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
- Berlin, Bochum, Bonn, Dresden, Duesseldorf, Erlangen, Essen, Frankfurt Am Main, Freiburg im Breisgau, Hamburg, Leipzig, Mannheim, Muenster, Munich, Tuebingen, and Ulm, GermanySee the 18 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 Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- St. Josef HospitalBochum, GermanyTaking people
- Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyTaking people
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, GermanyTaking people
- Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Goethe University FrankfurtFrankfurt Am Main, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Universitaetsklinikum Leipzig AorLeipzig, GermanyTaking people
- Universitaetsklinikum Mannheim GmbHMannheim, GermanyTaking people
- Universitaetsklinikum Muenster AöRMuenster, GermanyTaking people
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, GermanyTaking people
- LMU Klinikum Muenchen AöRMunich, GermanyTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking people
- NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbHUlm, GermanyTaking people
- Universitaetsklinikum Ulm AoRUlm, GermanyTaking 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).