Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis

PHASE3RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

November 8, 2024

Primary Completion Date

November 8, 2026

Study Completion Date

November 8, 2027

Conditions
Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Interventions
DRUG

Ofatumumab combined with daratumumab

All participants will begin acute first-line therapy prior to randomization, and participants who were receiving oral or intravenous corticosteroids at baseline will need to taper their doses according to a standard taper schedule starting 4 weeks after randomization (week 4). Patients will be randomly assigned to receive ofatumumab followed by daratumumab or ofatumumab followed by repeated intravenous globulin. The ofatumumab group will receive subcutaneous ofatumumab at weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24, while the ofatumumab-daratumumab group will receive daratumumab intravenously (on the second day of ofatumumab) in addition to ofatumumab, with a dose of 8 mg/kg at weeks 0, 1, 2, and 4, and a dose of 4 mg/kg at weeks 8, 12, 16, 20, and 24. The study will investigate the effects of up to 24 cycles of daratumumab.

DRUG

Ofatumumab

All participants were started on acute first-line therapy before randomization, and participants who were receiving oral or intravenous glucocorticoids at baseline were required to taper their doses according to a standard taper schedule starting 4 weeks after randomization (week 4). Ofatumumab was administered subcutaneously at weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24 in the ofatumumab group.

DRUG

Repeated intravenous immunoglobulin/plasma exchange therapy

Repeated intravenous immunoglobulin/plasma exchange therapy

Trial Locations (2)

213000

RECRUITING

The First People's Hospital of Changzhou, Changzhou

450000

RECRUITING

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

All Listed Sponsors
lead

The First People's Hospital of Changzhou

OTHER