biogen/studies/attachments/109MS424_Final_PLS_15Jan26_-_English_Master.pdf

109MS424_Final PLS_15Jan26 - English Master

biogen/studies/attachments/NCT05658484-Synopsis.pdf

NCT05658484-Synopsis

biogen/studies/attachments/Chinese_Translated_PLS_109MS424_ZH-CN.pdf

Plain Language Summary - Chinese for 109MS424

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.

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

Multiple Sclerosis

BG00012 (dimethyl fumarate)

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

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

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.

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.

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.

TECFIDERA®

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.

Beijing Hospital

Xiangya Hospital Central South University

West China Hospital of Sichuan University

The First Affiliated Hospital of Fujian Medical University

Nanfang Hospital, Southern Medical University

The Third Affiliated Hospital of Sun Yat-Sen University

The First Affiliated Hospital of Zhejiang University school

The Second Hospital of Hebei Medical University

The First People's Hospital of Yunnan Province

Renji Hospital, Shanghai Jiatong Uni. School of Medicine

Huashan Hospital, Fudan University

The First Hospital of China Medical University

The First Affiliated Hospital of Soochow University

The First Affiliated Hospital of Shanxi Medical University

Tianjin Medical University General Hospital

The First Affiliated Hospital of Wenzhou Medical University

Second Affiliated Hospital of Air Force Medical University

Approved

Dimethyl fumarate

dimethyl fumarate - Reference form

dimethyl fumarate - Test form

BG00012 placebo

TECHFIDERA