A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis

Description

The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.

Conditions

NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis

Study Overview

Study Details

Study overview

The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 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

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis

Condition
NMDAR Autoimmune Encephalitis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

La Jolla

UC San Diego, La Jolla, California, United States, 92037

Newport Beach

Hoag Memorial Hospital, Newport Beach, California, United States, 92658

San Francisco

UCSF- Multiple Sclerosis Centre, San Francisco, California, United States, 94158

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Iowa City

University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States, 52242

Baltimore

University of Maryland Medical Center, Baltimore, Maryland, United States, 21201

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21205

Boston

Brigham and Women's Hospital Department of Neurology, Boston, Massachusetts, United States, 02115

Rochester

Mayo Clinic - Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Reasonable exclusion of tumor or malignancy before baseline visit (randomization)
  • * Onset of AIE symptoms ≤ 9 months before randomization
  • * Meet the definition of "New Onset" or "Incomplete Responder" AIE
  • * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab or placebo
  • * For participants enrolled in the extended China enrollment phase at China's sites: participants who are current residents of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
  • * Age ≥ 12 years
  • * Diagnosis of probable or definite NMDAR encephalitis
  • * Age ≥ 18 years
  • * Diagnosis of LGI1 encephalitis
  • * Any untreated teratoma or thymoma at baseline visit (randomization)
  • * History of carcinoma or malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening
  • * For participants with NMDAR AIE, history of negative anti-NMDAR antibody in cerebrospinal fluid (CSF) using a cell-based assay within 9 months of symptom onset
  • * Historically known positivity to an intracellular antigen with high cancer association or glutamate decarboxylase 65 (GAD-65)
  • * Historically known positivity to any cell surface neuronal antibodies other than NMDAR and LGI1, in the absence of NMDAR and LGI1 antibody positivity
  • * Confirmed paraneoplastic encephalitis
  • * Confirmed central or peripheral nervous system demyelinating disease
  • * Alternative causes of associated symptoms
  • * History of herpes simplex virus encephalitis in the previous 24 weeks
  • * Any previous/concurrent treatment with interleukin-6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, or bone marrow transplantation
  • * Any previous treatment with anti-cluster of differentiation 19 antibody (CD19 antibody), complement inhibitors, neonatal Fc receptor antagonists, anti-B-lymphocyte stimulator monoclonal antibody
  • * Any previous treatment with T-cell depleting therapies, cladribine, or mitoxantrone
  • * Treatment with oral cyclophosphamide within 1 year prior to baseline
  • * Treatment with any investigational drug (including bortezomib) within 24 weeks prior to screening
  • * Concurrent use of more than one immunosuppressive therapy (IST) as background therapy
  • * Contraindication to all of the following rescue treatments: rituximab, intravenous immunoglobulin (IVIG), high-dose corticosteroids, or intravenous (IV) cyclophosphamide
  • * Any surgical procedure, except laparoscopic surgery or minor surgeries within 4 weeks prior to baseline, excluding surgery for thymoma or teratoma removal
  • * Planned surgical procedure during the study
  • * Evidence of progressive multifocal leukoencephalopathy
  • * Evidence of serious uncontrolled concomitant diseases
  • * Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection
  • * Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection
  • * Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit
  • * Positive hepatitis B (HBV) and hepatitis C (HCV) test at screening
  • * Evidence of latent or active tuberculosis (TB)
  • * History of drug or alcohol abuse within 1 year prior to baseline
  • * History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that, in the investigator's opinion, may lead to increased risk of complications such as GI perforation
  • * Receipt of live or live-attenuated vaccine within 6 weeks prior to baseline visit
  • * History of blood donation (1 unit or more), plasma donation or platelet donation within 90 days prior to screening
  • * History of severe allergic reaction to a biologic agent
  • * History of suicide attempt within 3 years prior to screening except if this is clearly associated with and occurs during the acute phase of LGI-1 or NMDAR encephalitis
  • * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes safe participation in and completion of the study
  • * Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2028-12-07