Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2028

Conditions
Neuromyelitis Optica (NMO)Neuromyelitis Optica Spectrum Disorders (NMOSD)
Interventions
DRUG

Slow-tapering glucocorticoids + Inebilizumab

Slow-tapering glucocorticoids+Inebilizumab arm: A 300 mg intravenous infusion of inebilizumab will be administered on Day 1 and Day 15, followed by 300 mg infusions every 26 weeks thereafter. Prednisone will be initiated at a daily dose of 60 mg as concomitant therapy with inebilizumab. The prednisone dose will be tapered as follows: a reduction of 5 mg every 2 weeks until reaching 20 mg/day(Week 16); thereafter, a reduction of 5 mg every 4 weeks until discontinuation (a total duration of 32 weeks for combined inebilizumab and glucocorticoids therapy).

DRUG

Rapid-tapering glucocorticoids + Inebilizumab

Rapid-tapering glucocorticoids+Inebilizumab arm: A 300 mg intravenous infusion of inebilizumab will be administered on Day 1 and Day 15, followed by 300 mg infusions every 26 weeks thereafter. Prednisone will be initiated at a daily dose of 60 mg as concomitant therapy with inebilizumab, with a tapering schedule of 5 mg reduction per week until discontinuation (a total duration of 12 weeks for combined inebilizumab and glucocorticoids therapy).

All Listed Sponsors
lead

Tianjin Medical University General Hospital

OTHER

NCT07132398 - Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD | Biotech Hunter | Biotech Hunter