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Relapsing Multiple SclerosisPhase 3FENhanceNCT04586010

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

A Phase 3 study testing Fenebrutinib and Teriflunomide in people with Relapsing Multiple Sclerosis, run by Hoffmann-La Roche at 158 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized in a 1:1 ratio to receive either fenebrutinib or teriflunomide. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
Fenebrutinib and Teriflunomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
746 participants
Where
158 sitesin 23 countries
Study dates
17 Mar 2021to 30 Nov 2027
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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
  • Cirrhosis (Child-Pugh Class A, B, or C)
  • Gilbert's syndrome

Trial locations and contacts

158 sites in 23 countries.

158 sites in 23 countries

United States32 sites

  • University of New Mexico; MS Specialty Clinic

    Albuquerque, New Mexico, 87131

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Johns Hopkins University School Of Medicine; Outpatient Center

    Baltimore, Maryland, 21287

  • The NeuroMedical Center

    Baton Rouge, Louisiana, 70810

  • St. Luke's University Health network

    Bethlehem, Pennsylvania, 18015

  • University of Alabama Birmingham

    Birmingham, Alabama, 35233

  • Profound Research, LLC

    Carlsbad, California, 92011

  • Miami Valley Hospital South; Dayton Physician's Office

    Centerville, Ohio, 45459

  • OhioHealth

    Columbus, Ohio, 43214

  • The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company

    Columbus, Ohio, 43235

  • Mountain View Clinical Research

    Denver, Colorado, 80209

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Advanced Neurology of Colorado, LLC

    Fort Collins, Colorado, 80528

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46805

  • Premier Neurology

    Greenville, South Carolina, 29605

  • NorthShore University HealthSystem

    Highland Park, Illinois, 60035

  • Alabama Neurology Associates

    Homewood, Alabama, 35209

  • University of California Irvine

    Irvine, California, 92697

  • Evergreen MS Center

    Kirkland, Washington, 98034

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920

  • Neurology Associates, PA; Research Department

    Maitland, Florida, 32751

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

    Milwaukee, Wisconsin, 53215

  • Oklahoma Medical Research Foundation; MS Center of Excellence

    Oklahoma City, Oklahoma, 73104

  • Quantum Clinical Research, Inc

    Pasadena, California, 91106

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

    Phoenix, Arizona, 85032

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

    Plano, Texas, 75024

  • Texas Institute for Neurological Disorders

    Sherman, Texas, 75092

  • Ochsner LSU Health

    Shreveport, Louisiana, 71103

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Holy Name Hospital; Institute For Clinical Research

    Teaneck, New Jersey, 07666

  • Multiple Sclerosis Center of Greater Washington

    Vienna, Virginia, 22182

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

China17 sites

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing

  • the First Hospital of Jilin University

    Changchun, 130021

  • Xiangya Hospital Central South University

    Changsha, 410008

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510260

  • The affiliated Hospital of Guiyang Medical College

    Guiyang

  • The First People?s Hospital of Yunnan Province

    Kunming, 650021

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 05000

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215031

  • 1st Affiliated Hospital of Shanxi Medical University

    Taiyuan

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Xinjiang People Hospital

    Ürümqi, 830000

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

    Wuhan, 430030

  • Tangdu Hospital, The Fourth Military Medical University

    Xi'an

Other trials in China

Italy12 sites

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

    Bergamo, Lombardy, 24127

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

    Catania, Sicily, 95123

  • AO.U. Policlinico Riuniti Foggia

    Foggia, Apulia, 71100

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Ospedale Regina Montis Regalis

    Mondovì (CN), Piedmont, 12084

  • AOU Seconda Università degli Studi

    Naples, Campania, 80131

  • AOU Policlinico - Università L. Vanvitelli

    Naples, Campania, 80138

  • Azienda Ospedaliera di Padova

    Padova, Veneto, 35128

  • A.O.U. di Parma

    Parma, Emilia-Romagna, 43126

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

    Rome, Lazio, 00133

  • Policlinico Umberto I

    Rome, Lazio, 00185

  • Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189

Other trials in Italy

Ukraine12 sites

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

    Dnipro, Tavria Okruha

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

    Dnipro, 49027

  • Ams of Ukraine

    Kharkiv, 61068

  • Medical Center Dopomoga Plus

    Kyiv, 02123

  • Medical Center of Private Execution First Private Clinic

    Kyiv, 03037

  • Lviv Regional Clinical Hospital

    Lviv, 79010

  • "Neurofocus" LLC

    Lviv, 79029

  • Odesa Regional Clinical Hospital

    Odesa, 65117

  • Medical Clinical Research Center of Medical Center LLC Health Clinic

    Vinnytsi, 21009

  • Salutem Medical Center

    Vinnytsia, KIEV Governorate, 21009

  • LCC "Medical center "Unimed"

    Zaporizhzhya, 69035

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

    Zaporizhzhya, 69600

Other trials in Ukraine

Spain11 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Virgen de Arrixaca

    EL Palmar (EL Palmar), Murcia, 30120

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Regional Universitario de Malaga ? Hospital General

    Málaga, 29010

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36213

Other trials in Spain

Germany9 sites

  • Jüdisches Krankenhaus Berlin

    Berlin, 13347

  • Studienzentrum Dr. Bischof GmbH

    Böblingen, 71034

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

    Dresden, 01307

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35385

  • Uniklinik Schleswig-Holstein

    Kiel, 24105

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

    Stuttgart, 70174

  • Universitätsklinikum Tübingen, Zentrum für Neurologie

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

    Westerstede, 26655

Other trials in Germany

Poland8 sites

  • ProNeuro Centrum Medyczne

    ?ory, 44-240

  • Neurocentrum Bydgoszcz sp. z o.o

    Bydgoszcz, 85-796

  • Care Clinic

    Katowice, 40-568

  • MT Medic Krosno

    Krosno, 38-400

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324

  • Rodzinne Centrum Medyczne Lubimed.pl

    Lublin, 20-492

  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

    Warsaw, 02-957

  • IBISMED Wielospecjalistyczne Centrum Medyczne

    Zabrze, 41-800

Other trials in Poland

Argentina7 sites

  • Neurologia Infantil Buenos Aires (NIBA)

    Buenos Aires, C1182ACA

  • IME - Instituto Médico Especializado

    Buenos Aires, C1405BCH

  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR

    Buenos Aires, C1424

  • CIER

    C. A. B. A., C1055AAF

  • Diagnostico Medico Oroño

    Rosario, 2000

  • Cer San Juan

    San Juan, J5400CEP

  • Centro de Investigaciones Médicas Tucuman

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Portugal7 sites

  • Hospital de Braga

    Braga, 4710-243

  • HUC

    Coimbra, 3000-075

  • Hospital Santo Antonio dos Capuchos

    Lisbon, 1169-050

  • Hospital da Luz

    Lisbon, 1500-650

  • Hospital Geral de Santo Antonio

    Porto, 4099-001

  • Hospital de Sao Joao

    Porto, 4200-319

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

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Peru6 sites

  • Hospital IV Alberto Sabogal Sologuren

    Bellavista, Callao 2

  • Hospital Nacional Guillermo Almenara Irigoyen

    La Victoria, Lima, Lima 13

  • Hospital Nacional Dos de Mayo

    Lima, 15018

  • Clinica Internacional Sede Lima

    Lima, Lima 01

  • Hospital Maria Auxiliadora

    Lima, Lima 29

  • Clinica Centenario Peruano Japonesa

    Pueblo Libre, Lima 21

Other trials in Peru

Russia6 sites

  • Center of Cardiology and Neurology

    Kirov, 610007

  • FSBIH Siberian Regional Medical Centre of FMBA of Russia

    Novosibirsk, 630007

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, Sankt-Peterburg, 194291

  • Pavlov State Medical Uni

    Saint Petersburg, Sankt-Peterburg, 197022

  • Republican clinical hospital named after G.G. Kuvatov

    Ufa, Bashkortostan Republic, 450005

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, Ulyanovsk Oblast, 432063

Other trials in Russia

Georgia5 sites

  • New Hospitals

    Tbilisi, 0114

  • Pineo Medical Ecosystem

    Tbilisi, 0114

  • St. Michael hospital

    Tbilisi, 0159

  • MediClab Georgia

    Tbilisi, 0160

  • Khechinashvili University Hospital

    Tbilisi, 0179

Other trials in Georgia

Hungary5 sites

  • Clinexpert Kft.

    Budapest, 1033

  • S-Medicon Egeszsegugyi Szolgaltato Kft.

    Budapest, 1044

  • Markhot Ferenc Oktatokorhaz és Rendelointezet

    Eger, 3300

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, 6725

Other trials in Hungary

Mexico5 sites

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, Sinaloa, 80020

  • Hospital General de Mexico

    Mexico, Tlaxcala, 06726

  • Grupo Medico de Investigacion Clinica Multidisciplinaria

    Mexico City, Mexico CITY (federal District), 03100

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100

  • Clinical Research Institute Saltillo

    Saltillo, Coahuila, 25050

Other trials in Mexico

North Macedonia3 sites

  • Clinical Hospital Stip

    Shtip, 2000

  • PHO General City Hospital 8th September Center for dialysis

    Skopje, 1000

  • University Clinic for Neurology - Skopje

    Skopje, 1000

Other trials in North Macedonia

Tunisia3 sites

  • Hopital Razi

    Mannouba, 2010

  • Fattouma Bourguiba Hospital

    Monastir, 5000

  • Hospital Habib Bourguiba

    Sfax, 3029

Other trials in Tunisia

Dominican Republic2 sites

  • NeuroINC

    Santiago de los Caballeros, 51000

  • Hospital Padre Billini

    Santo Domingo, 10210

Other trials in Dominican Republic

Hong Kong2 sites

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

  • Prince of Wales Hospital

    Shatin, New Territories

Other trials in Hong Kong

Switzerland2 sites

  • Inselspital Bern Medizin Neurologie

    Bern, 3010

  • Ospedale Regionale di Lugano - Civico

    Lugano, 6903

Other trials in Switzerland

Finland1 site

  • Helsinki University Central Hospital

    Helsinki, 00290

Other trials in Finland

Kenya1 site

  • The Aga Khan University-Kenya.

    Nairobi, 00100

Other trials in Kenya

Netherlands1 site

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

Serbia1 site

  • University Clinical Center of Serbia

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: A Phase III Multicenter Randomized, Double-blind, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension (OLE) phase of the study.

Being tested
Fenebrutinib, Teriflunomide, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FenebrutinibDrug

    Participants will receive fenebrutinib.

  • TeriflunomideDrug

    Participants will receive teriflunomide.

  • PlaceboDrug

    Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.

Study groups in NCT04586010
Study groupRoleWhat they receive
FenebrutinibExperimentalParticipants will receive oral (PO) fenebrutinib, with teriflunomide-matching placebo.
Receives: Drug: Fenebrutinib; Drug: Placebo
TeriflunomideActive comparatorParticipants will receive PO teriflunomide, with fenebrutinib-matching placebo in a blinded fashion.
Receives: Drug: Teriflunomide; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Relapse Rate (ARR)

    Measured: Minimum of 96 weeks

Secondary outcomes (12)

  1. Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12)

    Measured: Minimum of 96 weeks

  2. Time to Onset of Composite 24-week Confirmed Disability Progression (cCDP24)

    Measured: Minimum of 96 weeks

  3. Time to Onset of 12-week Confirmed Disability Progression (CDP12)

    Measured: Minimum of 96 weeks

  4. Time to Onset of 24-week Confirmed Disability Progression (CDP24)

    Measured: Minimum of 96 weeks

  5. Total Number of T1 Gadolinium Enhancing (Gd+) Lesions, New and/or Enlarging T2-weighted Lesions, as Detected by Magnetic Resonance Imaging (MRI)

    Measured: Baseline, Weeks 12, 24, 48 and 96

  6. Percentage Change in Total Brain Volume From Week 24 as Assessed by MRI

    Measured: From Week 24 to Week 96

  7. Change in Participant-reported Physical Impacts of Multiple Sclerosis (MS), as Measured by the Multiple Sclerosis Impact Scale (29-item), Version 2 (MSIS-29) Physical Scale

    Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  8. Time to Onset of 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT) Score

    Measured: Minimum of 96 weeks

  9. Percent Change From Baseline to Week 48 in the Concentration of Blood Neurofilament Light Chain (NfL)

    Measured: Baseline, Week 48

  10. Time to Onset of Composite 12-week Confirmed Progression Independent of Relapse Activity (cPIRA12)

    Measured: Minimum of 96 weeks

  11. Percentage of Participants With Adverse Events (AEs)

    Measured: Up to 4.5 years

  12. Plasma Concentrations of Fenebrutinib at Specified Timepoints

    Measured: Up to 4.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start17 Mar 2021
  3. Primary completion27 Jan 2026
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
746 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04586010
Sponsor's protocol ID
GN41851
Other IDs
2019-004857-10, 2022-502609-14-00, 2019
Acronym
FENhance
Status last verified
Sep 2026
First submitted
8 Oct 2020
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

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