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(s) studied
Investigational drug(s) / intervention(s)
Satralizumab: In Part 1, study drug will be administered after all other study-related procedures have been performed at a site visit at Weeks 0, 2, 4, and every 4 weeks (Q4W) thereafter. Participants will receive satralizumab according to body weight, administered as subcutaneous (SC) injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit. In Part 2, participants will be asked to choose from one of the following options: Option 1: continue on randomized, double-blind study drug; Option 2: start open-label satralizumab based on body weight; Option 3: stop study treatment and continue follow-up assessments. As of Protocol Version 6, participants in the NMDAR cohort who chose Option 1 will transition to either Option 2 or Option 3 at the time of the primary analysis.
Placebo: Satralizumab placebo prefilled syringe (PFS) is identical in composition to satralizumab PFS, but does not contain the satralizumab active ingredient and will be identical in appearance and packaging to satralizumab. A PFS (assembled with an needle safety device \[NSD\] and extended finger flange) filled with 0.5 milliliters (mL) of solution, corresponding to 60 milligrams (mg) satralizumab, may be used in Part 2 once it becomes available at the study site.
Study summary
The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.
Eligibility
Primary outcome measure(s)
- Part 1: Proportion of Participants in NMDAR AIE Cohort With Modified Rankin Scale (mRS) Score Improvement ≥ 1 From Baseline and no Use of Rescue Therapy at Week 24 — Baseline up to Week 24
- Part 1: Proportion of Participants in LGI1 AIE Cohort With mRS Score Improvement ≥ 1 From Baseline and no Use of Rescue Therapy at Week 52 — Baseline up to Week 52
- Part 2: Percentage of Participants With Adverse Events (AEs) — From Week 52 up to 4 years
Trial sites (56)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Hoag Memorial Hospital | Newport Beach | California | |
| UCSF- Multiple Sclerosis Centre | San Francisco | California | |
| University of Colorado | Aurora | Colorado | |
| Childrens National Health Center | Washington D.C. | District of Columbia | |
| Brigham and Women's Hospital Department of Neurology | Boston | Massachusetts | |
| Mayo Clinic - Rochester | Rochester | Minnesota | |
| NYU-Langone Medical Center | New York | New York | |
| University Hospitals of Cleveland | Cleveland | Ohio | |
| Cleveland Clinic Foundation | Cleveland | Ohio | |
| Medical College of Wisconsin | Milwaukee | Wisconsin | |
| Hospital Ramos Mejía | CABA | Argentina | |
| Hospital Britanico | Ciudad Autonoma Bs As | Argentina | |
| Sanatorio del Sur S.A. | San Miguel de Tucumán | Argentina | |
| Hospital Geral de Fortaleza | Fortaleza | Ceará | |
| CEDOES - Diagnóstico e Pesquisa | Vitória | Espírito Santo | |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | |
| Centro de Pesquisas Clinicas | São Paulo | São Paulo | |
| Hospital Israelita Albert Einstein | São Paulo | São Paulo | |
| Beijing Children's Hospital, Capital Medical University | Beijing | China | |
| Beijing Tongren Hospital | Beijing | China | |
| Beijing Tiantan Hospital,Capital Medical University | Beijing | China | |
| West China Hospital - Sichuan University | Chengdu | China | |
| Fujian Medical University Union Hospital | Fuzhou | China | |
| Affiliated Hospital of Jining Medical University | Jining | China | |
| Huashan Hospital, Fudan University | Shanghai | China | |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | China | |
| Fakultni nemocnice v Motole | Prague | Czechia | |
| Odense Universitetshospital, Neurologisk Afdeling N | Odense C | Denmark | |
| Hopital neurologique Pierre Wertheimer - CHU Lyon | Bron | France | |
| Hopital Pitié Salpétrière - CHU | Paris | France | |
| Komfo Anokye Teaching Hospital | Kumasi | Ghana | |
| Hadassah University Hospital Ein Kerem | Jerusalem | Israel | |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | |
| A. O. U. Federico II | Naples | Campania | |
| Irccs A.O.U.San Martino Ist | Genoa | Liguria | |
| Fondazione Istituto Neurologico Mondino IRCCS | Pavia | Lombardy | |
| AOU Policlinico Giaccone | Palermo | Sicily | |
| Fujita Health University Hospital | Aichi | Japan | |
| Chiba University Hospital | Chiba | Japan |
+ 16 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05503264 on ClinicalTrials.gov ↗ ← All trials in Italy