Individual Participant Data (IPD) Sharing Statement:ĭata from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Pathomechanisms in demyelination and astrocytopathy: autoantibodies to AQP4, MOG, GFAP, GRP78 and beyond. Kansas City, Kansas, United States, 66160īoston, Massachusetts, United States, 02114-3117 Palo Alto, California, United States, 94304 Scottsdale, Arizona, United States, 85259-5452 Participant has a serum total IgG level ≤ 5.5g/L.Participant tests positive for aquaporin-4 antibodies at screening.Participant has a current or medical history of IgA deficiency.Participant has a current or medical history of primary immunodeficiency.Participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess), or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP).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 must be clinically stable at the time of the Screening Visit and during the Screening Period.Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months prior to randomization.Positivity for serum MOG-Immunglobulin G (IgG) antibodies using cell-based assay at Screening.Acute disseminated encephalomyelitis or MOG antibody-associated encephalitis, brain stem encephalitis.
Transverse myelitis (including Longitudinally extensive spinal cord lesion (LETM)).Optic neuritis (single, recurrent, or simultaneous bilateral).Participant must have a history of myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) with any of the following clinical presentations: Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent.Why Should I Register and Submit Results?.
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