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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)

RecruitingPhase 2Ages 18 Years - 60 YearsAllHoffmann-La Roche
NCT07282574 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • RO7268489
  • Ocrelizumab
  • Placebo
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Where

114 sites
Brain and Mind Centre
Camperdown, Australia
Southern Neurology
Kogarah, Australia
John Hunter Hospital
New Lambton Heights, Australia
Box Hill Hospital
Box Hill, Australia
Austin Health
Heidelberg, Australia
Centro de Pesquisas Clinicas - CPCLIN
São Paulo, Brazil
CHU Strasbourg Hpital Hautepierre
Strasbourg, France
Hopital Caremeau
Nîmes, France

…and 106 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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