clinical trial · NCT05646563
Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris
Paroxysmal Nocturnal HemoglobinuriaNM8074Soliris
brief 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.
started
Jan 1, 2027
primary completion
Jul 1, 2029
completion
Aug 1, 2030
last updated
Apr 13, 2026
detailed description
The proposed study, NM8074-PNH-106, will enroll a planned number of 12 Soliris-treated PNH patients who have been diagnosed with hemolytic anemia and meet the defined inclusion criteria. This study will evaluate the safety, efficacy, and immunogenicity of NM8074 as both a mono- and combination therapy with complement component C5 blocker Soliris. Patients will be evenly divided into two cohorts.
official title
A Phase II, Open-Label Study of NM8074 in Soliris®-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol