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Not recruiting
Phase 2

BIIB091 & DRF

Sponsor:

Biogen

Code:

NCT05798520

Conditions

Relapsing Forms of Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

BIIB091

DRF

Placebo

Study Details

Brief summary:

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.

Conditions

Relapsing Forms of Multiple Sclerosis

Study ID

NCT05798520

Start date

Jul 25, 2023

Status verified date

Jun, 2025

Completion date

Sep 7, 2027

Anticipated

Primary completion date

Sep 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

275 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

BIIB091

Administered as specified in the treatment arm.

DRF

Administered as specified in the treatment arm.

Placebo

Administered as specified in the treatment arm.

Primary outcome measure

  • Part 1: Number of Participants With Adverse Events (AEs) [ Time Frame: Day 1 up to Week 50 ]
  • Part 1: Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: From signing the informed consent form (ICF) to Week 50 ]
  • Part 2: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions [ Time Frame: Week 8 to Week 16 ]

Central Contacts and Locations

Central contacts

US Biogen Clinical Trial Center

866-633-4636clinicaltrials@biogen.com

Global Biogen Clinical Trial Center

clinicaltrials@biogen.com

Locations

HonorHealth Neurology

Recruiting

Scottsdale, Arizona, United States, 85251

Contacts

Principal Investigator:

Suraj A. Muley

Alta Bates Summit Medical Center

Recruiting

Berkeley, California, United States, 94705

Contacts

Principal Investigator:

Joanna A. Cooper

University of California at Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Contacts

Principal Investigator:

Michael Sy

University of Colorado School of Medic

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Enrique Alvarez

University of Miami Miller School of Medicine

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Silvia Rosa Delgado

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Derrick Scott Robertson

Vero Beach Neurology and Research Institute

Recruiting

Vero Beach, Florida, United States, 32960

Contacts

Principal Investigator:

Stuart James Shafer

Fort Wayne Neurological Center

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

Principal Investigator:

Ajay Gupta

University of Kansas Medical Center Research Institute, Inc.

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Sharon G. Lynch

International Neurorehabilitation Institute

Recruiting

Lutherville, Maryland, United States, 21093

Contacts

Principal Investigator:

Daniel Becker

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Robert T. Naismith

Holy Name

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

Principal Investigator:

Mary Ann Picone

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131-0001

Contacts

Principal Investigator:

Clotilde Hainline

South Shore Neurologic Associates, P.C.

Recruiting

Patchogue, New York, United States, 11772

Contacts

Principal Investigator:

Mark Gudesblatt

Wake Forest University - School of Medicine - Central

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator:

Nuhad Abou Zeid

University of Cincinnati Physicians Company

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Principal Investigator:

Lawrence Phillip Goldstick

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Devon Scott Conway

The Boster Center for Multiple Sclerosis

Recruiting

Columbus, Ohio, United States, 43235

Contacts

Principal Investigator:

Aaron L. Boster

Neurology Clinic, PC

Recruiting

Cordova, Tennessee, United States, 38018

Contacts

Principal Investigator:

Lee S. Stein

Vanderbilt MS Center

Recruiting

Nashville, Tennessee, United States, 37215

Contacts

Principal Investigator:

Siddharama S Pawate

The University of Texas Health Science Center San Antonio

Recruiting

San Antonio, Texas, United States, 78229-3900

Contacts

Principal Investigator:

Tania Reyna

University of Wisconsin Hospital and Clinics

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Principal Investigator:

Christopher C. Luzzio

The Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Principal Investigator:

Ahmed Zayed Obeidat

More Information

Sponsor

Biogen

Last update posted

Jun 22, 2025

Last verified

Jun, 2025

Keywords

  • Multiple Sclerosis
  • Diroximel fumarate
  • BIIB091

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by Biogen on 2025-06-22.