Myelin oligodendrocyte glycoprotein (MOG)antibody-associated disease (MOG-AD)
Conditions
Interventions
Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Periods.
Study participants will receive fixed-unit doses of rozanolixizumab across body weight tiers.
Sponsors
MATSUO TETSUO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD - Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization - Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
Exclusion criteria
Exclusion criteria: - Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant - Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP). - Participant has a current or medical history of primary immunodeficiency - Participant tests positive for aquaporin-4 antibodies at screening - Participant has a serum total IgG level 5.5g/L or less
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: 1. Time from randomization to first independently centrally adjudicated relapse (TTFR) during the Double Blind (DB) Treatment Period 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 |
|---|---|
| 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 2. Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months) 3. Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period 4. Incidence of treatment-emergent adverse events (TEAEs) during DB Treatment Period Part B: 5. Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period | — |
Countries
Australia, Belgium, Brazil, Czech Republic, France, Germany, Italy, Japan, Mexico, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactGlobal Clinical Science & Operation
UCB Japan Co., Ltd.
Outcome results
None listed