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
- Diseases
- Multiple sclerosis
- 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
Sites (117)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Box Hill Hospital Coordinator of this site? Confirm its status | Box Hill | Australia | Recruiting |
| Brain and Mind Centre Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Southern Neurology Coordinator of this site? Confirm its status | Kogarah | Australia | Recruiting |
| John Hunter Hospital Coordinator of this site? Confirm its status | New Lambton Heights | Australia | Recruiting |
| Centro de Pesquisas Clinicas - CPCLIN Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| St. Josef Hospital Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Universitaetsklinikum Leipzig Aor Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Universitaetsklinikum Mannheim GmbH Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| LMU Klinikum Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Hospital General Universitario de Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Recruiting |
| Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Coordinator of this site? Confirm its status | Lleida | Spain | Recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Hospital Santa Caterina Ias Coordinator of this site? Confirm its status | Salt | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Complexo Hospitalario Universitario De Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Chu Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| CHRU de Nancy Coordinator of this site? Confirm its status | Nancy | France | Recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| University Hospital of Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Recruiting |
| Queen Elizabeth University Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Charing Cross Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Salford Care Organisation Coordinator of this site? Confirm its status | Salford | United Kingdom | Recruiting |
| Morriston Hospital Coordinator of this site? Confirm its status | Swansea | United Kingdom | Recruiting |
| Royal Cornwall Hospital Coordinator of this site? Confirm its status | Truro | United Kingdom | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Recruiting |
| S-Medicon Kft. Coordinator of this site? Confirm its status | Budapest IV | Hungary | Recruiting |
| Budapesti Uzsoki Utcai Korhaz Coordinator of this site? Confirm its status | Budapest XIV | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Recruiting |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| Universita' Degli Studi G. D'Annunzio Di Chieti Coordinator of this site? Confirm its status | Chieti Scalo | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona Coordinator of this site? Confirm its status | Salerno | Italy | Recruiting |
| Optimal Clinical Trials - Central Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| Optimal Clinical Trials - Christchurch Coordinator of this site? Confirm its status | Christchurch Central City | New Zealand | Recruiting |
| Neurocentrum Bydgoszcz sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| MA-LEK Clinical Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Neuro-Care Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Resmedica Sp. z o.o. Coordinator of this site? Confirm its status | Kielce | Poland | Recruiting |
| Szpital Uniwersytecki w Krakowie Coordinator of this site? Confirm its status | Krakowie | Poland | Recruiting |
| Somed Cr Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Zanamed Medical Clinic Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy Coordinator of this site? Confirm its status | Poznań | Poland | Recruiting |
| Centrum Medyczne Medyk Sp. z o.o. Coordinator of this site? Confirm its status | Rzeszow | Poland | Recruiting |
| Nmedis sp. z o.o. Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Centrum Medyczne NeuroProtect Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| EMC Instytut Medyczny S.A. Przychodnia EuroMediCare, Wrocław Łowiecka Coordinator of this site? Confirm its status | Wrocław | Poland | Recruiting |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Zabrze | Poland | Recruiting |
| ProNeuro Centrum Medyczne Coordinator of this site? Confirm its status | Zory | Poland | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Unidade Local De Saude De Sao Jose E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Lisboa Ocidental E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Entre O Douro E Vouga E.P.E. Coordinator of this site? Confirm its status | Santa Maria Da Feira | Portugal | Recruiting |
| Ankara City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Hacettepe University of Medicine Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Gazi University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Istanbul University Cerrahpasa Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Istanbul University Istanbul Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Ege University Medical Faculty Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
| Izmir Katip Celebi Universitesi Ataturk Research and Training Hospital Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
| Kocaeli University Medical Faculty Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Recruiting |
| Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.