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)
Public ClinicalTrials.gov record NCT05798520. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05798520
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 127 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 24, 2023
- Primary completion
- Feb 9, 2026
- Completion
- Feb 9, 2026
- Last update posted
- Feb 19, 2026
2023 – 2026
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Neurology | Scottsdale | Arizona | 85251 | — |
| Alta Bates Summit Medical Center | Berkeley | California | 94705 | — |
| University of California at Irvine Medical Center | Orange | California | 92868 | — |
| University of Colorado School of Medic | Aurora | Colorado | 80045 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Vero Beach Neurology and Research Institute | Vero Beach | Florida | 32960 | — |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | 46804 | — |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | — |
| International Neurorehabilitation Institute | Lutherville | Maryland | 21093 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Holy Name | Teaneck | New Jersey | 07666 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131-0001 | — |
| South Shore Neurologic Associates, P.C. | Patchogue | New York | 11772 | — |
| Wake Forest University - School of Medicine - Central | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati Physicians Company | Cincinnati | Ohio | 45267 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| The Boster Center for Multiple Sclerosis | Columbus | Ohio | 43235 | — |
| Neurology Clinic, PC | Cordova | Tennessee | 38018 | — |
| Vanderbilt MS Center | Nashville | Tennessee | 37215 | — |
| The University of Texas Health Science Center San Antonio | San Antonio | Texas | 78229-3900 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 54 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05798520, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 19, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05798520 live on ClinicalTrials.gov.