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

Last updated: September 4, 2024
Sponsor: Biogen
Overall Status: Active - Not Recruiting

Phase

4

Condition

Multiple Sclerosis

Scar Tissue

Memory Loss

Treatment

Dimethyl fumarate

Clinical Study ID

NCT05658484
109MS424
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • 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 beforescreening, with a prior brain magnetic resonance imaging (MRI) demonstratinglesion(s) consistent with MS or have showed evidence of GdE lesion(s) of the brainon an MRI performed within the 6 weeks prior to screening.

Exclusion

Key Exclusion Criteria:

  • An MS relapse that occurred within the 30 days prior to screening and/or theparticipant has not stabilized from a previous relapse prior to screening.

  • Current hepatitis C infection and current hepatitis B infection. Participants withimmunity to hepatitis B from previous natural infection or vaccination are eligibleto participate in the study.

  • 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 or positive test result at screening for human immunodeficiency virus (HIV).

  • Use at the time of enrollment and/or anticipated ongoing use of any traditionaland/or unlicensed medicines and/or traditional therapies and/or herbal preparations,which are known or considered by the Investigator to affect MS and endpoints thatare being considered in the study, including safety and efficacy.

  • Current enrollment in any other investigational drug study or participation in anyother investigational study within 6 months prior to screening.

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

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Dimethyl fumarate
Phase: 4
Study Start date:
June 09, 2023
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Beijing Hospital

    Beijing, 100730
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, 410008
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu City, 610041
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005
    China

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515
    China

    Site Not Available

  • The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, 510630
    China

    Site Not Available

  • The First Affiliated Hospital of Zhejiang University school

    Hangzhou, 310003
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Hebei, 050004
    China

    Site Not Available

  • The First People's Hospital of Yunnan Province

    Kunming, 650032
    China

    Site Not Available

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, 210008
    China

    Site Not Available

  • Huashan Hospital, Fudan University

    Shanghai, 200040
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiatong Uni. School of Medicine

    Shanghai, 200001
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shengyang, 110002
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215004
    China

    Site Not Available

  • The First Affiliated Hospital of Shanxi Medical University

    Taiyuan, 30001
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000
    China

    Site Not Available

  • Second Affiliated Hospital of Air Force Medical University

    Xi'An, 710038
    China

    Site Not Available

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