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. At the end of the DBT phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension phase 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 Locations

• Argentina
  • Buenos Aires, Argentina, C1424
    • Centro de Especialidades Neurológicas y Rehabilitación - CENyR
  • Buenos Aires, Argentina, C1012AAR
    • Instituto de Investigaciones Metabolicas (IDIM)
  • Buenos Aires, Argentina, C1405BCH
    • IME - Instituto Médico Especializado
  • C. A. B. A., Argentina, C1055AAF
    • CIER
  • Rosario, Argentina, 2000
    • Diagnostico Medico Oroño
  • San Juan, Argentina, J5400CEP
    • CER San Juan
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro de Investigaciones Médicas Tucuman
• China
  • Beijing, China
    • Beijing Tiantan Hospital，Capital Medical University
  • Beijing, China, 100034
    • Peking University First Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changsha, 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, China, 510080
    • The First Affiliated Hospital of Sun Yat-sen University
  • Guangzhou, China, 510260
    • The Second Affiliated Hospital of Guangzhou Medical University
  • Guiyang, China
    • The affiliated Hospital of Guiyang Medical College
  • Kunming, China, 650021
    • The First People?s Hospital of Yunnan Province
  • Shijiazhuang, China, 05000
    • The Second Hospital of Hebei Medical University
  • Suzhou, China, 215031
    • The First Affiliated Hospital of Soochow University
  • Taiyuan, China
    • 1st Affiliated Hospital of Shanxi Medical University
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Wuhan, China, 430030
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Xi'an, China
    • Tangdu Hospital, The Fourth Military Medical University
  • Ürümqi, China, 830000
    • Xinjiang People Hospital
• 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
• Georgia
  • Tbilisi, Georgia, 0179
    • Khechinashvili University Hospital
  • Tbilisi, Georgia, 0114
    • New Hospitals
  • Tbilisi, Georgia, 0114
    • Pineo Medical Ecosystem
  • Tbilisi, Georgia, 0160
    • MediClab Georgia
  • Tbilisi, Georgia, 0159
    • St. Michael hospital
• Germany
  • Berlin, Germany, 13347
    • Jüdisches Krankenhaus Berlin
  • Böblingen, Germany, 71034
    • Studienzentrum Dr. Bischof GmbH
  • Dresden, Germany, 01307
    • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
  • Giessen, Germany, 35385
    • Universitätsklinikum Gießen und Marburg GmbH
  • Kiel, Germany, 24105
    • Uniklinik Schleswig-Holstein
  • 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
  • Westerstede, Germany, 26655
    • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
• Hong Kong
  • Hong Kong, Hong Kong
    • Pamela Youde Nethersole Eastern Hospital
  • Shatin, New Territories, Hong Kong
    • Prince of Wales Hospital
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft.
  • Budapest, Hungary, 1044
    • S-Medicon Egeszsegugyi Szolgaltato Kft.
  • Eger, Hungary, 3300
    • Markhot Ferenc Oktatokorhaz es Rendelointezet
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Ferenc Korhaz
  • Szeged, Hungary, 6725
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
• Italy
  • Apulia
    • Foggia, Apulia, Italy, 71100
      • AO.U. Policlinico Riuniti Foggia
  • Campania
    • Napoli, Campania, Italy, 80131
      • AOU Seconda Università degli Studi
    • Napoli, Campania, Italy, 80138
      • AOU Policlinico - Università L. Vanvitelli
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43126
      • A.O.U. di Parma
  • Lazio
    • Rome, Lazio, Italy, 00185
      • Policlinico Umberto I
    • Rome, Lazio, Italy, 00189
      • Azienda Ospedaliera Sant'Andrea
    • Rome, Lazio, Italy, 00133
      • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
  • Lombardy
    • Bergamo, Lombardy, Italy, 24127
      • ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
    • Milan, Lombardy, Italy, 20132
      • IRCCS Ospedale San Raffaele
  • Piedmont
    • Mondovì (CN), Piedmont, Italy, 12084
      • Ospedale Regina Montis Regalis
  • Sicily
    • Catania, Sicily, Italy, 95123
      • AOU Policlinico V. Emanuele - P.O G. Rodolico
  • Veneto
    • Padua, Veneto, Italy, 35128
      • Azienda Ospedaliera Di Padova
• Kenya
  • Nairobi, Kenya, 00100
    • The Aga Khan University-Kenya.
• Mexico
  • Coahuila
    • Saltillo, Coahuila, Mexico, 25050
      • Clinical Research Institute Saltillo
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 03100
      • Grupo Medico de Investigacion Clinica Multidisciplinaria
    • Mexico City, Mexico CITY (federal District), Mexico, 03100
      • Health Pharma Professional Research
  • 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
  • Shtip, North Macedonia, 2000
    • Clinical Hospital Stip
  • Skopje, North Macedonia, 1000
    • PHO General City Hospital 8th September Center for dialysis
  • Skopje, North Macedonia, 1000
    • University Clinic for Neurology - Skopje
• Peru
  • Bellavista, Peru, Callao 2
    • Hospital IV Alberto Sabogal Sologuren
  • La Victoria, Lima, Peru, Lima 13
    • Hospital Nacional Guillermo Almenara Irigoyen
  • Lima, Peru, Lima 29
    • Hospital Maria Auxiliadora
  • Lima, Peru, 15018
    • Hospital Nacional Dos de Mayo
  • Lima, Peru, Lima 01
    • Clinica Internacional Sede Lima
  • Pueblo Libre, Peru, Lima 21
    • Clinica Centenario Peruano Japonesa
• 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
  • Plewiska, Poland, 62-064
    • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
  • Poznan, Poland, 60-693
    • MedPolonia
  • Warsaw, 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
  • Coimbra, Portugal, 3000-075
    • HUC
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz
  • Lisbon, Portugal, 1169-050
    • Hospital Santo Antonio dos Capuchos
  • Porto, Portugal, 4200-319
    • Hospital de Sao Joao
  • Porto, Portugal, 4099-001
    • Hospital Geral de Santo Antonio
  • Santa Maria da Feira, Portugal, 4520-211
    • Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião
• Russia
  • Kirov, Russia, 610007
    • Center of Cardiology and Neurology
  • Novosibirsk, Russia, 630007
    • FSBIH Siberian Regional Medical Centre of FMBA of Russia
  • Bashkortostan Republic
    • Ufa, Bashkortostan Republic, Russia, 450005
      • Republican clinical hospital named after G.G. Kuvatov
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 194291
      • Leningrad Regional Clinical Hospital
    • Saint Petersburg, Sankt-Peterburg, Russia, 197022
      • Pavlov State Medical Uni
  • Ulyanovsk Oblast
    • Ulyanovsk, Ulyanovsk Oblast, Russia, 432063
      • Ulyanovsk Regional Clinical Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28040
    • Fundación Jiménez Díaz
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga ? Hospital General
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Quiron de Madrid
  • Murcia
    • EL Palmar (EL Palmar), Murcia, Spain, 30120
      • Hospital Universitario Virgen de Arrixaca
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36213
      • Hospital Álvaro Cunqueiro
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern Medizin Neurologie
  • Lugano, Switzerland, 6903
    • Ospedale Regionale di Lugano - Civico
• Tunisia
  • Mannouba, Tunisia, 2010
    • Hopital Razi
  • Monastir, Tunisia, 5000
    • Fattouma Bourguiba Hospital
  • Sfax, Tunisia, 3029
    • Hospital Habib Bourguiba
• Ukraine
  • Dnipro, Ukraine, 49027
    • SI USSRI of Medical and Social Problems of Disabilities of MOHU
  • Kharkiv, Ukraine, 61068
    • Ams of Ukraine
  • Kyiv, Ukraine, 03037
    • Medical Center of Private Execution First Private Clinic
  • Kyiv, Ukraine, 02123
    • Medical Center Dopomoga Plus
  • Lviv, Ukraine, 79010
    • Lviv Regional Clinical Hospital
  • Lviv, Ukraine, 79029
    • "Neurofocus" LLC
  • Odesa, Ukraine, 65117
    • Odesa Regional Clinical Hospital
  • Vinnytsi, Ukraine, 21009
    • Medical Clinical Research Center of Medical Center LLC Health Clinic
  • Zaporizhzhia, Ukraine, 69600
    • Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
  • Zaporizhzhia, Ukraine, 69035
    • LCC "Medical center "Unimed"
  • KIEV Governorate
    • Vinnytsia, KIEV Governorate, Ukraine, 21009
      • Salutem Medical Center
  • Tavria Okruha
    • Dnipro, Tavria Okruha, Ukraine
      • Separated structural unit ?University hospital? of Dnipro State Medical University
• 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
    • St 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 Multiple Sclerosis a Singlepoint Healthcare Company
  • 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.

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.

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.
• 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

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
Plasma Concentrations of Fenebrutinib at Specified Timepoints		Up to 4.5 years
Time to Onset of Composite 12-week Confirmed Progression Independent of Relapse Activity (cPIRA12)		Minimum of 96 weeks
Change from Baseline to Week 48 in the Concentration of Blood Neurofilament Light Chain (NfL)		Up to 48 weeks

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 (Actual): January 27, 2026
• Study Completion (Estimated): November 30, 2027

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): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis; Substandard Drugs; Pharmaceutical Preparations; teriflunomide; fenebrutinib
• Other Study ID Numbers: GN41851; 2019-004857-10 (EudraCT Number); 2022-502609-14-00 (Ctis: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

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