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
Hoffmann-La Roche
360 participants
Mar 10, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria2
- PMS, in accordance with the revised 2017 McDonald criteria
- Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive
Exclusion Criteria6
- 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
Interventions
RO7268489 will be administered per schedule as specified in the arms.
Ocrelizumab will be administered per schedule as specified in the arms.
Placebo will be administered per schedule as specified in the arms.
Locations(16)
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NCT07282574