RECRUITING

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

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Conditions

Relapsing Multiple SclerosisSecondary Progressive Multiple SclerosisProgressive Relapsing Multiple Sclerosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

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

Quick Facts

Study Start:2024-04-16
Study Completion:2029-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06372145

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Participants are excluded from the study if any of the following criteria apply:
  2. * 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
  3. * 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
  4. * Active alcohol use disorder or a history of alcohol or drug abuse within 1 year prior to the opt-in visit
  5. * 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
  6. * 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.
  7. * 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.
  8. * 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).
  9. * Acute liver disease, cirrhosis, chronic liver disease (unless considered stable for more than 6 months).
  10. * 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.
  11. * 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.

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610
Contact-US@sanofi.com

Study Locations (Sites)

University of Alabama at Birmingham- Site Number : 8400013
Birmingham, Alabama, 35233
United States
North Central Neurology Associates- Site Number : 8400009
Cullman, Alabama, 35058
United States
Center for Neurology and Spine- Site Number : 8400089
Phoenix, Arizona, 85018
United States
University of California San Diego - La Jolla- Site Number : 8400101
La Jolla, California, 92037
United States
Collaborative Neuroscience Research- Site Number : 8400045
Los Alamitos, California, 90720
United States
Keck School of Medicine of University of Southern California- Site Number : 8400143
Los Angeles, California, 90033
United States
Private Practice - Dr. Regina Berkovich- Site Number : 8400059
West Hollywood, California, 90048
United States
University of Colorado- Site Number : 8400012
Denver, Colorado, 80262
United States
Advanced Neurology of Colorado- Site Number : 8400025
Fort Collins, Colorado, 80528
United States
MedStar Georgetown University Hospital- Site Number : 8400119
Washington, District of Columbia, 20007
United States
SFM Clinical Research- Site Number : 8400029
Boca Raton, Florida, 33487
United States
Neurology Associates - Maitland- Site Number : 8409902
Maitland, Florida, 32751
United States
University of Miami- Site Number : 8400063
Miami, Florida, 33136
United States
Aqualane Clinical Research- Site Number : 8400027
Naples, Florida, 34105
United States
Axiom Clinical Research of Florida- Site Number : 8400001
Tampa, Florida, 33609
United States
University of South Florida- Site Number : 8409905
Tampa, Florida, 33612
United States
Velocity Clinical Research - Savannah Neurology- Site Number : 8409903
Savannah, Georgia, 31406
United States
Consultants in Neurology- Site Number : 8409906
Northbrook, Illinois, 60062
United States
Springfield Clinic 1st - 800 Building- Site Number : 8400071
Springfield, Illinois, 62702
United States
Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center- Site Number : 8400039
Fort Wayne, Indiana, 46845
United States
University of Kansas Medical Center- Site Number : 8400023
Kansas City, Kansas, 66160
United States
Norton Neurology Services- Site Number : 8400127
Louisville, Kentucky, 40207
United States
The NeuroMedical Center- Site Number : 8400057
Baton Rouge, Louisiana, 70810
United States
Wayne State University- Site Number : 8400046
Detroit, Michigan, 48201
United States
Michigan Institute for Neurological Disorders- Site Number : 8400058
Farmington Hills, Michigan, 48334
United States
Memorial Healthcare Institute for Neuroscience- Site Number : 8400033
Owosso, Michigan, 48867
United States
Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400051
Golden Valley, Minnesota, 55422
United States
Sharlin Health & Neurology- Site Number : 8400093
Ozark, Missouri, 65721
United States
Missouri Baptist Medical Center- Site Number : 8400019
Saint Louis, Missouri, 63131
United States
Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400117
Las Vegas, Nevada, 89106
United States
The University of New Mexico- Site Number : 8400032
Albuquerque, New Mexico, 87106
United States
Icahn School of Medicine at Mount Sinai- Site Number : 8400038
New York, New York, 10029
United States
South Shore Neurologic Associates - Patchogue- Site Number : 8400100
Patchogue, New York, 11772
United States
Stony Brook University- Site Number : 8400042
Stony Brook, New York, 11794
United States
Wake Forest Baptist Medical Center - Winston-Salem - Medical Center Boulevard- Site Number : 8400116
Winston-Salem, North Carolina, 27157
United States
Dayton Center for Neurological Disorders- Site Number : 8400081
Centerville, Ohio, 45459
United States
Cleveland Clinic - Cleveland- Site Number : 8400125
Cleveland, Ohio, 44195
United States
The Ohio State University Wexner Medical Center - Ohio State Outpatient Care Upper Arlington- Site Number : 8400150
Columbus, Ohio, 43221
United States
The Boster Center for Multiple Sclerosis- Site Number : 8400147
Columbus, Ohio, 43235
United States
Medical Center at Elizabeth Place- Site Number : 8409901
Dayton, Ohio, 45408
United States
Providence St. Vincent's Medical Center- Site Number : 8400020
Portland, Oregon, 97225
United States
Premier Neurology- Site Number : 8400069
Greer, South Carolina, 29650
United States
Hope Neurology- Site Number : 8409904
Knoxville, Tennessee, 37922
United States
Neurology Center of San Antonio- Site Number : 8400036
San Antonio, Texas, 78258
United States
Texas Institute for Neurological Disorders - Sherman- Site Number : 8400151
Sherman, Texas, 75092
United States
University of Vermont Medical Center- Site Number : 8400130
Burlington, Vermont, 05401
United States
Neurological Associates - Richmond- Site Number : 8400097
Richmond, Virginia, 23226
United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-16
Study Completion Date2029-04-30

Study Record Updates

Study Start Date2024-04-16
Study Completion Date2029-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Relapsing Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
  • Progressive Relapsing Multiple Sclerosis