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
None
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.
Single group
ART5803
DrugA 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
ART5803-Cohort D
DrugA 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.
To assess the safety and tolerability of ART5803
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
To assess the safety and tolerability of ART5803
Clinically significant changes in physical examination findings.
To assess the safety and tolerability of ART5803
Clinically significant changes in neurological examination findings
To assess the safety and tolerability of ART5803
Vital signs - Systolic and diastolic blood pressure
To assess the effects of ART5803 on Patient Reported Outcomes (PROs)
Change from baseline in patient reported endpoints: Short Form Health Survey, Version 2 (SF-36-II) mental component domain score (Score range: 0-100. Higher score indicated better symptoms) (Cohort A only)
To assess the effects of ART5803 on Patient Reported Outcomes (PROs)
Change from baseline in patient reported endpoints: Trail Making Test, Part A (TMT-A) scores (Time to complete (higher = worse)) (Cohort A only)
To assess the effects of ART5803 on Patient Reported Outcomes (PROs)
Change from baseline in patient reported endpoints: European Quality of Life, 5-dimension, 5-level (EQ-5D-5L) scores (Score range: -0.281 to 1. Higher score indicated better symptoms) (Cohort A only)
To assess the effects of ART5803 on Patient Reported Outcomes (PROs)
Change from baseline in patient reported endpoints: Beck Depression Inventory-II (BDI-II) scores (Score range: 0-63. Higher score indicated worse symptoms) (Cohort A only)
To assess the changes in cognition following ART5803 administration
Change from baseline in Montreal Cognitive Assessment (MoCA) (Score range: 0-30. Higher score indicated better symptoms) (Cohort B and C only)
To assess the change in use of rescue medications following ART5803 administration
Proportion of participants with use of rescue therapy within 12 weeks of ART5803 administration Change in the frequency and dosage of rescue therapy from baseline to Week 11
Click on the lead sponsor to view all of their trials.
Arialys Australia Pty Ltd
Lead sponsor
Arialys Therapeutics
Collaborator
Seoul National University Hospital
Collaborator
