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Relapsing Forms of Multiple SclerosisPhase 3NCT05083923

A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)

A Phase 3 study testing Diroximel fumarate in people with Relapsing Forms of Multiple Sclerosis, run by Biogen at 52 sites in 2 countries.

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 objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF administered for up to 48 weeks in adult East Asian participants with RMS (Part 2). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Relapsing Forms of Multiple Sclerosis
What is being tested?
Diroximel fumarate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
52 sitesin 2 countries
Study dates
18 Nov 2021to 11 Sep 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

China29 sites

  • Beijing Hospital

    Beijing, Beijing Municipality, 100006

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Xiangya Hospital, Central South University

    Changsha, Hu'nan, 410008

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523059

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510630

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150040

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 10050

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yun'nan, 650032

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

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

    Shanghai, Shanghai Municipality, 200001

  • Shengjing Hospital of China Medical University

    Shengyang, Liaoning, 110004

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 30012

  • Tangshan Gongren Hospital

    Tangshan, Hebei, 063003

  • Tianjin Medical University Affiliated General Hospital

    Tianjin, Tianjin Municipality, 300052

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

    Wuhan, Hubei, 430030

  • Tangdu Hospital, Fourth Military Medical University

    Xi'an, Shan'xi, 710038

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia Hui, 750004

Other trials in China

Japan23 sites

  • NHO Asahikawa Medical Center

    Asahikawa-shi, Hokkaido, 070-8644

  • Juntendo University Hospital

    Bunkyō City, Tokyo-To, 113-8431

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Saitama Medical Center

    Kawagoe-shi, Saitama, 350-8550

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka, 807-8556

  • National Center of Neurology and Psychiatry

    Kodaira-shi, Tokyo-To, 187-8551

  • Southern Tohoku Medical Clinic

    Koriyama-shi, Fukushima, 963-8563

  • Kansai Medical University Medical Center

    Moriguchi-shi, Osaka, 570-8507

  • Iwate Medical University Uchimaru Medical Center

    Morioka, Iwate, 020-8505

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata, 951-8520

  • Obihiro Kosei Hospital

    Obihiro, Hokkaido, 080-0024

  • Ebara Hospital

    Ōta-ku, Tokyo-To, 145-0065

  • NHO Hokkaido Medical Center

    Sapporo, Hokkaido, 063-0005

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai, Miyagi, 983-8512

  • Department of Neurosurgery, Tokyo Women's Medical University

    Shinjuku-ku, Tokyo-To, 162-8666

  • Ehime University Hospital

    Toon-shi, Ehime, 791-0295

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

  • Yamaguchi University Hospital

    Ube-shi, Yamaguchi, 755-8505

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

  • Tokyo Womens Medical University Yachiyo Medical Center

    Yachiyo, Chiba, 276-8524

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

About this study

Official title: An Open-Label, Single-Arm, Multicenter, Phase 3 Study to Evaluate the Safety and Tolerability, and Pharmacokinetics of Diroximel Fumarate (BIIB098) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis

The primary objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF administered for up to 48 weeks in adult East Asian participants with RMS (Part 2).

The secondary objective of this study is to evaluate the pharmacokinetic(s) (PK) of DRF metabolites (monomethyl fumarate [MMF] and 2-hydroxyethyl succinimide [HES]) following multiple doses of DRF in a subset of adult East Asian participants with RMS (Part 1).

Being tested
Diroximel fumarate

What participants receive

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

  • Diroximel fumarateDrug

    Also called Vumerity, BIIB098, ALK8700

    Administered as specified in the treatment arm

Study groups in NCT05083923
Study groupRoleWhat they receive
Diroximel Fumarate (DRF)ExperimentalJapanese and Chinese participants will initiate treatment with DRF 231 milligrams (mg), oral capsule, twice daily on Day 1 through Day 7, followed by DRF 462 mg, oral capsules, twice daily from Day 8 up to Week 48.
Receives: Drug: Diroximel fumarate

What is being measured

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

  1. Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    An adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether/not related to the medicinal (investigational) product. An AE was considered treatment-emergent if it starts or worsens on or after the date of the first dose of study drug in the study until 1 day after the last dose of treatment, or completion of the safety follow-up visit, if applicable.(i.e. for participants who prematurely discontinued study treatment or withdrew from the study) . An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, is a medically important event. TEAEs included both serious and non-serious TEAEs.

    Measured: Baseline (Day 1) up to Week 24 (for prematurely discontinued participants, AEs were reported up to 2 weeks post discontinuation)

  2. Part 1: Number of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters

    Laboratory assessments included hematology, blood chemistry, and urinalysis parameters. Hematology parameters:basophils, hematocrit, red blood cell, total and differential leukocytes, platelets, lymphocytes, monocytes, neutrophils, eosinophils, hemoglobin. Blood chemistry parameters:sodium, potassium, chloride, glucose, calcium, uric acid, total protein, albumin, creatine phosphokinase, Lipid profile: blood cholesterol,high-density lipoprotein,low-density lipoprotein, and triglycerides,serum follicle-stimulating hormone,Vitamin D,thyroid stimulating hormone,serum pregnancy, HIV/Hepatitis screen,tuberculosis test,alanine aminotransferase,aspartate aminotransferase,Lactate Dehydrogenase,alkaline phosphatase,gamma glutamyl transferase,total bilirubin,blood urea nitrogen,creatinine and bicarbonate. Urinalysis parameters:color,pH,specific gravity,ketones,protein,glucose, bilirubin,nitrite,urobilinogen,occult blood,microscopic examination,urine albumin,beta-2-microglobulin,urine creatinine.

    Measured: Baseline (Day 1) to Week 24

  3. Part 1: Number of Participants With Abnormal Shift in 12-Lead Electrocardiogram (ECG) Values

    The number of participants with shifts to categorical values of ECG interpretation (e.g. abnormal) were presented by each cohort. Abnormal shift includes a shift from normal or unknown to abnormal.

    Measured: Baseline (Day 1) to Week 24

  4. Part 1: Number of Participants With Clinically Relevant Abnormalities in Vital Sign Parameters

    Vital sign assessment included temperature, pulse rate systolic blood pressure, diastolic blood pressure, and respiratory rate. The criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature < 36 and > 38 degrees Celsius (C), pulse rate < 60 and > 100 beats per minute (bpm), systolic blood pressure (< 90, > 140 and > 160 millimeters of mercury [mmHg]), diastolic blood pressure < 50, > 90 and > 100 mmHg, weight (7% or more increase from baseline, 7% or more decrease from baseline) and respiratory rate < 12 and > 20 breaths per minute.

    Measured: Baseline (Day 1) to Week 24

  5. Part 1: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Events

    The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation, suicidal behavior and non-suicidal self-injurious behavior. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, Suicidal behavior, completed suicide), suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan and intent) and non-suicidal self-injurious behavior.

    Measured: Baseline (Day 1) to Week 24

  6. Parts 1 and 2: Number of Participants With TEAEs and TESAEs

    An AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medicinal (investigational) product, whether/not related to medicinal (investigational) product. AE was considered treatment-emergent if it starts or worsens on or after the date of the first dose of study drug in the study until 1 day after the last dose of treatment. SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, is a medically important event. TEAEs included both serious and non-serious TEAEs. TEAEs and TESAEs for participants were collected cumulatively for Parts 1 and 2.

    Measured: From Day 1 up to the end of the study (up to Week 50)

  7. Part 2: Number of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters

    Laboratory assessments included hematology, blood chemistry, and urinalysis parameters. Hematology parameters:basophils, hematocrit, red blood cell, total and differential leukocytes, platelets, lymphocytes, monocytes, neutrophils, eosinophils, hemoglobin. Blood chemistry parameters:sodium, potassium, chloride, glucose, calcium, uric acid, total protein, albumin, creatine phosphokinase, Lipid profile: blood cholesterol,high-density lipoprotein,low-density lipoprotein, and triglycerides,serum follicle-stimulating hormone,Vitamin D,thyroid stimulating hormone,serum pregnancy, HIV/Hepatitis screen,tuberculosis test,alanine aminotransferase,aspartate aminotransferase,Lactate Dehydrogenase,alkaline phosphatase,gamma glutamyl transferase,total bilirubin,blood urea nitrogen,creatinine and bicarbonate. Urinalysis parameters:color,pH,specific gravity,ketones,protein,glucose, bilirubin,nitrite,urobilinogen,occult blood,microscopic examination,urine albumin,beta-2-microglobulin,urine creatinine.

    Measured: Baseline (Day 1) to Week 48

  8. Part 2: Number of Participants With Abnormal Shift in 12-Lead ECG Values

    The number of participants with shifts to categorical values of ECG interpretation (e.g. abnormal) were presented by each cohort. Abnormal shift includes a shift from normal or unknown to abnormal.

    Measured: Baseline (Day 1) to Week 48

  9. Part 2: Number of Participants With Clinically Relevant Abnormalities in Vital Sign Parameters

    Vital sign assessment included temperature, pulse rate systolic blood pressure, diastolic blood pressure, and respiratory rate. The criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature < 36 and > 38 degrees C, pulse rate < 60 and > 100 bpm, systolic blood pressure (< 90, > 140 and > 160 mmHg), diastolic blood pressure < 50, > 90 and > 100 mmHg, weight (7% or more increase from baseline, 7% or more decrease from baseline) and respiratory rate < 12 and > 20 breaths per minute.

    Measured: Baseline (Day 1) to Week 48

  10. Part 2: Number of Participants With C-SSRS Events

    The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation, suicidal behavior and non-suicidal self-injurious behavior. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, Suicidal behavior, completed suicide), suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan and intent) and non-suicidal self-injurious behavior.

    Measured: Baseline (Day 1) to Week 48

Secondary outcomes (11)

  1. Part 1: Plasma Concentrations of Monomethyl Fumarate (MMF)-Intensive Pharmacokinetic (PK) Analysis Set

    Summarized data for plasma concentration of MMF at all timepoints is reported.

    Measured: Pre-dose and at 0.5,1,2,3,4,6, and 8 hours post-dose from Day 29 to Day 169

  2. Part 1: Plasma Concentration of 2-Hydroxyethyl Succinimide (HES)-Intensive PK Analysis Set

    Summarized data for plasma concentration of HES at all timepoints is reported.

    Measured: Pre-dose and at 0.5,1,2,3,4,6, and 8 hours post-dose from Day 29 to Day 169

  3. Part 1: Plasma Concentrations of MMF-Sparse PK Analysis Set

    Measured: Pre-dose and 2 to 3 hours post-dose on Day 29 and Day 57

  4. Part 1: Plasma Concentrations of HES-Sparse PK Analysis Set

    Measured: Pre-dose and 2 to 3 hours post-dose on Day 29 and Day 57

  5. Part 1: Maximum Observed Concentration (Cmax) of MMF-Intensive PK Analysis Set

    Summarized data for Cmax at all timepoints is reported.

    Measured: Pre-dose and at 0.5,1,2,3,4,6, and 8 hours post-dose from Day 29 to Day 169

  6. Part 1: Cmax of HES-Intensive PK Analysis Set

    Summarized data for Cmax at all timepoints is reported.

    Measured: Pre-dose and at 0.5,1,2,3,4,6, and 8 hours post-dose from Day 29 to Day 169

  7. Part 1: Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of MMF-Intensive PK Analysis Set

    Summarized data for AUClast at all timepoints is reported.

    Measured: Pre-dose and at 0.5,1,2,3,4,6, and 8 hours post-dose from Day 29 to Day 169

  8. Part 1: AUClast of HES-Intensive PK Analysis Set

    Summarized data for AUClast at all timepoints is reported.

    Measured: Pre-dose and at 0.5,1,2,3,4,6, and 8 hours post-dose from Day 29 to Day 169

  9. Part 1: Time to Reach Cmax (Tmax) of MMF-Intensive PK Analysis Set

    Summarized data for Tmax at all timepoints is reported.

    Measured: Pre-dose and at 0.5,1,2,3,4,6, and 8 hours post-dose from Day 29 to Day 169

  10. Part 1: Tmax of HES-Intensive PK Analysis Set

    Summarized data for Tmax at all timepoints is reported.

    Measured: Pre-dose and at 0.5,1,2,3,4,6, and 8 hours post-dose from Day 29 to Day 169

  11. Part 1: Elimination Half-Life (t½) of MMF-Intensive PK Analysis Set

    Summarized data for t½ at all timepoints is reported.

    Measured: Pre-dose and at 0.5,1,2,3,4,6, and 8 hours post-dose from Day 29 to Day 169

Timeline

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

  1. First posted19 Oct 2021
  2. Study start18 Nov 2021
  3. Primary completion11 Sep 2024
  4. Study completion11 Sep 2024

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05083923
Sponsor's protocol ID
272MS303
Status last verified
Oct 2025
First submitted
6 Oct 2021
Last updated
24 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
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 3 study testing Diroximel fumarate in people with Relapsing Forms of Multiple Sclerosis, run by Biogen at 52 sites in 2 countries.

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 5 inclusion and 13 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 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in China, Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) (time frame: Baseline (Day 1) up to Week 24 (for prematurely discontinued participants, AEs were reported up to 2 weeks post discontinuation)). The study lists 10 primary outcomes in all. 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 NCT05083923.

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 24 Oct 2025.

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