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Taking people in United KingdomPhase 2

Tests RO7268489 added to ocrelizumab in progressive multiple sclerosis

Tests an add-on drug with ocrelizumab in adults with progressive multiple sclerosis.

Key facts

Who runs it
Hoffmann-La Roche
Where
Cardiff, Glasgow, London, Salford, Swansea, and Truro, United KingdomSee the 7 sitesAlso in 11 other countries, 110 sites
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)
Status
Recruiting
Phase
Phase 2
People taking part
360 people, planned
Started
10 Mar 2026
Expected to end
30 May 2030
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • RO7268489
  • Ocrelizumab
  • Placebo
Record updated
7 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with progressive multiple sclerosis who are receiving ocrelizumab. It tests RO7268489 as an add-on treatment.

Age
18 to 60 years
Sex
All sexes can join.
Disease stage
Progressive multiple sclerosis (PMS) by the revised 2017 McDonald criteria, with an EDSS score between 3.0 and 6.0 at screening. Disability must have worsened, independent of relapses, over the 2 years before screening.
Earlier treatment
People receiving ocrelizumab. Cannot have had intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks before screening.

Main reasons for not taking part

  • MS relapse in the 6 months before randomization
  • No peripheral venous access
  • Alcohol or drug abuse (substance use disorder) within the 5 years before screening
  • Cannot complete an MRI scan
  • Cannot take the required pre-medications for ocrelizumab

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Check if you might fit

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)?

Where in United Kingdom

Also in 11 other countries, 110 sites

  • University Hospital of WalesCardiff, United KingdomTaking people
  • Queen Elizabeth University HospitalGlasgow, United KingdomTaking people
  • Charing Cross HospitalLondon, United KingdomTaking people
  • Royal London HospitalLondon, United KingdomTaking people
  • Salford Care OrganisationSalford, United KingdomTaking people
  • Morriston HospitalSwansea, United KingdomTaking people
  • Royal Cornwall HospitalTruro, United KingdomTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • RO7268489 Dose 1 + OcrelizumabTreatment being tested

    Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.

    Treatment: RO7268489 and Ocrelizumab

  • RO7268489 Dose 2 + OcrelizumabTreatment being tested

    Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.

    Treatment: RO7268489 and Ocrelizumab

  • RO7268489 Dose 3 + OcrelizumabTreatment being tested

    Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.

    Treatment: RO7268489 and Ocrelizumab

  • Placebo + OcrelizumabPlacebo, for comparison

    Participants will receive RO7268489 matching placebo along with ocrelizumab as per the pre-defined regimen.

    Treatment: Ocrelizumab and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests RO7268489 added to ocrelizumab in progressive multiple sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07282574, who can take part
Record updated
7 October 2026