Adding RO7268489 to ocrelizumab for progressive multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Brain and Mind Centre
  Camperdown, New South Wales, Australia Recruiting
• Southern Neurology
  Kogarah, New South Wales, Australia Recruiting
• John Hunter Hospital
  New Lambton Heights, New South Wales, Australia Recruiting
• Box Hill Hospital
  Box Hill, Victoria, Australia Recruiting
• Austin Health
  Heidelberg, Victoria, Australia Recruiting
• Centro de Pesquisas Clinicas - CPCLIN
  São Paulo, São Paulo, Brazil Recruiting

+64 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: BP46016 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.