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

NCT05658484 | Completed Phase 4

• 1 other identifier: 109MS424
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate (ARR)

  ARR is defined as the number of confirmed MS relapses in a year. MS relapse is defined as new or recurrent neurologic symptoms, not associated with fever or infection, lasting for at least 24 hours, accompanied by one or more of the following: New objective neurological findings upon examination by the treating neurologist that are functionally consistent with findings on the Expanded Disability Status Scale (EDSS) (performed within 5 days of onset of symptoms) with an increase over the prior visit of ≥0.5 for the total score, an increase of ≥2 in 1 functional system (FS), except bladder/cognitive changes, and/or an increase of ≥1 in 2 FS, except bladder/cognitive changes

  Week 48

Secondary Outcomes (10)

• Change From Baseline in Number of Gadolinium-Enhancing (GdE) Lesions

  Week 24

• Number of GdE Lesions

  Week 24 and 48

• Percentage of Participants GdE-Lesion Free

  Week 24 and 48

• Percentage of Participants Relapsed

  Week 48

• Number of New T1 Hypo-Intense Lesions

  Baseline, Week 24 and 48

Study Arms (1)

Dimethyl fumarate (DMF)

EXPERIMENTAL

Participants will receive DMF 120 mg capsules, orally, twice daily (BID) for the first 7 days, followed by 240 mg BID (maintenance dose) after 7 days for up to Week 48.

Drug: Dimethyl fumarate

Interventions

Dimethyl fumarate DRUG

Administered as specified in the treatment arm.

Also known as: Tecfidera, DMF, BG00012

Dimethyl fumarate (DMF)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• An MS relapse that occurred within the 30 days prior to screening and/or the participant has not stabilized from a previous relapse prior to screening.
• Current hepatitis C infection and current hepatitis B infection. Participants with immunity to hepatitis B from previous natural infection or vaccination are eligible to participate in the study.
• 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 or positive test result at screening for human immunodeficiency virus (HIV).
• Use at the time of enrollment and/or anticipated ongoing use of any traditional and/or unlicensed medicines and/or traditional therapies and/or herbal preparations, which are known or considered by the Investigator to affect MS and endpoints that are being considered in the study, including safety and efficacy.
• Current enrollment in any other investigational drug study or participation in any other investigational study within 6 months prior to screening.

Sponsors & Collaborators

• Biogen: lead

Study Sites (15)

Beijing Hospital

Beijing, 100730, China

Location

Xiangya Hospital Central South University

Changsha, 410008, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, 350005, China

Location

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, 510630, China

Location

The Second Hospital of Hebei Medical University

Hebei, 050004, China

Location

The First People's Hospital of Yunnan Province

Kunming, 650032, China

Location

Renji Hospital, Shanghai Jiatong Uni. School of Medicine

Shanghai, 200001, China

Location

Huashan Hospital, Fudan University

Shanghai, 200040, China

Location

The First Hospital of China Medical University

Shengyang, 110002, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, 215004, China

Location

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, 30001, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000, China

Location

Second Affiliated Hospital of Air Force Medical University

Xi'an, 710038, China

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: June 9, 2023
• Primary Completion: March 27, 2025
• Study Completion: April 12, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (15)