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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 2Sponsored by Hoffmann-La Roche
Actively Recruiting
PhasePhase 2
SponsorHoffmann-La Roche
Started2026-03-10
Est. completion2028-05-30
Eligibility
Age18 Years – 60 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07282574
Summary
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
Age: 18 Years – 60 YearsHealthy volunteers accepted
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
Conditions2
Multiple SclerosisProgressive Multiple Sclerosis
Interventions2
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Actively Recruiting
PhasePhase 2
SponsorHoffmann-La Roche
Started2026-03-10
Est. completion2028-05-30
Eligibility
Age18 Years – 60 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07282574