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A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS)
Sponsor: Hoffmann-La Roche
Summary
The main purpose of this study is to assess the efficacy of RO7268489 in adults with progressive multiple sclerosis (PMS) receiving ocrelizumab. After the end of the double-blind period, an open-label (OL) extension may allow eligible participants to receive open-label RO7268489.
Official title: A Multi-center, Double-blind, Placebo-controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, a Monoacylglycerol Lipase Inhibitor, as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-03-10
Completion Date
2030-05-30
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
RO7268489
RO7268489 will be administered per schedule as specified in the arms.
Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
Placebo
Placebo will be administered per schedule as specified in the arms.
Locations (73)
Southern Neurology
Kogarah, New South Wales, Australia
Austin Health
Heidelberg, Victoria, Australia
Hopital Caremeau
Nîmes, Gard, France
Groupe Hospitalier Pellegrin
Bordeaux, Gironde, France
Hopital Purpan
Toulouse, Haute Garonne, France
Hopital Gui de Chauliac
Montpellier, Herault, France
CHU Nantes - Hopital Nord Laënnec
Saint-Herblain, Loire Atlantique, France
CHU Nancy Hôpital Central
Nancy, Meurthe Et Moselle, France
CHU Hopital Gabriel Montpied
Clermont-Ferrand, Puy De Dome, France
Hopital Neurologique Pierre Wertheimer
Bron, France
Groupe Hospitalier Pitie-Salpetriere
Paris, France
CHU Rennes - Hopital Pontchaillou
Rennes, France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Studienzentrum Neuropoint GmbH,
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Saxony, Germany
Charité Universitaetsmedizin Berlin - Campus Ch
Berlin, Germany
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Baranya, Hungary
Clinexpert Kft.
Budapest, Hungary
S-Medicon Egeszsegugyi Szolgaltato Kft.
Budapest, Hungary
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, Italy
Azienda Ospedaliera Universitaria- Universit degli Studi della Campania Luigi Vanvitelli
Naples, Campania, Italy
Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona
Salerno, Campania, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, Lombardy, Italy
Optimal Clinical Trials - Christchurch
Christchurch Central City, South Island, New Zealand
Optimal Clinical Trials - Central
Auckland, New Zealand
Nmedis sp. z o.o.
Rzeszw, Podkarpackie Voivodeship, Poland
Centrum Medyczne Pratia Katowice I
Katowice, Silesian Voivodeship, Poland
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Katowice, Silesian Voivodeship, Poland
ProNeuro Centrum Medyczne
?ory, Poland
SOMED - Lodzkie Centrum Osteoporozy
?ód?, Poland
M.A. LEK A.M.Maciejowscy SC.
Katowice, Poland
Resmedica NZOZ Kielce
Kielce, Poland
Samodzielny Publiczny Zakad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland
Szpital Specjalistyczny im. L. Rydygiera w Krakowie
Krakow, Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin, Poland
Zanamed Medical Clinic sp z o o
Lublin, Poland
Centrum Medyczne Medyk
Rzeszów, Poland
Centrum Medyczne NeuroProtect
Warsaw, Poland
Penta Hospitals Przychodnie, Wroclaw Wejherowska
Wroc?aw, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa SzyszkoSUM w Katowicach
Zabrze, Poland
Hospital de Braga
Braga, Portugal
ULS São José - Hospital de Sto António dos Capuchos;CRI Esclerose Múltipla
Lisbon, Portugal
Hospital Santa Caterina
Salt, Girona, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari Vall d Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Kocaeli University Medical Faculty
Kocaeli, Izmit, Turkey (Türkiye)
Hacettepe University of Medicine
Ankara, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, Turkey (Türkiye)
Ankara City Hospital
Ankara, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye)
Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Charing Cross Hospital
London, Greater London, United Kingdom
Queen Elizabeth University Hospital
Glasgow, Strathclyde, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Salford Care Organisation
Salford, United Kingdom
Morriston Hospital
Swansea, United Kingdom