Clinical Trials

Inclusion Criteria:

• Participant must be ≥ 18 to ≤ 89 years of age, at the time of signing the informed consent.
• Participant must have a history of myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) with any of the following clinical presentations:
  • Optic neuritis (single, recurrent, or simultaneous bilateral);
  • Transverse myelitis (including Longitudinally extensive spinal cord lesion (LETM));
  • Acute disseminated encephalomyelitis or MOG antibody-associated encephalitis, brain stem encephalitis;
  • Combined presentations.
• Positivity for serum MOG-Immunglobulin G (IgG) antibodies using cell-based assay at Screening.
• Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months prior to randomization.
• Participant must be clinically stable at the time of the Screening Visit and during the Screening Period.

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 relevant active infection (e.g., 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 a current or medical history of primary immunodeficiency.
• Participant has a current or medical history of IgA deficiency.
• Participant tests positive for aquaporin-4 antibodies at screening.
• Participant has a serum total IgG level ≤ 5.5g/L.

Eligibility last updated 2/10/22. Questions regarding updates should be directed to the study team contact.