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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 96 weeks

Awards & highlights

ExTINGUISH Trial Summary

This trial will test whether the investigational agent inebilizumab is better than placebo at treating NMDAR encephalitis.

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.Check my eligibility

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.See study design

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.

ExTINGUISH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with NMDAR encephalitis confirmed by a specific test.

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I have received IVIg or undergone plasma exchange at least 5 times in the last 30 days.

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I am 18 years old or older.

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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.

ExTINGUISH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change of modified Rankin score at 16 weeks

Inebilizumab safety measures by the number of treatment-emergent adverse events and serious adverse events

Secondary outcome measures

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 more

ExTINGUISH Trial 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.

0 / 7Eligibility criteria met

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Who is running the clinical trial?

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,573 Total Patients Enrolled

Stacey L Clardy, MD, PhDPrincipal InvestigatorUniversity of Utah

Media Library

Inebilizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04372615 — Phase 2

Encephalitis Research Study Groups: Placebo, Inebilizumab

Encephalitis Clinical Trial 2023: Inebilizumab Highlights & Side Effects. Trial Name: NCT04372615 — Phase 2

Inebilizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04372615 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary goals of this research?

"The aim of this 96-week study will be to monitor changes in modified Rankin score at 16 weeks. Additionally, researchers will compare results from the Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score, cognitive outcome tests, and a Kaplan-Meier analysis for patients enrolled in the trial."

Answered by AI

Are there any open slots in this trial for new patients?

"Yes, this is an active recruitment according to the latest update on clinicaltrials.gov which was October 21st, 2022. The original posting date for this study was March 30th, 2020."

Answered by AI

How many people will be taking part in this experiment?

"Yes, that is accurate. The website clinicaltrials.gov has information about the study's current status. According to the site, this trial was originally posted on 3/30/2022 and was most recently edited on 10/21/2022. They are looking for 116 participants between 20 sites."

Answered by AI

Could you please tell us how many hospitals are participating in this experiment?

"The locations of this clinical trial include UC Davis in Sacramento, California, St. Joseph Hospital and Medical Center Barrow Neurological Institute in Phoenix, Arizona, University of Utah in Salt Lake City, Utah as well other 20 medical centres."

Answered by AI

What is the background on Inebilizumab research?

"3 ongoing clinical trials are studying the efficacy of inebilizumab. 2 of these studies have reached phase 3. The 217 research sites for this medication are located around the world, with some concentration in Lille Cedex and Utah."

Answered by AI

What is the governing body's stance on Inebilizumab?

"Inebilizumab's safety is estimated to be a 2. While there is some data supporting its safety, none of the evidence collected thus far suggests that it is an effective medication."

Answered by AI

Have patients undergone this treatment before as part of a clinical trial?

"Since 2020, inebilizumab has been the focus of various clinical trials. The first study occurred in that same year and was sponsored by Viela Bio.270 people participated in this initial trial which led to Phase 3 drug approval for inebilizumab. Now, there are three separate ongoing studies involving this medication taking place across 48 cities and 28 countries."

Answered by AI

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