Inebilizumab for NMDAR Encephalitis
(ExTINGUISH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug called inebilizumab for patients with severe anti-NMDAR encephalitis, a serious brain disease. The drug aims to reduce specific immune cells that cause the disease. Researchers hope this will improve symptoms and outcomes for these patients.
Do I need to stop my current medications for this trial?
The trial requires participants to stop other immunomodulatory therapies for NMDAR encephalitis during the study. However, it does not specify if you need to stop other medications, so it's best to discuss your specific situation with the study team.
Who Is on the Research Team?
Stacey L Clardy, MD, PhD
Principal Investigator
University of Utah
Are You a Good Fit for This Trial?
Adults diagnosed with NMDAR encephalitis who've had recent standard treatments can join. They must be able to attend study visits, agree to use effective contraception if applicable, and not receive other immunomodulatory therapies during the trial. Exclusions include a history of certain infections or diseases, recent participation in another clinical trial, pregnancy, specific prior treatments, and severe allergies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either inebilizumab or placebo in addition to first-line immunotherapy, including a 3-day course of IVIg
Follow-up
Participants are monitored for safety and effectiveness after treatment, with primary outcomes assessed at 16 weeks and additional assessments at 24 and 96 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Inebilizumab
- Placebo
Inebilizumab is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor