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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)

NCT07282574 · Hoffmann-La Roche
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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
About this study
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.
Eligibility criteria
Inclusion Criteria: * PMS, in accordance with the revised 2017 McDonald criteria * Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive Exclusion Criteria: * MS relapse during the 6 months preceding the randomization date * Lack of peripheral venous access * History of alcohol or other drug abuse, in the opinion of the investigator, within 5 years prior to screening * Inability to complete an magnetic resonance imaging (MRI) * Contraindications to ocrelizumab mandatory pre-medications * Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening
Study design
Enrollment target: 360 participants
Allocation: randomized
Masking: quadruple
Age groups: adult
Timeline
Starts: 2026-03-10
Estimated completion: 2030-05-30
Last updated: 2026-08-17
Interventions
Drug: RO7268489Drug: OcrelizumabDrug: Placebo
Primary outcomes
  • Time From Randomization to the First Occurrence of Composite Confirmed Disability Progression (cCPD) Confirmed for at Least 12 Weeks (cCDP12) (Up to approximately 110 weeks)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: BP46016 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. Only)
ContactFastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry · contact
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (108)
Brain and Mind CentreRecruiting
Camperdown, New South Wales, Australia
Southern NeurologyRecruiting
Kogarah, New South Wales, Australia
John Hunter HospitalRecruiting
New Lambton Heights, New South Wales, Australia
Box Hill HospitalRecruiting
Box Hill, Victoria, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
CHU Strasbourg Hpital HautepierreRecruiting
Strasbourg, Bas Rhin, France
Hopital CaremeauRecruiting
Nîmes, Gard, France
Groupe Hospitalier PellegrinRecruiting
Bordeaux, Gironde, France
Hopital PurpanRecruiting
Toulouse, Haute Garonne, France
Hopital Gui de ChauliacRecruiting
Montpellier, Herault, France
CHU Nantes - Hopital Nord LaënnecRecruiting
Saint-Herblain, Loire Atlantique, France
CHU Nancy Hôpital CentralRecruiting
Nancy, Meurthe Et Moselle, France
CHU Hopital Gabriel MontpiedRecruiting
Clermont-Ferrand, Puy De Dome, France
Hopital Neurologique Pierre WertheimerRecruiting
Bron, France
Groupe Hospitalier Pitie-SalpetriereRecruiting
Paris, France
CHU Rennes - Hopital PontchaillouRecruiting
Rennes, France
Universitaetsklinikum FreiburgRecruiting
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsmedizin MannheimRecruiting
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum TuebingenRecruiting
Tübingen, Baden-Wurttemberg, Germany
Studienzentrum Neuropoint GmbH,Recruiting
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum UlmRecruiting
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum ErlangenRecruiting
Erlangen, Bavaria, Germany
LMU-Campus GrosshadernRecruiting
Munich, Bavaria, Germany
Klinikum rechts der Isar der TU MuenchenRecruiting
Munich, Bavaria, Germany
St. Josef-Hospital UniversitaetsklinikumRecruiting
Bochum, North Rhine-Westphalia, Germany
Universitaetsklinikum DuesseldorfRecruiting
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinkm EssenRecruiting
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus TU DresdenRecruiting
Dresden, Saxony, Germany
Universitaetsklinikum LeipzigRecruiting
Leipzig, Saxony, Germany
Charité Universitaetsmedizin Berlin - Campus ChRecruiting
Berlin, Germany
Universitaetsklinikum Hamburg-EppendorfRecruiting
Hamburg, Germany
Pecsi Tudomanyegyetem Klinikai KozpontRecruiting
Pécs, Baranya, Hungary
Clinexpert Kft.Recruiting
Budapest, Hungary
S-Medicon Egeszsegugyi Szolgaltato Kft.Recruiting
Budapest, Hungary
Bajcsy-Zsilinszky Korhaz es RendelointezetRecruiting
Budapest, Hungary
Budapesti Uzsoki Utcai KórházRecruiting
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont Kenezy Gyula CampusRecruiting
Debrecen, Hungary
Fondazione Università G. D'AnnunzioRecruiting
Chieti, Abruzzo, Italy
Azienda Ospedaliera Universitaria Federico IIRecruiting
Naples, Campania, Italy
Azienda Ospedaliera Universitaria- Universit degli Studi della Campania Luigi VanvitelliRecruiting
Naples, Campania, Italy
Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' AragonaRecruiting
Salerno, Campania, Italy
Azienda Ospedaliera Universitaria Policlinico Tor VergataRecruiting
Roma, Emilia-Romagna, Italy
IRCCS AOM Azienda Ospedaliera MetropolitanaRecruiting
Genoa, Liguria, Italy
Ospedale San RaffaeleRecruiting
Milan, Lombardy, Italy
Fondazione IRCCS Istituto Neurologico Carlo BestaRecruiting
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)Recruiting
Milan, Lombardy, Italy
Fondazione Istituto Neurologico Nazionale Casimiro MondinoRecruiting
Pavia, Lombardy, Italy
Optimal Clinical Trials - ChristchurchRecruiting
Christchurch Central City, South Island, New Zealand
Optimal Clinical Trials - CentralRecruiting
Auckland, New Zealand
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. LekRecruiting
Poznan, Greater Poland Voivodeship, Poland
Nmedis sp. z o.o.Recruiting
Rzeszw, Podkarpackie Voivodeship, Poland
Centrum Medyczne Pratia Katowice IRecruiting
Katowice, Silesian Voivodeship, Poland
NEURO-CARE Sp. z o.o. Sp. KomandytowaRecruiting
Katowice, Silesian Voivodeship, Poland
ProNeuro Centrum MedyczneRecruiting
?ory, Poland
SOMED - Lodzkie Centrum OsteoporozyRecruiting
?ód?, Poland
Neurocentrum Bydgoszcz sp z o.oRecruiting
Bydgoszcz, Poland
COPERNICUS Podmiot Leczniczy Sp z o oRecruiting
Gda?sk, Poland
M.A. LEK A.M.Maciejowscy SC.Recruiting
Katowice, Poland
Resmedica NZOZ KielceRecruiting
Kielce, Poland
Samodzielny Publiczny Zakad Opieki Zdrowotnej Szpital Uniwersytecki w KrakowieRecruiting
Krakow, Poland
Szpital Specjalistyczny im. L. Rydygiera w KrakowieRecruiting
Krakow, Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.Recruiting
Lublin, Poland
Zanamed Medical Clinic sp z o oRecruiting
Lublin, Poland
Centrum Medyczne MedykRecruiting
Rzeszów, Poland
Centrum Medyczne NeuroProtectRecruiting
Warsaw, Poland
Penta Hospitals Przychodnie, Wroclaw WejherowskaRecruiting
Wroc?aw, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa SzyszkoSUM w KatowicachRecruiting
Zabrze, Poland
Hospital de BragaRecruiting
Braga, Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de CoimbraRecruiting
Coimbra, Portugal
ULS São José - Hospital de Sto António dos Capuchos;CRI Esclerose MúltiplaRecruiting
Lisbon, Portugal
Hospital de Egas MonizRecruiting
Lisbon, Portugal
Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São SebastiãoRecruiting
Santa Maria da Feira, Portugal
Hospital Universitari de BellvitgeRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Santa CaterinaRecruiting
Salt, Girona, Spain
Complejo Hospitalario Universitario de Santiago.Recruiting
Santiago de Compostela, LA Coruna, Spain
Hospital Universitari Arnau de VilanovaRecruiting
Lleida, Lerida, Spain
Hospital Universitario Quironsalud MadridRecruiting
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Virgen de La ArrixacaRecruiting
El Palmar, Murcia, Spain
Hospital Alvaro CunqueiroRecruiting
Vigo, Pontevedra, Spain
Hospital de CrucesRecruiting
Barakaldo, Vizcaya, Spain
Complejo Hospitalario Universitario de AlbaceteRecruiting
Albacete, Spain
Hospital del MarRecruiting
Barcelona, Spain
Hospital Universitari Vall d HebronRecruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Spain
Hospital Universitario de la PrincesaRecruiting
Madrid, Spain
Hospital General Universitario Gregorio MaranonRecruiting
Madrid, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Hospital Clinico San CarlosRecruiting
Madrid, Spain
Hospital Regional Universitario de MalagaRecruiting
Málaga, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Spain
Kocaeli University Medical FacultyRecruiting
Kocaeli, Izmit, Turkey (Türkiye)
Hacettepe University of MedicineRecruiting
Ankara, Turkey (Türkiye)
Gazi University Medical FacultyRecruiting
Ankara, Turkey (Türkiye)
Ankara City HospitalRecruiting
Ankara, Turkey (Türkiye)
Istanbul University Istanbul Medical FacultyRecruiting
Istanbul, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical FacultyRecruiting
Istanbul, Turkey (Türkiye)
Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research HospitalRecruiting
Istanbul, Turkey (Türkiye)
Ege University Medical FacultyRecruiting
Izmir, Turkey (Türkiye)
Selcuk Universitesi Selcuklu Tip Fakultesi HastanesiRecruiting
Konya, Turkey (Türkiye)
Royal Cornwall HospitalRecruiting
Truro, Cornwall, United Kingdom
Charing Cross HospitalRecruiting
London, Greater London, United Kingdom
Queen Elizabeth University HospitalRecruiting
Glasgow, Strathclyde, United Kingdom
University Hospital of WalesRecruiting
Cardiff, United Kingdom
Royal London HospitalRecruiting
London, United Kingdom
Salford Care OrganisationRecruiting
Salford, United Kingdom
Morriston HospitalRecruiting
Swansea, United Kingdom