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)
Completed · Phase 2 · Has a placebo group
Conditions studied: Relapsing Forms of Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT05798520
- Run by
- Biogen
- People needed
- 127
- Starts
- 2023-07-25
- Expected to finish
- 2026-02-10
- Last updated by the study team
- 2026-02-20
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Alta Bates Summit Medical Center — Berkeley, California, United States
- University of California at Irvine Medical Center — Orange, California, United States
- University of Colorado School of Medic — Aurora, Colorado, United States
- University of Miami Miller School of Medicine — Miami, Florida, United States
- University of South Florida — Tampa, Florida, United States
- Vero Beach Neurology and Research Institute — Vero Beach, Florida, United States
- Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
- University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
- International Neurorehabilitation Institute — Lutherville, Maryland, United States
- Washington University — St Louis, Missouri, United States
- Holy Name — Teaneck, New Jersey, United States
- University of New Mexico — Albuquerque, New Mexico, United States
- South Shore Neurologic Associates, P.C. — Patchogue, New York, United States
- Wake Forest University - School of Medicine - Central — Winston-Salem, North Carolina, United States
- University of Cincinnati Physicians Company — Cincinnati, Ohio, United States
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
- The Boster Center for Multiple Sclerosis — Columbus, Ohio, United States
- Neurology Clinic, PC — Cordova, Tennessee, United States
- Vanderbilt MS Center — Nashville, Tennessee, United States
- The University of Texas Health Science Center San Antonio — San Antonio, Texas, United States
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
- The Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- 'MHAT Avis - Medica' OOD — Pleven, Bulgaria
- UMHAT 'Dr. Georgi Stranski', EAD — Pleven, Bulgaria
- HonorHealth Neurology — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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