Nervous System Diseases
Conditions
Interventions
Satralizumab Arm
Placebo Arm
Placebo
Sponsors
Hoffmann La Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Reasonable exclusion of tumor or malignancy before baseline visit (randomization) Onset of autoimmune encephalitis (AIE) symptoms =12 years Diagnosis of probable or definite NMDAR encephalitis Leucine-rich glioma-inactivated 1 (LGI1) AIE Cohort Age >=18 years Diagnosis of LGI1 encephalitis
Exclusion criteria
Exclusion criteria: 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 patients 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 GAD-65 Historically known positivity to any cell surface neuronal antibodies other than NMDAR and LGI1 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 IL-6 inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, or bone marrow transplantation Any previous treatment with anti-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 IST as background therapy Contraindication to all of the following rescue treatments: rituximab, 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 that may preclude patient participation Congenital or acquired immunodeficiency, including HIV infection Active or presence of recurrent bacterial, viral, funga
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Proportion of participants with mRS score improvement = 1 from baseline and no use of rescue therapy at Week 24 [ Time Frame: Baseline up to Week 24 ] mRS = Modified Rankin Scale Part 2: Percentage of participants with adverse events [ Time Frame: From Week 52 up to 2 years ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Time to mRS score improvement = 1 from baseline without use of rescue therapy [ Time Frame: Baseline up to Week 52 ] mRS = Modified Rankin Scale Part 1: Time to rescue therapy [ Time Frame: Baseline up to Week 52 ] Part 1: Time to seizure freedom or cessation of status epilepticus without use of rescue therapy [ Time Frame: Baseline up to Week 24 ] Seizure freedom defined as a cessation of seizures for at least 6 consecutive weeks Part 1: Change in CASE score from baseline at Week 24 [ Time Frame: Baseline up to Week 24 ] CASE = Clinical Assessment Scale in Autoimmune Encephalitis Part 1: MOCA total score at Week 24 [ Time Frame: Baseline up to Week 24 ] MOCA = Montreal Overall Cognitive Assessment; Part 1: RAVLT score at Week 24 (LGI1 AIE cohort) [ Time Frame: Baseline up to Week 24 ] RAVLT = Rey Auditory Verbal Learning Test. Part 1: mRS score at Week 24 (as measured on a 7-point scale; NMDAR AIE cohort) [ Time Frame: Baseline up to Week 24 ] mRS = Modified Rankin Scale Part 1: Percentage of participants with adverse events [ Time Frame: Baseline, Week 52, 2 Years ] Severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 | — |
Countries
Ghana
Contacts
Public ContactGladys Mills
Clinical Operations Lead
Outcome results
None listed