Generalized Myasthenia Gravis
Conditions
Brief summary
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)
Detailed description
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
Sponsors
Dianthus Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Czechia, Denmark, France, Italy, Netherlands, Norway, Poland, Spain, Sweden
Outcome results
None listed