Clinical trial NCT05658484: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2022-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: Week 48
Secondary outcomes:
measure: Change From Baseline in Number of Gadolinium-Enhancing (GdE) Lesions
timeFrame: Week 24
measure: Number of GdE Lesions
timeFrame: Week 24 and 48
measure: Percentage of Participants GdE-Lesion Free
timeFrame: Week 24 and 48
measure: Percentage of Participants Relapsed
timeFrame: Week 48
measure: Number of New T1 Hypo-Intense Lesions
timeFrame: Baseline, Week 24 and 48
measure: Number of New/Newly Enlarging T2 Hyperintense Lesions
timeFrame: Baseline, Week 24 and 48
measure: Total T2 Lesion Volume
timeFrame: Week 24 and 48
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 50
measure: Number of Participants With Change from Baseline in Clinical Laboratory Parameters, Electrocardiogram (ECG), and Vital Signs
timeFrame: Baseline to Week 48
measure: Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Events
timeFrame: Baseline to Week 48
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu City
country: China
facility: West China Hospital of Sichuan University
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-Sen University
city: Hebei
country: China
facility: The Second Hospital of Hebei Medical University
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiatong Uni. School of Medicine
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
city: Shengyang
country: China
facility: The First Hospital of China Medical University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Taiyuan
country: China
facility: The First Affiliated Hospital of Shanxi Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Xi'An
country: China
facility: Second Affiliated Hospital of Air Force Medical University
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: