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New MS pill aims to slow disability in phase 3 showdown

NCT ID NCT04586010

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study compares two daily pills—fenebrutinib and teriflunomide—in about 746 adults with relapsing multiple sclerosis. The goal is to see which one better reduces relapses and delays worsening disability. Participants take one of the two drugs for several years, with an option to continue in an open-label extension.

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

746 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Nov 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 test 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: * Acute liver disease * Chronic liver disease unless considered stable for \> 6 months

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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

  • "Neurofocus" LLC

    Lviv, 79029, Ukraine

  • 1st Affiliated Hospital of Shanxi Medical University

    Taiyuan, China

  • A.O.U. di Parma

    Parma, Emilia-Romagna, 43126, Italy

  • AO.U. Policlinico Riuniti Foggia

    Foggia, Apulia, 71100, Italy

  • AOU Policlinico - Università L. Vanvitelli

    Naples, Campania, 80138, Italy

  • AOU Policlinico V. Emanuele - P.O G. Rodolico

    Catania, Sicily, 95123, Italy

  • AOU Seconda Università degli Studi

    Naples, Campania, 80131, Italy

  • ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla

    Bergamo, Lombardy, 24127, Italy

  • Advanced Neurology of Colorado, LLC

    Fort Collins, Colorado, 80528, United States

  • Alabama Neurology Associates

    Homewood, Alabama, 35209, United States

  • Ams of Ukraine

    Kharkiv, 61068, Ukraine

  • Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189, Italy

  • Azienda Ospedaliera di Padova

    Padova, Veneto, 35128, Italy

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing, China

  • CIER

    C. A. B. A., C1055AAF, Argentina

  • Care Clinic

    Katowice, 40-568, Poland

  • Center for Neurology and Spine - Phoenix - Hunt - PPDS

    Phoenix, Arizona, 85032, United States

  • Center of Cardiology and Neurology

    Kirov, 610007, Russia

  • Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião

    Santa Maria da Feira, 4520-211, Portugal

  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR

    Buenos Aires, C1424, Argentina

  • Centro de Investigaciones Médicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324, Poland

  • Cer San Juan

    San Juan, J5400CEP, Argentina

  • Clinexpert Kft.

    Budapest, 1033, Hungary

  • Clinica Centenario Peruano Japonesa

    Pueblo Libre, Lima 21, Peru

  • Clinica Internacional Sede Lima

    Lima, Lima 01, Peru

  • Clinical Hospital Stip

    Shtip, 2000, North Macedonia

  • Clinical Research Institute Saltillo

    Saltillo, Coahuila, 25050, Mexico

  • Diagnostico Medico Oroño

    Rosario, 2000, Argentina

  • Evergreen MS Center

    Kirkland, Washington, 98034, United States

  • FSBIH Siberian Regional Medical Centre of FMBA of Russia

    Novosibirsk, 630007, Russia

  • Fattouma Bourguiba Hospital

    Monastir, 5000, Tunisia

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46805, United States

  • Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Grupo Medico de Investigacion Clinica Multidisciplinaria

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

  • HUC

    Coimbra, 3000-075, Portugal

  • Health Pharma Professional Research

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

  • Helsinki University Central Hospital

    Helsinki, 00290, Finland

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Holy Name Hospital; Institute For Clinical Research

    Teaneck, New Jersey, 07666, United States

  • Hopital Razi

    Mannouba, 2010, Tunisia

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36213, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital General de Mexico

    Mexico, Tlaxcala, 06726, Mexico

  • Hospital Geral de Santo Antonio

    Porto, 4099-001, Portugal

  • Hospital Habib Bourguiba

    Sfax, 3029, Tunisia

  • Hospital IV Alberto Sabogal Sologuren

    Bellavista, Callao 2, Peru

  • Hospital Maria Auxiliadora

    Lima, Lima 29, Peru

  • Hospital Nacional Dos de Mayo

    Lima, 15018, Peru

  • Hospital Nacional Guillermo Almenara Irigoyen

    La Victoria, Lima, Lima 13, Peru

  • Hospital Padre Billini

    Santo Domingo, 10210, Dominican Republic

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Regional Universitario de Malaga ? Hospital General

    Málaga, 29010, Spain

  • Hospital Santo Antonio dos Capuchos

    Lisbon, 1169-050, Portugal

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen de Arrixaca

    EL Palmar (EL Palmar), Murcia, 30120, Spain

  • Hospital Universitario de la Princesa

    Madrid, 28006, Spain

  • Hospital da Luz

    Lisbon, 1500-650, Portugal

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Hospital de Sao Joao

    Porto, 4200-319, Portugal

  • IBISMED Wielospecjalistyczne Centrum Medyczne

    Zabrze, 41-800, Poland

  • IME - Instituto Médico Especializado

    Buenos Aires, C1405BCH, Argentina

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Inselspital Bern Medizin Neurologie

    Bern, 3010, Switzerland

  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

    Warsaw, 02-957, Poland

  • Johns Hopkins University School Of Medicine; Outpatient Center

    Baltimore, Maryland, 21287, United States

  • Jüdisches Krankenhaus Berlin

    Berlin, 13347, Germany

  • Khechinashvili University Hospital

    Tbilisi, 0179, Georgia

  • LCC "Medical center "Unimed"

    Zaporizhzhya, 69035, Ukraine

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, Sankt-Peterburg, 194291, Russia

  • Lviv Regional Clinical Hospital

    Lviv, 79010, Ukraine

  • MT Medic Krosno

    Krosno, 38-400, Poland

  • Markhot Ferenc Oktatokorhaz és Rendelointezet

    Eger, 3300, Hungary

  • MedPolonia

    Poznan, 60-693, Poland

  • MediClab Georgia

    Tbilisi, 0160, Georgia

  • Medical Center Dopomoga Plus

    Kyiv, 02123, Ukraine

  • Medical Center of Private Execution First Private Clinic

    Kyiv, 03037, Ukraine

  • Medical Clinical Research Center of Medical Center LLC Health Clinic

    Vinnytsi, 21009, Ukraine

  • Miami Valley Hospital South; Dayton Physician's Office

    Centerville, Ohio, 45459, United States

  • Mountain View Clinical Research

    Denver, Colorado, 80209, United States

  • Multiple Sclerosis Center of Greater Washington

    Vienna, Virginia, 22182, United States

  • Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

    Zaporizhzhya, 69600, Ukraine

  • NeuroINC

    Santiago de los Caballeros, 51000, Dominican Republic

  • Neurocentrum Bydgoszcz sp. z o.o

    Bydgoszcz, 85-796, Poland

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, Sinaloa, 80020, Mexico

  • Neurologia Infantil Buenos Aires (NIBA)

    Buenos Aires, C1182ACA, Argentina

  • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych

    Plewiska, 62-064, Poland

  • Neurology Associates, PA; Research Department

    Maitland, Florida, 32751, United States

  • New Hospitals

    Tbilisi, 0114, Georgia

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920, United States

  • North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic

    Plano, Texas, 75024, United States

  • NorthShore University HealthSystem

    Highland Park, Illinois, 60035, United States

  • Ochsner LSU Health

    Shreveport, Louisiana, 71103, United States

  • Odesa Regional Clinical Hospital

    Odesa, 65117, Ukraine

  • OhioHealth

    Columbus, Ohio, 43214, United States

  • Oklahoma Medical Research Foundation; MS Center of Excellence

    Oklahoma City, Oklahoma, 73104, United States

  • Ospedale Regina Montis Regalis

    Mondovì (CN), Piedmont, 12084, Italy

  • Ospedale Regionale di Lugano - Civico

    Lugano, 6903, Switzerland

  • PHO General City Hospital 8th September Center for dialysis

    Skopje, 1000, North Macedonia

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong, Hong Kong

  • Pavlov State Medical Uni

    Saint Petersburg, Sankt-Peterburg, 197022, Russia

  • Peking University First Hospital

    Beijing, 100034, China

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143, Hungary

  • Pineo Medical Ecosystem

    Tbilisi, 0114, Georgia

  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

    Rome, Lazio, 00133, Italy

  • Policlinico Umberto I

    Rome, Lazio, 00185, Italy

  • Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie

    Stuttgart, 70174, Germany

  • Premier Neurology

    Greenville, South Carolina, 29605, United States

  • Prince of Wales Hospital

    Shatin, New Territories, Hong Kong

  • ProNeuro Centrum Medyczne

    ?ory, 44-240, Poland

  • Profound Research, LLC

    Carlsbad, California, 92011, United States

  • Quantum Clinical Research, Inc

    Pasadena, California, 91106, United States

  • Republican clinical hospital named after G.G. Kuvatov

    Ufa, Bashkortostan Republic, 450005, Russia

  • Rodzinne Centrum Medyczne Lubimed.pl

    Lublin, 20-492, Poland

  • S-Medicon Egeszsegugyi Szolgaltato Kft.

    Budapest, 1044, Hungary

  • SI USSRI of Medical and Social Problems of Disabilities of MOHU

    Dnipro, 49027, Ukraine

  • Salutem Medical Center

    Vinnytsia, KIEV Governorate, 21009, Ukraine

  • Separated structural unit ?University hospital? of Dnipro State Medical University

    Dnipro, Tavria Okruha, Ukraine

  • St. Luke's University Health network

    Bethlehem, Pennsylvania, 18015, United States

  • St. Michael hospital

    Tbilisi, 0159, Georgia

  • Studienzentrum Dr. Bischof GmbH

    Böblingen, 71034, Germany

  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

    Westerstede, 26655, Germany

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, 6725, Hungary

  • Tangdu Hospital, The Fourth Military Medical University

    Xi'an, China

  • Texas Institute for Neurological Disorders

    Sherman, Texas, 75092, United States

  • The Aga Khan University-Kenya.

    Nairobi, 00100, Kenya

  • The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company

    Columbus, Ohio, 43235, United States

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215031, China

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080, China

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016, China

  • The First People?s Hospital of Yunnan Province

    Kunming, 650021, China

  • The NeuroMedical Center

    Baton Rouge, Louisiana, 70810, United States

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 05000, China

  • The affiliated Hospital of Guiyang Medical College

    Guiyang, China

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510260, China

  • Tianjin Medical University General Hospital

    Tianjin, 300052, China

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030, China

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, Ulyanovsk Oblast, 432063, Russia

  • Uniklinik Schleswig-Holstein

    Kiel, 24105, Germany

  • University Clinic for Neurology - Skopje

    Skopje, 1000, North Macedonia

  • University Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • University of Alabama Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California Irvine

    Irvine, California, 92697, United States

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655, United States

  • University of New Mexico; MS Specialty Clinic

    Albuquerque, New Mexico, 87131, United States

  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

    Dresden, 01307, Germany

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35385, Germany

  • Universitätsklinikum Tübingen, Zentrum für Neurologie

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders

    Milwaukee, Wisconsin, 53215, United States

  • Xiangya Hospital Central South University

    Changsha, 410008, China

  • Xinjiang People Hospital

    Ürümqi, 830000, China

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG, Netherlands

  • the First Hospital of Jilin University

    Changchun, 130021, China

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Other studies related to the condition(s) this trial covers.