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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)

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)

Recruiting
18-60 years
All
Phase 2
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Overview

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.

Eligibility

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

Study details
    Progressive Multiple Sclerosis

NCT07282574

Hoffmann-La Roche

15 May 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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