Inectolizumab With Steroid Optimization in Newly Treated NMOSD

NANot yet recruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

May 31, 2026

Study Completion Date

September 30, 2026

Conditions
Neuromyelitis OpticaAutoimmune DiseasesDemyelinating Autoimmune Diseases, CNS
Interventions
DRUG

Inebilizumab + Rapid Steroid Tapering group

"Drug 1: Inebilizumab Generic Name: Inebilizumab Formulation: Injection (Intravenous) Dose: 300 mg Frequency:Day 6 (Week 0): First dose ;Day 20 (Week 2): Second dose ;Week 24: Third dose Route: Intravenous infusion Drug 2: Prednisone Generic Name: Prednisone Formulation: Tablet (Oral) Dose \& Tapering:Day 6-19: 60 mg daily;Day 20: 60 mg every other day (EOD)~;Day 34: 30 mg EOD → Day 48: 15 mg EOD → Day 62: 10 mg EOD → Day 76: 5 mg EOD → Day 90: Discontinue Route: Oral"

DRUG

Inebilizumab + Standard Steroid Tapering group

Drug 1: Inebilizumab Generic Name: Inebilizumab Formulation: Injection (Intravenous) Dose: 300 mg Frequency:Day 6 (Week 0): First dose ;Day 20 (Week 2): Second dose ;Week 24: Third dose Route: Intravenous infusion Drug 2: Prednisone Generic Name: Prednisone Formulation: Tablet (Oral) Dose \& Tapering:Day 6-34: 60 mg daily;Day 34: 60 mg EOD → Day 62: 30 mg EOD → Day 90: 15 mg EOD → Day 118: 10 mg EOD → Day 146: 5 mg EOD → Day 174:Discontinue; Route: Oral

All Listed Sponsors
lead

First Affiliated Hospital of Wenzhou Medical University

OTHER

NCT07159893 - Inectolizumab With Steroid Optimization in Newly Treated NMOSD | Biotech Hunter | Biotech Hunter