Tests RO7268489 added to ocrelizumab in progressive multiple sclerosis
Tests an add-on drug with ocrelizumab in adults with progressive multiple sclerosis.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Chieti Scalo, Genoa, Milan, Naples, Pavia, Rome, and Salerno, ItalySee the 10 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
- Which type of multiple sclerosis (MS) has your doctor told you that you have?
- Can you have MRI scans (scans that use strong magnets)?
Source: NCT07282574, who can take part
Where in Italy
- Universita' Degli Studi G. D'Annunzio Di ChietiChieti Scalo, ItalyTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyTaking people
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
- Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'AragonaSalerno, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07282574EU 2025-521636-10-00
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; MS relapse during the 6 months preceding the randomization date; Lack of peripheral venous access; Inability to complete a magnetic resonance imaging (MRI).