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Relapsing Multiple SclerosisPhase 2NCT05496894

A Study of Mitoxantrone Hydrochloride Liposome Injection for Relapsing Multiple Sclerosis

A Phase 2 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Relapsing Multiple Sclerosis, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
Mitoxantrone Hydrochloride Liposome Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
Aug 2022to 8 Nov 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Mitoxantrone Hydrochloride Liposome Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitoxantrone Hydrochloride Liposome InjectionDrug

    IV, once every 3 months (Q3M)

Study groups in NCT05496894
Study groupRoleWhat they receive
Mitoxantrone Hydrochloride Liposome Injection 4 mg/m^2 groupExperimentalParticipants will receive Mitoxantrone Hydrochloride Liposome Injection 4 mg/m^2 every 3 months (Q3M).
Receives: Drug: Mitoxantrone Hydrochloride Liposome Injection
Mitoxantrone Hydrochloride Liposome Injection 8 mg/m^2 groupExperimentalParticipants will receive Mitoxantrone Hydrochloride Liposome Injection 8 mg/m^2 every 3 months (Q3M).
Receives: Drug: Mitoxantrone Hydrochloride Liposome Injection
Mitoxantrone Hydrochloride Liposome Injection 12 mg/m^2 groupExperimentalParticipants will receive Mitoxantrone Hydrochloride Liposome Injection 12 mg/m^2 every 3 months (Q3M).
Receives: Drug: Mitoxantrone Hydrochloride Liposome Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 48

Secondary outcomes (14)

  1. Annualized Relapse Rate (ARR)

    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).

    Measured: Week 48

  2. Number of Relapses

    Measured: Week 48

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

    Measured: Week 48

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

    Measured: Week 48

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

    Measured: Week 48

  6. Change from baseline to Week 48 in T25FW walking speed.

    Measured: Week 48

  7. Number of new or enlarged T2 lesions.

    Measured: Week 48

  8. Change from baseline in brain MRI Gd-enhancing T1 lesion volume at Weeks 12、24、36、48.

    Measured: Week 12、24、36、48

  9. Change from baseline in brain MRI T2 lesion volume at Weeks 12、24、36、48.

    Measured: Week 12、24、36、48

  10. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Week 56

  11. Plasma concentration of Mitoxantrone Hydrochloride Liposome Injection.

    Measured: Week 12

  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.

    Measured: Week 36

  13. 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.

    Measured: Week 36

  14. 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.

    Measured: Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study startAug 2022 (estimated)
  3. Primary completion8 Nov 2022
  4. Study completion8 Nov 2022

Why it stopped: Due to the company's project adjustment, decided to stop this study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05496894
Sponsor's protocol ID
HE071-CSP-030
Status last verified
Dec 2022
First submitted
28 Jul 2022
Last updated
15 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Relapsing Multiple Sclerosis, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05496894.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.

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