AzTrials
AzTrials

Multiple Sclerosis, Primary ProgressivePhase 3FENtrepidNCT04544449

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

A Phase 3 study testing Fenebrutinib and Ocrelizumab in people with Multiple Sclerosis, Primary Progressive, run by Hoffmann-La Roche at 190 sites in 28 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis, Primary Progressive
What is being tested?
Fenebrutinib and Ocrelizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
985 participants
Where
190 sitesin 28 countries
Study dates
26 Oct 2020to 21 Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For sites in Germany and Italy only, enrollment is restricted to participants aged 46-65 years
  • A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria (Thompson et al. 2018).
  • Disability progression in the 12 months prior to screening.
  • Expanded Disability Status Scale (EDSS) score from 3.0 to 6.5 inclusive at screening.
  • Pyramidal functional subscore >=2 at screening.
  • For participants currently receiving proton pump inhibitors (PPIs), H2-receptor antagonists (H2RAs), symptomatic treatment for MS (e.g. fampridine, cannabis) and/or physiotherapy: treatment at a stable dose during the screening period prior to the initiation of study treatment and plans to remain at a stable dose for the duration of study treatment.
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  • Neurologically stable for at least 30 days prior to randomization and baseline assessments.
  • Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds.
  • Ability to perform 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.
  • 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

  • For participants enrolled in Germany and in Italy only: Presence of gadolinium-enhancing lesions on T1-weighted MRI (T1Gd +) lesion on the screening MRI
  • Any known or suspected active infection (excluding onychomycosis) 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).
  • Participants with a previous history of a serious Infusion-Related Reaction (IRR) (Common Terminology Criteria for Adverse Events [CTCAE] Grade >= 4) and/or any hypersensitivity reaction to ocrelizumab.
  • History of cancer including hematologic malignancy and solid tumors within 10 years of screening. Exceptions: Basal/squamous cell carcinoma of skin cured by excision. In situ carcinoma of the cervix successfully treated by curative therapy >1 year prior to screening.
  • Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.
  • Presence of cirrhosis (Child-Pugh Class A, B, or C)
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  • Chronic liver disease unless considered stable for >6 months
  • Acute liver disease
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids, immunosuppressants or specific medication that could impact the primary evaluation of the study.
  • History of alcohol or other drug abuse within 12 months prior to screening.
  • Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 6 or 12 months (as applicable from the local label for ocrelizumab) after final dose of study drug.
  • Male participants intending to father a child during the study or for 28 days after final dose of study drug.
  • Lack of peripheral venous access.
  • Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.
  • Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
  • Immunocompromised state, history of primary or secondary (non-drug related) immunodeficiency, or history of transplantation or antirejection therapy
  • Known bleeding diathesis, anemia, or history of hospitalization or transfusion for gastrointestinal (GI) bleed
  • Any previous treatment with cladribine, mitoxantrone, daclizumab, alemtuzumab, or cyclophosphamide
  • OLE Exclusion Criteria:
  • Chronic liver disease unless considered stable for > 6 months
  • Acute liver disease
  • Cirrhosis (Child-pugh Class A, B or C)
  • Gilbert's syndrome

Trial locations and contacts

190 sites in 28 countries.

190 sites in 28 countries

United States43 sites

  • Dent Neurological Institute

    Amherst, New York, 14226

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Johns Hopkins University School Of Medicine

    Baltimore, Maryland, 21287

  • Sutter East Bay Medical Foundation

    Berkeley, California, 94705

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Atrium Health Neurosciences Institute ? Charlotte

    Charlotte, North Carolina, 28204

  • UC Health, LLC.

    Cincinnati, Ohio, 45267

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Neurology Clinic PC

    Cordova, Tennessee, 38018

  • Wayne State University

    Detroit, Michigan, 48201

  • Yale University School Of Medicine

    Fairfield, Connecticut, 06824

  • Fullerton Neurology and Headache Center

    Fullerton, California, 92835

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • Hackensack U Med Ctr

    Hackensack, New Jersey, 07601

  • Alabama Neurology Associates

    Homewood, Alabama, 35209

  • Uni of Texas Health Science Center At Houston

    Houston, Texas, 77030

  • Josephson Wallack Munshower Neurology PC

    Indianapolis, Indiana, 46256

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Evergreen MS Center

    Kirkland, Washington, 98034

  • Hope Neurology

    Knoxville, Tennessee, 37922

  • Cleveland Clinic Lou Ruvo

    Las Vegas, Nevada, 89106

  • Barnabas Health Ambulatory Care Center

    Livingston, New Jersey, 07039

  • Neurology Associates PA

    Maitland, Florida, 32751

  • Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226-3596

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Jersey Shore University Medical Centre

    Neptune City, New Jersey, 07753

  • Columbia University Medical Center

    New York, New York, 10032

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Neurological Services of Orlando

    Orlando, Florida, 32806

  • Providence Brain and Spine Institute

    Portland, Oregon, 97225

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607-6520

  • University of Rochester

    Rochester, New York, 14642

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Texas Institute for Neurological Disorders

    Sherman, Texas, 75092

  • Washington University

    St Louis, Missouri, 63128

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Palo Alto Medical Foundation Research Center

    Sunnyvale, California, 94086

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • University of South Florida

    Tampa, Florida, 33612

  • Holy Name Hospital

    Teaneck, New Jersey, 07666

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Dragonfly Research, LLC

    Wellesley, Massachusetts, 02481

Other trials in United States

Ukraine13 sites

  • CNPE City Clinical Hospital #3 of Chernivtsi City Council

    Chernivtsi, Chernihiv Governorate, 58022

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

    Dnipro, Tavria Okruha

  • Regional Clinical Hospital

    Ivano-Frankivsk, 76008

  • Ams of Ukraine

    Kharkiv, Kharkiv Governorate, 61068

  • MEDBUD

    Kyiv, KIEV Governorate, 03037

  • Volyn Regional Clinical Hospital

    Lutsk, 43024

  • Lviv Regional Clinical Hospital

    Lviv, KIEV Governorate, 79010

  • "Neurofocus" LLC

    Lviv, 79029

  • Odesa Regional Clinical Hospital

    Odesa, 65117

  • Salutem Medical Center

    Vinnytsia, KIEV Governorate, 21009

  • Medical Clinical Research Center of Medical Center LLC Health Clinic

    Vinnytsia, 21009

  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

    Zaporizhzhya, Kharkiv Governorate, 69600

  • Medical Centre of PE First Private Clinic

    Zhytomyr, Crimean Regional Governmenta, 10008

Other trials in Ukraine

Russia11 sites

  • Vertebronevrologiya LLC

    Kazan', Tatarstan Republic, 420047

  • Center of Cardiology and Neurology

    Kirov, 610007

  • Krasnoyarsk State Medical Academy

    Krasnoyarsk, Krasnoyarsk Krai, 660022

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

    Krasnoyarsk, Krasnoyarsk Krai, 660037

  • Federal center of brain research and neurotechnologies

    Moskva, Moscow Oblast, 117997

  • City Clinical Hospital #24

    Moskva, Moscow Oblast, 127015

  • State Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630087

  • National Center of Social Significant Disease

    Saint Petersburg, Sankt-Peterburg, 197110

  • City Hospital #40 of Resort Administrative District

    Saint Petersburg, Sankt-Peterburg, 197706

  • Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik

    Tyumen, Tyumen Oblast, 625048

  • Sverdlovsk Regional Clinical Hospital 1

    Yekaterinburg, Sverdlovsk Oblast, 620102

Other trials in Russia

Canada10 sites

  • Fraser Health Authority - Fraser Health Multiple Sclerosis

    Burnaby, British Columbia, V5G 2X6

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 1Z1

  • Clinique NeuroOutaouais

    Gatineau, Quebec, J8Y 1W2

  • Recherche Sepmus Inc.

    Greenfield Park, Quebec, J4V 2J2

  • London Health Sciences Centre Uni Campus

    London, Ontario, N6A 5A5

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B-1W8

  • University of British Columbia

    Vancouver, British Columbia, V6T 1Z3

Other trials in Canada

Poland10 sites

  • Neurocentrum Bydgoszcz sp. z o.o

    Bydgoszcz, 85-796

  • Care Clinic

    Katowice, 40-568

  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Katowice, 40-749

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324

  • Med Polonia

    Późna, 60-693

  • Centrum Medyczne "MEDYK"

    Rzeszów, 35-055

  • Nmedis sp. z o.o.

    Rzeszów, 35-323

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-684

  • Wro Medica

    Wroc?aw, 51-685

  • SPSK nr 1

    Zabrze, 41-800

Other trials in Poland

Turkey (Türkiye)10 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Baskent Universitesi Ankara Hastanesi

    Çankaya, 06490

  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Sancaktepe Training and Research Hospital

    Istanbul, 34785

  • Selcuk University Medical Faculty

    Istanbul, 42131

  • Kocaeli University Hospital

    Kocaeli, 41380

  • Mersin University Medical Faculty

    Mersin, 33079

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55139

  • Karadeniz Tecnical Uni. Med. Fac.

    Trabzon, 61080

  • Van Yuzuncu Yil University Hospital

    Van, 65080

Other trials in Turkey (Türkiye)

Spain9 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, LA Coruna, 15006

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Puerta del Mar

    Cadiz, 11009

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, Lerida, 25198

  • Hospital Ramon y Cajal

    Madrid, 28034

  • 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

Italy8 sites

  • Irccs A.O.U.San Martino Ist

    Genoa, Liguria, 16132

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Ospedale Civile di Montichiari

    Montichiari, Lombardy, 25018

  • AOU Seconda Università degli Studi

    Naples, Campania, 80138

  • A.R.N.A.S. Civico Di Cristina Benfratelli

    Palermo, Sicily, 90127

  • A.O.U. di Parma

    Parma, Emilia-Romagna, 43126

  • IRCCS Istituto Neurologico Neuromed

    Pozzilli, Molise, 86077

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

    Rome, Lazio, 00133

Other trials in Italy

Australia7 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Brain and Mind Research Institute

    Camperdown, New South Wales, 2050

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • John Hunter Hospital

    New Lambton, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Brazil7 sites

  • Freire Pesquisa Clinica

    Belo Horizonte, Minas Gerais, 30150-320

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310

  • Clinica Neurologica

    Joinville, Santa Catarina, 89202-190

  • Núcleo de Pesquisa do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90430-001

  • IMV Pesquisa Neurológica

    Porto Alegre, Rio Grande do Sul, 90620-130

  • Hospital Universitario Gaffree e Guinle

    Rio de Janeiro, 20270-004

  • Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01228-200

Other trials in Brazil

Germany7 sites

  • Charite - Universitatsmedizin Berlin

    Berlin, 10117

  • Studienzentrum Dr. Bischof GmbH

    Böblingen, 71034

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

    Dresden, 01307

  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

    Freiburg im Breisgau, 79106

  • Klinikum rechts der Isar der TU Muenchen

    München, 81675

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191

Other trials in Germany

Argentina6 sites

  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR

    Buenos Aires, C1424

  • Focus CECIC

    Buenos Aires

  • Instituto De Neurología Cognitiva - INECO

    Capital Federal, 000C1021

  • Instituto Reumatológico Strusberg

    Córdoba, X5000EDC

  • Fundacion Rosarina de Neurorehabilitacion

    Rosario, 2000

  • Centro de Investigaciones Médicas Tucuman

    San Miguel, T4000AXL

Other trials in Argentina

France6 sites

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076

  • Hopital Pierre Wertheimer

    Bron, 69677

  • CHRU de Montpellier, Hopital Gui de Chauliac

    Montpellier, 34295

  • Hopital Guillaume Et Rene Laennec

    Nantes, 44805

  • Hôpital Pasteur

    Nice, 06002

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67091

Other trials in France

Hungary5 sites

  • Clinexpert Kft.

    Budapest, 1033

  • S-Medicon Egeszsegugyi Szolgaltato Kft.

    Budapest, 1044

  • Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet

    Budapest, 1204

  • Markhot Ferenc Oktatokorhaz és Rendelointezet

    Eger, 3300

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

Other trials in Hungary

Mexico5 sites

  • Grupo Médico Camino S.C.

    México, Mexico CITY (federal District), 03600

  • Mexico Centre for Clinical Research

    Mexico City, Mexico CITY (federal District), 03100

  • Clinstile S.A de C.V.

    Mexico City, Mexico CITY (federal District), 06700

  • Hospital Juarez de Mexico

    Mexico City, Mexico CITY (federal District), 07760

  • Clinical Research Institute

    Tialnepantla, Mexico, 54055

Other trials in Mexico

Portugal5 sites

  • Unidade Local de Saúde de Braga

    Braga, 4710-243

  • Hospital Santo Antonio dos Capuchos

    Lisbon, 1169-050

  • Hospital de Santa Maria

    Lisbon, 1649-035

  • Hospital Geral de Santo Antonio

    Porto, 4099-001

  • Hospital de Sao Joao

    Porto, 4200-319

Other trials in Portugal

United Kingdom4 sites

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Charing Cross Hospital

    London, W6 8RF

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

  • Morriston Hospital

    Swansea, SA6 6NL

Other trials in United Kingdom

Colombia3 sites

  • Organizacion Sanitas Internacional

    Bogotá

  • Fundacion Clinica Valle del Lili

    Cali

  • Instituto Neurologico de Colombia INDEC

    Medellín

Other trials in Colombia

Greece3 sites

  • Hospital Eginition

    Athens, 115 28

  • 401 Military Hospital of Athens

    Athens, 11525

  • AHEPA Univ. General Hospital of Thessaloniki

    Thessaloniki, 54636

Other trials in Greece

Israel3 sites

  • Rambam Medical Center

    Haifa, 3109601

  • The Chaim Sheba Medical Center

    Ramat Gan, 5262100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Peru3 sites

  • Hospital IV Alberto Sabogal Sologuren

    Bellavista, Callao 2

  • Clinica Internacional

    Lima, 15001

  • Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo

    Lima, Lima 01

Other trials in Peru

Austria2 sites

  • Kepler Universitätsklinikum GmbH - Neuromed Campus

    Linz, 4020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Bulgaria2 sites

  • UMHAT Dr. Georgi Stranski

    Pleven, 5800

  • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD

    Sofia, 1113

Other trials in Bulgaria

Chile2 sites

  • CeCim Biocinetic

    Santiago, 8331143

  • Clinica Alemana

    Vitacura, 0

Other trials in Chile

Denmark2 sites

  • Aarhus Universitetshospital

    Aarhus N, 8200

  • Rigshospitalet

    Glostrup Municipality, 2600

Other trials in Denmark

Switzerland2 sites

  • Universitätsspital Basel

    Basel, 4031

  • Inselspital Bern Medizin Neurologie

    Bern, 3010

Other trials in Switzerland

North Macedonia1 site

  • University Clinic of Neurology

    Skopje, 1000

Other trials in North Macedonia

Puerto Rico1 site

  • San Juan MS Center

    Guaynabo, 968

Other trials in Puerto Rico

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 Ocrelizumab in Adult Patients With Primary Progressive Multiple Sclerosis.

A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). 985 participants were enrolled and recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

Being tested
Fenebrutinib, Ocrelizumab, Placebo matched to ocrelizumab, Placebo matched to fenebrutinib
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

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

  • FenebrutinibDrug

    Participants will receive fenebrutinib.

  • OcrelizumabDrug

    Participants will receive ocrelizumab.

  • Placebo matched to ocrelizumabDrug

    Participants will receive ocrelizumab-matching placebo.

  • Placebo matched to fenebrutinibDrug

    Participants will receive fenebrutinib-matching placebo

Study groups in NCT04544449
Study groupRoleWhat they receive
FenebrutinibExperimentalParticipants will receive oral fenebrutinib and IV ocrelizumab-matching placebo.
Receives: Drug: Fenebrutinib; Drug: Placebo matched to ocrelizumab
OcrelizumabActive comparatorParticipants will receive IV ocrelizumab and oral fenebrutinib-matching placebo.
Receives: Drug: Ocrelizumab; Drug: Placebo matched to fenebrutinib

What is being measured

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

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

    Measured: Minimum of 120 weeks

Secondary outcomes (9)

  1. Time to Onset of Composite 24-week CDP (cCDP24)

    Measured: Minimum of 120 weeks

  2. Time to Onset of 12-week CDP (CDP12)

    Measured: Minimum of 120 weeks

  3. Time to Onset of 24-week CDP (CDP24)

    Measured: Minimum of 120 weeks

  4. Percentage Change in Total Brain Volume Assessed by Magnetic Resonance Imaging (MRI)

    Measured: From Week 24 to Week 120

  5. Percent Change from Screening in Blood Neurofilament Light Chain (NfL) Levels

    Measured: Up to Week 120

  6. Change from Baseline in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) Measured by the Multiple Sclerosis Impact Scale, 29-Item [MSIS-29] Physical Scale

    Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120

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

    Measured: Minimum of 120 weeks

  8. Percentage of Participants with Adverse Events (AEs)

    Measured: Up to 4.7 years

  9. Plasma Concentrations of Fenebrutinib at Specified Timepoints

    Measured: Up to 4.7 years

Timeline

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

  1. First posted10 Sep 2020
  2. Study start26 Oct 2020
  3. Primary completion17 Sep 2025
  4. Study completion21 Jul 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
985 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04544449
Sponsor's protocol ID
GN41791
Other IDs
2019-003919-53, 2022-502611-10-00, 2019
Acronym
FENtrepid
Status last verified
Sep 2026
First submitted
4 Sep 2020
Last updated
17 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fenebrutinib and Ocrelizumab in people with Multiple Sclerosis, Primary Progressive, run by Hoffmann-La Roche at 190 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 190 sites in United States, Ukraine, Russia, Canada, Poland and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Onset of Composite 12-Week Confirmed Disability Progression (cCDP12) (time frame: Minimum of 120 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04544449.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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