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

Conditions

NMDAR or LGI1 mediated autoimmune Encephalitis

Brief summary

1. NMDAR AIE cohort: Proportion of participants with mRS score improvement >=1 from baseline and no use of rescue therapy at Week 24, 2. LGI1 AIE cohort: Proportion of participants with mRS score improvement >=1 from baseline and no use of rescue therapy at week 52

Detailed description

1. NMDAR AIE cohort: Time to mRS score improvement >=1 from baseline without use of rescue therapy, 2. NMDAR AIE cohort: Time to rescue therapy, 3. NMDAR AIE cohort: Proportion of participants with sustained seizure cessation at Week 24, as defined by 4 consecutive weeks of no seizures maintained until Week 24, and no use of rescue therapy, 4. NMDAR AIE cohort: Change in CASE score from baseline at Week 24, 5. NMDAR AIE cohort: MOCA total score at Week 24, 6 . NMDAR AIE cohort: mRS score at Week 24 (as measured on a 7-point scale, 7. LGI1 AIE cohort: Time to mRS score improvement >=1 from baseline without use of rescue therapy, 8. LGI1 AIE cohort: Time to rescue therapy, 9. LGI1 AIE cohort: Proportion of participants with sustained seizure cessation at Week 24, as defined by 4 consecutive weeks of no seizures maintained until Week 24, and no use of rescue therapy, 10. LGI1 AIE cohort: Change in CASE score from baseline at Week 52, 11. LGI1 AIE cohort: MoCA total score at Week 52, 12. LGI1 AIE cohort: RAVLT score at Week 52, 13. Incidence, seriousness, and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, 14 . Change from baseline in targeted vital signs, clinical laboratory test results, electrocardiogram (ECG) results, weight, height (<18 years only), and Columbia-Suicide Severity Rating Scale (C-SSRS)

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. NMDAR AIE cohort: Proportion of participants with mRS score improvement >=1 from baseline and no use of rescue therapy at Week 24, 2. LGI1 AIE cohort: Proportion of participants with mRS score improvement >=1 from baseline and no use of rescue therapy at week 52	—

Secondary

Measure	Time frame
1. NMDAR AIE cohort: Time to mRS score improvement >=1 from baseline without use of rescue therapy, 2. NMDAR AIE cohort: Time to rescue therapy, 3. NMDAR AIE cohort: Proportion of participants with sustained seizure cessation at Week 24, as defined by 4 consecutive weeks of no seizures maintained until Week 24, and no use of rescue therapy, 4. NMDAR AIE cohort: Change in CASE score from baseline at Week 24, 5. NMDAR AIE cohort: MOCA total score at Week 24, 6 . NMDAR AIE cohort: mRS score at Week 24 (as measured on a 7-point scale, 7. LGI1 AIE cohort: Time to mRS score improvement >=1 from baseline without use of rescue therapy, 8. LGI1 AIE cohort: Time to rescue therapy, 9. LGI1 AIE cohort: Proportion of participants with sustained seizure cessation at Week 24, as defined by 4 consecutive weeks of no seizures maintained until Week 24, and no use of rescue therapy, 10. LGI1 AIE cohort: Change in CASE score from baseline at Week 52, 11. LGI1 AIE cohort: MoCA total score at Week 52, 12. L	—

Measure

Time frame

1. NMDAR AIE cohort: Time to mRS score improvement >=1 from baseline without use of rescue therapy, 2. NMDAR AIE cohort: Time to rescue therapy, 3. NMDAR AIE cohort: Proportion of participants with sustained seizure cessation at Week 24, as defined by 4 consecutive weeks of no seizures maintained until Week 24, and no use of rescue therapy, 4. NMDAR AIE cohort: Change in CASE score from baseline at Week 24, 5. NMDAR AIE cohort: MOCA total score at Week 24, 6 . NMDAR AIE cohort: mRS score at Week 24 (as measured on a 7-point scale, 7. LGI1 AIE cohort: Time to mRS score improvement >=1 from baseline without use of rescue therapy, 8. LGI1 AIE cohort: Time to rescue therapy, 9. LGI1 AIE cohort: Proportion of participants with sustained seizure cessation at Week 24, as defined by 4 consecutive weeks of no seizures maintained until Week 24, and no use of rescue therapy, 10. LGI1 AIE cohort: Change in CASE score from baseline at Week 52, 11. LGI1 AIE cohort: MoCA total score at Week 52, 12. L

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Countries

Austria, Czechia, Denmark, France, Italy, Netherlands, Poland, Spain

Outcome results