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

Last updated: September 16, 2024
Sponsor: Biogen
Overall Status: Completed

Phase

3

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

Diroximel fumarate

Clinical Study ID

NCT05083923
272MS303
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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, atscreening and baseline visit (Day 1).

  • Neurologically stable with no evidence of relapse within 30 days prior to baselinevisit (Day 1).

  • For Japanese participants: Born in Japan and biological parents and grandparentswere 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 grandparentswere 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

Key Exclusion Criteria:

  • Has a multiple sclerosis (MS) relapse that has occurred within the 30 days prior torandomization and/or the participant has not stabilized from a previous relapseprior to randomization.

  • History of severe allergic or anaphylactic reactions or of any allergic reactionsthat, in the opinion of the investigator, are likely to be exacerbated by anycomponent of the study treatment.

  • History of, or ongoing, malignant disease, including solid tumors and hematologicmalignancies.

  • Has a history of gastrointestinal (GI) surgery (except appendectomy orcholecystectomy that occurred more than 6 months prior to screening), irritablebowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), orother clinically significant and active GI condition per the investigator'sdiscretion.

  • History of clinically significant recurring or active GI symptoms (e.g., nausea,diarrhea, dyspepsia, constipation) within 90 days of screening, including symptomsthat require the initiation of symptomatic medical treatment (e.g., initiation of amedication to treat gastroesophageal reflux disease) or a change in symptomaticmedical treatment (e.g., an increase in dose) within 90 days prior to screening.

  • History of systemic hypersensitivity reaction to DRF, dimethyl fumarate (DMF), MMFor other fumaric esters, the excipients contained in the formulation, and ifappropriate, 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 14days 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 suspectedSARS-CoV-2 infection.

  • For participants who had close contact with individual(s) with suspected SARS-CoV-2infection within 14 days prior to Day 1, as determined by the Investigator, will beeligible for rescreening, provided that the participant is asymptomatic for 14 daysafter 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 behavioroccurring in the past 12 months as assessed by the C-SSRS at Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 102
Treatment Group(s): 1
Primary Treatment: Diroximel fumarate
Phase: 3
Study Start date:
November 18, 2021
Estimated Completion Date:
September 11, 2024

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230022
    China

    Site Not Available

  • Beijing Hospital

    Beijing, Beijing 100006
    China

    Site Not Available

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou, Gansu 730030
    China

    Site Not Available

  • Dongguan People's Hospital

    Dongguan, Guangdong 523059
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510260
    China

    Site Not Available

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510630
    China

    Site Not Available

  • Tangshan Gongren Hospital

    Tangshan, Hebei 063003
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150040
    China

    Site Not Available

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150086
    China

    Site Not Available

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

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Xiangya Hospital, Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 10050
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215004
    China

    Site Not Available

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shengyang, Liaoning 110004
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Site Not Available

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

    Shanghai, Shanghai 200001
    China

    Site Not Available

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi 30012
    China

    Site Not Available

  • Tangdu Hospital, Fourth Military Medical University

    Xi'an, Shanxi 710038
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Site Not Available

  • Tianjin Medical University Affiliated General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Site Not Available

  • Research Site

    Tianjin, 300052
    China

    Active - Recruiting

  • Chiba University Hospital

    Chiba-shi, Chiba-Ken 260-8677
    Japan

    Site Not Available

  • Tokyo Womens Medical University Yachiyo Medical Center

    Yachiyo-City, Chiba-Ken 276-8524
    Japan

    Site Not Available

  • Ehime University Hospital

    Toon-shi, Ehime-Ken 791-0295
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka-shi, Fukuoka-Ken 814-0180
    Japan

    Site Not Available

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka-Ken 807-8556
    Japan

    Site Not Available

  • Southern Tohoku Medical Clinic

    Koriyama-shi, Fukushima-Ken 963-8563
    Japan

    Site Not Available

  • NHO Asahikawa Medical Center

    Asahikawa-shi, Hokkaido 070-8644
    Japan

    Site Not Available

  • Obihiro Kosei Hospital

    Obihiro-City, Hokkaido 080-0024
    Japan

    Site Not Available

  • NHO Hokkaido Medical Center

    Sapporo-shi, Hokkaido 063-0005
    Japan

    Site Not Available

  • University of Tsukuba Hospital

    Tsukuba-shi, Ibaraki-Ken 305-8576
    Japan

    Site Not Available

  • Iwate Medical University Uchimaru Medical Center

    Morioka-shi, Iwate-Ken 020-8505
    Japan

    Site Not Available

  • Yokohama City University Hospital

    Yokohama-shi, Kanagawa-Ken 236-0004
    Japan

    Site Not Available

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai City, Miyagi-Ken 983-8512
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai City, Miyagi-Ken 980-8574
    Japan

    Site Not Available

  • Niigata University Medical & Dental Hospital

    Niigata-shi, Niigata-Ken 951-8520
    Japan

    Site Not Available

  • Kansai Medical University Medical Center

    Moriguchi-shi, Osaka-Fu 570-8507
    Japan

    Site Not Available

  • Saitama Medical Center

    Kawagoe-shi, Saitama-Ken 350-8550
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo-To 113-8431
    Japan

    Site Not Available

  • National Center of Neurology and Psychiatry

    Kodaira-shi, Tokyo-To 187-8551
    Japan

    Site Not Available

  • Ebara Hospital

    Ota-ku, Tokyo-To 145-0065
    Japan

    Site Not Available

  • Department of Neurosurgery, Tokyo Women's Medical University

    Shinjuku-ku, Tokyo-To 162-8666
    Japan

    Site Not Available

  • Wakayama Medical University Hospital

    Wakayama-shi, Wakayama-Ken 641-8510
    Japan

    Site Not Available

  • Yamaguchi University Hospital

    Ube-shi, Yamaguchi-Ken 755-8505
    Japan

    Site Not Available

  • Research Site

    Asahikawa-shi, 070-8644
    Japan

    Active - Recruiting

  • Research Site

    Bunkyo-ku, 113-8431
    Japan

    Active - Recruiting

  • Research Site

    Chiba-City, 260-8677
    Japan

    Site Not Available

  • Research Site

    Fukuoka-shi, 814-0180
    Japan

    Active - Recruiting

  • Research Site

    Kawagoe-shi, 350-8550
    Japan

    Active - Recruiting

  • Research Site

    Kitakyushu-shi, 807-8555
    Japan

    Active - Recruiting

  • Research Site

    Kodaira, 187-8551
    Japan

    Site Not Available

  • Research Site

    Koriyama-shi, 963-8052
    Japan

    Active - Recruiting

  • Research Site

    Moriguchi-shi, 570-8507
    Japan

    Active - Recruiting

  • Research Site

    Morioka-shi, 020-8505
    Japan

    Active - Recruiting

  • Research Site

    Niigata-shi, 951-8510
    Japan

    Active - Recruiting

  • Research Site

    Obihiro-City, 080-0024
    Japan

    Active - Recruiting

  • Research Site

    Ota-ku, 145-0065
    Japan

    Active - Recruiting

  • Research Site

    Sapporo-shi, 063-0005
    Japan

    Active - Recruiting

  • Research Site

    Sendai City, 980-8574
    Japan

    Active - Recruiting

  • Research Site

    Shinjukuku, 162-8666
    Japan

    Site Not Available

  • Research Site

    Toon, 791-0295
    Japan

    Site Not Available

  • Research Site

    Tsukuba-shi, 305-8576
    Japan

    Active - Recruiting

  • Research Site

    Ube City, 755-8505
    Japan

    Site Not Available

  • Research Site

    Wakayama City, 641-8510
    Japan

    Site Not Available

  • Research Site

    Yachiyo-City, 276-8524
    Japan

    Active - Recruiting

  • Research Site

    Yokohama-shi, 236-0004
    Japan

    Active - Recruiting

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