Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04411641) looked at a medicine called tolebrutinib (60 mg) compared to a placebo (an inactive dummy treatment) in people with multiple sclerosis (MS). In the main, double-blind phase of the trial — where neither participants nor their doctors knew who was getting which treatment — 377 people received the placebo and 754 received tolebrutinib. A smaller, open-label follow-on phase (where everyone knew they were receiving tolebrutinib) involved a further 196 participants. The trial's main focus was on measuring how long it took before a participant's disability, as measured by a standard MS disability scale called the EDSS (which runs from 0, meaning no disability, to 10), worsened in a meaningful and lasting way over at least six months. The reported data shows that, for the main outcome — time until a confirmed, lasting worsening of disability over six months — the placebo group reached that point at a median (middle value across the group) of approximately 11.97 months, while the tolebrutinib group reached it at approximately 12.04 months. For a similar measure tracked over three months instead of six, the figures were approximately 11.96 months (placebo) and 12.04 months (tolebrutinib). The reported data also shows that, on average, participants taking tolebrutinib had approximately 1.84 new or enlarging brain lesions per year on MRI scans, compared with approximately 2.95 in the placebo group. For the walking test and hand-dexterity test outcomes, as well as for the measure of disability improvement, the reported numbers between the two groups were broadly similar and close together. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 40202696) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Multiple Sclerosis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 18 and 60 years old (inclusive)
- You have been diagnosed with non-relapsing secondary progressive multiple sclerosis (a type of MS that gets gradually worse without sudden flare-ups) according to specific 2017 diagnostic guidelines
- Your disability level, as measured by a standard MS scale (EDSS), scores between 3.0 and 6.5 at the start of the study
- There is recorded evidence that your disability has gotten worse over the 12 months before joining the study
- You have had no MS relapses (sudden worsening of symptoms) for at least 24 months
- You agree to use an appropriate method of contraception as required by local guidelines during the study
- If you are a woman who could become pregnant, you are not currently pregnant or breastfeeding, and you agree to use an acceptable form of contraception during the study
Who may not be able to join:
- You have a serious health condition, such as a very short life expectancy, that could interfere with taking part in the study
- You have evidence of certain infections, including HIV, active hepatitis B or C, tuberculosis, or a condition called PML, or you have had an organ transplant
- You have a persistent, recurring, or active serious infection that could affect your participation, as decided by the study doctor
- You have had any cancer in the 5 years before joining the study
- You have had problems with alcohol or drug misuse in the past year
- You were admitted to hospital for a mental health condition in the past 2 years
- You have significant abnormal results on blood tests (including signs of liver problems) or on a heart tracing (ECG) at the start of the study
- You have a bleeding disorder or known problem with how your platelets (blood clotting cells) work
- Your platelet count (a blood clotting measure) is below 150,000/μL at the start of the study
- You have had a significant bleeding event, such as bleeding in the brain or gut, in the 6 months before joining the study
- Your white blood cell (lymphocyte) count is below the normal range at the start of the study
- You have received a live vaccine within 2 months before your first treatment visit
- You have had major surgery in the 4 weeks before joining the study, or you are planning to have major surgery during the study
- You have received certain MS medications or treatments within a specific recent time period (confirm with trial site)
- You are currently taking certain medicines that affect specific liver enzymes called CYP3A or CYP2C8 (confirm with trial site)
- You are currently taking blood thinners or anti-clotting medicines, such as high-dose aspirin (more than 81mg/day), clopidogrel, or warfarin
- You are unable to have an MRI scan for any reason
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Sciences & Operations, Sanofi
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to Onset of 6-Month Confirmed Disability Progression (CDP) as Assessed by Expanded Disability Status Scale (EDSS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.