A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease
A Phase 2a, Open-label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of ART5803 in Participants With Anti-NMDAR Encephalitis and AntiNMDAR Autoantibody-Associated Psychiatric Disease
Arialys Australia Pty Ltd
30 participants
May 15, 2026
INTERVENTIONAL
Conditions
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
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
A monovalent (one-armed) antibody, that binds to the NTD of the NMDAR NR1 subunit without causing NMDAR inhibition, activation, or receptor internalization, while simultaneously blocking the ability of the pathogenic anti-NMDAR autoantibodies to bind to the receptor. 1. Sentinel participants: 30 mg/kg 2. Subsequent participants: up to 60 mg/kg 3. Schedule: Q1W for 4 doses then Q2W for 4 doses
A monovalent (one-armed) antibody, that binds to the NTD of the NMDAR NR1 subunit without causing NMDAR inhibition, activation, or receptor internalization, while simultaneously blocking the ability of the pathogenic anti-NMDAR autoantibodies to bind to the receptor. Participants receive ART5803 by intravenous infusion once a week for 4 weeks, then every 2 weeks for 8 weeks, for a total of 8 doses. Sentinel participants receive 30 mg per kg. Additional participants may receive up to 60 mg per kg based on Safety Review Committee guidance.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07093333