NMDA Satralizumab (Autoimmune Encephalitis)

NMDA Satralizumab (Autoimmune Encephalitis)

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Purpose of this Study

We are doing this study to find out if a drug called satralizumab (the study drug) is a safe and effective option for people with autoimmune encephalitis.

Who Can Participate?

Eligibility

Children and adults ages 12+ who:
  • Are diagnosed with NMDAR encephalitis or probable NMDAR encephalitis
  • Have had symptoms for fewer than 9 months before joining the study
For more information, contact the study team at lynn.rodgers@duke.edu.

Age Range

12-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you or your child choose to join this study, you/they will get a random assignment (like a coin flip) to either:
  • Get the study drug; OR
  • Get a placebo (inactive substance with no drug in it)
The study drug and placebo are given as injections (shots) every 4 weeks. The study is blinded for one year, which means that neither you/your child nor the research team will know if you/they are getting the study drug or a placebo. At the end of the blinded period, there will be an extension period. During this period, you/your child will have the choice to begin taking the study drug on an unblinded basis or to continue participating as a blinded participant. You/your child will have various tests done during your time in the study. These tests include:
  • Electroencephalograms or EEGs (a test that measures electrical activity in the brain)
  • Electrocardiograms or ECGs (a test that records electrical signals in the heart)
  • Blood draws
  • Physical exams

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

Yes

Study Details

Full Title

A Phase III, Randomized, Double-blinded, Placebo-controlled, Multicenter Basket Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Satralizumab in Patients with Anti-N-Methyl-D-Aspartic Acid Receptor (NMDAR) or Anti-Leucine-Rich Glioma-Inactivated 1 (LGI-1) Encephalitis

Principal Investigator

Heather
Van Mater

Protocol Number

PRO00115920

Phase

III

Enrollment Status

Pending Open to Enrollment