MOG001
This phase 3, multicenter, randomized, and placebo-controlled trial evaluates the efficacy and safety of rozanolixizumab in adult participants with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The study includes an open-label extension period for patient follow-up.
A pivotal phase 3, randomized, double-blind, placebo-controlled, multicenter study with an open-label extension period evaluating the efficacy and safety of rozanolixizumab in adult participants with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). EudraCT: 2021-000352-19.
Sponsor: UCB
Phase: III
Status: Follow-up
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Public study eligibility criteria
Inclusion
- * Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent
- * Confirmed diagnosis of MOGAD consistent with published diagnostic criteria for MOGAD
- * Participant has history of relapsing MOGAD 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
- * 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