RECRUITING

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

Conditions

NMDAR Autoimmune Encephalitis LGI1 Autoimmune Encephalitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-09-27

Study Completion:2028-12-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05503264

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.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Reference Study ID Number: WN43174, https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.)

global-roche-genentech-trials@gene.com

Global Medical Information:

CONTACT

global.medical_information@roche.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

UC San Diego

La Jolla, California, 92037

United States

Hoag Memorial Hospital

Newport Beach, California, 92658

United States

UCSF- Multiple Sclerosis Centre

San Francisco, California, 94158

United States

University of Colorado

Aurora, Colorado, 80045

United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242

United States

University of Maryland Medical Center

Baltimore, Maryland, 21201

United States

Johns Hopkins Hospital

Baltimore, Maryland, 21205

United States

Brigham and Women's Hospital Department of Neurology

Boston, Massachusetts, 02115

United States

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

United States

NYU-Langone Medical Center

New York, New York, 10016

United States

University Hospitals of Cleveland

Cleveland, Ohio, 44106

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44915

United States

Univ of Pennsylvania Med Ctr

Philadelphia, Pennsylvania, 19104

United States

University of Texas at Houston

Houston, Texas, 77030

United States

Swedish Neuroscience Institute

Seattle, Washington, 98122

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-27

Study Completion Date2028-12-07

Study Record Updates

Study Start Date2022-09-27

Study Completion Date2028-12-07

Terms related to this study

Additional Relevant MeSH Terms

NMDAR Autoimmune Encephalitis
LGI1 Autoimmune Encephalitis