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NCT04548999Active, not recruitingPhase 3

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)

A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 May 2026

Brief summary (registry, in English)

To demonstrate the superiority of a higher dose of ocrelizumab over the approved dose of ocrelizumab as assessed by risk reduction in composite confirmed disability progression (cCDP) sustained for at least 12 weeks.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
310 (estimated)
First submitted
18 Dec 2023
Start date
23 Oct 2020
Lead sponsor
F. Hoffmann-La Roche AG
EU CT number
2023-506515-18-00
EudraCT number
2020-000894-26

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 310
  • 56 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti microbials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening

Other illness

  • History of relapsing remitting or secondary progressive MS at screening
  • History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
  • Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
  • History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)

Other

  • Immunocompromised state

Who the study is looking for

  • Ages 18-55 years at time of screening
  • Diagnosis of PPMS, in accordance with the revised McDonald criteria 2017
  • Expanded disability status scale (EDSS) score at screening and baseline 3- 6.5, inclusive
  • Score of ≥ 2.0 on the Functional Systems (FS) scale for the pyramidal system that was due to lower extremity findings at screening and baseline
  • Documented MRI of brain with abnormalities consistent with MS
  • Patients must be neurologically stable for at least 30 days prior to randomization and baseline assessments

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (56)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Noorderhart
Coordinator of this site? Confirm its status
PeltBelgiumCompleted
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
Coordinator of this site? Confirm its status
PlevenBulgariaActive, not recruiting
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Coordinator of this site? Confirm its status
DresdenGermanyActive, not recruiting
Universitaetsmedizin Greifswald KöR
Coordinator of this site? Confirm its status
GreifswaldGermanyActive, not recruiting
Medizinische Hochschule Hannover
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HanoverGermanyActive, not recruiting
Universitaet Leipzig
Coordinator of this site? Confirm its status
LeipzigGermanyActive, not recruiting
Universitaet Muenster
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MuensterGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Universitaetsklinikum Ulm AoR
Coordinator of this site? Confirm its status
UlmGermanyActive, not recruiting
DKD HELIOS Klinik Wiesbaden GmbH
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WiesbadenGermanyActive, not recruiting
Aalborg University Hospital
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GistrupDenmarkCompleted
Rigshospitalet
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GlostrupDenmarkCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainCompleted
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainCompleted
Besancon University Hospital Center
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Besancon CedexFranceCompleted
Centre Hospitalier Regional Et Universitaire De Brest
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Brest Cedex 2FranceCompleted
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceCompleted
Chu Gabriel Montpied
Coordinator of this site? Confirm its status
Clermont-FerrandFranceCompleted
Groupement Des Hopitaux De L'Institut Catholique De Lille
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Lille CedexFranceCompleted
CHRU De Nancy
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Nancy CedexFranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceCompleted
Eginitio Hospital
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AthensGreeceCompleted
401 General Military Hospital of Athens
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AthensGreeceCompleted
Orszagos Mentalis Ideggyogyaszati Es Idegsebeszeti Intezet
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BudapestHungaryCompleted
Uno Medical Trials Kft.
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Budapest XVHungaryCompleted
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryCompleted
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryCompleted
Pest Megyei Flor Ferenc Korhaz
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KistarcsaHungaryCompleted
Azienda Socio Sanitaria Territoriale Della Valle Olona
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Busto ArsizioItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyActive, not recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyActive, not recruiting
Neurological Institute Foundation Casimiro Mondino
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PaviaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Neurocentrum Bydgoszcz sp. z o.o
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BydgoszczPolandActive, not recruiting
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
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CracowPolandActive, not recruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandActive, not recruiting
MA-LEK Clinical Sp. z o.o.
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KatowicePolandActive, not recruiting
Centrum Neurologii Krzysztof Selmaj
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ŁódźPolandActive, not recruiting
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
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LublinPolandActive, not recruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
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OswiecimPolandActive, not recruiting
Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej
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Plewiska k. PoznaniaPolandActive, not recruiting
EMC Instytut Medyczny S.A.
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PoznanPolandActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Specjalistyczny Nr 3 W Rybniku
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RybnikPolandActive, not recruiting
Nmedis sp. z o.o.
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RzeszówPolandActive, not recruiting
EUROMEDIS Sp z o o
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SzczecinPolandActive, not recruiting
Centrum Medyczne NeuroProtect
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WarsawPolandActive, not recruiting
Instytut Psychiatrii I Neurologii
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WarsawPolandActive, not recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalCompleted
Centro Hospitalar Universitario Lisboa Central E.P.E.
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LisbonPortugalCompleted
Centro Hospitalar De Lisboa Ocidental E.P.E.
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LisbonPortugalCompleted
Centro Hospitalar Universitário de Santo Antonio,E.P.E.
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PortoPortugalCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.