A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD)
The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.
| Condition(s) | NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis. |
| Who can participate | Inclusion 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 NMDAR AIE Cohort: * Age ≥ 12 years * Diagnosis of probable or definite NMDAR encephalitis LGI1 AIE Cohort * Age ≥ 18 years * Diagnosis of LGI1 |
| Ages | 12 Years |
| Sex | All |
| Lead sponsor | Hoffmann-La Roche |
| Locations | Birmingham, Alabama, United States; La Jolla, California, United States; Newport Beach, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States (+87 more sites) |
| Start date | 2022-09-27 |
| NCT ID | NCT05503264 |
| Official listing | https://clinicaltrials.gov/study/NCT05503264 |