A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
We could not find results for this trial
I know where the results areWhat it 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
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
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 lesionsNumber of GdE Lesions
Week 24 and 48
MRI lesionsPercentage of Participants GdE-Lesion Free
Week 24 and 48
MRI lesionsPercentage of Participants Relapsed
Week 48
RelapsesNumber of New T1 Hypo-Intense Lesions
Baseline, Week 24 and 48
MRI lesionsNumber of New/Newly Enlarging T2 Hyperintense Lesions
Baseline, Week 24 and 48
MRI lesionsTotal T2 Lesion Volume
Week 24 and 48
MRI lesionsNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to Week 50
SafetyNumber of Participants With Change from Baseline in Clinical Laboratory Parameters, Electrocardiogram (ECG), and Vital Signs
Baseline to Week 48
SafetyNumber 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
Started
Jun 2023
Main results due
Mar 2025
Finished
Apr 2025
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