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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) (FUSION)

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Biogen

Status and phase

Enrolling
Phase 2

Conditions

Relapsing Forms of Multiple Sclerosis

Treatments

Drug: BIIB091
Drug: DRF
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05798520
2022-502552-31 (Other Identifier)
257MS201

Details and patient eligibility

About

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.

Enrollment

275 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  1. Diagnosis of RMS [relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS)] in accordance with the 2017 Revised McDonald criteria.

  2. Time since MS symptom onset is <20 years.

  3. Must have expanded disability status scale (EDSS) score of 0 through 5.0 at screening and baseline.

  4. Must have at least 1 of the following occurring prior to Baseline (Day 1):

    • ≥2 clinical relapses in the last 24 months (but not within 30 days prior to Baseline [Day 1]) with at least 1 relapse during the last 12 months prior to randomization.
    • ≥1 clinical relapse within the past 24 months (but not within 30 days prior to Baseline [Day 1]) and ≥1 new brain MRI lesion (Gd-positive and/or new or enlarging T2 hyperintense lesion) within the past 12 months prior to randomization. The screening MRI could be used to satisfy this criterion (if needed for inclusion, local reading is required). For new or enlarging T2 hyperintense lesions, the reference scan cannot be >12 months prior to randomization.
    • ≥1 GdE lesion on brain MRI within 6 months prior to randomization.

Key Exclusion Criteria:

  1. Diagnosis of primary progressive multiple sclerosis (PPMS) in accordance with the 2017 Revised McDonald criteria.

  2. 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.

  3. 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:

    • Known hypersensitivity to any components of the study treatment
    • Known hypersensitivity to previous fumarate or bruton's tyrosine kinase (BTK) inhibitor treatments
    • History of hypersensitivity to parenteral administration of Gd-based contrast agents
  4. Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within the past 4 weeks prior to Baseline.

  5. History of human immunodeficiency virus (HIV) infection or a positive or indeterminate test result at screening for HIV.

  6. Current or history of hepatitis C infection regardless of viral load.

  7. Current or history of hepatitis B infection.

  8. Current enrollment or plan to enroll in any other drug, biological, device, clinical study, or treatment with an investigational drug or approved therapy for investigational use within 90 days prior to randomization or 5 half-lives of the drug or therapy, whichever is longer.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

275 participants in 6 patient groups

Part 1: BIIB091 High Dose + Matching Placebo for DRF
Experimental group
Description:
Participants will receive BIIB091 high dose and matching placebo for DRF, orally, for up to 48 weeks.
Treatment:
Drug: Placebo
Drug: BIIB091
Part 1: BIIB091 Low Dose + Matching Placebo for DRF
Experimental group
Description:
Participants will receive BIIB091 low dose and matching placebo for DRF, orally, for up to 48 weeks.
Treatment:
Drug: Placebo
Drug: BIIB091
Part 1: DRF + Matching Placebo for BIIB091
Active Comparator group
Description:
Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.
Treatment:
Drug: Placebo
Drug: DRF
Part 2: BIIB091 + DRF Standard Dose
Experimental group
Description:
Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF standard dose, orally, for up to 48 weeks.
Treatment:
Drug: DRF
Drug: BIIB091
Part 2: BIIB091 + DRF Low Dose
Experimental group
Description:
Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF low dose, orally, for up to 48 weeks.
Treatment:
Drug: DRF
Drug: BIIB091
Part 2: DRF + Matching Placebo for BIIB091
Active Comparator group
Description:
Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.
Treatment:
Drug: Placebo
Drug: DRF

Trial contacts and locations

76

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Central trial contact

Global Biogen Clinical Trial Center; US Biogen Clinical Trial Center

Data sourced from clinicaltrials.gov

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