CompletedPhase 4Relapsing MSNCT05658484

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 19 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

  • Annualized Relapse Rate (ARR)

    Week 48

    Disability progressionRelapsesThinking and memoryBladder, bowel and sexual function

Other measures (10)

  • Change From Baseline in Number of Gadolinium-Enhancing (GdE) Lesions

    Week 24

    MRI lesions
  • Number of GdE Lesions

    Week 24 and 48

    MRI lesions
  • Percentage of Participants GdE-Lesion Free

    Week 24 and 48

    MRI lesions
  • Percentage of Participants Relapsed

    Week 48

    Relapses
  • Number of New T1 Hypo-Intense Lesions

    Baseline, Week 24 and 48

    MRI lesions
  • Number of New/Newly Enlarging T2 Hyperintense Lesions

    Baseline, Week 24 and 48

    MRI lesions
  • Total T2 Lesion Volume

    Week 24 and 48

    MRI lesions
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Up to Week 50

    Safety
  • Number of Participants With Change from Baseline in Clinical Laboratory Parameters, Electrocardiogram (ECG), and Vital Signs

    Baseline to Week 48

    Safety
  • Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Events

    Baseline to Week 48

Who could take part

Relapsing MS · 18 to 65

Key Inclusion Criteria: * Must have a baseline (pre-dose on Day 1) Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive. * Must have experienced at least 1 documented relapse within the 12 months before screening, with a prior brain magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS or have showed evidence of GdE lesion(s) of the brain on an MRI performed within the 6 weeks prior to screening. Key Exclusion Criteria: * An MS relapse that occurred within the 30 days prior to screening and/or the participant has not stabilized from a previous relapse prior to screening. * Current hepatitis C infection and current hepatitis B infection. Participants with immunity to hepatitis B from previous natural infection or vaccination are eligible to participate in the study. * History of severe allergic or anaphylactic reactions or of any allergic reactions that, in the opinion of the Investigator, are likely to be exacerbated by any component of the study treatment. * History or positive test result at screening for human immunodeficiency virus (HIV). * Use at the time of enrollment and/or anticipated ongoing use of any traditional and/or unlicensed medicines and/or traditional therapies and/or herbal preparations, which are known or considered by the Investigator to affect MS and endpoints that are being considered in the study, including safety and efficacy. * Current enrollment in any other investigational drug study or participation in any other investigational study within 6 months prior to screening. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The primary objective of the study is to assess the efficacy of DMF in Chinese participants with RMS at Week 48. The secondary objectives of the study are to assess the efficacy and safety of DMF in Chinese participants with RMS.

Papers

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    History

      1. Started

        Jun 2023

      2. Main results due

        Mar 2025

      3. Finished

        Apr 2025

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