Research Study to Evaluate an Investigational Treatment Study to Treat Encephalitis
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Basket Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Anti-N-METHYL-D-ASPARTIC ACID RECEPTOR (NMDAR) Or Anti-LEUCINE-RICH GLIOMA-INACTIVATED 1 (LGI1) Encephalitis
- Sex: Any
- Age: Child (Birth - 17), Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase III
- Conditions Being Studied: Brain and Nervous System, Encephalitis
Study Purpose
The purpose of this study is to assess the effects, good or bad, of an investigational treatment in participants with autoimmune encephalitis. In the study, half of the participants will receive an investigational treatment, and the other half will receive a placebo. This investigational treatment is in addition to the continuation or completion of standard therapy for autoimmune encephalitis. The effects will be compared between those who receive investigational treatment and those who receive placebo. A placebo looks exactly like the study drug but has no active ingredient.
Who Can Participate
Participants 12 years old and older with onset of autoimmune encephalitis symptoms within the last 9 months may be eligible for this study.
Locations
UH Minoff Health Center at Chagrin Highlands
3909 Orange Place
Orange Village OH, 44122
UH Suburban Health Center
1611 South Green Road
South Euclid OH, 44121
UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106
- UH IRB: STUDY20220926
- StudyID: 2022-0853
- ClinicalTrials.gov: NCT05503264
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