Generalized Myasthenia Gravis
Conditions
Brief summary
- Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit - Occurrence of TEAEs leading to permanent withdrawal of IMP up to the EOS Visit - Occurrence of Adverse Event(s) of Special Monitoring (AESM) up to the EOS Visit
Detailed description
- Percent change in total Immunoglobulin G (IgG) from Baseline to the end of Week 6 of each Treatment Period (TP) - Absolute change in total IgG from Baseline to the end of Week 6 of each TP - Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG ADL) total score at the end of Week 6 of each TP - Change from Baseline in Quantitative Myasthenia Gravis (QMG) total score at the end of Week 6 of each TP
Interventions
DRUGRozanolixizumab
DRUG-
Sponsors
UCB Biopharma
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit - Occurrence of TEAEs leading to permanent withdrawal of IMP up to the EOS Visit - Occurrence of Adverse Event(s) of Special Monitoring (AESM) up to the EOS Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percent change in total Immunoglobulin G (IgG) from Baseline to the end of Week 6 of each Treatment Period (TP) - Absolute change in total IgG from Baseline to the end of Week 6 of each TP - Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG ADL) total score at the end of Week 6 of each TP - Change from Baseline in Quantitative Myasthenia Gravis (QMG) total score at the end of Week 6 of each TP | — |
Countries
Italy, Poland
Outcome results
None listed