Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD)
Conditions
Brief summary
For Part A: 1.Time from randomization to first independently centrally adjudicated relapse (TTFR) during the Double Blind (DB) Treatment Period, For Part B: 2. Incidence of treatment-emergent adverse events (TEAEs) during Open-Label Extension (OLE) Treatment Period 3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period
Detailed description
For Part A 1. Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the End of Double-Blind/Early Withdrawal (EDB/EWD) Visit, Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the end of the EDB/EWD Visit (with confirmation at 3 months), Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period, Incidence of treatment-emergent adverse events (TEAEs) during DB Treatment Period, For Part B 5. Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Part A: 1.Time from randomization to first independently centrally adjudicated relapse (TTFR) during the Double Blind (DB) Treatment Period, For Part B: 2. Incidence of treatment-emergent adverse events (TEAEs) during Open-Label Extension (OLE) Treatment Period 3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period | — |
Secondary
| Measure | Time frame |
|---|---|
| For Part A 1. Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the End of Double-Blind/Early Withdrawal (EDB/EWD) Visit, Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the end of the EDB/EWD Visit (with confirmation at 3 months), Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period, Incidence of treatment-emergent adverse events (TEAEs) during DB Treatment Period, For Part B 5. Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period | — |
Countries
Belgium, Czechia, France, Germany, Greece, Italy, Poland, Portugal, Spain, Sweden