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Adding RO7268489 to ocrelizumab for progressive multiple sclerosis

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

PHASE2 · Hoffmann-La Roche · NCT07282574

This trial will test whether adding RO7268489 to ocrelizumab helps adults with progressive multiple sclerosis.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment360 (estimated)
Ages18 Years to 60 Years
SexAll
SponsorHoffmann-La Roche (industry)
Drugs / interventionsocrelizumab
Locations47 sites (Kogarah, New South Wales and 46 other locations)
Trial IDNCT07282574 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized, double-blind, placebo-controlled study tests RO7268489 as an add-on to standard ocrelizumab treatment in adults with progressive multiple sclerosis. Eligible participants with EDSS scores of 3.0–6.0 who are receiving ocrelizumab are randomized to receive RO7268489 or placebo while continuing ocrelizumab, and investigators will monitor safety, pharmacokinetics, pharmacodynamics, and measures of efficacy. MRI and clinical disability scales will be used to track disease activity and progression, and an open-label extension may allow continued RO7268489 exposure after the double-blind period. The sponsor is Hoffmann‑La Roche with trial sites in Australia and France.

Who should consider this trial

Good fit: Adults with progressive multiple sclerosis by the 2017 McDonald criteria, an EDSS of 3.0 to 6.0, and who are currently receiving ocrelizumab are the intended participants.

Not a fit: People who had an MS relapse within six months, cannot undergo MRI, have contraindications to ocrelizumab pre-medications, or recently received IVIg or plasmapheresis are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, adding RO7268489 could slow disability progression or reduce disease activity in people with progressive MS who are already treated with ocrelizumab.

How similar studies have performed: RO7268489 is a novel compound and add-on therapies to anti-CD20 treatment like ocrelizumab remain experimental with limited prior success in progressive MS.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* PMS, in accordance with the revised 2017 McDonald criteria
* Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive

Exclusion Criteria:

* 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

Where this trial is running

Kogarah, New South Wales and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Progressive Multiple Sclerosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.