drugset
drugset / Trial / NCT05972967

Safety and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria Patients With a Sub-optimal Response to Ravulizumab

NCT05972967 ↗

Phase 2 Completed 12 enrolled Omeros Corporation
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of OMS906 for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients who have a sub-optimal response to ravulizumab.

Timeline

Start
2023-03-27
Primary completion
2024-10-10
Completion
2024-10-10

Outcome

Met primary endpoint

release “OMS906, A Novel Alternative Pathway MASP-3 Inhibitor, Improved Hematologic Parameters in PNH Patients with Suboptimal Response to Ravulizumab Treatment: Phase 2 Dose-Finding Study Interim Results” omeros.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ZALTENIBART Monoclonal antibody 3 mg/kg Intravenous
Subject ZALTENIBART Monoclonal antibody 5 mg/kg Intravenous

Indications

paroxysmal nocturnal hemoglobinuria