Generalized Myasthenia Gravis
Conditions
Brief summary
• Plasma concentrations of zilucoplan (ZLP) sampled at Week 4 (Day 29) • Change from Baseline in sheep red blood cell (sRBC) lysis at Week 4 (Day 29) • Change from Baseline in complement component 5 (C5) levels at Week 4 (Day 29)
Detailed description
• Occurrence of treatment-emergent adverse events (TEAEs) during the course of the study, • Occurrence of treatment-emergent serious adverse events (TESAE)s, • Occurrence of TEAEs leading to permanent withdrawal of investigational medicinal product (IMP), • Occurrence of treatment-emergent infections, • Occurrence of antidrug antibody (ADA) and anti- polyethylene glycol (PEG) antibodies at Week 4 (Day 29)., • Change in MG-activities of daily living (MG-ADL) score from Baseline to Week 4 (Day 29)., • Change in Quantitative MG (QMG) score from Baseline to Week 4 (Day 29)., • Myasthenia Gravis Foundation of America Post-Interventional Status (MGFA PIS) at Week 4 (Day 29)., • Change in Pediatric Quality of Life Inventory (PedsQoL), Version 4 domain scores from Baseline to Week 4 (Day 29).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Plasma concentrations of zilucoplan (ZLP) sampled at Week 4 (Day 29) • Change from Baseline in sheep red blood cell (sRBC) lysis at Week 4 (Day 29) • Change from Baseline in complement component 5 (C5) levels at Week 4 (Day 29) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Occurrence of treatment-emergent adverse events (TEAEs) during the course of the study, • Occurrence of treatment-emergent serious adverse events (TESAE)s, • Occurrence of TEAEs leading to permanent withdrawal of investigational medicinal product (IMP), • Occurrence of treatment-emergent infections, • Occurrence of antidrug antibody (ADA) and anti- polyethylene glycol (PEG) antibodies at Week 4 (Day 29)., • Change in MG-activities of daily living (MG-ADL) score from Baseline to Week 4 (Day 29)., • Change in Quantitative MG (QMG) score from Baseline to Week 4 (Day 29)., • Myasthenia Gravis Foundation of America Post-Interventional Status (MGFA PIS) at Week 4 (Day 29)., • Change in Pediatric Quality of Life Inventory (PedsQoL), Version 4 domain scores from Baseline to Week 4 (Day 29). | — |
Countries
Italy, Poland