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Clinical Trials in Denmark / NCT06372145
Active, not recruiting Phase 3

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

NCT06372145 · tracked via the Priya Life Science Denmark tracker
Sponsor
Phase
Phase 3
Started
2024-04-16
Last updated
2026-08-17

Condition(s) studied

Relapsing Multiple SclerosisSecondary Progressive Multiple SclerosisProgressive Relapsing Multiple Sclerosis

Investigational drug(s) / intervention(s)

TolebrutinibPlaceboTeriflunomide →

Tolebrutinib: Pharmaceutical form:Tablet-Route of administration:oral

Placebo: Pharmaceutical form:Tablet-Route of administration:oral

Teriflunomide: Pharmaceutical form:Tablet-Route of administration:oral

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (352)

FacilityCityRegionStatus
The University of Alabama at Birmingham- Site Number : 8400013 Birmingham Alabama
~North Central Neurology Associates, PC- Site Number : 8400009 Cullman Alabama
Center for Neurology and Spine- Site Number : 8400089 Phoenix Arizona
Collaborative Neuroscience Research- Site Number : 8400045 Los Alamitos California
USC- Site Number : 8400143 Los Angeles California
University of California San Diego Medical Center- Site Number : 8400101 San Diego California
Regina Berkovich, MD, PhD- Site Number : 8400059 West Hollywood California
University of Colorado- Site Number : 8400012 Denver Colorado
Advanced Neurosciences Research- Site Number : 8400025 Fort Collins Colorado
Georgetown University Medical Center- Site Number : 8400119 Washington D.C. District of Columbia
SFM Clinical Research, LLC- Site Number : 8400029 Boca Raton Florida
University of Florida Health- Site Number : 8400159 Gainesville Florida
Neurology Associates- Site Number : 8409902 Maitland Florida
University of Miami- Site Number : 8400063 Miami Florida
Aqualane Clinical Research- Site Number : 8400027 Naples Florida
Axiom Clinical Research of Florida- Site Number : 8400001 Tampa Florida
University of South Florida- Site Number : 8409905 Tampa Florida
Velocity Clinical Research- Site Number : 8409903 Savannah Georgia
Consultants In Neurology- Site Number : 8409906 Northbrook Illinois
Springfield Clinic, LLP- Site Number : 8400071 Springfield Illinois
Indiana University Health, Inc- Site Number : 8400039 Fort Wayne Indiana
University of Kansas Medical Center- Site Number : 8400023 Kansas City Kansas
University of Kentucky- Site Number : 8400106 Lexington Kentucky
Norton Neurology MS Services- Site Number : 8400127 Louisville Kentucky
The NeuroMedical Center- Site Number : 8400057 Baton Rouge Louisiana
Ochsner Clinic Foundation- Site Number : 8400107 New Orleans Louisiana
Tufts Medical Center- Site Number : 8400072 Boston Massachusetts
University of Massachusetts- Site Number : 8400014 Worcester Massachusetts
Wayne State University- Site Number : 8400046 Detroit Michigan
Michigan Institute Neuro Disorders- Site Number : 8400058 Farmington Hills Michigan
Memorial Healthcare Institute for Neuroscience- Site Number : 8400033 Owosso Michigan
Minneapolis Clinic of Neurology- Site Number : 8400051 Golden Valley Minnesota
Mayo Clinic- Site Number : 8400111 Rochester Minnesota
Sharlin Health & Neurology- Site Number : 8400093 Ozark Missouri
Missouri Baptist Medical Center- Site Number : 8400019 St Louis Missouri
Lou Ruvo Center for Brain Health- Site Number : 8400117 Las Vegas Nevada
University of New Mexico- Site Number : 8400032 Albuquerque New Mexico
Mount Sinai Medical Center- Site Number : 8400038 New York New York
NYU Langone South Shore Neurologic Associates- Site Number : 8400100 Patchogue New York
Neurology Associates of Stony Brook- Site Number : 8400042 Stony Brook New York

+ 312 more sites — see the full list on the official registry below.

More Sanofi trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06372145 on ClinicalTrials.gov ↗ ← All trials in Denmark