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

NCT ID: NCT05083923

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2024-09-11

Brief 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).

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).

Conditions

Relapsing Forms of Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diroximel Fumarate (DRF)

Japanese 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.

Group Type: EXPERIMENTAL

Diroximel fumarate

Intervention Type: DRUG

Administered as specified in the treatment arm

Interventions

Diroximel fumarate

Administered as specified in the treatment arm

Intervention Type: DRUG

Other Intervention Names

Vumerity; BIIB098; ALK8700

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Hospital

Beijing, Beijing Municipality, China

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Dongguan People's Hospital

Dongguan, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Tangshan Gongren Hospital

Tangshan, Hebei, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Xiangya Hospital, Central South University

Changsha, Hu'nan, China

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

Wuhan, Hubei, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shengyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia Hui, China

Tangdu Hospital, Fourth Military Medical University

Xi'an, Shan'xi, China

Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

Shanghai, Shanghai Municipality, China

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Tianjin Medical University Affiliated General Hospital

Tianjin, Tianjin Municipality, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yun'nan, China

Chiba University Hospital

Chiba, Chiba, Japan

Tokyo Womens Medical University Yachiyo Medical Center

Yachiyo, Chiba, Japan

Ehime University Hospital

Toon-shi, Ehime, Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka, Japan

Southern Tohoku Medical Clinic

Koriyama-shi, Fukushima, Japan

NHO Asahikawa Medical Center

Asahikawa-shi, Hokkaido, Japan

Obihiro Kosei Hospital

Obihiro, Hokkaido, Japan

NHO Hokkaido Medical Center

Sapporo, Hokkaido, Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan

Iwate Medical University Uchimaru Medical Center

Morioka, Iwate, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Miyagi, Japan

Niigata University Medical & Dental Hospital

Niigata, Niigata, Japan

Kansai Medical University Medical Center

Moriguchi-shi, Osaka, Japan

Saitama Medical Center

Kawagoe-shi, Saitama, Japan

Juntendo University Hospital

Bunkyō City, Tokyo-To, Japan

National Center of Neurology and Psychiatry

Kodaira-shi, Tokyo-To, Japan

Ebara Hospital

Ōta-ku, Tokyo-To, Japan

Department of Neurosurgery, Tokyo Women's Medical University

Shinjuku-ku, Tokyo-To, Japan

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

Yamaguchi University Hospital

Ube-shi, Yamaguchi, Japan

Countries

China; Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

272MS303

Identifier Type: -

Identifier Source: org_study_id