RECRUITING

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

Description

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

Conditions

Relapsing Multiple SclerosisSecondary Progressive Multiple SclerosisProgressive Relapsing Multiple Sclerosis
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Related Conditions:

Relapsing Multiple SclerosisSecondary Progressive Multiple SclerosisProgressive Relapsing Multiple Sclerosis

Study Overview

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Study Details

Study overview

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

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

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

Condition
Relapsing Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham- Site Number : 8400013, Birmingham, Alabama, United States, 35233

Cullman

North Central Neurology Associates- Site Number : 8400009, Cullman, Alabama, United States, 35058

Phoenix

Center for Neurology and Spine- Site Number : 8400089, Phoenix, Arizona, United States, 85018

La Jolla

University of California San Diego - La Jolla- Site Number : 8400101, La Jolla, California, United States, 92037

Los Alamitos

Collaborative Neuroscience Research- Site Number : 8400045, Los Alamitos, California, United States, 90720

Los Angeles

Keck School of Medicine of University of Southern California- Site Number : 8400143, Los Angeles, California, United States, 90033

West Hollywood

Private Practice - Dr. Regina Berkovich- Site Number : 8400059, West Hollywood, California, United States, 90048

Denver

University of Colorado- Site Number : 8400012, Denver, Colorado, United States, 80262

Fort Collins

Advanced Neurology of Colorado- Site Number : 8400025, Fort Collins, Colorado, United States, 80528

Washington

MedStar Georgetown University Hospital- Site Number : 8400119, Washington, District of Columbia, United States, 20007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Study Record Dates

2029-04-30