CompletedPhase 2

A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)

United States127 participantsStarted 2023-07-25

Plain-language summary

In this study, researchers will learn more about a study drug called BIIB091 in participants with MS who may be experiencing relapses. It is a 2-part study. In Part 1, one set of participants will take either BIIB091 or diroximel fumarate (DRF). In Part 2, a different set of participants will take either a combination of BIIB091 and DRF or DRF alone. The goal of the study is to learn more about the safety of BIIB091 and to compare the effects of the study drug when taken alone or together with DRF. The main question researchers are trying to answer are: * How many participants have new or worsening medical problems (adverse events) after taking BIIB091 or DRF? * How many new areas of inflammation occur in the brain after treatment with BIIB091 and DRF? Researchers will use magnetic resonance imaging (MRI) scans to compare images of the brain before and after treatment. They will also explore the effect of BIIB091 and DRF on the heart using electrocardiograms (ECGs). The study will be done as follows: * After screening, participants who joined Part 1 will be randomly assigned to receive either a high or low dose of BIIB091, or the standard dose of DRF. * The results of Part 1 will be used to choose the best dose of BIIB091 to use in Part 2. * Participants who join Part 2 will be randomly assigned to receive either a standard dose of DRF, a combo of BIIB091 and the standard dose of DRF, or a combo of BIIB91 with a low dose of DRF. * Neither the researchers nor the participants will know which drug or dose the participants will receive in either part of the study. * The treatment period will last 48 weeks in each part of the study. Participants will take the drugs by mouth 2 times a day. * Each part will also have a follow-up safety period that lasts up to 2 weeks. * In total, participants in each part will have 20 study visits, or more if they have a relapse. The total study duration for participants will be up to 54 weeks.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Diagnosis of RMS \[relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS)\] in accordance with the 2017 Revised McDonald criteria.
✓. Time since MS symptom onset is \<20 years.
✓. Must have expanded disability status scale (EDSS) score of 0 through 5.0 at screening and baseline.
✓. Must have at least 1 of the following occurring prior to Baseline (Day 1):

Exclusion criteria

✕. Diagnosis of primary progressive multiple sclerosis (PPMS) in accordance with the 2017 Revised McDonald criteria.
✕. An MS relapse that has occurred within 30 days prior to Baseline (Day 1) or the participant has not stabilized from a previous relapse at the time of screening.
✕. History of severe allergic, anaphylactic reactions or hypersensitivity reaction to BIIB091 or DRF, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study, including the following:
✕

What they're measuring

Part 1: Number of Participants With Adverse Events (AEs)

Timeframe: Day 1 up to Week 50

Part 1: Number of Participants With Serious Adverse Events (SAEs)

Timeframe: From signing the informed consent form (ICF) to Week 50

Part 2: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions

Timeframe: Week 8 to Week 16

Trial details

NCT IDNCT05798520

SponsorBiogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-10

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