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New hope for progressive MS: ocrelizumab trial targets disability

NCT ID NCT04035005

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether ocrelizumab (Ocrevus) can slow disability progression in adults with primary progressive multiple sclerosis (PPMS). Over 1,000 participants receive either the drug or a placebo. The main goal is to see if the drug delays worsening of hand function and walking ability. The study also includes an open-label extension for those who complete the blinded phase.

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 could confirm ocrelizumab as an effective treatment to slow disability progression in people with primary progressive MS, including those later in the disease course.
What could go wrong
This is a late-stage trial, but results may still show limited benefit or side effects. The study includes a placebo group, so some participants will not receive the active drug during the blinded phase.

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

1,013 people

The number who actually took part.

Started

Aug 2019

Expected to finish

Jan 2028

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 65 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: * EDSS score at screening and baseline \>= 3.0 to 8.0, inclusive * Disease duration from the onset of MS symptoms relative to randomization date: Less than 20 years in participants with an EDSS score at screening 7.0 - 8.0 Less than 15 years in participants with an EDSS at screening 5.5 - 6.5 Less than 10 years in participants with an EDSS at screening \<= 5.0 * Documented history or presence at screening of at least one of the following laboratory findings in a cerebrospinal fluid specimen: Elevated immunoglobulin G (IgG) index or one or more IgG oligoclonal bands detected by isoelectric focusing * Screening and baseline 9-HPT completed in \> 25 seconds (average of the two hands) * Neurological stability for ≥ 30 days prior to baseline * Ability to complete the 9-HPT within 240 seconds with each hand at screening and baseline * Neurological stability for \>/= 30 days prior to baseline * Participants previously treated with immunosuppressants, immunomodulators, or other immunomodulatory therapies must undergo an appropriate washout period according to the local label of the immunosuppressant/immunomodulatory drug used * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required. * For female participants without reproductive potential: Women may be enrolled if surgically sterile (i.e hysterectomy, complete bilateral oophorectomy) or post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile Exclusion Criteria: * History of relapsing-remitting or secondary progressive MS at screening * Confirmed serious opportunistic infection including: active bacterial, viral, fungal, mycobacterial infection or other infection, including tuberculosis or atypical mycobacterial disease * Participants who have or have had confirmed or a high degree of suspicion of progressive multifocal leukoencephalopathy (PML) * Known active malignancy or are being actively monitored for recurrence of malignancy * Immunocompromised state * Receipt of a live-attenuated vaccine within 6 weeks prior to randomization * Inability to complete an MRI or contraindication to Gd administration. * Participants requiring symptomatic treatment of MS and/or physiotherapy who are not on a stable regimen. Participants must not initiate symptomatic treatment of MS or physiotherapy within 4 weeks of randomization. * Contraindications to mandatory premedications for infusion-related reactions, including: uncontrolled psychosis for corticosteroids and closed-angle glaucoma for antihistamines * Known presence of other neurologic disorders * Pregnant or breastfeeding, or intending to become pregnant during the study and for 6 or 12 months after last infusion of the study drug * Lack of peripheral venous access * Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participant from participating in the study * 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 * History of primary or secondary immunodeficiency * Treatment with any investigational agent within 24 weeks prior to screening (Visit 1) or 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS * Previous treatment with B-cell targeting therapies * Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation * Any previous history of transplantation or anti-rejection therapy * Treatment with IV Ig or plasmapheresis within 12 weeks prior to randomization * Systemic corticosteroid therapy within 4 weeks prior to screening * Positive serum human chorionic gonadotropin (hCG) measured at screening or positive urine β-hCG at baseline * Positive screening tests for hepatitis B * Any additional exclusionary criterion as per ocrelizumab (Ocrevus®) local label, if more stringent than the above * Lack of MRI activity at screening/baseline if more than 650 participants without MRI activity have already been enrolled, as defined by T1 Gd+ lesion(s) and/or new and/or enlarged T2 lesion(s) in the screening, to ensure that at least 350 participants with MRI activity will be randomized Eligibility Criteria for OLE Phase: * Completed the 144 weeks of double-blind treatment phase of the trial or are ongoing in the double blind treatment phase at the time of the primary analysis, and who, in the opinion of the investigator, may benefit from treatment with Ocrelizumab. Participants who withdrew from study treatment and received another DMT or commercial ocrelizumab will not be allowed to enter in the OLE phase. * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required. * For female participants without reproductive potential: Women may be enrolled if surgically sterile (i.e. hysterectomy, complete bilateral oophorectomy) or post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile

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Conditions

The condition(s) this trial relates to.

chronic progressive 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, primary progressive

Contacts and locations

Locations

  • AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2

    Naples, Campania, 80138, Italy

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141, United States

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera Sant'andrea

    Rome, Lazio, 00189, Italy

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • Belyayev Clinical Hospital of the Kuzbass

    Kemerovo, 650066, Russia

  • Brain and Mind Research Institute

    Camperdown, New South Wales, 2050, Australia

  • CHRU Nancy

    Nancy, 54035, France

  • CHU Mohammed VI

    Marrakesh, 40080, Morocco

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33076, France

  • CHU de Nimes - Hopital Universitaire Caremeau

    Nîmes, 30900, France

  • Cai Ferate Clinical Hospital

    Constanța, 900123, Romania

  • Campus Neurologico Senior

    Torres Vedras, 2560-280, Portugal

  • Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites

    Rabat, 10100, Morocco

  • Centre Hospitalier Universitaire de Clermont Ferrand

    Clermont-Ferrand, 63003, France

  • Centrum Medyczne Medyk

    Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

  • Centrum Medyczne NeuroProtect Zablocinska 10

    Warsaw, 01-684, Poland

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324, Poland

  • City Clinical Hospital #24

    Moscow, Moscow Oblast, 127015, Russia

  • City Clinical Hospital #4

    Saransk, Saratov Oblast, 430032, Russia

  • City Clinical Hospital a n Buyanov V M

    Moscow, Moscow Oblast, 115516, Russia

  • City Hospital #40 of Kurortniy Administrative District

    Saint Petersburg, Sankt-Peterburg, 197706, Russia

  • Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

    Bogotá, 111321, Colombia

  • Clinical Center Nis

    Niš, 18000, Serbia

  • Clinical Centre of Vojvodina

    Nova Sad, 21000, Serbia

  • Clinical Hospital Centre Zemun

    Belgrade, 11080, Serbia

  • Clinical Hospital Sestre Milosrdnice

    Zagreb, 10000, Croatia

  • Clinical Research Institute

    Tlalnepantla, 54055, Mexico

  • Cliniques Universitaires St-Luc

    Brussels, 1200, Belgium

  • Columbus Neuroscience

    Westerville, Ohio, 43082-6910, United States

  • Communal Non-Commercial Enterprise Clinical Hospital #15 of the Podilskyi District ofthe Kyiv City

    Kyiv, KIEV Governorate, 04070, Ukraine

  • Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, 61022, Ukraine

  • Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

    Lviv, Kharkiv Governorate, 79010, Ukraine

  • Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

    Lviv, Lviv Oblast, 79010, Ukraine

  • Complejo Asistencial Universitario de Salamanca ? H. Clinico

    Salamanca, 37007, Spain

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36312, Spain

  • Copernicus Podmiot Leczniczy Sp z o o

    Gda?sk, 80-803, Poland

  • Dalhousie Multiple Sclerosis Research Unit

    Halifax, Nova Scotia, B3H 4K4, Canada

  • Dunedin Hospital

    Dunedin, New Zealand

  • EUROMEDIS Sp z o o

    Szczecin, 70-215, Poland

  • FSBIH Siberian Regional Medical Centre of FMBA of Russia

    Novosibirsk, 630007, Russia

  • Fattouma Bourguiba University Hospital

    Monastir, 5000, Tunisia

  • Fondazione Istituto G. Giglio di Cefalu

    Cefalù, Sicily, 90015, Italy

  • Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, Lombardy, 27100, Italy

  • Fondazione PTV Policlinico Tor Vergata

    Rome, Lazio, 00133, Italy

  • Galen Clinic

    Lublin, 20-064, Poland

  • General Hospital Uzice

    Užice, 31000, Serbia

  • General Hospital Varazdin

    Varaždin, 42000, Croatia

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Grupo Medico Camino

    Mexico City, Mexico CITY (federal District), 03310, Mexico

  • Hopital Civil

    Strasbourg, 67098, France

  • Hopital Guillaume Et Rene Laennec

    Nantes, 44805, France

  • Hopital Razi

    LA Mannouba, 2010, Tunisia

  • Hospital Angeles Chihuahua

    Chihuahua City, 31238, Mexico

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Garcia de Orta

    Almada, 2805-267, Portugal

  • Hospital Habib Bourguiba

    Sfax, 3029, Tunisia

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Hospital de Santo Antonio

    Porto, 4099-001, Portugal

  • Hotel Dieu de France

    Achrafieh Beirut, 000000, Lebanon

  • IRCCS AOM Azienda Ospedaliera Metropolitana

    Genoa, Liguria, 16132, Italy

  • Instituto Neurologico de Colombia INDEC

    Medellín, Antioquia, 50012, Colombia

  • Khechinashvili University Hospital

    Tbilisi, 179, Georgia

  • Kirov State Medical Academy

    Kirov, 610027, Russia

  • Krasnoyarsk State Medical Academy

    Krasnoyarsk, Krasnoyarsk Krai, 660022, Russia

  • Kyiv City Clinical Hospital #4

    Kyiv, KIEV Governorate, 03110, Ukraine

  • LLC Medical Center Family Medicine Clinic

    Dnipro, 49600, Ukraine

  • LLC Medical Center Health Clinic

    Vinnytsia, Volhynian Governorate, 21009, Ukraine

  • LLC Medical Center INET 09

    Zaporizhzhia, 69035, Ukraine

  • LLC Medical Center Unimed

    Zaporizhzhia, Zaporizhzhia Oblast, 69000, Ukraine

  • MA-LEK Clinical Sp. Z o.o.

    Katowice, 40-571, Poland

  • MEDIS Limited Liability Company

    Nizhny Novgorod, Niznij Novgorod, 603137, Russia

  • MS & Neurologisch Revalidatie Centrum

    Overpelt, 3900, Belgium

  • MS and Neuromuscular Center of Excellence

    Clearwater, Florida, 33761, United States

  • Mazowieckie Centrum Badan Klinicznych

    Grodzisk Mazowiecki, 05-825, Poland

  • Med-Polonia Sp. z o.o.

    Poznan, 60-693, Poland

  • Medical Center Artes Medicum LLC

    Kyiv, Kyiv Oblast, 02002, Ukraine

  • Medical Center Salutem

    Vinnytsia, Podolia Governorate, 21009, Ukraine

  • Medical Center of LLC Medical Center Dopomoga Plus

    Kyiv, 02000, Ukraine

  • Medical Centre of PE First Private Clinic

    Kyiv, KIEV Governorate, 03037, Ukraine

  • Military Hospital of Tunis

    Tunis, 1008, Tunisia

  • Military Medical Academy

    Belgrade, 11000, Serbia

  • Military Medical Academy HBAT

    Pleven, 5800, Bulgaria

  • Morriston Hospital

    Swansea, SA6 6NL, United Kingdom

  • Moscow Regional Research Clinical Institute Na Mfvladimirskiy

    Moscow, Moscow Oblast, 129110, Russia

  • Multiprofile Hospital For Active Treatment Avis Medica

    Pleven, 5800, Bulgaria

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

    Sofia, 1113, Bulgaria

  • Municipal NPE Regional Clinical Center of Neurosurgery and Neurology of Transcarpathian RC

    Uzhhorod, KIEV Governorate, 88018, Ukraine

  • Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

    Kherson, Kherson Governorate, 73000, Ukraine

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

    Zaporizhzhia, 69600, Ukraine

  • NEURO-MEDIC Sp. z o. o.

    Katowice, 40-686, Poland

  • National Center of Socially Significant Diseases

    Saint Petersburg, Sankt-Peterburg, 197110, Russia

  • Neftyanik Medical and Sanitary Unit

    Tumen, Moscow Oblast, 625000, Russia

  • Neurocentrum Bydgoszcz sp z o.o

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, Sinaloa, 80020, Mexico

  • Neurological Services of Orlando

    Orlando, Florida, 32806, United States

  • New Zealand Clinical Research - Christchurch

    Christchurch, 8011, New Zealand

  • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

    Nizhny Novgorod, Niznij Novgorod, 603126, Russia

  • Novo-Med Zielinski i wsp SpJ

    Katowice, 40-584, Poland

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, Lombardy, 20132, Italy

  • Peninsula College of Medicine and Dentistry

    Plymouth, PL6 8BX, United Kingdom

  • Perm Regional Clinical Hospital of Znak Pocheta Medal

    Perm, 614990, Russia

  • Pineo Medical Ecosystem LTD

    Tbilisi, 0114, Georgia

  • Private Enterprise Clinic Medicom

    Kyiv, 04219, Ukraine

  • Przychodnia EuroMediCare

    Wroclaw, Lower Silesian Voivodeship, 50-220, Poland

  • Queen Elizabeth University Hospital - PPDS

    Glasgow, G51 4TF, United Kingdom

  • RESMEDICA Spolka z o.o.

    Kielce, Świętokrzyskie Voivodeship, 25-726, Poland

  • Raigmore Hospital - PPDS

    Inverness, IV2 3JH, United Kingdom

  • Recherche Sepmus Inc.

    Greenfield Park, Quebec, J4V 2J2, Canada

  • Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak

    Lublin, Lublin Voivodeship, 20-410, Poland

  • Research Center of Neurology of RAMS

    Moskva, Moscow Oblast, 125367, Russia

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF, United Kingdom

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • SBHI of Nizhny Novgorod region City Clinical Hospital #3

    Nizhny Novgorod, Niznij Novgorod, 603155, Russia

  • SC Clubul Sanatatii SRL

    Campulung Muscel, 115100, Romania

  • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3

    Rybnik, Silesian Voivodeship, 44-200, Poland

  • Saint George University Medical Hospital

    El Achrafiyé, DUMMY_VALUE, Lebanon

  • Salford Royal Hospital

    Salford, M6 8HD, United Kingdom

  • Siberian State Medical University of Roszdrav

    Tomsk, 634050, Russia

  • Specjalistyczna Praktyka Lekarska Dr n.med. Stanislaw Ochudlo

    Katowice, 40-752, Poland

  • Spitalul Judetean de Urgenta Deva

    Deva, Hunedoara County, 330084, Romania

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • Sverdlovsk Regional Clinical Hospital 1

    Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-503, Poland

  • Targu Mures Clinical Emergency County Hospital

    Târgu Mure?, 540136, Romania

  • The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company

    Columbus, Ohio, 43235-5422, United States

  • The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0141, Georgia

  • The National Hospital for Neurology & Neurosurgery

    London, GT LON, WC1N 3BG, United Kingdom

  • The Royal London Hospital

    London, E1 1BB, United Kingdom

  • Treatment and Diagnostic Center of LLC MRT Elit

    Kropyvnytskyi, KIEV Governorate, 25005, Ukraine

  • Treatment and diagnostic Center Neuro Global of LLC Neuro Global

    Krykhivtsi, Ivano-Frankivsk Oblast, 76493, Ukraine

  • ULS de Loures-Odivelas, EPE - Hospital de Loures

    Loures, Lisbon District, 2674-514, Portugal

  • UZ Antwerpen

    Edegem, Antwerpen, 2650, Belgium

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, Ulyanovsk Oblast, 432063, Russia

  • Unidad de Investigacion en Salud de Chihuahua

    Mexico City, 14050, Mexico

  • University Clinical Center Kragujevac

    Kragujevac, 34000, Serbia

  • University Clinical Center of Serbia -PPDS

    Belgrade, 11000, Serbia

  • University Hospital Center Zagreb

    Zagreb, 10000, Croatia

  • University Hospital of Wales

    Cardiff, CF14 4XW, United Kingdom

  • University hospital of Dnipro State Medical University

    Dnipro, 49089, Ukraine

  • University of Alberta

    Edmonton, Alberta, T6G 2G3, Canada

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Nottingham

    Nottingham, NG7 2UH, United Kingdom

  • Uniwersytecki Szpital Kliniczny w Bialymstoku Marii Sklodowskiej Curie 24a

    Bia?ystok, 15-276, Poland

  • Vero Neurology

    Vero Beach, Florida, 32960, United States

  • Vertebronevrologiya LLC

    Kazan', Tatarstan Republic, 420043, Russia

  • Volyn Regional Clinical Hospital

    Lutsk, 43005, Ukraine

  • Wojewodzki Szpital Specjalistyczny

    Olsztyn, 10-561, Poland

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