NCT03608033

Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Omeros Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effect of OMS721 on 24-hour urine protein excretion (UPE) in IgA nephropathy (IgAN) patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE ≥ 2 g/day) assessed at 36 weeks from baseline.

Detailed description

This is a Phase 3, double-blind, randomized, placebo-controlled, study in patients aged 18 years and above with a biopsy-confirmed diagnosis of IgAN and with 24-hour UPE that is \> 1 g/day. The purpose of this study is to evaluate the efficacy and safety of narsoplimab (OMS721) compared to placebo on proteinuria and whether narsoplimab has the ability to slow disease progression in primary IgAN patients. The primary objective of the study is to evaluate proteinuria reduction as assessed by 24-hour UPE at 36 weeks from baseline. The trial will continue beyond 36 weeks in a blinded fashion to provide confirmatory evidence of long-term efficacy based on the annualized slope of eGFR over 24 months. The trial will enroll approximately 450 patients with 225 patients per arm, all having biopsy-proven IgAN with eGFR≥30 mL/min/1.73m\^2 and 24 hour UPE \>1g/day. The study duration for each patient is expected to last approximately 112 weeks.

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
BIOLOGICAL	OMS721	Biological: OMS721
OTHER	Vehicle (D5W or saline)	5% Dextrose in water or normal saline solution

Timeline

• Start date: 2018-04-05
• Primary completion: 2024-01-12
• Completion: 2024-01-12
• First posted: 2018-07-31
• Last updated: 2025-12-09
• Results posted: 2025-12-09

Locations

139 sites across 23 countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, Czechia, Germany, Greece, Hungary, India, Italy, Lithuania, Poland, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study