A study to evaluate the efficacy and safety of rozanolixizumab in adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD)
- Conditions
- Myelin oligodendrocyte glycoprotein (MOG)antibody-associated disease (MOG-AD)
- Registration Number
- JPRN-jRCT2021210052
- Lead Sponsor
- MATSUO TETSUO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 11
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part A:<br>1. Time from randomization to first independently centrally adjudicated relapse (TTFR) during the Double Blind (DB) Treatment Period<br>Part B:<br>2. Incidence of treatment-emergent adverse events (TEAEs) during Open-Label Extension (OLE)Treatment Period <br>3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period
- Secondary Outcome Measures
Name Time Method Part A:<br>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<br>2. Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)<br>3. Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period<br>4. Incidence of treatment-emergent adverse events (TEAEs) during DB Treatment Period<br>Part B:<br>5. Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period