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A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis

Study Purpose

The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS inflammation, to evaluate the effects of BIIB091 combination therapy with DRF compared with the DRF monotherapy arm on additional MRI measures of active CNS inflammation, to investigate the safety and tolerability of BIIB091 combination therapy with DRF in participants with RMS.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 55 Years
Gender	All

More Inclusion & 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 or positive test result at screening for human immunodeficiency virus (HIV). 6. Current or history of hepatitis C infection regardless of viral load. 7. Current or possible hepatitis B. 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05798520
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Biogen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Director
Principal Investigator Affiliation	Biogen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Bulgaria, Czechia, Germany, Italy, Poland, Puerto Rico, Romania, Spain, Switzerland, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsing Forms of Multiple Sclerosis

Arms & Interventions

Arms

Experimental: Part 1: BIIB091 High Dose + Matching Placebo for DRF

Participants will receive BIIB091 high dose and matching placebo for DRF, orally, for up to 48 weeks.

Experimental: Part 1: BIIB091 Low Dose + Matching Placebo for DRF

Participants will receive BIIB091 low dose and matching placebo for DRF, orally, for up to 48 weeks.

Active Comparator: Part 1: DRF + Matching Placebo for BIIB091

Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.

Experimental: Part 2: BIIB091 + DRF Standard Dose

Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF standard dose, orally, for up to 48 weeks.

Experimental: Part 2: BIIB091 + DRF Low Dose

Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF low dose, orally, for up to 48 weeks.

Active Comparator: Part 2: DRF + Matching Placebo for BIIB091

Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.

Interventions

Drug: - BIIB091

Administered as specified in the treatment arm.

Drug: - DRF

Administered as specified in the treatment arm.

Drug: - Placebo

Administered as specified in the treatment arm.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

HonorHealth Neurology, Scottsdale, Arizona

Status

Recruiting

Address

HonorHealth Neurology

Scottsdale, Arizona, 85251

Site Contact

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A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis

Study Purpose

Recruitment Criteria

Inclusion Criteria:

Exclusion Criteria:

Trial Details

Arms

Interventions

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