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

Multiple Sclerosis Clinical Trial

Official title:

A Multicenter, Postmarketing Study of Dimethyl Fumarate (Tecfidera; BG00012) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05658484
• Other study ID #: 109MS424
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 9, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 30, 2025
• Est. primary completion date: April 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Dimethyl fumarate
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing
China	Xiangya Hospital Central South University	Changsha
China	West China Hospital of Sichuan University	Chengdu City
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	The Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou
China	The Second Hospital of Hebei Medical University	Hebei
China	The First People's Hospital of Yunnan Province	Kunming
China	Huashan Hospital, Fudan University	Shanghai
China	Renji Hospital, Shanghai Jiatong Uni. School of Medicine	Shanghai
China	The First Hospital of China Medical University	Shengyang
China	The First Affiliated Hospital of Soochow University	Suzhou
China	The First Affiliated Hospital of Shanxi Medical University	Taiyuan
China	Tianjin Medical University General Hospital	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou
China	Second Affiliated Hospital of Air Force Medical University	Xi'An

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Number of Gadolinium-Enhancing (GdE) Lesions		Week 24
Secondary	Number of GdE Lesions		Week 24 and 48
Secondary	Percentage of Participants GdE-Lesion Free		Week 24 and 48
Secondary	Percentage of Participants Relapsed		Week 48
Secondary	Number of New T1 Hypo-Intense Lesions		Baseline, Week 24 and 48
Secondary	Number of New/Newly Enlarging T2 Hyperintense Lesions		Baseline, Week 24 and 48
Secondary	Total T2 Lesion Volume		Week 24 and 48
Secondary	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.	Up to Week 50
Secondary	Number of Participants With Change from Baseline in Clinical Laboratory Parameters, Electrocardiogram (ECG), and Vital Signs		Baseline to Week 48
Secondary	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.	Baseline to Week 48