Narsoplimab:
ARTEMIS-IgAN
Some patients with IgAN have lectin pathway activation (as determined by glomerular deposition of mannose-binding lectin [MBL], L-ficolin, MBL-associated serine protease [MASP], and C4d), and these patients had increased proteinuria and kidney damage compared with those with no lectin pathway involvement.
Narsoplimab, also called OMS721 is a human monoclonal antibody against mannan-associated lectin-binding serine protease−2 (MASP-2).
A prior Phase 2 study reported that narsoplimab treatment is safe, is well tolerated, and may result in clinically meaningful reductions in proteinuria and stability of eGFR in high-risk patients with advanced IgAN.
Enroll in this clinical study
What is ARTEMIS-IgAN study?
This is a Phase 3, double-blind, randomized, placebo-controlled, study.
The study consists of five periods:
Screening, Run-In, Initial Treatment (Weeks 1-12), Response Evaluation (Weeks 13-36), and Follow-Up (Weeks 37-144).
Patients will be randomized 1:1 to weekly intravenous narsoplimab or placebo during the initial treatment period (Weeks 1–12)
All patients will continue optimized renin-angiotensin system (RAS) blockade.
Patients will be assessed for re-treatment based on their response to 24-hour UPE. Additional treatment may be given to patients whose 24-hour UPE is > 1 g/day following the Initial Treatment Period and who relapse during the Response Evaluation and Follow-Up periods. Patients may be qualified for Open-Label Treatment with OMS721 after Week 72.
Approximately 450 patients are planned to be enrolled in two groups of 225 patients per arm.
Eligibility Criteria
01
Age 18 years or older at the onset of Screening
03
Mean of two proteinuria measurements > 1 g/day at baseline
05
Estimated glomerular filtration rate of ≥ 30 mL/min/1.73 m2 at Screening and baseline
02
Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening
04
Proteinuria of > 1 g/day within 6 months prior to Screening or uPCR > 0.75 by spot urine at Screening