Trial intelligence / Profile preview

Efgartigimod in Anti-NMDAR Encephalitis

NCT07822776Phase 2

Key facts

Status: Recruiting
Start: Jun 2026
Primary completion: Dec 2027
Countries: 1
Sponsor: Beijing Tongren Hospital

Drugs: efgartigimod alfa
Conditions: anti-N-methyl D-aspartate receptor encephalitis

Overview

Phase 2, open-label, single-arm trial of efgartigimod alfa in anti-N-methyl D-aspartate receptor encephalitis, sponsored by Beijing Tongren Hospital. Primary endpoint: modified Rankin Scale at 4 weeks. Started Jun 2026; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Efgartigimod treatment group
Efgartigimod 10 mg/kg IV weekly for 4 weeks.

Who it enrols

Adults with newly diagnosed or relapsed anti-NMDAR encephalitis, positive for anti-NMDAR IgG, mRS score >=2, who have received recent glucocorticoid therapy but not IVIG or plasma exchange within 2 weeks.

Endpoints

Primary

modified Rankin Scale4 weeks

Secondary

Clinical Assessment Scale for Autoimmune Encephalitis12 weeks
Clinical Global Impression Scale12 weeks
Glasgow Coma Scale12 weeks
Anti-NMDAR Encephalitis One-Year Functional Status Score12 weeks
Time of clinical improvement4 weeks
Anti-NMDAR antibody levels12 weeks
Total IgG levels12 weeks

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