/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