A PHASE 2, RANDOMIZED, BLINDED, PLACEBOCONTROLLED, STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOMETRICS, AND EFFICACY OF DNTH103 IN ADULTS WITH GENERALIZED MYASTHENIA GRAVIS (MAGIC)

Trial status: Authorised Efficacy: Change from baseline to Week 13 in MG-ADL scale score, Efficacy: Change from baseline to Week 13 in Quantitative Myasthenia Gravis (QMG) scale score, Efficacy: Change from baseline to Week 13 in Myasthenia Gravis Composite (MGC) scale score, Pharmacokinetics/Pharmacodynamics: Serum concentrations and PK parameters, including Cmax and Cmin, Pharmacokinetics/Pharmacodynamics: PD parameters (eg, CH50 [complement hemolysis 50%]) in serum ex vivo, Immunogenicity: Incidence and titer of antidrug antibodies against DNTH103levels against DNTH103, Safety and tolerability over 52 weeks in the OLE: Incidence of TEAEs and treatment-emergent SAEs up to Week 52 in the OLE Safety and tolerability of DNTH103 up to Week 13: Incidence of TEAEs and treatment-emergent SAEs up to Week 13 (end of the RCT period)

Efficacy: Change from baseline to Week 13 in MG-ADL scale score, Efficacy: Change from baseline to Week 13 in Quantitative Myasthenia Gravis (QMG) scale score, Efficacy: Change from baseline to Week 13 in Myasthenia Gravis Composite (MGC) scale score, Pharmacokinetics/Pharmacodynamics: Serum concentrations and PK parameters, including Cmax and Cmin, Pharmacokinetics/Pharmacodynamics: PD parameters (eg, CH50 [complement hemolysis 50%]) in serum ex vivo, Immunogenicity: Incidence and titer of antidrug antibodies against DNTH103levels against DNTH103, Safety and tolerability over 52 weeks in the OLE: Incidence of TEAEs and treatment-emergent SAEs up to Week 52 in the OLE

Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 54 participants