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ACTIVE NOT RECRUITING

NCT06372145

PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2024-04-16

Completion Date

2029-04-30

Last Updated

2026-08-17

Healthy Volunteers

Conditions

Relapsing Multiple Sclerosis Secondary Progressive Multiple Sclerosis Progressive Relapsing Multiple Sclerosis

Interventions

DRUG

Tolebrutinib

Pharmaceutical form:Tablet-Route of administration:oral

DRUG

Placebo

Pharmaceutical form:Tablet-Route of administration:oral

DRUG

Teriflunomide

Pharmaceutical form:Tablet-Route of administration:oral

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

Locations (352)

The University of Alabama at Birmingham- Site Number : 8400013

Birmingham, Alabama, United States

~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

Ochsner Clinic Foundation- Site Number : 8400107

New Orleans, Louisiana, United States

Tufts Medical Center- Site Number : 8400072

Boston, Massachusetts, United States

University of Massachusetts- Site Number : 8400014

Worcester, Massachusetts, United States

Wayne State University- Site Number : 8400046

Detroit, Michigan, United States

Michigan Institute Neuro Disorders- Site Number : 8400058

Farmington Hills, Michigan, United States

Memorial Healthcare Institute for Neuroscience- Site Number : 8400033

Owosso, Michigan, United States

Minneapolis Clinic of Neurology- Site Number : 8400051

Golden Valley, Minnesota, United States

Mayo Clinic- Site Number : 8400111

Rochester, Minnesota, United States

Sharlin Health & Neurology- Site Number : 8400093

Ozark, Missouri, United States

Missouri Baptist Medical Center- Site Number : 8400019

St Louis, Missouri, United States

Lou Ruvo Center for Brain Health- Site Number : 8400117

Las Vegas, Nevada, United States

University of New Mexico- Site Number : 8400032

Albuquerque, New Mexico, United States

Mount Sinai Medical Center- Site Number : 8400038

New York, New York, United States

NYU Langone South Shore Neurologic Associates- Site Number : 8400100

Patchogue, New York, United States

Neurology Associates of Stony Brook- Site Number : 8400042

Stony Brook, New York, United States

Wake Forest University Baptist Medical Center- Site Number : 8400116

Winston-Salem, North Carolina, United States

Dayton Center for Neurological Disorders- Site Number : 8400081

Centerville, Ohio, United States

Cleveland Clinic Foundation-Mellen Center for MS- Site Number : 8400125

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center- Site Number : 8400150

Columbus, Ohio, United States

The Boster Center for Multiple Sclerosis- Site Number : 8400147

Columbus, Ohio, United States

UC Health, LLC- Site Number : 8409901

Dayton, Ohio, United States

Providence Multiple Sclerosis Center- Site Number : 8400020

Portland, Oregon, United States

Premier Neurology- Site Number : 8400069

Greenville, South Carolina, United States

HOPE Neurology- Site Number : 8409904

Knoxville, Tennessee, United States

Lone Star Neurology of San Antonio- Site Number : 8400036

San Antonio, Texas, United States

University of Vermont - Larner College of Medicine- Site Number : 8400130

Burlington, Vermont, United States

Neurological Associates- Site Number : 8400097

Richmond, Virginia, United States

Investigational Site Number : 0320002

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320004

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320007

CABA, Buenos Aires F.D., Argentina

Investigational Site Number : 0320001

CABA, Buenos Aires F.D., Argentina

Investigational Site Number : 0329901

CABA, Buenos Aires F.D., Argentina

Investigational Site Number : 0320003

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320006

Córdoba, Argentina

Investigational Site Number : 0320005

San Miguel de Tucumán, Argentina

Investigational Site Number : 0360001

St Leonards, New South Wales, Australia

Investigational Site Number : 0360006

Kent Town, South Australia, Australia

Investigational Site Number : 0360007

Melbourne, Victoria, Australia

Investigational Site Number : 0400003

Innsbruck, Austria

Investigational Site Number : 0400004

Linz, Austria

Investigational Site Number : 0400002

Vienna, Austria

Investigational Site Number : 0560005

Bruges, Belgium

Investigational Site Number : 0560009

Brussels, Belgium

Investigational Site Number : 0560004

Ghent, Belgium

Investigational Site Number : 0560006

Leuven, Belgium

Investigational Site Number : 0560008

Liège, Belgium

Investigational Site Number : 0560001

Overpelt, Belgium

Investigational Site Number : 0560007

Woluwe-Saint-Lambert, Belgium

HC UFG - Hospital Das Clinicas de Goias- Site Number : 0760003

Goiânia, Goiás, Brazil

Instituto de Neurologia de Curitiba- Site Number : 0760002

Curitiba, Paraná, Brazil

Hospital Sao Lucas da PUCRS- Site Number : 0760001

Porto Alegre, Rio Grande do Sul, Brazil

CPQuali Pesquisa Clinica- Site Number : 0760007

São Paulo, São Paulo, Brazil

Investigational Site Number : 1000002

Pleven, Bulgaria

Investigational Site Number : 1000005

Plovdiv, Bulgaria

Investigational Site Number : 1000004

Sofia, Bulgaria

Investigational Site Number : 1000008

Sofia, Bulgaria

Investigational Site Number : 1000001

Sofia, Bulgaria

Investigational Site Number : 1000006

Sofia, Bulgaria

Investigational Site Number : 1000011

Sofia, Bulgaria

Investigational Site Number : 1000009

Sofia, Bulgaria

Investigational Site Number : 1240002

Edmonton, Alberta, Canada

Investigational Site Number : 1240017

Burnaby, British Columbia, Canada

Investigational Site Number : 1249901

Vancouver, British Columbia, Canada

Investigational Site Number : 1240011

Halifax, Nova Scotia, Canada

Investigational Site Number : 1240012

Hamilton, Ontario, Canada

Investigational Site Number : 1240003

Ottawa, Ontario, Canada

Investigational Site Number : 1240008

Toronto, Ontario, Canada

Investigational Site Number : 1240013

Toronto, Ontario, Canada

Investigational Site Number : 1240006

Gatineau, Quebec, Canada

Investigational Site Number : 1240021

Lévis, Quebec, Canada

Investigational Site Number : 1240004

Montreal, Quebec, Canada

Investigational Site Number : 1240015

Montreal, Quebec, Canada

Investigational Site Number : 1240007

Sherbrooke, Quebec, Canada

Investigational Site Number : 1240001

Québec, Canada

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

And 252 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (352)