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New MS pill aims to outperform current treatment

NCT ID NCT04586023

Disease control Sponsor: Hoffmann-La Roche 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 5 times

Summary

This Phase 3 study compares fenebrutinib, an experimental oral drug, to teriflunomide, an approved MS therapy, in 751 adults with relapsing multiple sclerosis. The goal is to see if fenebrutinib better reduces relapse rates and delays disability progression. Participants take either drug or placebo for a double-blind period, with a possible open-label extension.

What this could mean

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

Active substance
Fenebrutinib
What this could lead to
If successful, fenebrutinib could offer a new oral option to reduce MS relapses and slow disability progression.
What could go wrong
This is a large Phase 3 trial, but fenebrutinib may not prove more effective than the existing drug teriflunomide. Side effects are possible, and results may not apply to all MS patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

751 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Jul 2027

An estimate. End dates often move.

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.

Inclusion Criteria: * Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening * A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria * Ability to complete the 9-hole Peg Test (9-HPT) for each hand in \< 240 seconds * Ability to perform the Timed 25-foot Walk Test (T25FWT) in \< 150 seconds * For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs * For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm OLE Inclusion Criteria: * Completed the DBT phase of the study (remaining on study treatment; no other disease-modifying therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib * Participants randomized to the teriflunomide treatment arm during the DBT phase must undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first administration of open-label fenebrutinib * For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs * For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm Exclusion Criteria: * Disease duration of \> 10 years from the onset of symptoms and an EDSS score at screening \< 2.0 * Female participants who are pregnant or breastfeeding, or intending to become pregnant * Male participants who intend to father a child during the study * A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS) * Any known or suspected active infection at screening, including but not limited to a positive screening tests for hepatitis B (HBV) and hepatitis C (HCV), an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML) * History of cancer including hematologic malignancy and solid tumors within 10 years of screening * Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study and clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal (GI) disease * Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption * Hypoproteinemia * Acute liver disease * Chronic liver disease unless considered stable for \> 6 months * Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's syndrome * Participants with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * History of alcohol or other drug abuse within 12 months prior to screening * History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of human immunodeficiency virus (HIV) infection * Inability to complete an MRI scan * Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening (inhaled and topical corticosteroids are allowed) * Receipt of a live-attenuated vaccine within 6 weeks prior to randomization * Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period OLE Exclusion Criteria: * Chronic liver disease unless considered stable for \> 6 months * Acute liver disease * Cirrhosis (Child-pugh Class A, B or C) * Gilbert's syndrome

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Relapsing multiple sclerosis

Contacts and locations

Locations

  • A. O. U. Federico II

    Naples, Campania, 80131, Italy

  • AHEPA Univ. General Hospital of Thessaloniki

    Thessaloniki, 54636, Greece

  • AOU Policlinico Giaccone

    Palermo, Sicily, 90129, Italy

  • American Health Network Institute, LLC

    Avon, Indiana, 46123, United States

  • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari

    Bari, Apulia, 70124, Italy

  • Bakirkoy State Mental Hospital

    Istanbul, 34000, Turkey (Türkiye)

  • Baskent Universitesi Ankara Hastanesi

    Çankaya, 06490, Turkey (Türkiye)

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, São Paulo, 09715-090, Brazil

  • CHU de Québec

    Québec, Quebec, G1J 1Z4, Canada

  • CHU toulouse - Hôpital Purpan

    Toulouse, 31059, France

  • CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

    Chicoutimi, Quebec, G7H 5H6, Canada

  • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika

    Gdansk, 80-803, Poland

  • Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01228-200, Brazil

  • Centrum Neurologii Klinicznej

    Krakow, 31-505, Poland

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324, Poland

  • Christian Medical College and Hospital

    Ludhiana, Punjab, 141008, India

  • Clinica Neurologica

    Joinville, Santa Catarina, 89202-190, Brazil

  • Clinstile S.A de C.V.

    Mexico City, Mexico CITY (federal District), 06700, Mexico

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004, India

  • Ege Üniversitesi Tip Fakültesi

    Lzmir, 35100, Turkey (Türkiye)

  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

    Krasnoyarsk, Krasnoyarsk Krai, 660037, Russia

  • Federal center of brain research and neurotechnologies

    Moskva, Moscow Oblast, 117997, Russia

  • Fond. Istituto Neurologico C.Besta

    Milan, Lombardy, 20133, Italy

  • Freire Pesquisa Clinica

    Belo Horizonte, Minas Gerais, 30150-320, Brazil

  • Gazi University Medical Faculty

    Ankara, 06500, Turkey (Türkiye)

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Grupo Médico Camino S.C.

    México, Mexico CITY (federal District), 03600, Mexico

  • Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

    Sønderborg, 6400, Denmark

  • Hope Neurology

    Knoxville, Tennessee, 37922, United States

  • Hopital Gabriel Montpied CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • Hospital Eginition

    Athens, 115 28, Greece

  • Hospital Santa Marcelina

    São Paulo, São Paulo, 08270-070, Brazil

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hôpital Charles Nicolle

    Rouen, 76031, France

  • Hôpital Pasteur

    Nice, 06002, France

  • IBISMED Wielospecjalistyczne Centrum Medyczne

    Zabrze, 41-800, Poland

  • IMV Pesquisa Neurológica

    Porto Alegre, Rio Grande do Sul, 90110-000, Brazil

  • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

    Pavia, Lombardy, 27100, Italy

  • IRCCS Istituto Neurologico Neuromed

    Pozzilli, Molise, 86077, Italy

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310, Brazil

  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

    Oświęcim, 32-600, Poland

  • Integrated Neurology Services PLLC

    Falls Church, Virginia, 22043, United States

  • Irccs A.O.U.San Martino Ist

    Genoa, Liguria, 16132, Italy

  • Jordy Sinapse Medicina LTDA ME

    São Paulo, Brazil

  • Karadeniz Tecnical Uni. Med. Fac.

    Trabzon, 61080, Turkey (Türkiye)

  • Keimyung University Dongsan Medical Center

    Daegu, 41931, South Korea

  • Kepler Universitätskliniken GmbH - Med Campus III

    Linz, 4021, Austria

  • Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

    Warsaw, 02-097, Poland

  • Kocaeli University Hospital

    Kocaeli, 41380, Turkey (Türkiye)

  • Krasnoyarsk State Medical Academy

    Krasnoyarsk, Krasnoyarsk Krai, 660022, Russia

  • L2 Ip Instituto de Pesquisas Clinicas Ltda ME

    Brasília, Federal District, 70200-730, Brazil

  • Los Angeles Biomedical Research Institute at Harbor-UCLA

    Torrance, California, 90502, United States

  • MHATNP Sveti Naum EAD

    Sofia, 1113, Bulgaria

  • MUCH - Montreal Neurological Institute & Hospital

    Montreal, Quebec, H3A 2B4, Canada

  • Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

    Krakow, 31-637, Poland

  • Max Super Speciality Hospital

    New Delhi, National Capital Territory of Delhi, 110017, India

  • MedPolonia

    Poznan, 60-693, Poland

  • Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226-3596, United States

  • Mersin University Medical Faculty

    Mersin, 33079, Turkey (Türkiye)

  • Mexico Centre for Clinical Research

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • NCL Institute Neuroscience

    Rome, Lazio, 00178, Italy

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

    Późna, 61-853, Poland

  • NZOZ Vitamed

    Bydgoszcz, 85-079, Poland

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Center of Social Significant Disease

    Saint Petersburg, Sankt-Peterburg, 197110, Russia

  • Nebbiolo Center for Clinical Trials

    Tomsk, 634009, Russia

  • Neuro Institute of New England P.C.

    Foxborough, Massachusetts, 02035, United States

  • Neurocentrum Bydgoszcz sp. z o.o

    Bydgoszcz, 85-796, Poland

  • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych

    Plewiska, 62-064, Poland

  • North Central Neurology Associates

    Cullman, Alabama, 35058, United States

  • Nucare

    Guatemala City, 01015, Guatemala

  • Núcleo de Pesquisa do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

  • Ondokuz Mayis University School of Medicine

    Samsun, 55139, Turkey (Türkiye)

  • Ospedale Binaghi

    Cagliari, Sardinia, 09126, Italy

  • Ospedale Civile di Montichiari

    Montichiari, Lombardy, 25018, Italy

  • Ospedale S.Camillo Forlanini

    Rome, Lazio, 00152, Italy

  • Policlinico Universitario A. Gemelli

    Rome, Lazio, 00168, Italy

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, 160012, India

  • Praxis Pesquisa Médica

    Santo André, São Paulo, 09090-790, Brazil

  • RESMEDICA Spolka z o.o.

    Kielce, 25-726, Poland

  • Regional Clinical Hospital N.A. Semashko

    Nizhny Novgorod, Niznij Novgorod, 603126, Russia

  • Regional clinical hospital named after prof. S.V. Ochapovsky

    Krasnodar, 350086, Russia

  • SRM Institute of Medical Sciences

    Vadapalani, Tamil Nadu, 600026, India

  • Salford Royal NHS Foundation Trust

    Salford, M6 8HD, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sancaktepe Training and Research Hospital

    Istanbul, 34785, Turkey (Türkiye)

  • Selcuk University Medical Faculty

    Istanbul, 42131, Turkey (Türkiye)

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Seth G.S Medical College K.E.M Hospital

    Mumbai, Maharashtra, 400012, India

  • Sir Gangaram Hospital

    New Delhi, National Capital Territory of Delhi, 110060, India

  • Sydvestjysk Sygehus Esbjerg

    Esbjerg, 6700, Denmark

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • UMHAT Dr. Georgi Stranski

    Pleven, 5800, Bulgaria

  • Unidad de Investigación en Salud

    Chihuahua City, 31203, Mexico

  • Unidad de investigacion en salud (UIS)

    Mexico City, 14050, Mexico

  • Universita? G. D'Annunzio

    Chieti, Abruzzo, 66100, Italy

  • University General Hospital of Larisa

    Larissa, 411 10, Greece

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 1Z1, Canada

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • Van Yuzuncu Yil University Hospital

    Van, 65080, Turkey (Türkiye)

  • Wojewódzki Szpital Specjalistyczny Nr 3

    Rybnik, 44-200, Poland

  • Wro Medica

    Wroc?aw, 51-685, Poland

  • Xenoscience

    Phoenix, Arizona, 85004, United States

  • Zydus Hospital

    Ahmedabad, Gujarat, 380054, India

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