A Study of Mitoxantrone Hydrochloride Liposome Injection for Relapsing Multiple Sclerosis

December 13, 2022 updated by: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Xuanwu Hospital Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

  • 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;
  • Presence of the following clinically significant diseases: myocardial infarction, acute coronary syndrome, viral myocarditis, pulmonary embolism within 6 months; coronary revascularization within 6 months; arrhythmia requiring Class Ia or Ш antiarrhythmic drugs;
  • Laboratory tests in screening phase, such as white blood cell count, neutrophil count, platelet count, hemoglobin, creatinine clearance, etc., are abnormal with clinical significance (according to the judgment of the investigator); positive results for Hepatitis B Surface Antigen (HBsAg), Hepatitis C Antibody (HCVAb), syphilis antibody test; total bilirubin > 1.5x ULN, or alanine aminotransferase or aspartate aminotransferase > 3x ULN;
  • Participants could not complete MRI scan before randomization, such as participants with claustrophobia;
  • Participants with active or uncontrolled infection (defined as requiring systemic anti-infective therapy and the temperature ≥ 38℃ (axillary temperature) before receiving drugs and unexplainable);
  • Investigator believe that participants have other disease that are not suitable for participating in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mitoxantrone Hydrochloride Liposome Injection 4 mg/m^2 group
Participants will receive Mitoxantrone Hydrochloride Liposome Injection 4 mg/m^2 every 3 months (Q3M).
Drug: Mitoxantrone Hydrochloride Liposome Injection
IV, once every 3 months (Q3M)
Experimental: Mitoxantrone Hydrochloride Liposome Injection 8 mg/m^2 group
Participants will receive Mitoxantrone Hydrochloride Liposome Injection 8 mg/m^2 every 3 months (Q3M).
Drug: Mitoxantrone Hydrochloride Liposome Injection
IV, once every 3 months (Q3M)
Experimental: Mitoxantrone Hydrochloride Liposome Injection 12 mg/m^2 group
Participants will receive Mitoxantrone Hydrochloride Liposome Injection 12 mg/m^2 every 3 months (Q3M).
Drug: Mitoxantrone Hydrochloride Liposome Injection
IV, once every 3 months (Q3M)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The cumulative number of new Gadolinium (Gd)-enhancing lesions at the end of 48 weeks of Mitoxantrone Hydrochloride Liposome Injection treatment in brain MRI.
Time Frame: Week 48
Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Annualized Relapse Rate (ARR)
Time Frame: Week 48
ARR at Week 48 is calculated as the ratio of the sum of all participants confirmed relapse counts divided by the sum of all participants treatment duration (in years).
Week 48
Number of Relapses
Time Frame: Week 48
Week 48
Time to Onset of Confirmed Disability Progression for at least 6 Months
Time Frame: Week 48
Week 48
Time to Onset of Confirmed Disability Progression for at least 3 Months
Time Frame: Week 48
Week 48
Proportion of participants with ≥ 20% improvement from baseline in T25FW walking speed.
Time Frame: Week 48
Week 48
Change from baseline to Week 48 in T25FW walking speed.
Time Frame: Week 48
Week 48
Number of new or enlarged T2 lesions.
Time Frame: Week 48
Week 48
Change from baseline in brain MRI Gd-enhancing T1 lesion volume at Weeks 12、24、36、48.
Time Frame: Week 12、24、36、48
Week 12、24、36、48
Change from baseline in brain MRI T2 lesion volume at Weeks 12、24、36、48.
Time Frame: Week 12、24、36、48
Week 12、24、36、48
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: Week 56
Week 56
Plasma concentration of Mitoxantrone Hydrochloride Liposome Injection.
Time Frame: Week 12
Week 12
Descriptive analysis of the rate of change in the number or proportion of B cells from baseline to different time points in different dose groups.
Time Frame: Week 36
Week 36
Descriptive analysis of the rate of change in the number or proportion of T cells from baseline to different time points in different dose groups.
Time Frame: Week 36
Week 36
Descriptive analysis of the rate of change in the number or proportion of NK cells from baseline to different time points in different dose groups.
Time Frame: Week 36
Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HE071-CSP-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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