A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis

In brief

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]). SUBSTUDY: ToleDYNAMIC substudy

Key facts

Study ID

NCT06372145

Run by

Sanofi

People needed

2500

Starts

2024-04-16

Expected to finish

2029-04-30

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• ~North Central Neurology Associates, PC- Site Number : 8400009 — Cullman, Alabama, United States
• Center for Neurology and Spine- Site Number : 8400089 — Phoenix, Arizona, United States
• Collaborative Neuroscience Research- Site Number : 8400045 — Los Alamitos, California, United States
• USC- Site Number : 8400143 — Los Angeles, California, United States
• University of California San Diego Medical Center- Site Number : 8400101 — San Diego, California, United States
• Regina Berkovich, MD, PhD- Site Number : 8400059 — West Hollywood, California, United States
• University of Colorado- Site Number : 8400012 — Denver, Colorado, United States
• Advanced Neurosciences Research- Site Number : 8400025 — Fort Collins, Colorado, United States
• Georgetown University Medical Center- Site Number : 8400119 — Washington D.C., District of Columbia, United States
• SFM Clinical Research, LLC- Site Number : 8400029 — Boca Raton, Florida, United States
• University of Florida Health- Site Number : 8400159 — Gainesville, Florida, United States
• Neurology Associates- Site Number : 8409902 — Maitland, Florida, United States
• University of Miami- Site Number : 8400063 — Miami, Florida, United States
• Aqualane Clinical Research- Site Number : 8400027 — Naples, Florida, United States
• Axiom Clinical Research of Florida- Site Number : 8400001 — Tampa, Florida, United States
• University of South Florida- Site Number : 8409905 — Tampa, Florida, United States
• Velocity Clinical Research- Site Number : 8409903 — Savannah, Georgia, United States
• Consultants In Neurology- Site Number : 8409906 — Northbrook, Illinois, United States
• Springfield Clinic, LLP- Site Number : 8400071 — Springfield, Illinois, United States
• Indiana University Health, Inc- Site Number : 8400039 — Fort Wayne, Indiana, United States
• University of Kansas Medical Center- Site Number : 8400023 — Kansas City, Kansas, United States
• University of Kentucky- Site Number : 8400106 — Lexington, Kentucky, United States
• Norton Neurology MS Services- Site Number : 8400127 — Louisville, Kentucky, United States
• The NeuroMedical Center- Site Number : 8400057 — Baton Rouge, Louisiana, United States
• The University of Alabama at Birmingham- Site Number : 8400013 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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