- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05496894
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
Withdrawn
Conditions
Intervention / Treatment
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
Interventional
Phase
- 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
-
-
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
Ages Eligible for Study
16 years to 53 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 |
Intervention / Treatment |
---|---|
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).
|
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).
|
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).
|
IV, once every 3 months (Q3M)
|
What is the study measuring?
Primary Outcome Measures
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
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.
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)
August 1, 2022
Primary Completion (Actual)
November 8, 2022
Study Completion (Actual)
November 8, 2022
Study Registration Dates
First Submitted
July 28, 2022
First Submitted That Met QC Criteria
August 9, 2022
First Posted (Actual)
August 11, 2022
Study Record Updates
Last Update Posted (Estimate)
December 15, 2022
Last Update Submitted That Met QC Criteria
December 13, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Mitoxantrone
Other Study ID 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.
Clinical Trials on Relapsing Multiple Sclerosis
-
BiogenWithdrawnRelapsing-Remitting Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenAbbVieTerminatedMultiple Sclerosis | Relapsing-Remitting Multiple SclerosisUnited States, Denmark, Italy, United Kingdom, Czechia, Canada, Hungary, Spain, Australia, Israel, Georgia, Serbia, Russian Federation, Ukraine, India, Poland, Brazil, France, Argentina, Germany, Greece, Ireland, Mexico, Moldova, Republic... and more
-
EMD SeronoPfizerCompletedRelapsing-remitting Multiple SclerosisUnited States, United Kingdom, Argentina, Austria, Brazil, France, Germany, Italy, Netherlands, Russian Federation, Spain, Switzerland
-
National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)CompletedRelapsing-Remitting Multiple SclerosisUnited States
-
BiogenTerminatedRelapsing-Remitting Multiple SclerosisUnited States, Spain, Germany, Australia, Sweden, Czechia, France, Italy, United Kingdom
-
Novartis PharmaceuticalsWithdrawnMultiple Sclerosis (Relapsing Remitting)
-
Genzyme, a Sanofi CompanyTerminatedRelapsing-remitting Multiple SclerosisSweden, Poland, Russian Federation, United States, Canada
-
Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple SclerosisGermany
Clinical Trials on Mitoxantrone Hydrochloride Liposome Injection
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruitingPeripheral T Cell LymphomaChina
-
Hui ZengCSPC Ouyi Pharmaceutical Co., Ltd.RecruitingRelapsed or Refractory Acute Myeloid LeukemiaChina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruitingA Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic CancerAdvanced Pancreatic Cancer
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.CompletedRecurrent/Refractory LymphomaChina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.UnknownRelapsed or Refractory Peripheral T-cell and NK/T-cell LymphomaChina
-
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co....Not yet recruitingNeuromyelitis Optica Spectrum Disorder
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.TerminatedUnresectable or Metastatic Bone and Soft Tissue SarcomaChina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Terminated
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.TerminatedAdvanced Gastric CarcinomaChina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RecruitingDiffuse Large B-Cell LymphomaChina