Inebilizumab treatment 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
Inebilizumab, a medicine that lowers certain immune cells, is being given to people with anti‑NMDAR encephalitis to help improve recovery and reduce relapse.
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-11416210 on NIH RePORTER |
What this research studies
If you join, you would be randomly assigned to receive inebilizumab or a placebo and neither you nor your care team would know which you get (double‑blind). The trial focuses on people with anti‑NMDAR encephalitis and includes regular clinic visits, infusions, and testing of blood and spinal fluid for NMDAR antibodies and other disease markers. Doctors will track symptoms, need for intensive care, relapses, and side effects to understand safety and clinical benefit. The study is a Phase 2b trial designed to compare outcomes between the groups and explore biological markers linked to improvement.
Who could benefit from this research
Good fit: People diagnosed with anti‑NMDAR encephalitis (typically confirmed by NMDAR IgG antibodies in cerebrospinal fluid), usually in the acute or subacute phase, would be the intended participants.
Not a fit: People whose symptoms are caused by a different condition, who lack NMDAR antibodies, or who have advanced irreversible brain injury or contraindications to B‑cell–depleting therapy may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could speed recovery, reduce long‑term disability, and lower the chance of relapse for people with anti‑NMDAR encephalitis.
How similar studies have performed: Other B‑cell–depleting therapies (used off‑label) have shown benefit in retrospective series, but high‑quality randomized evidence for inebilizumab in NMDAR encephalitis is currently limited and this approach is relatively new for this disease.
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.