What the trial was testing
The trial enrolled 130 patients with multiple sclerosis. The study was sponsored by Sanofi and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was mid-stage testing (phase 2/3). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
The 60 mg dose reduced new brain lesions by 87% in people with relapsing MS.
The Lancet. Neurology · 2021 · NCT03889639
These findings — that the highest dose dramatically reduced MS-related inflammation visible on brain scans — were published in the The Lancet. Neurology and represent the headline result of the study.
Researchers tracked outcomes across 130 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with multiple sclerosis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was a mid-stage study and tolebrutinib is not yet FDA-approved for multiple sclerosis. The results were promising enough that larger studies are now underway. If you have relapsing MS, ask your doctor about clinical trials testing tolebrutinib or other BTK inhibitors, or discuss currently approved disease-modifying therapies.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open multiple sclerosis trials
Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System
The aim of this work is to elaborate a statistical model to predict the effectiveness of robotic treatment in subjects with neurological diseases. The model will be used to understand which subjects are most responsive to this type of treatment
Genes and Environment in Multiple Sclerosis
The purpose of the research study is to identify the genetic, environmental and immune profiles that may increase a person's risk of developing multiple sclerosis (MS). While MS is not a disease caused by a single variation in genetic material (DNA), a single environmental factor, or a single malfunction in immune cells, there are genetic alterations, environmental exposures and immunologic factors that make the development of MS more likely. Obtaining information about who is at risk for MS will be beneficial in the future if the investigators can identify effective ways to prevent or slow down the progression of this disease.