116 Participants Needed

Inebilizumab for NMDAR Encephalitis

(ExTINGUISH Trial)

Recruiting at 38 trial locations
SL
KW
KW
Overseen ByKa-Ho Wong, MBA
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Utah
Must be taking: Methylprednisolone, IVIg, Plasmapheresis
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

SL

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

I have been diagnosed with NMDAR encephalitis confirmed by a specific test.
I have received IVIg or undergone plasma exchange at least 5 times in the last 30 days.
Written informed consent and any locally required authorization obtained from the participant/legal representative prior to performing any protocol-related procedures, including screening evaluations
See 6 more

Exclusion Criteria

Severe drug allergic history or anaphylaxis to two or more food products or medicines
I have not received a live vaccine recently.
I have received the specific treatments required before being randomly assigned to a trial group.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either inebilizumab or placebo in addition to first-line immunotherapy, including a 3-day course of IVIg

16 weeks

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

96 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Inebilizumab
  • Placebo
Trial Overview The trial is testing Inebilizumab against a placebo in patients already receiving standard care for NMDAR encephalitis. The main goal is to see how well participants recover over 16 weeks by looking at changes in their disability levels measured by the modified Rankin score.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: InebilizumabActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Inebilizumab is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Uplizna for:
🇪🇺
Approved in European Union as Uplizna for:
🇨🇦
Approved in Canada as Uplizna for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security