A Study of Mitoxantrone Hydrochloride Liposome Injection for Relapsing Multiple Sclerosis

NCT05496894 | Withdrawn Phase 2

• 1 other identifier: HE071-CSP-030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• The cumulative number of new Gadolinium (Gd)-enhancing lesions at the end of 48 weeks of Mitoxantrone Hydrochloride Liposome Injection treatment in brain MRI.

  Week 48

Secondary Outcomes (14)

• Annualized Relapse Rate (ARR)

  Week 48

• Number of Relapses

  Week 48

• Time to Onset of Confirmed Disability Progression for at least 6 Months

  Week 48

• Time to Onset of Confirmed Disability Progression for at least 3 Months

  Week 48

• Proportion of participants with ≥ 20% improvement from baseline in T25FW walking speed.

  Week 48

Study Arms (3)

Mitoxantrone Hydrochloride Liposome Injection 4 mg/m^2 group

EXPERIMENTAL

Participants will receive Mitoxantrone Hydrochloride Liposome Injection 4 mg/m\^2 every 3 months (Q3M).

Drug: Mitoxantrone Hydrochloride Liposome Injection

Mitoxantrone Hydrochloride Liposome Injection 8 mg/m^2 group

EXPERIMENTAL

Participants will receive Mitoxantrone Hydrochloride Liposome Injection 8 mg/m\^2 every 3 months (Q3M).

Drug: Mitoxantrone Hydrochloride Liposome Injection

Mitoxantrone Hydrochloride Liposome Injection 12 mg/m^2 group

EXPERIMENTAL

Participants will receive Mitoxantrone Hydrochloride Liposome Injection 12 mg/m\^2 every 3 months (Q3M).

Drug: Mitoxantrone Hydrochloride Liposome Injection

Interventions

Mitoxantrone Hydrochloride Liposome Injection DRUG

IV, once every 3 months (Q3M)

Mitoxantrone Hydrochloride Liposome Injection 12 mg/m^2 group; Mitoxantrone Hydrochloride Liposome Injection 4 mg/m^2 group; Mitoxantrone Hydrochloride Liposome Injection 8 mg/m^2 group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 55 years of age (inclusive);
• Diagnosis of relapsing multiple sclerosis (RMS);
• Disease duration of secondary progressive multiple sclerosis (SPMS) with superimposed relapses ≤ 5 years;
• Expanded disability status scale (EDSS) score of 3 to 8;
• Participants who have received disease-modifying therapy still relapse or aggravate; or participants who, in the opinion of the investigator, are suitable for treatment with Mitoxantrone Hydrochloride Liposome Injection;
• Participants voluntarily sign informed consent, and complete the study according to the protocol.

You may not qualify if:

• Pregnant or lactating female participants or participants planning to have a child during the study;
• History of severe drug allergy, or allergy or intolerance to gadolinium, anthracyclines or liposome drugs;
• History of vitamin B12 deficiency;
• Participants with malignant tumor diagnosed within 5 years before the screening phase, except the skin basal cell carcinoma under effective control, and Stage I Squamous Cell Carcinoma);
• Participants with history of interstitial lung disease or with pneumonia according to chest X-ray in the screening phase;
• Participants with serious or active skin diseases, or clinically significant skin abnormalities in physical examination in the screening phase;
• History of severe immunodeficiency;
• History of drug and/or alcohol abuse, or mental disorder;
• Participants has a progressive neurological disorder or optic neuritis other than MS; or has other disease that should be treated more preferentially than MS, or that could interfere with the study or compromise participants compliance with treatment;
• MRI before randomization shows cervical spinal cord compression or lesions in non-MS characteristic areas of the brain, and the lesions can explain the changes in clinical symptoms and signs;
• MS relapse in the screening phase;
• Participated in other drug clinical studies and received investigational product within 3 months before screening or within 5 half-lives of the investigational product (whichever was longer), or participated in medical device clinical studies which is judged by the investigator to have a possible impact on the results of this study;
• Participants who have received disease-modifying therapy or immunosuppressive agents or systemic corticosteroids within the washout period before the first dose (e.g., 4 weeks for interferon, PEGylated interferon, glatiramer acetate, dimethyl fumarate and 12 weeks for fingolimod, siponimod, intravenous immunoglobulin or plasma exchange, etc.)
• Participants who have received anthracyclines or cardiotoxic drugs before screening;
• Participants who previously received total body irradiation or total lymphatic irradiation, or received stem cell therapy or any type of bone marrow transplantation, or received solid organ transplantation;

Sponsors & Collaborators

• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: lead

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 11, 2022
• Study Start: August 1, 2022
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)