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.
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
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)
Parallel
RO7268489
DrugRO7268489 will be administered per schedule as specified in the arms.
Ocrelizumab
DrugOcrelizumab will be administered per schedule as specified in the arms.
Placebo
DrugPlacebo will be administered per schedule as specified in the arms.
Time From Randomization to the First Occurrence of Composite Confirmed Disability Progression (cCPD) Confirmed for at Least 12 Weeks (cCDP12)
Time from randomization to the first occurrence of cCDP12 according to at least one of the following 3 criteria: 1. 12-week confirmed disability progression (CDP12) 2. 12-week confirmed increase in Timed 25-Foot Walk Test (T25FWT) or 3. 12-week confirmed increase in 9-Hole Peg Test (9-HPT) The EDSS is a disability scale is based on a standard neurological examination that ranges in 0.5-point steps from 0 (normal) - 10 (death). T25FWT=time taken to walk 25 feet, typically measured in seconds. The longer it takes to walk, the higher score, which indicates deterioration. Lower times indicate better performance and greater mobility. In 9-HPT, participants are instructed to place pegs one by one into each of nine holes arranged in a board stabilized with a plastic nonslip sheet on a solid table, and then to remove these pegs from the holes. The shorter time it takes to complete the task indicates a better outcome.
Time From Randomization to the First Occurrence of 24-Week Confirmed ≥4-Point Decrease (Worsening) in Symbol Digit Modalities Test (SDMT)
The SDMT is a performance measure of processing speed that is widely used to assess cognitive function in response to treatment. It's brief, easy to administer, and involves a simple substitution task that healthy children and adults can easily perform. Using a reference key, the participant has 90 seconds to pair specific numbers with given geometric figures. The total SDMT score is the total number of correct responses and ranges from 0 to 110, with a higher score indicating a higher level of processing speed. A four-point change from baseline is typically considered clinically meaningful.
Time to Onset of 24-Week cCDP (cCDP24)
Time to Onset of 12-Week Confirmed Disability Progression CDP (CDP12)
Time to Onset of 24-Week CDP (CDP24)
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