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New MS drug shows promise for asian patients in safety trial

NCT ID NCT05083923

Disease control Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tested the safety and tolerability of diroximel fumarate (Vumerity) in 136 East Asian adults with relapsing forms of multiple sclerosis. Participants took the drug for up to 48 weeks, and researchers monitored side effects, lab results, and drug levels in the blood. The goal was to see if the drug is safe and tolerable for this specific population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
diroximel fumarate (Vumerity)
What this could lead to
If successful, this could confirm that diroximel fumarate is a safe and tolerable treatment option for relapsing multiple sclerosis in East Asian patients.
What could go wrong
This is a single-arm, open-label study without a placebo or comparator, so results may not prove effectiveness. Side effects like flushing, stomach issues, or liver problems are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

136 people

The number who actually took part.

Started

Nov 2021

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Must have a diagnosis of RMS, as defined by revised 2017 McDonald's criteria. * Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0, inclusive, at screening and baseline visit (Day 1). * Neurologically stable with no evidence of relapse within 30 days prior to baseline visit (Day 1). * For Japanese participants: Born in Japan and biological parents and grandparents were of Japanese origin. If previously lived outside of Japan for more than 5 years, must not have had a significantly modified diet since leaving Japan. * For Chinese participants: Born in China, and biological parents and grandparents were of Chinese origin. If previously lived outside of China for more than 5 years, must not have had a significantly modified diet since leaving China. Key Exclusion Criteria: * Has a multiple sclerosis (MS) relapse that has occurred within the 30 days prior to randomization and/or the participant has not stabilized from a previous relapse prior to randomization. * 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 of, or ongoing, malignant disease, including solid tumors and hematologic malignancies. * Has a history of gastrointestinal (GI) surgery (except appendectomy or cholecystectomy that occurred more than 6 months prior to screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically significant and active GI condition per the investigator's discretion. * History of clinically significant recurring or active GI symptoms (e.g., nausea, diarrhea, dyspepsia, constipation) within 90 days of screening, including symptoms that require the initiation of symptomatic medical treatment (e.g., initiation of a medication to treat gastroesophageal reflux disease) or a change in symptomatic medical treatment (e.g., an increase in dose) within 90 days prior to screening. * History of systemic hypersensitivity reaction to DRF, dimethyl fumarate (DMF), MMF or other fumaric esters, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study. * Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days prior to Screening, between screening and baseline visit (Day 1), or at baseline visit (Day 1), including but not limited to a fever (temperature \>37.5 degrees Celsius \[°C\]), new and persistent cough, breathlessness, or loss of taste and/or smell. Evidence of current SARS-CoV-2 infection within 14 days prior to Screening or during Screening, will be eligible for rescreening, provided that the participant is asymptomatic for 14 days prior to rescreening. * Have close contact within 14 days prior to Day 1 with individual(s) with suspected SARS-CoV-2 infection. * For participants who had close contact with individual(s) with suspected SARS-CoV-2 infection within 14 days prior to Day 1, as determined by the Investigator, will be eligible for rescreening, provided that the participant is asymptomatic for 14 days after the contact. * History or positive test result at screening for human immunodeficiency virus (HIV). * Previous participation in this study or previous studies with DRF, DMF, or MMF. * Has a clinically significant history of suicidal ideation or suicidal behavior occurring in the past 12 months as assessed by the C-SSRS at Screening. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing forms of multiple sclerosis

Contacts and locations

Locations

  • Beijing Hospital

    Beijing, Beijing Municipality, 100006, China

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • Chiba University Hospital

    Chiba, Chiba, 260-8677, Japan

  • Department of Neurosurgery, Tokyo Women's Medical University

    Shinjuku-ku, Tokyo-To, 162-8666, Japan

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523059, China

  • Ebara Hospital

    Ōta-ku, Tokyo-To, 145-0065, Japan

  • Ehime University Hospital

    Toon-shi, Ehime, 791-0295, Japan

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yun'nan, 650032, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180, Japan

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia Hui, 750004, China

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180, China

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka, 807-8556, Japan

  • Iwate Medical University Uchimaru Medical Center

    Morioka, Iwate, 020-8505, Japan

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006, China

  • Juntendo University Hospital

    Bunkyō City, Tokyo-To, 113-8431, Japan

  • Kansai Medical University Medical Center

    Moriguchi-shi, Osaka, 570-8507, Japan

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030, China

  • NHO Asahikawa Medical Center

    Asahikawa-shi, Hokkaido, 070-8644, Japan

  • NHO Hokkaido Medical Center

    Sapporo, Hokkaido, 063-0005, Japan

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • National Center of Neurology and Psychiatry

    Kodaira-shi, Tokyo-To, 187-8551, Japan

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata, 951-8520, Japan

  • Obihiro Kosei Hospital

    Obihiro, Hokkaido, 080-0024, Japan

  • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

    Shanghai, Shanghai Municipality, 200001, China

  • Saitama Medical Center

    Kawagoe-shi, Saitama, 350-8550, Japan

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 30012, China

  • Shengjing Hospital of China Medical University

    Shengyang, Liaoning, 110004, China

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072, China

  • Southern Tohoku Medical Clinic

    Koriyama-shi, Fukushima, 963-8563, Japan

  • Tangdu Hospital, Fourth Military Medical University

    Xi'an, Shan'xi, 710038, China

  • Tangshan Gongren Hospital

    Tangshan, Hebei, 063003, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 10050, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150040, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004, China

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260, China

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086, China

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510630, China

  • Tianjin Medical University Affiliated General Hospital

    Tianjin, Tianjin Municipality, 300052, China

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai, Miyagi, 983-8512, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Tokyo Womens Medical University Yachiyo Medical Center

    Yachiyo, Chiba, 276-8524, Japan

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030, China

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576, Japan

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510, Japan

  • Xiangya Hospital, Central South University

    Changsha, Hu'nan, 410008, China

  • Yamaguchi University Hospital

    Ube-shi, Yamaguchi, 755-8505, Japan

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004, Japan

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