Clinical Trial

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

Recruiting Phase 2
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Summary
This study will evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics (PK) of ART5803 in adult participants with a confirmed diagnosis of anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis (ANRE) or anti-NMDAR autoantibody-associated psychiatric disease
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-13
Trial Details
NCT Number NCT07093333
Lead Sponsor Arialys Australia Pty Ltd
Collaborators: Arialys Therapeutics, Seoul National University Hospital
Conditions Anti-N-methyl-D-aspartate Receptor (NMDAR) Encephalitis (ANRE), Anti-N-methyl-D-aspartate Receptor (NMDAR) Antibody-associated Psychiatric Disease, Autoimmune Encephalitis
Enrollment 30 participants
Start Date 2026-05-15
Primary Completion 2027-11-30 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-12