Inebilizumab for anti-NMDAR encephalitis
A Phase-2b, Double-Blind, Randomized Controlled Trial to Evaluate the Activity and Safety of Inebilizumab in Anti-N-methyl-D-aspartate receptor (NMDAR) Encephalitis and Assess Markers of Disease
This trial gives inebilizumab to people with anti-NMDAR encephalitis to see if it is safe and helps lower the antibodies and improve recovery.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Utah State Higher Education System--University of Utah NIH-funded |
| Lab location | 1 site (Salt Lake City, United States) |
| Project ID | NIH-11184226 on NIH RePORTER |
What this research studies
If I join, I would be randomly assigned to receive either inebilizumab or a placebo and neither I nor my care team would know which one I get. Doctors will follow my symptoms, any side effects, and whether I need intensive support, while measuring antibody levels in my cerebrospinal fluid and blood over time. The study enrolls people diagnosed with anti-NMDAR encephalitis confirmed by CSF antibodies and follows them for months to track recovery and safety. The researchers are testing a B-cell–targeting approach added to usual care to see if it speeds recovery and reduces long-term disability.
Who could benefit from this research
Good fit: Ideal candidates are people with a confirmed diagnosis of anti-NMDAR encephalitis (positive CSF NMDAR-IgG), typically in the acute or subacute phase of illness.
Not a fit: People without NMDAR antibodies, those whose encephalitis has a different cause, or those with contraindications to immunotherapy are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this could lower disease-causing antibodies, improve recovery, and reduce the number of patients left with long-term disability from NMDAR encephalitis.
How similar studies have performed: Other B-cell–targeting therapies such as rituximab have shown benefit in observational series, and inebilizumab has worked in related autoimmune neurologic diseases, but randomized data specifically for NMDAR encephalitis are limited.
Where this research is happening
Salt Lake City, United States
- Utah State Higher Education System--University of Utah — Salt Lake City, United States (Active)
Researchers
- Principal investigator: Clardy, Stacey Lynn — Utah State Higher Education System--University of Utah
- Study coordinator: Clardy, Stacey Lynn
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.