RecruitingPHASE2INTERVENTIONAL

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)

This important study is testing a new medicine, RO7268489, alongside an existing treatment called ocrelizumab, for adults battling progressive forms of multiple sclerosis (MS). The main goal is to find out if adding RO7268489 can make a difference in managing the condition and to check its safety. Participants will be divided into groups, some receiving RO7268489, some ocrelizumab only, and some a dummy medicine (placebo), so that researchers can carefully compare the effects. Once the main comparison part of the study finishes, eligible participants might have the option to continue receiving RO7268489 openly, meaning they will know which treatment they are getting. This research aims to explore new ways to help people living with progressive MS.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

360

Start

10 Mar 2026

Estimated completion

30 May 2030

Progressive Multiple Sclerosis

What is this study about?

This study is investigating a new medicine called RO7268489 for people with a type of multiple sclerosis (MS) that gets steadily worse over time, known as progressive MS. This is a crucial area of research, as finding effective treatments for progressive MS is a priority. The study wants to see if adding RO7268489 to an existing MS medicine, ocrelizumab, can improve how people manage their condition. It's like trying out a new tool to see if it can make a bigger difference when used with a tool we already have.

Researchers will also be closely watching to make sure RO7268489 is safe and to understand how it works in the body. They will compare RO7268489 with a dummy medicine (called a placebo) and with ocrelizumab on its own. This scientific way of testing helps to show whether any changes seen are truly due to the new medicine or if they might have happened anyway.

If the initial results are promising, eligible participants might have the opportunity to continue receiving RO7268489 after the main part of the study ends. This ongoing access can be important for people who find the medicine helpful. Studies like this are vital steps in developing new and better treatments for MS, offering hope for people living with this condition.

Key takeaways

This study is testing a new medicine (RO7268489) for progressive MS.
It's an 'add-on' treatment, meaning it's given with existing ocrelizumab.
The main goals are to check effectiveness and safety.
Participants will have regular medical checks and MRI scans.
There's a chance to get the new medicine openly after the main study.

Who may be eligible?

To be able to join this study, you generally need to be an adult between 18 and 60 years old and have a diagnosis of progressive multiple sclerosis. Your MS should also be at a certain level of severity, meaning it affects your daily life but still allows for a range of activities. This will be checked using a standard scale for disability.

There are also some reasons why you might not be able to join. For example, if you've had an MS flare-up recently (in the last six months), or if you've had certain other treatments like specific blood transfusions or special immune system treatments in the past few months. You also need to be able to have an MRI scan, as these are important for monitoring MS, and not have any history of drug or alcohol misuse in the last five years.

The research team will carry out a thorough check to make sure the study is right and safe for you. They will review your medical history and conduct several tests. If you are interested, it's best to discuss this with your doctor and the study team, as they can explain all the specific requirements in detail.

Quick self-check

Are you between 18 and 60 years old?
Do you have a diagnosis of progressive multiple sclerosis?
Have you been free from an MS flare-up in the last 6 months?
Can you have an MRI scan?
Have you avoided certain other MS treatments or blood therapies in recent months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it will involve regular visits to the clinic over a period of time. These visits will include various assessments, such as physical exams, blood tests, and MRI scans, to monitor your health and how the treatment is working. You will receive either the new medicine (RO7268489), ocrelizumab, or a placebo (a dummy medicine) as an add-on treatment, and you won't know which one you are getting during the main part of the study. All study medicines will be provided. The initial double-blind period, where neither you nor your doctor knows which treatment you are receiving, will be followed by a possible open-label period where eligible participants will know that they are receiving RO7268489. The total duration of your participation could extend over several years, including the follow-up periods, but the study team will provide a detailed schedule of visits and what to expect at each stage.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment that might help your progressive MS before it's widely available. You'll also receive close medical attention and monitoring throughout the study. However, like all medicines, RO7268489 may have side effects, which the study team will discuss with you. There's also no guarantee that the treatment will be effective for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (73)

Southern Neurology
Kogarah, Australia· Recruiting
Austin Health
Heidelberg, Australia· Recruiting
Hopital Caremeau
Nîmes, France· Recruiting
Groupe Hospitalier Pellegrin
Bordeaux, France· Recruiting
Hopital Purpan
Toulouse, France· Recruiting
Hopital Gui de Chauliac
Montpellier, France· Recruiting
CHU Nantes - Hopital Nord Laënnec
Saint-Herblain, France· Recruiting
CHU Nancy Hôpital Central
Nancy, France· Recruiting
CHU Hopital Gabriel Montpied
Clermont-Ferrand, France· Recruiting
Hopital Neurologique Pierre Wertheimer
Bron, France· Recruiting
Groupe Hospitalier Pitie-Salpetriere
Paris, France· Recruiting
CHU Rennes - Hopital Pontchaillou
Rennes, France· Recruiting

+61 more sites — see the official record for the full list.

Common questions

What is progressive MS?

Progressive MS is a form of multiple sclerosis where symptoms gradually worsen over time, rather than coming in periods of flare-ups and recovery.

What is ocrelizumab?

Ocrelizumab is a medicine currently used for some types of MS. In this study, RO7268489 is being tested as an additional treatment for those already taking ocrelizumab.

What does 'add-on therapy' mean?

It means the new medicine, RO7268489, would be given in addition to ocrelizumab, which you would already be taking for your MS.

What is a placebo?

A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the effects of the new medicine accurately.

Will I know if I'm getting the new medicine?

During the main part of the study, neither you nor your doctor will know if you are getting RO7268489, ocrelizumab, or the placebo. However, in a later part, if you're eligible, you might receive RO7268489 openly, meaning you'll know you're getting it.

How to find out more

Reference Study ID Number: BP46016 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. Only) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.