NCT05496894

A Study of Mitoxantrone Hydrochloride Liposome Injection for Relapsing Multiple Sclerosis

A Phase Ⅱ Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection for Relapsing Multiple Sclerosis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, single-arm, open-label Phase II study to evaluate the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection with different doses in participants with Relapsing Multiple Sclerosis. Participants will be randomly enrolled into three treatment groups: Mitoxantrone Hydrochloride Liposome Injection 4 mg/m\^2 group, Mitoxantrone Hydrochloride Liposome Injection 8 mg/m\^2 group, and Mitoxantrone Hydrochloride Liposome Injection 12 mg/m\^2 group. The primary outcome measure is the cumulative number of new Gd-enhancing lesions at the end of 48 weeks of Mitoxantrone Hydrochloride Liposome Injection treatment in brain MRI.

Detailed description

Multiple sclerosis is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. It is characterised by multi-focal recurrent attacks of neurological symptoms and signs with variable recovery.This is a multicenter, randomized, single-arm, open-label Phase II study to evaluate the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection with different doses in participants with Relapsing Multiple Sclerosis. Participants will be randomly enrolled into three treatment groups: Mitoxantrone Hydrochloride Liposome Injection 4 mg/m\^2 group, Mitoxantrone Hydrochloride Liposome Injection 8 mg/m\^2 group, and Mitoxantrone Hydrochloride Liposome Injection 12 mg/m\^2 group. The primary outcome measure is the cumulative number of new Gd-enhancing lesions at the end of 48 weeks of Mitoxantrone Hydrochloride Liposome Injection treatment in brain MRI.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome Injection	IV, once every 3 months (Q3M)

Timeline

• Start date: 2022-08-01
• Primary completion: 2022-11-08
• Completion: 2022-11-08
• First posted: 2022-08-11
• Last updated: 2022-12-15

Locations

1 site across 1 country: China