Inebilizumab for NMDAR Encephalitis

(ExTINGUISH Trial)

Recruiting at 38 trial locations

Overseen By Ka-Ho Wong, MBA

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Must be taking: Methylprednisolone, IVIg, Plasmapheresis

Must not be taking: Biologic B cell-depleting, Methotrexate

Disqualifiers: Pregnancy, Active infection, Transplant history, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

116 Participants Needed

Trial Summary

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.

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.

Research Team

Stacey L Clardy, MD, PhD

Principal Investigator

University of Utah

Eligibility Criteria

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Inebilizumab Active Control 1 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: Placebo Placebo Group 1 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.

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

Approved in United States as Uplizna for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive

Approved in European Union as Uplizna for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive

Approved in Canada as Uplizna for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+