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

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 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsing Multiple Sclerosis
• Intervention / Treatment: Drug: Fenebrutinib; Drug: Placebo; Drug: Teriflunomide

• Study Type: Interventional
• Enrollment (Actual): 746
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: GN41851 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1424
    • Centro de Especialidades Neurológicas y Rehabilitación - CENyR
  • C. A. B. A., Argentina, C1055AAF
    • CIER
  • Ciudad Autonoma Buenos Aires, Argentina, C1405CBA
    • NeuroSite
  • Ciudad Autonoma de Buenos Aires, Argentina, C1012AAR
    • Instituto de Investigaciones Metabolicas (IDIM)
  • Rosario, Argentina, S2000CTC
    • Diagnostico Medico Oroño
  • San Juan, Argentina, J5400CEP
    • CER San Juan
  • San Miguel de Tucuman, Argentina, T4000AXL
    • Centro de Investigaciones Medicas Tucuman
• China
  • Beijing City, China, 100034
    • Peking University First Hospital
  • Beijing City, China, 100050
    • Beijing Tiantan Hospital,Capital Medical University
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changsha City, China, 410008
    • Xiangya Hospital Central South University
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Chongqing, China, 400016
    • The First Affiliated Hospital, Chongqing Medical University
  • Guangzhou City, China, 510080
    • The First Affiliated Hospital of Sun Yat-sen University
  • Guangzhou City, China, 510260
    • The Second Affiliated Hospital of Guangzhou Medical University
  • Guiyang, China
    • The affiliated Hospital of Guiyang Medical College
  • Kunming City, China, 650021
    • The First People?s Hospital of Yunnan Province
  • Lanzhou, China, 730030
    • Lanzhou University Second Hospital
  • Nanjing City, China, 210008
    • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
  • Shanghai, China, 200127
    • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shijiazhuang, China, 050000
    • The Second Hospital of Hebei Medical University
  • Suzhou City, China, 215031
    • The First Affiliated Hospital of Soochow University; Neurology department
  • Taiyuan City, China, 030000
    • 1st Affiliated Hospital of Shanxi Medical University
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Urumqi City, China, 830000
    • Xinjiang People Hospital
  • Wuhan City, China, 430030
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Xi'an City, China, 710038
    • Tangdu Hospital, The Fourth Military Medical University; Neurology Department
• Dominican Republic
  • Santiago de los Caballeros, Dominican Republic, 51000
    • NeuroINC
  • Santo Domingo, Dominican Republic, 10210
    • Hospital Padre Billini
• Finland
  • Helsinki, Finland, 00290
    • Helsinki University Central Hospital; Department of Neurology
• Georgia
  • Tbilisi, Georgia, 0159
    • Archangel St. Michael Multiprofile Clinical Hospital
  • Tbilisi, Georgia, 0160
    • MediClab Georgia
  • Tbilisi, Georgia, 0114
    • New Hospitals; Neurology and Neurorehabilitation
  • Tbilisi, Georgia, 0114
    • Pineo Medical Ecosystem; Neurological Department
  • Tbilisi, Georgia, 0179
    • Khechinashvili University Hospital; Neurological Department
• Germany
  • Berlin, Germany, 13347
    • Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
  • Böblingen, Germany, 71034
    • Studienzentrum fur Neurologie und Psychiatrie
  • Dresden, Germany, 01307
    • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
  • Gießen, Germany, 35392
    • Universitätsklinikum Gießen und Marburg GmbH; Neurologie
  • Kiel, Germany, 24105
    • Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie
  • Münster, Germany, 48149
    • Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
  • Sande, Germany, 26452
    • Nordwest-Krankenhaus Sanderbusch gGMBH; Neurologische Klinik
  • Stuttgart, Germany, 70174
    • Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen, Zentrum für Neurologie
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm; Klinik für Neurologie
  • Westerstede, Germany, 26655
    • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
• Hong Kong
  • Hong Kong, Hong Kong
    • Pamela Youde Nethersole Eastern Hospital; Department of Medicine
  • Shatin, New Territories, Hong Kong
    • Prince of Wales Hospital; Division of Neurology, Department of Medicine and Therapeutics
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft.
  • Budapest, Hungary, 1138
    • S-Medicon Egeszsegugyi Szolgaltato Kft.
  • Eger, Hungary, 3300
    • Markhot Ferenc Oktatokorhaz és Rendelointezet; Neurologiai és Stroke Osztaly
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flór Ferenc Kórház
  • Szeged, Hungary, 6725
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
• Italy
  • Abruzzo
    • L'Aquila, Abruzzo, Italy, 67100
      • Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla
  • Campania
    • Napoli, Campania, Italy, 80131
      • AOU Seconda Università degli Studi; Dip. Assistenziale Integrato Medicina Int-II Clinica Neurologica
    • Napoli, Campania, Italy, 80138
      • AOU Policlinico - Università L. Vanvitelli; D.A.I. di Medicina Interna e Specialistica
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43126
      • A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti)
  • Lazio
    • Roma, Lazio, Italy, 00133
      • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
    • Roma, Lazio, Italy, 00185
      • Policlinico Umberto I; Centro Sclerosi Multipla DAI Neuroscienze e Salute Mentale
    • Roma, Lazio, Italy, 00189
      • Azienda Ospedaliera Sant'Andrea; UOC Neurologia
  • Lombardia
    • Bergamo, Lombardia, Italy, 24127
      • ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
    • Milano, Lombardia, Italy, 20132
      • IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
  • Marche
    • Torrette - Ancona, Marche, Italy, 60100
      • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
  • Piemonte
    • Mondovì (CN), Piemonte, Italy, 12084
      • Ospedale Regina Montis Regalis; SC Neurologia, Centro Sclerosi Multipla
  • Puglia
    • Foggia, Puglia, Italy, 71100
      • AO.U. Policlinico Riuniti Foggia; Neurologia Univ.-Centro intradip. malattie demielinizzanti
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
    • Siena, Toscana, Italy, 53100
      • AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Azienda Ospedaliera di Padova; Clinica Neurologica
• Kenya
  • Nairobi, Kenya, 00100
    • Aga Khan University Hospital
• Mexico
  • Coahuila
    • Saltillo, Coahuila, Mexico, 25050
      • Clinical Research Institute Saltillo
  • Mexico CITY (federal District)
    • Cdmx, Mexico CITY (federal District), Mexico, 03100
      • Health Pharma Professional Research
    • Mexico City, Mexico CITY (federal District), Mexico, 03100
      • Grupo Medico de Investigacion Clinica Multidisciplinaria
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80020
      • Neurociencias Estudios Clinicos S.C.
  • Tlaxcala
    • Mexico, Tlaxcala, Mexico, 06726
      • Hospital General de Mexico
• Netherlands
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum - Sittard Geleen
• North Macedonia
  • Skopje, North Macedonia, 1000
    • PHO General City Hospital 8th September Center for dialysis
  • Skopje, North Macedonia, 1000
    • University Clinic for Neurology - Skopje
  • Stip, North Macedonia, 2000
    • Clinical Hospital Stip
• Peru
  • Bellavista, Peru, Callao 2
    • Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
  • LIma, Peru, Lima 01
    • Clinica Internacional Sede Lima
  • La Victoria, Lima, Peru, Lima 13
    • HOSPITAL NACIONAL GUILLERMO ALMENARA IRIGOYEN; Unidad de Investigacion en Neurologia
  • Lima, Peru, 15003
    • Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
  • Lima, Peru, Lima 29
    • Hospital Maria Auxiliadora
  • Pueblo Libre, Peru, Lima 21
    • Clinica Centenario Peruano Japonesa; Neurology
• Poland
  • ?ory, Poland, 44-240
    • ProNeuro Centrum Medyczne
  • Bydgoszcz, Poland, 85-796
    • Neurocentrum Bydgoszcz sp. z o.o
  • Katowice, Poland, 40-568
    • Care Clinic
  • Krosno, Poland, 38-400
    • MT Medic Krosno
  • Lodz, Poland, 90-324
    • Centrum Neurologii Krzysztof Selmaj
  • Lublin, Poland, 20-492
    • Rodzinne Centrum Medyczne Lubimed.pl
  • Opole, Poland, 45-221
    • Wojewodzki Szpital Specjalistyczny im. Sw. Jadwigi Slaskiej; Oddzia? Neurologii
  • Plewiska, Poland, 62-064
    • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
  • Poznan, Poland, 60-693
    • MedPolonia
  • Warszawa, Poland, 02-957
    • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
  • Zabrze, Poland, 41-800
    • IBISMED Wielospecjalistyczne Centrum Medyczne
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
  • Coimbra, Portugal, 3000-075
    • HUC; Servico de Neurologia
  • Lisboa, Portugal, 1169-050
    • Hospital Santo Antonio dos Capuchos; Servico de Neurologia
  • Lisboa, Portugal, 1500-650
    • Hospital da Luz; Neurologia
  • Porto, Portugal, 4099-001
    • Hospital Geral de Santo Antonio; Servico de Neurologia
  • Porto, Portugal, 4200-319
    • Hospital de Sao Joao; Servico de Neurologia
  • Santa Maria Da Feira, Portugal, 4520-211
    • Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião; Servilo de Neurologia
• Russian Federation
  • Kirov, Russian Federation, 610007
    • Center of cardiology and neurology
  • Novosibirsk, Russian Federation, 630007
    • FSBIH Siberian Regional Medical Centre of FMBA of Russia
  • Baskortostan
    • UFA, Baskortostan, Russian Federation, 450005
      • Republican clinical hospital named after G.G. Kuvatov
  • Sankt Petersburg
    • Sankt-petersburg, Sankt Petersburg, Russian Federation, 197376
      • N.P. Bechtereva Institute of the Human Brain
    • St Petersburg, Sankt Petersburg, Russian Federation, 194291
      • Leningrad Regional Clinical Hospital
    • St Petersburg, Sankt Petersburg, Russian Federation, 197022
      • Pavlov State Medical Uni ; Neurology
  • Uljanovsk
    • Ulyanovsk, Uljanovsk, Russian Federation, 432063
      • Ulyanovsk Regional Clinical Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia; Clinic of neurology
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal; Servicio de Neurologia
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz; Servicio de Neurología
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa; Servicio de Neurologia
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena; Servicio de Neurologia
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge; Servicio de Neurologia
  • Madrid
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Quiron de Madrid; Servicio de Neurologia
  • Murcia
    • EL Palmar (EL Palmar), Murcia, Spain, 30120
      • Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
  • Pontevedra
    • Vigo, Pontevedra, Spain
      • Hospital Alvaro Cunqueiro; Servicio de Neurologia
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
  • Lugano, Switzerland, 6903
    • Ospedale Regionale di Lugano - Civico; Neurologia
• Tunisia
  • Mannouba, Tunisia, 2010
    • Hopital Razi; Neurology Department
  • Monastir, Tunisia, 5000
    • Fattouma Bourguiba Hospital
  • Sfax, Tunisia, 3029
    • Hospital Habib Bourguiba
• Ukraine
  • Kharkov, Ukraine, 61068
    • Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
  • Lviv, Ukraine, 79010
    • Lviv Regional Clinical Hospital; Department of Neurology
  • Odesa, Ukraine, 65117
    • Odesa Regional Clinical Hospital; Neurosurgery Department
  • Chernihiv Governorate
    • Kyiv, Chernihiv Governorate, Ukraine, 02123
      • Medical Center Dopomoga Plus
    • Lviv, Chernihiv Governorate, Ukraine, 79007
      • MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
  • KIEV Governorate
    • Dnipro, KIEV Governorate, Ukraine, 49027
      • SI USSRI of Medical and Social Problems of Disabilities of MOHU
    • Kyiv, KIEV Governorate, Ukraine, 03037
      • Medical Center of Private Execution First Private Clinic
    • Vinnytsia, KIEV Governorate, Ukraine, 21050
      • Salutem Medical Center
  • Katerynoslav Governorate
    • Zaporizhzhia, Katerynoslav Governorate, Ukraine, 69600
      • Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
    • Zaporizhzhye, Katerynoslav Governorate, Ukraine, 69063
      • Zaporizhia City Multispecialty Clinical Hospital #9
  • Kharkiv Governorate
    • Dnipro, Kharkiv Governorate, Ukraine, 49038
      • Separated structural unit ?University clinic? of Dnipro State Medical University
  • Podolia Governorate
    • Vinnytsia, Podolia Governorate, Ukraine, 21009
      • Medical Clinical Research Center of Medical Center LLC Health Clinic
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama Birmingham
    • Homewood, Alabama, United States, 35209
      • Alabama Neurology Associates
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Center for Neurology and Spine - Phoenix - Hunt - PPDS
  • California
    • Carlsbad, California, United States, 92011
      • Profound Research, LLC
    • Irvine, California, United States, 92697
      • University of California Irvine
    • Pasadena, California, United States, 91105
      • SC3 Research Group, Inc
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurology of Colorado, LLC
  • Florida
    • Maitland, Florida, United States, 32751
      • Neurology Associates, PA; Research Department
  • Illinois
    • Highland Park, Illinois, United States, 60035
      • Northshore University Healthsystem
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Fort Wayne Neurological Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70810
      • The Neuromedical Center
    • Shreveport, Louisiana, United States, 71103
      • Ochsner LSU Health
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School Of Medicine; Outpatient Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Hospital; Institute For Clinical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico; MS Specialty Clinic
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Miami Valley Hospital South; Dayton Physician's Office
    • Columbus, Ohio, United States, 43214
      • OhioHealth
    • Columbus, Ohio, United States, 43235
      • The Boster Center for MS
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Medical Research Foundation; MS Center of Excellence
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Health Network
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Premier Neurology
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • New Orleans Center for Clinical Research
  • Texas
    • Plano, Texas, United States, 75024
      • North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic
    • Sherman, Texas, United States, 75092
      • Texas Institute for Neurological Disorders
  • Virginia
    • Vienna, Virginia, United States, 22182
      • Multiple Sclerosis Center of Greater Washington
  • Washington
    • Kirkland, Washington, United States, 98034
      • Evergreen MS Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

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 MS (PPMS) or non-active secondary progressive MS (SPMS).
• Any known or suspected active infection at screening, including but not limited to a positive screening test for Hepatitis B and C, 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 disease.
• Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
• Hypoproteinemia.
• 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 Inclusion Criteria:

• Completed the Double-Blind Treatment (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fenebrutinib; Participants will receive oral fenebrutinib with teriflunomide-matching placebo.	Drug: Fenebrutinib; Participants will receive fenebrutinib.; Drug: Placebo; Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
Active Comparator: Teriflunomide; Participants will receive oral teriflunomide with fenebrutinib-matching placebo in a blinded fashion.	Drug: Placebo; Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.; Drug: Teriflunomide; Participants will receive teriflunomide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Annualized Relapse Rate (ARR)	Minimum of 96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Adverse Events (AEs)		Up to 4.5 years
Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12)		Minimum of 96 weeks
Time to Onset of Composite 24-week Confirmed Disability Progression (cCDP24)		Minimum of 96 weeks
Time to Onset of 12-week Confirmed Disability Progression (CDP12)		Minimum of 96 weeks
Time to Onset of 24-week Confirmed Disability Progression (CDP24)		Minimum of 96 weeks
Total Number of T1 Gadolinium Enhancing (Gd+) Lesions, New and/or Enlarging T2-weighted Lesions as Detected by Magnetic Resonance Imaging (MRI)		Baseline, Weeks 12, 24, 48 and 96
Percentage Change in Total Brain Volume from Week 24 as Assessed by MRI		From Week 24 to Week 96
Change in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) Measured by the Multiple Sclerosis, 29-Item [MSIS-29] Physical Scale	The MSIS-29, Version 2 is a 29-item patient-reported measure of the physical and psychological impacts of MS. Participants are asked to rate how much their functioning and well-being has been impacted over the past 14 days on a 4-point scale, from "Not at all" (1) to "Extremely" (4). The physical score is the sum of items 1-20, which is then transformed to a 0-100 scale. The psychological score is the sum of items 21-29, transformed to a 0-100 scale. Higher scores indicate a greater impact of MS.	Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96
Time to Onset of 12-week Confirmed 4-point worsening in Symbol Digit Modality Test (SDMT) Score	The SDMT is used for detecting the presence of cognitive impairment and changes in cognitive functioning over time and in response to treatment. The SDMT is brief, is easy to administer test, and involves a simple substitution task. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses will be collected only orally, and administration time is approximately 5 minutes. The number of correct responses in 90 seconds will be considered the SDMT score. A decrease by 4 points on the SDMT score from baseline represents a clinically meaningful change in cognitive processing. The SDMT score ranges from 0 to 110. The higher the results, the better processing speed/working memory.	Minimum of 96 weeks
Change from Baseline to Week 48 in the Concentration of Serum Neurofilament Light Chain (NfL)		Up to 48 weeks
Plasma Concentrations of Fenebrutinib at Specified Timepoints		Up to 4.5 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Estimated): October 2, 2025
• Study Completion (Estimated): November 27, 2025

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Teriflunomide
• Other Study ID Numbers: GN41851; 2019-004857-10 (EudraCT Number); 2022-502609-14-00 (Registry Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No