臨床研究等提出・公開システム

An Open-Label, Single-Arm, Multicenter, Phase 3 Study to Evaluate the Safety and Tolerability, and Pharmacokinetics of Diroximel Fumarate (BIIB098) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis

A Study of Diroximel Fumarate (DRF) in Adult Participants from the Asia-Pacific Region with Relapsing Forms of Multiple Sclerosis (RMS)

Hanna Jerome Thomas

Biogen Japan Ltd.

Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027

japan-medinfo@biogen.com

Biogen Japan Medical Information

Biogen Japan Ltd.

Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027

+81-120-560-086

japan-medinfo@biogen.com

Not Recruiting

Nov. 15, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Must have a diagnosis of RMS, as defined by revised 2017 McDonald's criteria.

EDSS score between 0.0 and 5.0, inclusive, at Screening and Baseline (Visit 1).

Neurologically stable with no evidence of relapse within 30 days prior to Baseline (Visit 1).

For Japanese participants: Born in Japan and biological parents and grandparents were of Japanese origin.
If previously lived outside of Japan for more than 5 years, must not have had a significantly modified diet since leaving Japan.

For Chinese participants: Born in China, and biological parents and grandparents were of Chinese origin.
If previously lived outside of China for more than 5 years, must not have had a significantly modified diet since leaving China.

Has an MS relapse that has occurred within the 30 days prior to randomization and/or the participant has not stabilized from a previous relapse prior to randomization.

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 of, or ongoing, malignant disease, including solid tumors and hematologic malignancies.

History of systemic hypersensitivity reaction to DRF, DMF, MMF or other fumaric esters, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study.

Evidence of current SARS-CoV-2 infection within 14 days prior to Screening, between Screening and Baseline Visit, or at Baseline Visit, including but not limited to a fever (temperature > 37.5 degrees celsius), new and persistent cough, breathlessness, or loss of taste and/or smell.

Have close contact within 14 days prior to Day 1 with a SARS-CoV-2 positive individual.

History or positive test result at Screening for HIV.

Previous participation in this study or previous studies with DRF, DMF, or MMF.

Has a clinically significant history of suicidal ideation or suicidal behavior occurring in the past 12 months as assessed by the C-SSRS at Screening.

Both

Relapsing Forms of Multiple Sclerosis (RMS)

Research Name: BIIB098 (also known as ALK8700)
Generic Name: Diroximel Fumarate (DRF)
Trade Name: Vumerity
Participants will initiate treatment with DRF 231 mg twice daily on Day 1 through Day 7, followed by 462 mg twice daily from Day 8 onwards.

Part 1
Incidence of AEs and SAEs at Week 24

Quantitative and qualitative changes from baseline
(Visit 1) to Week 24 in clinical laboratory parameters, ECGs, and vital signs

Incidence of C-SSRS events at Baseline (Visit 1) and through Week 24

Part 2
Incidence of AEs and SAEs up to Week 48

Quantitative and qualitative changes from baseline (Visit 1) to Week 48 in clinical laboratory parameters, ECGs, and vital signs

Incidence of C-SSRS events at Baseline (Visit 1) and through Week 48

Part 1
Plasma concentrations of MMF and HES

Noncompartmental plasma PK parameters of MMF and HES, including the following:
Cmax
AUClast
Tmax
t1/2 (MMF only)

+81-6-6992-1001

Sept. 08, 2021

Yes

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

China