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New MS drug combo shows promise in early trial

NCT ID NCT05798520

Disease control Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called BIIB091, alone or combined with an approved MS drug (diroximel fumarate), in 127 people with relapsing multiple sclerosis. The goal was to check safety and see if it reduces brain inflammation on MRI scans. Participants took pills twice daily for 48 weeks, and neither they nor their doctors knew which treatment they received.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BIIB091 (an experimental drug) and diroximel fumarate (an approved MS drug)
What this could lead to
If successful, this could point toward a new treatment option for people with relapsing multiple sclerosis, possibly improving disease control when used alone or with an existing therapy.
What could go wrong
This is an early Phase 2 study with only 127 participants, so results may not apply to everyone. The drug may cause side effects or fail to show clear benefit over current treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

127 people

The number who actually took part.

Started

Jul 2023

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis secondary progressive multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing forms of multiple sclerosis

Contacts and locations

Locations

  • 'MHAT Avis - Medica' OOD

    Pleven, 5800, Bulgaria

  • Acibadem City Clinic Tokuda University Hospital Ead

    Sofia, 1407, Bulgaria

  • Alta Bates Summit Medical Center

    Berkeley, California, 94705, United States

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Roma, 00133, Italy

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    Roma, 00161, Italy

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

    Naples, 80138, Italy

  • COPERNICUS Podmiot Leczniczy Sp. z o. o.,

    Gdansk, 80-803, Poland

  • Caribbean Center for Clinical Research

    Guaynabo, San Juan, 00968, Puerto Rico

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081, Poland

  • Centrum Neurologii K. Selmaj

    Lodz, 90-324, Poland

  • DCC Neoclinic EAD

    Sofia, 1408, Bulgaria

  • Diagnostic Consultation Center CONVEX EOOD

    Sofia, 1680, Bulgaria

  • Fakultni Thomayerova nemocnice

    Praha 4-Krc, 14059, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005, Czechia

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 65691, Czechia

  • Fondazione Istituto G.Giglio di Cefalù

    Cefalù, Palermo, 90015, Italy

  • Fondazione Istituto Neurologico Casimiro Mondino

    Pavia, 27100, Italy

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804, United States

  • Holy Name

    Teaneck, New Jersey, 07666, United States

  • HonorHealth Neurology

    Scottsdale, Arizona, 85251, United States

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14011, Spain

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo

    Pozzilli, Isernia, 86077, Italy

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Inselspital - Universitaetsspital Bern

    Bern, 3010, Switzerland

  • Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K

    Oświęcim, 32-600, Poland

  • International Neurorehabilitation Institute

    Lutherville, Maryland, 21093, United States

  • Klinikum Bayreuth GmbH- Hohe Warte

    Bayreuth, Bavaria, 95445, Germany

  • Krajska zdravotni a.s. - Nemocnice Teplice o.z.

    Teplice, 41529, Czechia

  • M.A. - LEK A.M.Maciejowscy SC.

    Katowice, 40-571, Poland

  • MHATNP 'Sv.Naum', EAD

    Sofia, 1113, Bulgaria

  • Med-Polonia Sp. z o.o.

    Poznan, 60-693, Poland

  • NZOZ 'NEURO-KARD', 'Ilkowski i Partnerzy' Sp. Partn. Lek.

    Poznan, 61-853, Poland

  • Nemocnice Jihlava p.o.

    Jihlava, 58633, Czechia

  • NeuroProtect Sp. z o.o.

    Warsaw, 01-684, Poland

  • Neurology Clinic, PC

    Cordova, Tennessee, 38018, United States

  • Neuropraxis Muenchen Sued

    Unterhaching, Bavaria, 82008, Germany

  • Nzoz Novo-Med

    Katowice, 40-650, Poland

  • Nzoz Palomed

    Rzeszów, 35-323, Poland

  • Ospedale Regionale di Lugano

    Lugano, Canton Ticino, 6903, Switzerland

  • Resmedica Sp.z o.o

    Kielce, 25-726, Poland

  • S.C Clubul Sanatatii SRL

    Campulung Muscel, 115100, Romania

  • S.C Neurocity S.R.L

    Bucharest, 11302, Romania

  • Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II

    Grodzisk Mazowiecki, 05-825, Poland

  • South Shore Neurologic Associates, P.C.

    Patchogue, New York, 11772, United States

  • Spitalul Universitar de Urgenta Elias

    Bucharest, 11461, Romania

  • Studienzentrum fur Neurologie und Psychiatrie

    Böblingen, Baden-Wurttemberg, 71034, Germany

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-503, Poland

  • The Boster Center for Multiple Sclerosis

    Columbus, Ohio, 43235, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • The University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229-3900, United States

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431, Bulgaria

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800, Bulgaria

  • UMHAT 'Sv. Georgi', EAD

    Plovdiv, 4002, Bulgaria

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Universitaetsspital Zuerich

    Zurich, 8091, Switzerland

  • University First MHAT-Sofia, 'St. Joan Krastitel' EAD

    Sofia, 1142, Bulgaria

  • University of California at Irvine Medical Center

    Orange, California, 92868, United States

  • University of Cincinnati Physicians Company

    Cincinnati, Ohio, 45267, United States

  • University of Colorado School of Medic

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160, United States

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792, United States

  • Vanderbilt MS Center

    Nashville, Tennessee, 37215, United States

  • Vero Beach Neurology and Research Institute

    Vero Beach, Florida, 32960, United States

  • Wake Forest University - School of Medicine - Central

    Winston-Salem, North Carolina, 27157, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Wielospecjalistyczne Centrum Medyczne Ibismed

    Zabrze, 41-800, Poland

  • ZNS - Zentrum fuer Neurologisch-Psychiatrische Studien

    Siegen, North Rhine-Westphalia, 57076, Germany

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