A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease

Exclusion criteria

• ✕.3.1.1 Cohort A Inclusion Criteria The criteria below must be applied to all participants screened for Cohort A (participants with chronic ANRE) of the study.
• ✕. The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of informed consent. For the purposes of this study, the minimum age is 19 years in South Korea and 18 years in Australia.
• ✕. The participant, or their legally authorized representative (LAR), must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. For participants who are unable to sign the consent form themselves, informed consent must be obtained from their LAR in accordance with local regulations and ethical guidelines.
• ✕. The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the Investigator.
• ✕. The participant has a diagnosis of ANRE according to the Graus et al criteria (Graus et al, 2016), with symptom onset \>9 months to ≤36 months (or ≤120 months with Sponsor approval) prior to Week 0, Day 0.
• ✕. The participant has a positive cell-based assay result for CSF anti-NMDAR IgG autoantibody within 9 months of Week 0, Day 0. Participants without a positive CSF anti-NMDAR IgG autoantibody result within 9 months of Week 0, Day 0 may undergo a LP at Screening prior to the first study drug administration to confirm the presence of anti-NMDAR IgG autoantibodies in CSF (see Section 7.6.4.6.1).
• ✕. Participants treated with IVIG must have completed treatment at least 7 days prior to Week 0, Day 0.
• ✕. Participants previously treated with immunotherapy must be receiving a stable dose (per Investigator discretion) for ≥1 month before Week 0, Day 0.