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

NCT07093333 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-12

No results posted yet for this study

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

Conditions

  • Anti-N-methyl-D-aspartate Receptor (NMDAR) Encephalitis (ANRE)
  • Anti-N-methyl-D-aspartate Receptor (NMDAR) Antibody-associated Psychiatric Disease
  • Autoimmune Encephalitis

Interventions

DRUG

ART5803

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

DRUG

ART5803-Cohort D

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.

Sponsors & Collaborators

  • Arialys Therapeutics

    collaborator INDUSTRY

  • Seoul National University Hospital

    collaborator OTHER

  • Arialys Australia Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Pete Flynn, PhD · Arialys Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2027-11-30
Completion
2028-05-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093333 on ClinicalTrials.gov