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Multiple SclerosisPhase 4NCT05658484

A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China

A Phase 4 study testing Dimethyl fumarate in people with Multiple Sclerosis, run by Biogen at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Dimethyl fumarate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
15 sitesChina
Study dates
9 Jun 2023to 12 Apr 2025
Phase
Phase 4
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Beijing Hospital

    Beijing, 100730

  • Xiangya Hospital Central South University

    Changsha, 410008

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005

  • The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, 510630

  • The Second Hospital of Hebei Medical University

    Hebei, 050004

  • The First People's Hospital of Yunnan Province

    Kunming, 650032

  • Renji Hospital, Shanghai Jiatong Uni. School of Medicine

    Shanghai, 200001

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • The First Hospital of China Medical University

    Shengyang, 110002

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215004

  • The First Affiliated Hospital of Shanxi Medical University

    Taiyuan, 30001

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • Second Affiliated Hospital of Air Force Medical University

    Xi'an, 710038

Other trials in China

About this study

Official title: A Multicenter, Postmarketing Study of Dimethyl Fumarate (Tecfidera; BG00012) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China

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.

Being tested
Dimethyl fumarate
Medical subject headings
Multiple Sclerosis

What participants receive

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

  • Dimethyl fumarateDrug

    Also called Tecfidera, DMF, BG00012

    Administered as specified in the treatment arm.

Study groups in NCT05658484
Study groupRoleWhat they receive
Dimethyl fumarate (DMF)ExperimentalParticipants will receive DMF 120 mg capsules, orally, twice daily (BID) for the first 7 days, followed by 240 mg BID (maintenance dose) after 7 days for up to Week 48.
Receives: Drug: Dimethyl fumarate

What is being measured

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

  1. Annualized Relapse Rate (ARR)

    ARR is defined as the number of confirmed MS relapses in a year. MS relapse is defined as new or recurrent neurologic symptoms, not associated with fever or infection, lasting for at least 24 hours, accompanied by one or more of the following: New objective neurological findings upon examination by the treating neurologist that are functionally consistent with findings on the Expanded Disability Status Scale (EDSS) (performed within 5 days of onset of symptoms) with an increase over the prior visit of ≥0.5 for the total score, an increase of ≥2 in 1 functional system (FS), except bladder/cognitive changes, and/or an increase of ≥1 in 2 FS, except bladder/cognitive changes

    Measured: Week 48

Secondary outcomes (10)

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

    Measured: Week 24

  2. Number of GdE Lesions

    Measured: Week 24 and 48

  3. Percentage of Participants GdE-Lesion Free

    Measured: Week 24 and 48

  4. Percentage of Participants Relapsed

    Measured: Week 48

  5. Number of New T1 Hypo-Intense Lesions

    Measured: Baseline, Week 24 and 48

  6. Number of New/Newly Enlarging T2 Hyperintense Lesions

    Measured: Baseline, Week 24 and 48

  7. Total T2 Lesion Volume

    Measured: Week 24 and 48

  8. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect and is a medically important event.

    Measured: Up to Week 50

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

    Measured: Baseline to Week 48

  10. Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Events

    The C-SSRS is a clinician-administered instrument that systematically assess suicidal ideation and behavior rating scale. It rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent). The scale identifies specific behaviors ranging from "preparatory acts or behavior" to "suicide" which may be indicative of an individual's intent to complete suicide.

    Measured: Baseline to Week 48

Timeline

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

  1. First posted20 Dec 2022
  2. Study start9 Jun 2023
  3. Primary completion27 Mar 2025
  4. Study completion12 Apr 2025

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05658484
Sponsor's protocol ID
109MS424
Status last verified
May 2025
First submitted
12 Dec 2022
Last updated
16 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dimethyl fumarate in people with Multiple Sclerosis, run by Biogen at 15 sites 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Annualized Relapse Rate (ARR) (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 NCT05658484.

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 16 May 2025.

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