Batoclimab as induction and maintenance therapy in patients with myasthenia gravis: rationale and study design of a phase 3 clinical trial
Benatar M, Wiendl H, Nowak R, Zheng Y, Macias W. Batoclimab as induction and maintenance therapy in patients with myasthenia gravis: rationale and study design of a phase 3 clinical trial. BMJ Neurology Open 2024, 6: e000536. PMID: 38268752, PMCID: PMC10806862, DOI: 10.1136/bmjno-2023-000536.Peer-Reviewed Original ResearchMG-ADLMyasthenia gravisInstitutional Review Board/Independent Ethics CommitteePhase 3 clinical trialsPlacebo-treated patientsPlacebo-controlled studyBaseline to weekHuman monoclonal antibodyLong-term extensionMyasthenia Gravis ActivitiesWritten Informed ConsentMaintenance periodInduction therapyMaintenance therapyDeclaration of HelsinkiPrimary endpointMaintenance treatmentQuadruple-blindSubcutaneous injectionPatientsPlaceboMonoclonal antibodiesMyastheniaInformed consentQ2W
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