Actively Recruiting
A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease
Led by Arialys Australia Pty Ltd · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
A
Arialys Australia Pty Ltd
Lead Sponsor
A
Arialys Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years able to provide informed consent
- Diagnosed with anti-NMDAR encephalitis or anti-NMDAR autoantibody-associated psychiatric disease
- Positive anti-NMDAR IgG autoantibody test in cerebrospinal fluid within specified recent timeframes
- Stable immunotherapy or psychiatric medication use as per study requirements
- No active cancer or residual teratoma; prior teratoma fully resected at least 1 week before treatment
- Willingness to use highly effective contraception if sexually active and of childbearing potential
- Negative pregnancy test for females of childbearing potential at screening
- Ability and willingness to comply with all study procedures
- Adequate disease severity based on specific cognitive or psychiatric assessments
You will not qualify if you...
- Pregnant or breastfeeding individuals or those planning pregnancy during the study
- Use of investigational agents or NMDAR modulators other than ART5803 within specified timeframes
- Previous exposure to ART5803 or other NMDAR-targeting antibodies
- Conditions interfering with study participation or safety as determined by investigator
- Coexisting CNS demyelinating disorders or significant psychiatric/neurologic disorders other than ANRE, unless approved
- Positive hepatitis B or C test at screening
- Known allergy or anaphylaxis history to ART5803 components or biologic therapies
- History or current moderate to severe substance use disorder within 12 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
Research Team
A
April Purcell
CONTACT
M
Mari Maurer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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