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Monoclonal Antibodies

Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome (aHUS Trial)

Phase 3
Recruiting
Research Sponsored by Omeros Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 771 days post-dose
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

The purpose of this study is to evaluate the platelet count change from baseline and safety of OMS721 in adults and adolescents with atypical hemolytic uremic syndrome (aHUS). The study will also evaluate pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody response (ADA).

Eligible Conditions
  • Atypical Hemolytic Uraemic Syndrome
  • Thrombotic Microangiopathy
  • Atypical Hemolytic Uremic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~771 days post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 771 days post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The effect of OMS721 as measured by platelet count change from baseline
Secondary study objectives
Change from baseline in haptoglobin
Change from baseline in serum LDH
Change from baseline in serum creatinine
+7 more

Side effects data

From 2020 Phase 2 trial • 58 Patients • NCT02222545
50%
AE by System Organ
100%
80%
60%
40%
20%
0%
Study treatment Arm
aHUS OMS721-TMA-001 Medium Dose
HSCT-TMA-001 High Dose (N=28)
aHUS OMS721-TMA-001 Low Dose
TTP OMS721-TMA-001 High Dose
aHUS OMS721-TMA-001 High Dose
TTP OMS721-TMA-001 Medium Dose

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OMS721Experimental Treatment1 Intervention
Administration of OMS721
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
3,723 Total Patients Enrolled
Eckhard Leifke, M.D.Study DirectorOmeros Corporation
~9 spots leftby Dec 2025
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