Actively Recruiting
The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis
Led by University of Utah · Updated on 2025-07-01
116
Participants Needed
39
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Determine the difference in the modified Rankin score at 16 weeks in participants with anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with "first-line" immunomodulatory therapies provided as standard-of-care, and either inebilizumab (investigational agent) or placebo.
CONDITIONS
Official Title
The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of NMDAR encephalitis confirmed by positive anti-NMDA receptor IgG antibody in cerebrospinal fluid
- Subacute onset of mental status changes consistent with autoimmune encephalitis
- Age 12 years or older at consent; participants under 18 must weigh at least 40 kilograms
- Signed informed consent obtained before any study procedures
- Sexually active participants with partners capable of becoming pregnant must use effective contraception during and after the study
- Willing to avoid other immunomodulatory therapies for NMDAR encephalitis during the study
- Received at least 3 days of high-dose corticosteroids and either IVIg or plasmapheresis within 90 days before randomization
- Modified Rankin Score of 3 or higher at screening indicating moderate disability
- Ability and willingness to attend study visits and complete the study
You will not qualify if you...
- Any condition that interferes with study treatment or safety, including recent herpes simplex virus encephalitis or known central nervous system demyelinating disease
- Active or chronic serious infection
- History of solid organ or cell transplantation
- Enrollment in another investigational treatment study within 4 weeks or 5 half-lives prior to randomization
- Pregnant or lactating individuals, or those planning pregnancy during study and 12 months after
- Allergy or severe reaction to components of the investigational agent or biologic therapies
- Receipt of certain immunosuppressive treatments or biologic B cell-depleting therapies within specified time frames prior to screening
- Severe allergic history or anaphylaxis to multiple food or medicine products
- Known primary immunodeficiency or conditions increasing infection risk
- Active malignancy or history of malignancy active within last 10 years except certain treated skin or ovarian tumors
- Abnormal blood counts or low immune cell levels at screening
- Active hepatitis B or C infection
- Use of live or attenuated vaccines within 4 weeks prior to study start
- History of tuberculosis or signs of active TB without completed treatment
- Active, clinically significant infection at randomization
- History of alcohol or drug abuse affecting safety or compliance
- Recurrence of NMDAR encephalitis within last 5 years or untreated disease longer than 3 months
- Abnormal liver function tests or low platelet/hemoglobin counts requiring safety review
- Untreated hepatitis C infection
- Coexisting autoantibodies requiring safety review
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
St. Joseph Hospital and Medical Center Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
3
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
4
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
5
UC Irvine
Orange, California, United States, 92868
Actively Recruiting
6
UC Davis
Sacramento, California, United States, 95816
Actively Recruiting
7
Children's Hospital Colorado Main Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
8
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
10
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
11
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
12
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
13
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
14
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
15
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
16
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
17
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
18
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
19
Washington University in St. Louis School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
20
SUNY Downstate
Brooklyn, New York, United States, 11203
Actively Recruiting
21
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
22
Columbia University Medical Center
New York, New York, United States, 10033
Actively Recruiting
23
University of Rochester
Rochester, New York, United States, 14618
Actively Recruiting
24
SUNY Buffalo
Williamsville, New York, United States, 14221
Actively Recruiting
25
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27101
Actively Recruiting
26
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
27
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
28
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
29
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
30
Vanderbilt University
Nashville, Tennessee, United States, 37212
Actively Recruiting
31
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
32
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
33
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
34
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
35
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
36
Erasmus Medical University Center
Rotterdam, Netherlands
Actively Recruiting
37
Erasmus University Rotterdam
Rotterdam, Netherlands
Actively Recruiting
38
Hospital Clínic Barcelona
Barcelona, Spain
Actively Recruiting
39
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona
Barcelona, Spain
Actively Recruiting
Research Team
S
Stacey L Clardy, MD, PhD
CONTACT
K
Ka-Ho Wong, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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