AChR-Ab Seropositive Generalized Myasthenia Gravis, gMG, MG, Myasthenia Gravis
Conditions
Brief summary
MP - 1. Incidence, severity, and relatedness of AEs and SAEs, MP - 2. Clinically meaningful changes in vital signs, ECGs, and laboratory parameters, ISA 2 - 1. Incidence, severity, and relatedness of adverse events and serious adverse events in the DBTP, ISA 2 - 2. Clinically meaningful changes in vital signs, electrocardiograms, and laboratory parameters in the DBTP
Detailed description
MP - 1. Change in MG disease severity as measured by change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score or Myasthenia Gravis Impairment Index (MGII) total score, MP - 2. Proportion of participants reaching minimal symptom expression (MSE) and other percentage improvements at variable time points., ISA 2 - 1. MG-ADL total score change from baseline at week 12, ISA 2 - 2. QMG total score change from baseline at week 12, ISA 2 - 3. MG-ADL total score actual values and changes from baseline over time up to week 12, ISA 2 - 4. QMG total score actual values and changes from baseline over time up to week 12, ISA 2 - 5. Proportion of participants reaching MSE at any point by week 12, ISA 2 - 6. Proportion of participants who have ≥3-point reduction in MG-ADL at week 12, ISA 2 - 7. Proportion of participants who have ≥5-point reduction in QMG at week 12, ISA 2 - 8. Proportion of participants who have a positive PASS at week 12, ISA 2 - 9. Proportion of participants who have a 50% MG-ADL total score improvement at week 12
Interventions
DRUGARGX-117
DRUGPlacebo to match Empasiprubart IV (ARGX-117)
Sponsors
Argenx
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MP - 1. Incidence, severity, and relatedness of AEs and SAEs, MP - 2. Clinically meaningful changes in vital signs, ECGs, and laboratory parameters, ISA 2 - 1. Incidence, severity, and relatedness of adverse events and serious adverse events in the DBTP, ISA 2 - 2. Clinically meaningful changes in vital signs, electrocardiograms, and laboratory parameters in the DBTP | — |
Secondary
| Measure | Time frame |
|---|---|
| MP - 1. Change in MG disease severity as measured by change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score or Myasthenia Gravis Impairment Index (MGII) total score, MP - 2. Proportion of participants reaching minimal symptom expression (MSE) and other percentage improvements at variable time points., ISA 2 - 1. MG-ADL total score change from baseline at week 12, ISA 2 - 2. QMG total score change from baseline at week 12, ISA 2 - 3. MG-ADL total score actual values and changes from baseline over time up to week 12, ISA 2 - 4. QMG total score actual values and changes from baseline over time up to week 12, ISA 2 - 5. Proportion of participants reaching MSE at any point by week 12, ISA 2 - 6. Proportion of participants who have ≥3-point reduction in MG-ADL at week 12, ISA 2 - 7. Proportion of participants who have ≥5-point reduction in QMG at week 12, ISA 2 - 8. Proportion of participants who have a positive PASS at week 12, ISA 2 - 9. Proportion of par | — |
Outcome results
None listed