A Phase 3, open-label extension study to evaluate the long-term safety and efficacy of rozanolixizumab in adult participants with ocular myasthenia gravis

Conditions

Ocular Myasthenia Gravis

Brief summary

1. Incidence of treatment-emergent adverse events (TEAEs), 2. Incidence of treatment-emergent serious adverse events (TESAEs), 3. Incidence of TEAEs leading to permanent withdrawal of study treatment

Detailed description

1. Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome part), 2. Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular score, 3. Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score, 4. Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-item Scale (revised version) (MG-QoL15r) total score, 5. Study participant who generalizes to Myasthenia Gravis Foundation of America (MGFA) class ≥2 over time, 6. Change from Baseline in MGII total and generalized score over time, 7. Change from Baseline in MG-ADL total score over time

Related papers

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Interventions

DRUGRystiggo 140 mg/ml solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incidence of treatment-emergent adverse events (TEAEs), 2. Incidence of treatment-emergent serious adverse events (TESAEs), 3. Incidence of TEAEs leading to permanent withdrawal of study treatment	—

Secondary

Measure	Time frame
1. Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome part), 2. Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular score, 3. Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score, 4. Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-item Scale (revised version) (MG-QoL15r) total score, 5. Study participant who generalizes to Myasthenia Gravis Foundation of America (MGFA) class ≥2 over time, 6. Change from Baseline in MGII total and generalized score over time, 7. Change from Baseline in MG-ADL total score over time	—

Measure

Time frame

1. Change from Baseline at Day 43 in (Myasthenia Gravis Impairment Index) MGII ocular score (Patient-Reported Outcome part), 2. Change from Baseline at Day 43 in Myasthenia Gravis Activities of Daily Living (MG-ADL) ocular score, 3. Change from Baseline at Day 43 in Myasthenia Gravis Symptoms Patient-Reported Outcome (MGSPRO) ocular muscle weakness scale score, 4. Change from Baseline at Day 43 in Myasthenia Gravis Quality of Life 15-item Scale (revised version) (MG-QoL15r) total score, 5. Study participant who generalizes to Myasthenia Gravis Foundation of America (MGFA) class ≥2 over time, 6. Change from Baseline in MGII total and generalized score over time, 7. Change from Baseline in MG-ADL total score over time

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Outcome results

None listed