NCT05889299

Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Omeros Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, fixed-dose study. The primary objective is to assess safety and tolerability of OMS906 in patients with PNH. Patients will receive 5 mg/kg OMS906 administered as subcutaneous (SC) injections at 4-week intervals.

Conditions

• Paroxysmal Nocturnal Hemoglobinuria

Interventions

Type	Name	Description
DRUG	OMS906 study drug	OMS906 study drug dose repeat-dose 5mg/kg SC administration at 4-week intervals

Timeline

• Start date: 2022-12-09
• Primary completion: 2023-10-30
• Completion: 2024-06-30
• First posted: 2023-06-05
• Last updated: 2023-06-05

Locations

1 site across 1 country: Ukraine

Regulatory

• FDA-regulated drug study