Table of contents
- Trial overview
- Who can participate
- Study design and treatment groups
- What the study measures
- Trial status and size
- What this means for patients
Trial overview
This clinical trial is studying RO7268489 in adults with progressive forms of multiple sclerosis (PMS), which means multiple sclerosis that has continued to worsen over time.[1] The study is designed to see whether RO7268489, given as an add-on to ocrelizumab, can help slow disability progression.[1]
Who can participate
The trial is for adults with progressive forms of multiple sclerosis.[1] The source data do not list the full inclusion and exclusion rules, so the exact participation criteria are not fully shown here.[1]
Study design and treatment groups
This is an interventional study, which means researchers assign the study treatment rather than just observing people.[1] It is a Phase 2 trial, so it is looking more closely at whether the treatment may work and continuing to evaluate safety.[1]
The study compares different doses of RO7268489 with a placebo, which is a look-alike treatment with no active study drug.[1] RO7268489 is being tested as add-on therapy to ocrelizumab, meaning it is given together with an existing treatment.[1]
What the study measures
The main outcome is the time from randomization to the first sign of composite confirmed disability progression confirmed for at least 12 weeks, also called cCDP12.[1] This is a combined measure that checks whether disability has clearly gotten worse and stayed worse over time.[1]
The study uses three possible ways to define this worsening: confirmed disability progression for 12 weeks (CDP12), a 12-week confirmed increase in the Timed 25-Foot Walk Test (T25FWT), or a 12-week confirmed increase in the 9-Hole Peg Test (9-HPT).[1] The walking test looks at walking speed, and the peg test looks at hand and finger function.[1]
Trial status and size
The study status is Authorised, and the planned enrollment is 375 participants.[1] This gives the study enough people to compare RO7268489 doses with placebo in the target population.[1]
What this means for patients
For people living with progressive multiple sclerosis, this trial is trying to find out whether RO7268489 can help slow down worsening disability when used with ocrelizumab.[1] The study focuses on real-life function, such as walking and hand use, because these changes matter in daily life.[1]
Because this is a Phase 2 study, the results may help researchers decide whether larger studies should be done later.[1]
