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Could a stronger dose of ocrevus slow MS disability better?

NCT ID NCT04548999

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This Phase 3 trial is testing whether a higher dose of the drug ocrelizumab (Ocrevus) can better slow disability progression in people with primary progressive multiple sclerosis (PPMS). About 769 adults with PPMS are receiving either the standard approved dose or a higher dose based on their weight. The study measures how long it takes for disability to worsen, aiming to see if the higher dose offers more protection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ocrelizumab (Ocrevus)
What this could lead to
If successful, this higher dose could offer better control of disability progression for people with primary progressive multiple sclerosis.
What could go wrong
This is an early-stage Phase 3 trial comparing two doses, so it may not show a meaningful benefit over the standard dose. Higher doses also carry increased risk of side effects like infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

769 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of PPMS * EDSS score at screening and baseline, from 3 to 6.5 inclusive * Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds * Average 9HPT score over four trials (two trials with each hand) at screening and over four trials (two trials with each hand) at baseline respectively, up to 250 (inclusive) seconds * Score of ≥ to 2.0 on the Functional Systems (FS) scale for the pyramidal system that was due to lower extremity findings at screening and baseline * Documented magnetic resonance imaging (MRI) of brain with abnormalities consistent with MS * Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization * Participants must be neurologically stable for at least 30 days prior to randomization and baseline * Disease duration from the onset of MS symptoms; if EDSS score at screening is ≤ 5, disease duration must be less than 10 years; If EDSS score at screening is \> 5, disease duration must be less than 15 years * Documented evidence of the presence of at least one cerebrospinal fluid-specific oligoclonal bands * Females of childbearing potential: agreement to remain abstinent or use adequate contraceptive methods * Female participants, without reproductive potential may be enrolled e.g. if post-menopausal or if surgically sterile Exclusion Criteria: * History of relapsing remitting or secondary progressive MS at screening * Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening * History of confirmed or suspected progressive multifocal leukoencephalopathy * History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening * Immunocompromised state * Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization * Inability to complete an MRI or contraindication to gadolinium administration * Contraindications to mandatory pre-medications for infusion-related reaction (IRRs) * Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * Significant, uncontrolled disease that may preclude participant from participating in the study * History of or currently active primary or secondary, non-drug-related, immunodeficiency * Pregnant or breastfeeding or intending to become pregnant * Lack of peripheral venous access * History of alcohol or other drug abuse within 12 months prior to screening * Treatment with any investigational agent or treatment with any experimental procedure for MS * Previous use of anti-cluster of differentiation 20 (CD20s) (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy * Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab * Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline * Previous treatment with natalizumab within 4.5 months of baseline * Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline * Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. If the washout requirements are not described in the applicable local label, then the wash out period must be five times the half-life of the medication * Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation * Any previous history of transplantation or anti-rejection therapy * Treatment with IV immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization * Systemic corticosteroid therapy within 4 weeks prior to screening * Positive screening tests for active, latent, or inadequately treated hepatitis B * Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab * Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above

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Conditions

The condition(s) this trial relates to.

chronic progressive multiple sclerosis multiple sclerosis primary progressive multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • 21st Century Neurology

    Phoenix, Arizona, 85004, United States

  • 401 Military Hospital of Athens

    Athens, 11525, Greece

  • 5th Cherkasy City Center of Primary Health Care

    Cherkasy, 18029, Ukraine

  • A. O. U. Federico II

    Naples, Campania, 80131, Italy

  • AOU Città della Salute e della Scienza

    Turin, Piedmont, 10126, Italy

  • AOU Seconda Università degli Studi

    Naples, Campania, 80138, Italy

  • Aalborg Universitetshospital

    Aalborg, 9000, Denmark

  • Advanced Neurosciences Institute

    Nashville, Tennessee, 37205, United States

  • Advanced Neurosciences Research LLC

    Fort Collins, Colorado, 80524, United States

  • Alabama Neurology Associates

    Homewood, Alabama, 35209, United States

  • Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189, Italy

  • Baptist Health Lexington

    Nicholasville, Kentucky, 40356, United States

  • Baskent Universitesi Ankara Hastanesi

    Çankaya, 06490, Turkey (Türkiye)

  • CEMIC Saavedra

    Buenos Aires, 1431, Argentina

  • CH St Vincent de Paul

    Lille, 59000, France

  • CHU Brest Hopital La Cavale Blanche

    Brest, 29609, France

  • CHU Hopital Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • CHU de Besancon Hopital Jean Minjoz

    Besançon, 25030, France

  • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika

    Gdansk, 80-803, Poland

  • CPQuali Pesquisa Clinica Ltda

    São Paulo, São Paulo, 01228-000, Brazil

  • Center of Cardiology and Neurology

    Kirov, 610007, Russia

  • Centre de Recherche Saint-Louis

    Lévis, Quebec, G6W 0M5, Canada

  • Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz

    Lisbon, 1349-019, Portugal

  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR

    Buenos Aires, C1424, Argentina

  • Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

    Guadalajara, Jalisco, 44130, Mexico

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-684, Poland

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324, Poland

  • Charing Cross Hospital

    London, W6 8RF, United Kingdom

  • Chum Campus Notre Dame

    Montreal, Quebec, H2X 0A9, Canada

  • City Clinical Hospital #24

    Moskva, Moscow Oblast, 127015, Russia

  • City Hospital #40 of Kurortniy Administrative District

    Saint Petersburg, Sankt-Peterburg, 197706, Russia

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Neurologica

    Joinville, Santa Catarina, 89201-165, Brazil

  • Clinstile S.A de C.V.

    Mexico City, Mexico CITY (federal District), 06700, Mexico

  • Cumhuriyet Universitesi Tip Fakultesi

    Center, 58060, Turkey (Türkiye)

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191, Germany

  • EMC Instytut Medyczny SA

    Późna, 60-309, Poland

  • Ege Üniversitesi Tip Fakültesi

    Lzmir, 35100, Turkey (Türkiye)

  • Erciyes Universitesi

    Kayseri, 38039, Turkey (Türkiye)

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

    Krasnoyarsk, Krasnoyarsk Krai, 660037, Russia

  • FSBIH Siberian Regional Medical Centre of FMBA of Russia

    Novosibirsk, 630007, Russia

  • Federal center of brain research and neurotechnologies

    Moskva, Moscow Oblast, 117997, Russia

  • Gazi University Medical Faculty

    Ankara, 06500, Turkey (Türkiye)

  • Grupo Médico Camino S.C.

    México, 03600, Mexico

  • Haseki Training and Research Hospital

    Istanbul, 34096, Turkey (Türkiye)

  • Hopital Central - CHU de Nancy

    Nancy, 54035, France

  • Hopital Cote De Nacre

    Caen, 14033, France

  • Hopital Hautepierre - CHU Strasbourg

    Strasbourg, 67098, France

  • Hospital Eginition

    Athens, 115 28, Greece

  • Hospital Geral de Santo Antonio

    Porto, 4099-001, Portugal

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

  • Hospital Nacional Dos de Mayo

    Lima, Peru

  • Hospital Nacional Guillermo Almenara Irigoyen

    La Victoria, Lima, Lima 13, Peru

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Santo Antonio dos Capuchos

    Lisbon, 1169-050, Portugal

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Puerta De Hierro Majadahonda

    Madrid, 28222, Spain

  • Hospital Universitario Virgen de Arrixaca

    Murcia, Spain

  • Hospital das Clinicas - UFG

    Goiânia, Goiás, 74605-020, Brazil

  • Hospital das Clinicas - UNICAMP

    Campinas, São Paulo, 13083-888, Brazil

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • IMV Pesquisa Neurológica

    Porto Alegre, Rio Grande do Sul, 90110-000, Brazil

  • INECO

    Rosario, S2000QGB, Argentina

  • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

    Pavia, Lombardy, 27100, Italy

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

    Lublin, 20-410, Poland

  • Inselspital Bern Medizin Neurologie

    Bern, 3010, Switzerland

  • Instituto Méderi de Pesquisa e Saúde

    Passo Fundo, Rio Grande do Sul, 99010-120, Brazil

  • Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo

    Lima, Lima 01, Peru

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310, Brazil

  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

    Warsaw, 02-957, Poland

  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

    Oświęcim, 32-600, Poland

  • International Neurorehabilitation Institute

    Lutherville, Maryland, 21093, United States

  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • Jersey Shore University Medical Centre

    Neptune City, New Jersey, 07753, United States

  • Kistarcsai Flor Ferenc Korhaz

    Kistarcsa, 2143, Hungary

  • Kocaeli University Hospital

    Kocaeli, 41380, Turkey (Türkiye)

  • Krasnoyarsk State Medical Academy

    Krasnoyarsk, Krasnoyarsk Krai, 660022, Russia

  • L2 Ip Instituto de Pesquisas Clinicas Ltda ME

    Brasília, Federal District, 70200-730, Brazil

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Lone Star Neurology of San Antonio

    San Antonio, Texas, 78258, United States

  • Lvivska oblasna tsentralna likarnia

    Lviv, 79010, Ukraine

  • MA-LEK Clinical Sp. Z o.o.

    Katowice, 40-595, Poland

  • MHATNP Sveti Naum EAD

    Sofia, 1113, Bulgaria

  • MS and Neuromuscular Center of Excellence

    Clearwater, Florida, 33761, United States

  • MUCH - Montreal Neurological Institute & Hospital

    Montreal, Quebec, H3A 2B4, Canada

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114, United States

  • Medical Center Dopomoga Plus

    Kyiv, 02123, Ukraine

  • Medical Clinical Research Center of Medical Center LLC Health Clinic

    Vinnytsi, 21009, Ukraine

  • Medizinische Hochschule Hannover, Klinik für Neurologie

    Hanover, 30625, Germany

  • Mersin University Medical Faculty

    Mersin, 33079, Turkey (Türkiye)

  • Michigan Institute for Neurological Disorders

    Farmington Hills, Michigan, 48334, United States

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

    Zaporizhzhia, 69600, Ukraine

  • N.P. Bechtereva Institute of the Human Brain

    Saint Petersburg, Sankt-Peterburg, 197376, Russia

  • National Center of Social Significant Disease

    Saint Petersburg, Sankt-Peterburg, 197110, Russia

  • National Hospital for Neurology and Neurosurgery,

    London, WC1 3BG, United Kingdom

  • Neurocentrum Bydgoszcz sp. z o.o

    Bydgoszcz, 85-796, Poland

  • Neurociencias Prisma, A.C

    San Luis Potosí City, San Luis Potosí, 78216, Mexico

  • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych

    Plewiska, 62-064, Poland

  • Neurology Clinic PC

    Cordova, Tennessee, 38018, United States

  • Nmedis sp. z o.o.

    Rzeszów, 35-323, Poland

  • Northwell Health

    Great Neck, New York, 11021, United States

  • Ondokuz Mayis University School of Medicine

    Samsun, 55139, Turkey (Türkiye)

  • Ospedale S.Antonio Abate

    Gallarate, Lombardy, 21013, Italy

  • Osrodek Badan Klinicznych Euromedis

    Szczecin, 70-215, Poland

  • Perm SMA n.a. academ. E.A. Vagner

    Perm, 614990, Russia

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024, Hungary

  • Praxis Pesquisa Médica

    Santo André, São Paulo, 09090-790, Brazil

  • Regional Clinical Hospital

    Ivano-Frankivsk, 76008, Ukraine

  • Regional clinical hospital named after prof. S.V. Ochapovsky

    Krasnodar, 350086, Russia

  • Research Center of Neurology of RAMS

    Moscow, Moscow Oblast, 125367, Russia

  • Revalidatie en MS Centrum

    Overpelt, 3900, Belgium

  • Rigshospitalet Glostrup

    Glostrup Municipality, 2600, Denmark

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • SHI Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

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

    Dnipro, 49027, Ukraine

  • Sancaktepe Training and Research Hospital

    Istanbul, 34785, Turkey (Türkiye)

  • Selcuk University Medical Faculty

    Istanbul, 42131, Turkey (Türkiye)

  • Semmelweis Egyetem Idegsebeszeti és Neurointervencios Klinika

    Budapest, 1145, Hungary

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400, Hungary

  • St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU

    Kharkiv, 61068, Ukraine

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine

    Kharkiv, 61068, Ukraine

  • Sumy Regional Clinical Hospital

    Sumy, 40031, Ukraine

  • Szpital Specjalistyczny im. Rydygiera w Krakowie

    Krakow, 31-826, Poland

  • Texas Institute for Neurological Disorders

    Sherman, Texas, 75092, United States

  • UMHAT Dr. Georgi Stranski

    Pleven, 5800, Bulgaria

  • UNO Medical Trials Kft.

    Budapest, 1152, Hungary

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, Ulyanovsk Oblast, 432063, Russia

  • University of California Irvine

    Irvine, California, 92697, United States

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Universität Leipzig

    Leipzig, 04103, Germany

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

    Dresden, 01307, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsklinikum Tübingen, Zentrum für Neurologie

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsmedizin Greifswald

    Greifswald, 17475, Germany

  • Vertebronevrologiya LLC

    Kazan', Tatarstan Republic, 420047, Russia

  • Volyn Regional Clinical Hospital

    Lutsk, 43005, Ukraine

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wheaton Franciscan Healthcare - St. Francis Outpatient Center

    Milwaukee, Wisconsin, 53215, United States

  • Wojewódzki Szpital Specjalistyczny Nr 3

    Rybnik, 44-200, Poland

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