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
- Diseases
- Multiple sclerosis
- 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
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noorderhart Coordinator of this site? Confirm its status | Pelt | Belgium | Completed |
| University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Active, not recruiting |
| Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsmedizin Greifswald KöR Coordinator of this site? Confirm its status | Greifswald | Germany | Active, not recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Active, not recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Active, not recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| DKD HELIOS Klinik Wiesbaden GmbH Coordinator of this site? Confirm its status | Wiesbaden | Germany | Active, not recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Gistrup | Denmark | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup | Denmark | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Completed |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Completed |
| Besancon University Hospital Center Coordinator of this site? Confirm its status | Besancon Cedex | France | Completed |
| Centre Hospitalier Regional Et Universitaire De Brest Coordinator of this site? Confirm its status | Brest Cedex 2 | France | Completed |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Completed |
| Chu Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Completed |
| Groupement Des Hopitaux De L'Institut Catholique De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| CHRU De Nancy Coordinator of this site? Confirm its status | Nancy Cedex | France | Completed |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Completed |
| Eginitio Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| 401 General Military Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Orszagos Mentalis Ideggyogyaszati Es Idegsebeszeti Intezet Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Uno Medical Trials Kft. Coordinator of this site? Confirm its status | Budapest XV | Hungary | Completed |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Completed |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Completed |
| Pest Megyei Flor Ferenc Korhaz Coordinator of this site? Confirm its status | Kistarcsa | Hungary | Completed |
| Azienda Socio Sanitaria Territoriale Della Valle Olona Coordinator of this site? Confirm its status | Busto Arsizio | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Neurological Institute Foundation Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Sant Andre Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| Neurocentrum Bydgoszcz sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| MA-LEK Clinical Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Centrum Neurologii Krzysztof Selmaj Coordinator of this site? Confirm its status | Łódź | Poland | Active, not recruiting |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Oswiecim | Poland | Active, not recruiting |
| Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej Coordinator of this site? Confirm its status | Plewiska k. Poznania | Poland | Active, not recruiting |
| EMC Instytut Medyczny S.A. Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Specjalistyczny Nr 3 W Rybniku Coordinator of this site? Confirm its status | Rybnik | Poland | Active, not recruiting |
| Nmedis sp. z o.o. Coordinator of this site? Confirm its status | Rzeszów | Poland | Active, not recruiting |
| EUROMEDIS Sp z o o Coordinator of this site? Confirm its status | Szczecin | Poland | Active, not recruiting |
| Centrum Medyczne NeuroProtect Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Instytut Psychiatrii I Neurologii Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Completed |
| Centro Hospitalar Universitario Lisboa Central E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Centro Hospitalar De Lisboa Ocidental E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Centro Hospitalar Universitário de Santo Antonio,E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Completed |
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This page is information, not medical advice. Discuss any trial with your doctor.