Trials / Not Yet Recruiting
Not Yet RecruitingNCT07093333
A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Antibody-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 Anti-NMDAR Antibody-Associated Psychiatric Disease
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Arialys Australia Pty Ltd · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety, tolerability, 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 antibody-associated psychiatric disease
Detailed description
Anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis is one of the most common causes of autoimmune encephalitis. The disease is caused by the development of autoantibodies against the amino (N)-terminal domain (NTD) of the NMDAR subunit 1 (NR1) that bind and cross link the receptors, leading to receptor internalization and loss of function. Arialys has developed a monovalent (one-armed) antibody, ART5803, 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. There is also an increasing body of data supporting the potential link between broader psychiatric diseases and the presence of autoantibodies against the NMDAR.
Conditions
- Anti-N-methyl-D-aspartate Receptor (NMDAR) Encephalitis (ANRE)
- Anti-N-methyl-D-aspartate Receptor (NMDAR) Antibody-associated Psychiatric Disease
- Autoimmune Encephalitis
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2026-12-30
- Completion
- 2027-03-30
- First posted
- 2025-07-30
- Last updated
- 2025-07-30
Source: ClinicalTrials.gov record NCT07093333. Inclusion in this directory is not an endorsement.