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NCT07282574RecruitingPhase 2

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)

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

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
360 (estimated)
First submitted
5 Dec 2025
Start date
10 Mar 2026
Primary completion date
30 May 2028
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07282574
EU CT number
2025-521636-10-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 360
  • From 10 Mar 2026 to the primary completion date, 30 May 2028
  • 117 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of alcohol or other drug abuse (substance use disorder) based on Diagnostic and Statistical Manual for Mental Disorders, fifth edition (DSM-5) criteria, within 5 years prior to screening
  • Contraindications to ocrelizumab mandatory pre-medications
  • Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening

Other

  • MS relapse during the 6 months preceding the randomization date
  • Lack of peripheral venous access
  • Inability to complete a magnetic resonance imaging (MRI)

Who the study is looking for

  • PMS, in accordance with the revised 2017 McDonald criteria
  • Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive
  • Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (117)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Box Hill Hospital
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Box HillAustraliaRecruiting
Brain and Mind Centre
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CamperdownAustraliaRecruiting
Austin Health
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HeidelbergAustraliaRecruiting
Southern Neurology
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KogarahAustraliaRecruiting
John Hunter Hospital
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New Lambton HeightsAustraliaRecruiting
Centro de Pesquisas Clinicas - CPCLIN
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São PauloBrazilRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
St. Josef Hospital
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BochumGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyRecruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyRecruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyRecruiting
Universitaetsklinikum Leipzig Aor
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LeipzigGermanyRecruiting
Universitaetsklinikum Mannheim GmbH
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MannheimGermanyRecruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyRecruiting
LMU Klinikum Muenchen AöR
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MunichGermanyRecruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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MunichGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
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UlmGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Hospital General Universitario de Albacete
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AlbaceteSpainRecruiting
Hospital Universitario de Cruces
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BarakaldoSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainRecruiting
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
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LleidaSpainRecruiting
Hospital Universitario de la Princesa
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainRecruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainRecruiting
Hospital Santa Caterina Ias
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SaltSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Complexo Hospitalario Universitario De Vigo
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VigoSpainRecruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Hospices Civils de Lyon
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BronFranceRecruiting
Chu Gabriel Montpied
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Clermont-FerrandFranceRecruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceRecruiting
CHRU de Nancy
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NancyFranceRecruiting
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
University Hospital of Wales
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CardiffUnited KingdomRecruiting
Queen Elizabeth University Hospital
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GlasgowUnited KingdomRecruiting
Charing Cross Hospital
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LondonUnited KingdomRecruiting
Royal London Hospital
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LondonUnited KingdomRecruiting
Salford Care Organisation
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SalfordUnited KingdomRecruiting
Morriston Hospital
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SwanseaUnited KingdomRecruiting
Royal Cornwall Hospital
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TruroUnited KingdomRecruiting
Semmelweis University
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BudapestHungaryRecruiting
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
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BudapestHungaryRecruiting
Clinexpert Kft.
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Budapest IIIHungaryRecruiting
S-Medicon Kft.
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Budapest IVHungaryRecruiting
Budapesti Uzsoki Utcai Korhaz
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Budapest XIVHungaryRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryRecruiting
University of Pecs
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PécsHungaryRecruiting
Universita' Degli Studi G. D'Annunzio Di Chieti
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Chieti ScaloItalyRecruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyRecruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyRecruiting
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
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SalernoItalyRecruiting
Optimal Clinical Trials - Central
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AucklandNew ZealandRecruiting
Optimal Clinical Trials - Christchurch
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Christchurch Central CityNew ZealandRecruiting
Neurocentrum Bydgoszcz sp. z o.o
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BydgoszczPolandRecruiting
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
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CracowPolandRecruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandRecruiting
MA-LEK Clinical Sp. z o.o.
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KatowicePolandRecruiting
Pratia S.A.
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KatowicePolandRecruiting
Neuro-Care Sp. z o.o. sp.k.
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KatowicePolandRecruiting
Resmedica Sp. z o.o.
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KielcePolandRecruiting
Szpital Uniwersytecki w Krakowie
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KrakowiePolandRecruiting
Somed Cr Sp. z o.o. sp.k.
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LodzPolandRecruiting
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
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LublinPolandRecruiting
Zanamed Medical Clinic Sp. z o.o.
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LublinPolandRecruiting
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
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PoznańPolandRecruiting
Centrum Medyczne Medyk Sp. z o.o.
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RzeszowPolandRecruiting
Nmedis sp. z o.o.
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RzeszówPolandRecruiting
Centrum Medyczne NeuroProtect
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WarsawPolandRecruiting
EMC Instytut Medyczny S.A. Przychodnia EuroMediCare, Wrocław Łowiecka
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WrocławPolandRecruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
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ZabrzePolandRecruiting
ProNeuro Centrum Medyczne
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ZoryPolandRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalRecruiting
Unidade Local De Saude De Sao Jose E.P.E.
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LisbonPortugalRecruiting
Unidade Local De Saude De Lisboa Ocidental E.P.E.
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LisbonPortugalRecruiting
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
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Santa Maria Da FeiraPortugalRecruiting
Ankara City Hospital
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AnkaraTurkey (Türkiye)Recruiting
Hacettepe University of Medicine
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AnkaraTurkey (Türkiye)Recruiting
Gazi University Medical Faculty
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AnkaraTurkey (Türkiye)Recruiting
Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital
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IstanbulTurkey (Türkiye)Recruiting
Istanbul University Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Recruiting
Istanbul University Istanbul Medical Faculty
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IstanbulTurkey (Türkiye)Recruiting
Ege University Medical Faculty
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IzmirTurkey (Türkiye)Recruiting
Izmir Katip Celebi Universitesi Ataturk Research and Training Hospital
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IzmirTurkey (Türkiye)Recruiting
Kocaeli University Medical Faculty
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KocaeliTurkey (Türkiye)Recruiting
Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
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KonyaTurkey (Türkiye)Recruiting

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