Overview

Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD)

Status:
Not yet recruiting

Trial end date:
2025-04-15

Target enrollment:

Participant gender:

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase Ⅱ study to evaluate the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection with different doses in participants with neuromyelitis optica spectrum disorder (NMOSD). Participants will be randomly enrolled into three groups: Mitoxantrone Hydrochloride Liposome Injection 8 mg/m^2 group, Mitoxantrone Hydrochloride Liposome Injection 12 mg/m^2 group, and Placebo group. The primary outcome measure is time to first protocol-defined relapse.

Phase:

Phase 2

Details

Lead Sponsor:

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Treatments:

Mitoxantrone