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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05646563
Study type Interventional
Source NovelMed Therapeutics
Contact Rekha Bansal
Phone 216-440-2696
Email clinicalsae@novelmed.com
Status Not yet recruiting
Phase Phase 2
Start date March 2025
Completion date January 2027

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