A Randomized, Double-blind, Placebo-controlled Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD)

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.1 site in 1 country46 target enrollmentNovember 28, 2022

ConditionsNeuromyelitis Optica Spectrum Disorder

InterventionsMitoxantrone Hydrochloride Liposome Injection

Overview

Phase: Phase 2
Intervention: Mitoxantrone Hydrochloride Liposome Injection
Conditions: Neuromyelitis Optica Spectrum Disorder
Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Enrollment: 46
Locations: 1
Primary Endpoint: Time to First Protocol-defined Relapse
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 28, 2022

End Date

July 18, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18-60 years (inclusive) at the time of signing the informed consent form, both men and women;
•Participants meet the 2015 international consensus diagnostic criteria for neuromyelitis optica spectrum disease (NMOSD) and are AQP4-IgG positive or negative (acceptable test results within 24 weeks before signing the informed consent form);
•Experienced at least 2 attacks within 1 year before screening and/or at least 3 relapses in the past 24 months, but have at least 1 documented clinical evidence of attack or relapse (including the first attack) within 12 months before screening;
•Expanded disability status scale (EDSS) ≤ 7.5 points at screening and baseline retest;
•Participants voluntarily sign the informed consent form and voluntarily complete the trial according to the protocol requirements.

Exclusion Criteria

•Pregnant or lactating female participants, or participants planning to have a child during the study;
•Any surgical procedure within 4 weeks before randomization, with evidence of other demyelinating diseases or progressive multifocal leukoencephalopathy (PML);
•Known active infection (excluding nail bed fungal infection or dental caries) within 4 weeks before randomization;
•Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV antibody) is positive;
•History of drug or alcohol abuse or mental disorder within 1 year before randomization;
•Evidence of active tuberculosis (TB; excluding patients receiving drugs to prevent latent TB infection);
•Evidence of active interstitial lung disease;
•Receipt of any live or live attenuated vaccine within 6 weeks before randomization;
•History of malignancy, including solid tumors, hematological malignancies, and carcinoma in situ (except completely resected and cured basal cell carcinoma and squamous cell carcinoma or cervical carcinoma in situ) within the past 5 years;
•History of severe drug allergy, allergy or intolerance to Mitoxantrone and liposomes (shock, allergic reactions);

Arms & Interventions

Mitoxantrone Hydrochloride Liposome Injection 8 mg/m^2 group

Intervention: Mitoxantrone Hydrochloride Liposome Injection

Mitoxantrone Hydrochloride Liposome Injection 12 mg/m^2 group

Intervention: Mitoxantrone Hydrochloride Liposome Injection

Placebo Injection every 12 weeks (Q12W).

Intervention: Mitoxantrone Hydrochloride Liposome Injection

Outcomes

Primary Outcomes

Time to First Protocol-defined Relapse

Time Frame: Up to Week 48

Time to First Protocol-defined Relapse was defined as time from randomization to first occurrence of relapse. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neuromyelitis optica spectrum disorder (NMOSD).