A Study of Mitoxantrone Hydrochloride Liposome Injection for Relapsing Multiple Sclerosis
Status:
Not yet recruiting
Trial end date:
2028-08-01
Target enrollment:
Participant gender:
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.