Inebilizumab for Autoimmune Encephalitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Autoimmune Encephalitis+1 MoreInebilizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Autoimmune Encephalitis
  • Encephalitis

Treatment Effectiveness

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 96 weeks

16 weeks
Change of modified Rankin score at 16 weeks
Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score (continuous logistic regression), corrected from baseline value to week 24 (weeks 6 and 16).
24 weeks
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).
6 weeks
Proportion of participants who meet the protocol-defined criteria for needing rescue therapy at week 6.
mRS at week 6 as measured by proportional odds logistic regression/shift analysis.
96 weeks
Inebilizumab safety measures by the number of treatment-emergent adverse events and serious adverse events
Survival as measured by a Kaplan-Meier analysis.
Time to mRS ≤ 2, corrected for baseline value.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Inebilizumab
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

116 Total Participants · 2 Treatment Groups

Primary Treatment: Inebilizumab · Has Placebo Group · Phase 2

Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Inebilizumab
Drug
ActiveComparator Group · 1 Intervention: Inebilizumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 96 weeks

Who is running the clinical trial?

University of UtahLead Sponsor
1,000 Previous Clinical Trials
1,782,122 Total Patients Enrolled
Stacey L Clardy, MD, PhDPrincipal InvestigatorUniversity of Utah

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The study found that the anti-NMDA receptor IgG antibody can be detected in the cerebrospinal fluid of patients with confirmed diagnosis of NMDA receptor encephalitis.
Participants must be at least 18 years old and must provide written consent, including authorization required by laws like the Health Insurance Portability and Accountability Act in the United States and the EU Data Privacy Directive in the EU, before any protocol-related procedures can be done, including screening evaluations.
Female study participants who are sexually active and have non-sterilized partners must use a highly effective contraceptive method from the time of screening or from the time they leave the hospital/rehabilitation center, whichever comes first
Participants who are sexually active with a female partner of childbearing potential must agree to use contraception at screening or upon discharge from hospitalization/inpatient rehabilitation
The person's mental state changes suddenly and it is thought to be due to an autoimmune disease that affects the brain.
The person is willing to stop using other treatments that could help improve their condition for the duration of the study.
A patient must have received at least 3 days of methylprednisolone 1000 mg IV or equivalent corticosteroid within 30 days prior to randomization (Day 1)
Plasma exchange, or plasmapheresis, is a process where the plasma (the clear liquid part of blood) is removed from the body and replaced with other fluids
References