drugset / Trial / NCT07822776
Efgartigimod in Anti-NMDA Receptor Encephalitis.
Phase 2
Recruiting
20 enrolled
Beijing Tongren Hospital
Beijing Huaxin Hospital · collabFirst Affiliated Hospital of Zhejiang University · collabHenan Provincial People's Hospital · collabPeking Union Medical College · collabShandong Provincial Hospital · collabThe Second Hospital of Hebei Medical University · collabXijing Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a multicenter, open-label, single-arm exploratory trial designed to enroll 20 eligible patients with anti-NMDAR encephalitis. It aims to evaluate the efficacy and safety of efgartigimod in the acute phase of anti-NMDAR encephalitis. The study drug is efgartigimod, α injection administered intravenously at a dose of 10 mg/kg (maximum dose 1200 mg). Each infusion lasts approximately 1 hour, administered weekly for a total of 4 doses. The primary endpoint is the change in modified Rankin Scale (mRS) score at week 4 (day 28) post-treatment compared to baseline.
Timeline
- Start
- 2026-06-25
- Primary completion
- 2027-12-31
- Completion
- 2028-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efgartigimod Alfa | Protein / enzyme biologic | 10 mg/kg | Intravenous |