drugset / Trial / NCT05646563

Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris

NCT05646563

Phase 2 Not yet recruiting 12 enrolled NovelMed Therapeutics
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase II, open-label study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 in PNH patients undergoing complement-inhibitor therapy with Soliris.

Timeline

Start
2027-01
Primary completion
2029-07
Completion
2030-08

Drugs

EvaluationDrugModalityDoseRoute
Subject RUXOPRUBART Monoclonal antibody 20 mg/kg Intravenous
Background Eculizumab Monoclonal antibody Intravenous