Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria
brief summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).
detailed description
This is a Phase 1b, proof of concept, open-label, uncontrolled study. The primary objective is to assess the safety and tolerability of OMS906 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). The study evaluated 3 dosing regimens: (1) 5 mg/kg SC administered every 4 weeks (Q4W), (2) 5 mg/kg IV administered once followed by administration of additional doses of 5 mg/kg IV at the occurrence of protocol-defined subclinical breakthrough hemolysis, and (3) 8 mg/kg IV every 8 weeks (Q8W) on a fixed-dosing (FD) schedule
official title
A Phase 1b Proof of Concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria