Ocular Myasthenia Gravis
Conditions
Brief summary
Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (PRO part)
Detailed description
Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score, Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-item Scale (revised version) (MG-QoL15r) total score, Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular subdomain score, Change from Baseline at Day 43 in Myasthenia Gravis Impairment Index (MGII) ocular score (Physical Examination part), Incidence of treatment-emergent adverse events (TEAEs), Incidence of treatment-emergent serious adverse events (TESAEs), Incidence of TEAEs leading to permanent withdrawal of study treatment
Interventions
DRUGPlacebo matching Test 0.9% sodium chloride solution for injection.
Sponsors
UCB Biopharma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (PRO part) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score, Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-item Scale (revised version) (MG-QoL15r) total score, Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular subdomain score, Change from Baseline at Day 43 in Myasthenia Gravis Impairment Index (MGII) ocular score (Physical Examination part), Incidence of treatment-emergent adverse events (TEAEs), Incidence of treatment-emergent serious adverse events (TESAEs), Incidence of TEAEs leading to permanent withdrawal of study treatment | — |
Outcome results
None listed