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Completed Phase 2 Interventional

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)

ClinicalTrials.gov ID: NCT05798520

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.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 6:06 PM EDT

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

Study identification

NCT ID
NCT05798520
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Biogen
Industry
Enrollment
127 participants

Conditions and interventions

Interventions

  • BIIB091 Drug
  • DRF Drug
  • Placebo Drug

Drug

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 Jul 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05798520 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →