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Monoclonal Antibodies

OMS721 for Immunoglobulin A Nephropathy

Phase 3
Waitlist Available
Research Sponsored by Omeros Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 112
Awards & highlights
Pivotal Trial

Summary

This trial is testing OMS721 (narsoplimab) to see if it can help adults with severe IgA nephropathy by reducing protein in their urine and slowing down kidney damage.

Eligible Conditions
  • Immunoglobulin A Nephropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 112
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 112 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Assessment of percentage of participants with presence of neutralizing antibodies
Assessment of pharmacodynamics of narsoplimab intravenous infusion
Assessment of pharmacodynamics of narsoplimab intravenous infusion with presence of positive anti-drug antibodies
+3 more

Side effects data

From 2020 Phase 2 trial • 58 Patients • NCT02222545
71%
AE by System Organ
36%
SAE by System Organ
100%
80%
60%
40%
20%
0%
Study treatment Arm
HSCT-TMA-001 High Dose (N=28)
aHUS OMS721-TMA-001 Low Dose
TTP OMS721-TMA-001 High Dose
TTP OMS721-TMA-001 Medium Dose
aHUS OMS721-TMA-001 Medium Dose
aHUS OMS721-TMA-001 High Dose

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OMS721Experimental Treatment1 Intervention
Administration of OMS721
Group II: PlaceboPlacebo Group1 Intervention
Administration of Vehicle (D5W or Saline Solution)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Narsoplimab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Omeros CorporationLead Sponsor
28 Previous Clinical Trials
3,447 Total Patients Enrolled
~46 spots leftby Nov 2025
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