A Multicenter, Open-Label, Outpatient Study To Evaluate The Safe And Effective Use Of A Zilucoplan Auto-Injector Combination Product For Subcutaneous Self-Administration By Study Participants With Generalized Myasthenia Gravis (DV0013)

Research summary

DV0013 is a Phase 3b, multicenter, open-label study to evaluate the safe and effective use of a ZLP-AI combination product for sc self-administration of ZLP solution (the IMP) by study participants with generalized myasthenia gravis (gMG), planned to be conducted in Europe and the US. The study will aim to reflect real-world use scenarios by including participants who are already self-administering ZLP using the PFS on a once-daily dosing regimen as part of the MG0011 long-term open-label extension (OLE) study or who are on commercial ZLP treatment for at least 1 month prior to Screening. DV0013 will consist of 9 visits (2 clinic visits and 7 remote telephone visits) and 14 self-administrations using the ZLP-AI

Principal Investigator

Dr Maria Leite

Contact us

Email: ana.cavey@ouh.nhs.uk

IRAS number

1009938