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Investigating long-term safety of tolebrutinib for multiple sclerosis

An Interventional, Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, or Nonrelapsing Secondary Progressive Multiple Sclerosis

Phase 3 Interventional Sanofi · NCT06372145

This study is testing the long-term safety of tolebrutinib in adults with multiple sclerosis who have already taken part in earlier trials.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2500 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionstolebrutinib
Locations315 sites (Birmingham, Alabama and 314 other locations)
Trial IDNCT06372145 on ClinicalTrials.gov

What this trial studies

This Phase 3 extension study aims to evaluate the long-term safety and tolerability of tolebrutinib in adults with relapsing or progressive forms of multiple sclerosis who have previously participated in earlier pivotal trials. Participants will receive open-label tolebrutinib for approximately three years, with specific protocols for those who were on other treatments in prior studies. The study will also assess the impact of prior treatments on the safety profile of tolebrutinib.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with relapsing or progressive multiple sclerosis who have completed prior tolebrutinib trials.

Not a fit: Patients with active systemic infections or those at risk for hepatitis reactivation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety of tolebrutinib, potentially leading to improved treatment options for multiple sclerosis patients.

How similar studies have performed: Previous studies of tolebrutinib have shown promising results, indicating that this approach is built on a foundation of prior success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

- Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 pivotal tolebrutinib trials (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.

OR

- The Phase 2b LTS (LTS16004) or Phase 3 tolebrutinib pivotal trial participants who temporarily discontinued IMP due to a national emergency and completed the trial visits.

ToleDYNAMIC Substudy: Inclusion criteria are those of the main study

Exclusion Criteria:

* Participants are excluded from the study if any of the following criteria apply:
* The participant is at risk for or has a persistent chronic, active (including fever higher than 38°C and clinically unstable), or recurring systemic infection, as judged by the Investigator
* For participants initiating OL tolebrutinib in the LTS17043 study: Participants at risk of developing or having reactivation of hepatitis, ie, results at the unblinding visit (RMS) or opt-in visit (PMS) for serological markers for hepatitis B and C viruses indicating acute or chronic infection
* Active alcohol use disorder or a history of alcohol or drug abuse within 1 year prior to the opt-in visit
* Current alcohol intake equal to or exceeding the following at the opt-in visit: more than 2 drinks per day for men and more than 1 drink per day for women
* Abnormal ECG during the opt-in visit considered in the Investigator's judgment to be clinically significant, such as QTcF \>500 msec, in the context of this study.
* A bleeding disorder, known platelet dysfunction, abnormal platelet count (\<100,000/microliter), history of significant bleeding event or other conditions and planned procedures that may predispose the participant to excessive bleeding during the study, as judged by the Investigator.
* For participants initiating OL tolebrutinib in the LTS17043 study: Confirmed unblinding visit (RMS) or opt-in visit (PMS) alanine aminotransferase (ALT) more than 1.5 × upper limit of normal (ULN) OR aspartate aminotransferase (AST) more than 1.5 × ULN OR alkaline phosphatase more than 2 × ULN (unless caused by non-liver-related disorder or explained by a stable chronic liver disorder) OR total bilirubin more than 1.5 × ULN (unless due to Gilbert syndrome or non-liver-related disorder).
* Acute liver disease, cirrhosis, chronic liver disease (unless considered stable for more than 6 months).
* Participants who developed clinically relevant cardiovascular, hepatic, endocrine, neuropsychiatric or other major systemic disease making implementation of the protocol or interpretation of the trial results difficult or that would put the patient at risk by participating in the trial, as judged by the Investigator.
* The participant is receiving treatment during the study period with drugs not permitted by the study protocol, including potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes.

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

ToleDYNAMIC Substudy: Exclusion criteria are those of the main study

Where this trial is running

Birmingham, Alabama and 314 other locations

+265 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsing Multiple SclerosisSecondary Progressive Multiple SclerosisProgressive Relapsing Multiple Sclerosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.