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 1 - 1. Incidence, severity, and relatedness of adverse events and serious adverse events in parts A and B, ISA 1 - 2. Clinically meaningful changes in vital signs, electrocardio grams, and laboratory parameters in parts A and B
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., ISA1 - 1. Myasthenia Gravis Activities of Daily Living (MG-ADL) total score change from baseline at week 18 in part B (cycle 2 day 29) compared with MG-ADL total score change from baseline at week 4 in part A, ISA 1 - 2. Proportion of participants reaching minimal symptom expression (MSE) at any point in part B cycles 1 and 2, and part B cycles 1 or 2, ISA 1 - 3. MG-ADL total score actual values and changes from baseline over time in part B compared with part A, ISA 1 - 4. Quantitative Myasthenia Gravis (QMG) total score change from baseline at week 18 in part B (cycle 2 day 29) compared with QMG total score change from baseline at week 4 in part A, ISA 1 - 5. QMG total score actual values and changes from baseline over time in part B compared with part A, ISA 1 - 6. Proportion of participants who have a 50% MG-ADL total score improvement in part B cycles 1 and 2, ISA 1 - 7. Proportion of participants who have positive patient acceptable symptom state (PASS) in part B cycles 1 and 2, and part B cycles 1 or 2
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 1 - 1. Incidence, severity, and relatedness of adverse events and serious adverse events in parts A and B, ISA 1 - 2. Clinically meaningful changes in vital signs, electrocardio grams, and laboratory parameters in parts A and B | — |
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., ISA1 - 1. Myasthenia Gravis Activities of Daily Living (MG-ADL) total score change from baseline at week 18 in part B (cycle 2 day 29) compared with MG-ADL total score change from baseline at week 4 in part A, ISA 1 - 2. Proportion of participants reaching minimal symptom expression (MSE) at any point in part B cycles 1 and 2, and part B cycles 1 or 2, ISA 1 - 3. MG-ADL total score actual values and changes from baseline over time in part B compared with part A, ISA 1 - 4. Quantitative Myasthenia Gravis (QMG) total score change from baseline at week 18 in part B (cycle 2 day 29) compared with QMG total score change from baseline at week 4 in part A, ISA | — |
Outcome results
None listed