NCT05403138View on ClinicalTrials.gov

Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL

Enrollment

135

Participants

Timeline

Start Date

November 1, 2022

Primary Completion Date

November 1, 2025

Study Completion Date

December 1, 2025

Conditions

Neuromyelitis OpticaNeuromyelitis Optica Spectrum DisorderNMO Spectrum Disorder

Interventions

DRUG

Daratumumab

Induction Phase: (8mg/kg) via intravenous (IV) evey 2 weeks for two cycles. Maintenance Phase: (4mg/kg) IV every 4 weeks.

DRUG

Placebo

Induction Phase: matching placebo (8mg/kg) via intravenous (IV) every 2 weeks for two cycles; Maintenance Phase: matching placebo (4mg/kg) IV every 4 weeks.

Trial Locations (1)

300052

Tianjin Medical University General Hospital, Tianjin

All Listed Sponsors

lead

Tianjin Medical University General Hospital

OTHER