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Looking for participantsPhase2

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)

Sponsor: Hoffmann-La Roche

NCT ID: NCT07282574

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
RO7268489 (drug), Ocrelizumab (drug), Placebo (drug)
How long the study runs
Study runs about 50 months (dates as stated)
About the drug or intervention
RO7268489 — drug: RO7268489 will be administered per schedule as specified in the arms. · Ocrelizumab — drug: Ocrelizumab will be administered per schedule as specified in the arms. · Placebo — drug: Placebo will be administered per schedule as specified in the arms.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 60 Years
Who
All
Number of participants
360
Started
2026-03-10
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for progressive multiple sclerosis
  • • Phase2 - 360 participants
  • • The main purpose of this study is to assess the efficacy of RO7268489 in adults with progressive multiple sclerosis (PMS) receiving ocrelizumab

Who can take part?

  • • Ages 18 Years to 60 Years
  • • Diagnosed with progressive multiple sclerosis

Where?

  • • Truro - Royal Cornwall Hospital
  • • London - Charing Cross Hospital
  • • Glasgow - Queen Elizabeth University Hospital
  • • Cardiff - University Hospital of Wales
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Progressive Multiple Sclerosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 60 Years
  • Who can join: All genders

What the study is looking for

  • ✓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...

Who cannot take part

  • ✗MS relapse during the 6 months preceding the randomization date
  • ✗Lack of peripheral venous access
  • ✗History of alcohol or other drug abuse (substance use disorder) based on Diagnostic and Statistical Manual for...
  • ✗Inability to complete a magnetic resonance imaging (MRI)
  • ✗Contraindications to ocrelizumab mandatory pre-medications
See the full 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 * Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit Exclusion Criteria: * MS relapse during the 6 months preceding the randomization date * Lack of peripheral venous access * 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 * Inability to complete a 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 Is This Study? (7 UK sites)

Royal Cornwall Hospital

Truro TR1 3HD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Abi Weeks

rch-tr.CornwallResearch@nhs.net01872 25 6424

Charing Cross Hospital

London W6 8RF, United Kingdom

Recruiting

Queen Elizabeth University Hospital

Glasgow G51 4TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

University Hospital of Wales

Cardiff CF14 4XW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elen de Lacy

PHW.Research@wales.nhs.uk02920 104468

Royal London Hospital

London E1 2AT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Salford Care Organisation

Salford M6 8HD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Katie Doyle

RDResearch@nca.nhs.uk---

Morriston Hospital

Swansea SA6 6NL, United Kingdom

Recruiting

How to Get in Touch

Reference Study ID Number: BP46016 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10