Back to resultsA Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dimethyl fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
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 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. Key Exclusion Criteria: 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Beijing HospitalRecruiting
- Xiangya Hospital Central South UniversityRecruiting
- West China Hospital of Sichuan UniversityRecruiting
- The First Affiliated Hospital of Fujian Medical UniversityRecruiting
- Nanfang Hospital, Southern Medical UniversityRecruiting
- The Third Affiliated Hospital of Sun Yat-Sen UniversityRecruiting
- The First Affiliated Hospital of Zhejiang University schoolRecruiting
- The Second Hospital of Hebei Medical UniversityRecruiting
- The First People's Hospital of Yunnan ProvinceRecruiting
- Renji Hospital, Shanghai Jiatong Uni. School of MedicineRecruiting
- Huashan Hospital, Fudan UniversityRecruiting
- The First Hospital of China Medical UniversityRecruiting
- The First Affiliated Hospital of Soochow UniversityRecruiting
- The First Affiliated Hospital of Shanxi Medical UniversityRecruiting
- Tianjin Medical University General HospitalRecruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
- Second Affiliated Hospital of Air Force Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dimethyl fumarate (DMF)
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change From Baseline in Number of Gadolinium-Enhancing (GdE) Lesions
Number of GdE Lesions
Percentage of Participants GdE-Lesion Free
Percentage of Participants Relapsed
Number of New T1 Hypo-Intense Lesions
Number of New/Newly Enlarging T2 Hyperintense Lesions
Total T2 Lesion Volume
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect and is a medically important event.
Number of Participants With Change from Baseline in Clinical Laboratory Parameters, Electrocardiogram (ECG), and Vital Signs
Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Events
The C-SSRS is a clinician-administered instrument that systematically assess suicidal ideation and behavior rating scale. It rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent). The scale identifies specific behaviors ranging from "preparatory acts or behavior" to "suicide" which may be indicative of an individual's intent to complete suicide.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05658484
Brief Title
A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
Official Title
A Multicenter, Postmarketing Study of Dimethyl Fumarate (Tecfidera; BG00012) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
April 16, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dimethyl fumarate (DMF)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dimethyl fumarate
Other Intervention Name(s)
Tecfidera, DMF, BG00012
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Annualized Relapse Rate (ARR)
Description
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
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Change From Baseline in Number of Gadolinium-Enhancing (GdE) Lesions
Time Frame
Week 24
Title
Number of GdE Lesions
Time Frame
Week 24 and 48
Title
Percentage of Participants GdE-Lesion Free
Time Frame
Week 24 and 48
Title
Percentage of Participants Relapsed
Time Frame
Week 48
Title
Number of New T1 Hypo-Intense Lesions
Time Frame
Baseline, Week 24 and 48
Title
Number of New/Newly Enlarging T2 Hyperintense Lesions
Time Frame
Baseline, Week 24 and 48
Title
Total T2 Lesion Volume
Time Frame
Week 24 and 48
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect and is a medically important event.
Time Frame
Up to Week 50
Title
Number of Participants With Change from Baseline in Clinical Laboratory Parameters, Electrocardiogram (ECG), and Vital Signs
Time Frame
Baseline to Week 48
Title
Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Events
Description
The C-SSRS is a clinician-administered instrument that systematically assess suicidal ideation and behavior rating scale. It rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent). The scale identifies specific behaviors ranging from "preparatory acts or behavior" to "suicide" which may be indicative of an individual's intent to complete suicide.
Time Frame
Baseline to Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Key Exclusion Criteria:
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.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Biogen Clinical Trial Center
Phone
866-633-4636
Email
clinicaltrials@biogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Global Biogen Clinical Trial Center
Email
clinicaltrials@biogen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangya Hospital Central South University
City
Changsha
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital of Sichuan University
City
Chengdu City
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhejiang University school
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Hebei Medical University
City
Hebei
ZIP/Postal Code
050004
Country
China
Individual Site Status
Recruiting
Facility Name
The First People's Hospital of Yunnan Province
City
Kunming
ZIP/Postal Code
650032
Country
China
Individual Site Status
Recruiting
Facility Name
Renji Hospital, Shanghai Jiatong Uni. School of Medicine
City
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of China Medical University
City
Shengyang
ZIP/Postal Code
110002
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Shanxi Medical University
City
Taiyuan
ZIP/Postal Code
30001
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Second Affiliated Hospital of Air Force Medical University
City
Xi'An
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
IPD Sharing URL
https://vivli.org/
Learn more about this trial
A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
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