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Monoclonal Antibodies
Inebilizumab for NMDAR Encephalitis (ExTINGUISH Trial)
Phase 2
Recruiting
Led By Stacey L Clardy, MD, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of NMDAR encephalitis, defined by subacute onset of change in mental status consistent with autoimmune encephalitis and a positive cell-based assay for anti-NMDA receptor IgG antibody in the CSF confirmed in study-specified laboratories
Received IVIg at a minimum dose of 2 g/kg or plasma exchange/plasmapheresis with a minimum of 5 treatments within 30 days before randomization
Must not have
Presence of an active or chronic serious infection
Recent history (last 5 years) of herpes simplex virus encephalitis or known central nervous system demyelinating disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, Inebilizumab may cause reactions related to the immune system since it's designed to modify immune responses. This could potentially lead to infusion-related reactions or increase susceptibility to infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with NMDAR encephalitis confirmed by a specific test.
Select...
I have received IVIg or undergone plasma exchange at least 5 times in the last 30 days.
Select...
I am 18 years old or older.
Select...
I agree to use effective birth control if I can have children and am sexually active.
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I am a man who can father children and will use effective birth control.
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I agree not to take other immune therapies for NMDAR encephalitis during the study.
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I've had high-dose steroids via IV in the last month.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a serious ongoing infection.
Select...
I have not had herpes brain infection or nerve damage diseases in the last 5 years.
Select...
My NMDAR encephalitis has come back within the specified time.
Select...
I have a condition that makes me more likely to get infections.
Select...
I have a history of cancer, but it may fit the exceptions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change of modified Rankin score at 16 weeks
Inebilizumab safety measures by the number of treatment-emergent adverse events and serious adverse events
Secondary study objectives
Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score (continuous logistic regression), corrected from baseline value to week 24 (weeks 6 and 16).
Cognitive outcome at week 24 as measured by mean scaled score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) + components of Delis-Kaplan Executive Function System (D-KEFS).
Proportion of participants who meet the protocol-defined criteria for needing rescue therapy at week 6.
+3 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: InebilizumabActive Control1 Intervention
Approximately 58 patients will receive Inebilizumab in addition to first line immunotherapy.
(Approximately 116 participants will be randomized in a 1:1 ratio to 2 treatment groups; approximately 58 participants to each treatment group).
All participants will also receive a 3 day course of IVIg.
Group II: PlaceboPlacebo Group1 Intervention
Approximately 58 patients will receive placebo in addition to first line immunotherapy.
(Approximately 116 participants will be randomized in a 1:1 ratio to 2 treatment groups; approximately 58 participants to each treatment group).
All participants will also receive a 3 day course of IVIg.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Encephalitis, including corticosteroids, intravenous immunoglobulin (IVIG), plasmapheresis, and B-cell depletion therapies like Inebilizumab, primarily work by modulating the immune system. Inebilizumab, an anti-CD19 monoclonal antibody, depletes B cells, which are key players in the autoimmune response that can cause Encephalitis.
Corticosteroids reduce inflammation by suppressing the overall immune response, IVIG provides a pool of antibodies that can neutralize harmful autoantibodies, and plasmapheresis removes these autoantibodies from the blood. These mechanisms are crucial for Encephalitis patients as they help to control the immune-mediated damage to the brain, thereby reducing symptoms and preventing further neurological deterioration.
Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: Analysis of aquaporin-4-immunoglobulin G-seropositive participants taking inebilizumab for ⩾4 years in the N-MOmentum trial.B-cell-targeted treatment for multiple sclerosis: mechanism of action and clinical data.
Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: Analysis of aquaporin-4-immunoglobulin G-seropositive participants taking inebilizumab for ⩾4 years in the N-MOmentum trial.B-cell-targeted treatment for multiple sclerosis: mechanism of action and clinical data.
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,130 Previous Clinical Trials
1,793,455 Total Patients Enrolled
Stacey L Clardy, MD, PhDPrincipal InvestigatorUniversity of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with NMDAR encephalitis confirmed by a specific test.I have not received a live vaccine recently.I have received the specific treatments required before being randomly assigned to a trial group.I have received IVIg or undergone plasma exchange at least 5 times in the last 30 days.I am 18 years old or older.I don't have any health issues that would make the study risky for me.I agree to use effective birth control if I can have children and am sexually active.I received the BCG vaccine within the required timeframe.I have a serious ongoing infection.I can and will go to all study visits and complete the study.I have not had herpes brain infection or nerve damage diseases in the last 5 years.I am a man who can father children and will use effective birth control.I agree not to take other immune therapies for NMDAR encephalitis during the study.My NMDAR encephalitis has come back within the specified time.I have a condition that makes me more likely to get infections.I have a history of cancer, but it may fit the exceptions.I have taken certain medications within the required timeframes.I've had high-dose steroids via IV in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Inebilizumab
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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