Clinical Trials

Inclusion Criteria:

- Participant must be ≥18 to ≤89 years of age, at the time of signing the informed
consent

- Confirmed diagnosis of MOG-AD, which entails that the participant must have:

1. History of any of the following core clinical demyelinating events:

- 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

2. Positive serum MOG-IgG antibody test 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 (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 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/22/22. Questions regarding updates should be directed to the study team contact.