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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06372145

Public ClinicalTrials.gov record NCT06372145. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 3:08 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT06372145
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
2,500 participants

Conditions and interventions

Interventions

  • Tolebrutinib Drug
  • Placebo Drug
  • Teriflunomide Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 15, 2024
Primary completion
Apr 29, 2029
Completion
Apr 29, 2029
Last update posted
Feb 12, 2026

2024 – 2029

United States locations

U.S. sites
52
U.S. states
27
U.S. cities
50
Facility City State ZIP Site status
The University of Alabama at Birmingham- Site Number : 8400013 Birmingham Alabama 35233
~North Central Neurology Associates, PC- Site Number : 8400009 Cullman Alabama 35058
Center for Neurology and Spine- Site Number : 8400089 Phoenix Arizona 85018
Collaborative Neuroscience Research- Site Number : 8400045 Los Alamitos California 90720
USC- Site Number : 8400143 Los Angeles California 90033
University of California San Diego Medical Center- Site Number : 8400101 San Diego California 92037-0943
Regina Berkovich, MD, PhD- Site Number : 8400059 West Hollywood California 90048
University of Colorado- Site Number : 8400012 Denver Colorado 80262
Advanced Neurosciences Research- Site Number : 8400025 Fort Collins Colorado 80528
Georgetown University Medical Center- Site Number : 8400119 Washington D.C. District of Columbia 20007
SFM Clinical Research, LLC- Site Number : 8400029 Boca Raton Florida 33487
University of Florida Health- Site Number : 8400159 Gainesville Florida 32608
Neurology Associates- Site Number : 8409902 Maitland Florida 32751
University of Miami- Site Number : 8400063 Miami Florida 33136
Aqualane Clinical Research- Site Number : 8400027 Naples Florida 34105
Axiom Clinical Research of Florida- Site Number : 8400001 Tampa Florida 33609-4052
University of South Florida- Site Number : 8409905 Tampa Florida 33612
Velocity Clinical Research- Site Number : 8409903 Savannah Georgia 31406
Consultants In Neurology- Site Number : 8409906 Northbrook Illinois 60062
Springfield Clinic, LLP- Site Number : 8400071 Springfield Illinois 62702
Indiana University Health, Inc- Site Number : 8400039 Fort Wayne Indiana 46815
University of Kansas Medical Center- Site Number : 8400023 Kansas City Kansas 66160-7321
University of Kentucky- Site Number : 8400106 Lexington Kentucky 40536
Norton Neurology MS Services- Site Number : 8400127 Louisville Kentucky 40207
The NeuroMedical Center- Site Number : 8400057 Baton Rouge Louisiana 70810
Ochsner Clinic Foundation- Site Number : 8400107 New Orleans Louisiana 70121
Tufts Medical Center- Site Number : 8400072 Boston Massachusetts 02111
University of Massachusetts- Site Number : 8400014 Worcester Massachusetts 01655
Wayne State University- Site Number : 8400046 Detroit Michigan 48201
Michigan Institute Neuro Disorders- Site Number : 8400058 Farmington Hills Michigan 48334
Memorial Healthcare Institute for Neuroscience- Site Number : 8400033 Owosso Michigan 48867
Minneapolis Clinic of Neurology- Site Number : 8400051 Golden Valley Minnesota 55422
Mayo Clinic- Site Number : 8400111 Rochester Minnesota 55905
Sharlin Health & Neurology- Site Number : 8400093 Ozark Missouri 65721
Missouri Baptist Medical Center- Site Number : 8400019 St Louis Missouri 63131
Lou Ruvo Center for Brain Health- Site Number : 8400117 Las Vegas Nevada 89106
University of New Mexico- Site Number : 8400032 Albuquerque New Mexico 87131
Mount Sinai Medical Center- Site Number : 8400038 New York New York 10021
NYU Langone South Shore Neurologic Associates- Site Number : 8400100 Patchogue New York 11772
Neurology Associates of Stony Brook- Site Number : 8400042 Stony Brook New York 11794
Wake Forest University Baptist Medical Center- Site Number : 8400116 Winston-Salem North Carolina 27157
Dayton Center for Neurological Disorders- Site Number : 8400081 Centerville Ohio 45459
Cleveland Clinic Foundation-Mellen Center for MS- Site Number : 8400125 Cleveland Ohio 44195
The Ohio State University Wexner Medical Center- Site Number : 8400150 Columbus Ohio 43221
The Boster Center for Multiple Sclerosis- Site Number : 8400147 Columbus Ohio 43235
UC Health, LLC- Site Number : 8409901 Dayton Ohio 45417
Providence Multiple Sclerosis Center- Site Number : 8400020 Portland Oregon 97225
Premier Neurology- Site Number : 8400069 Greenville South Carolina 29605
HOPE Neurology- Site Number : 8409904 Knoxville Tennessee 37922
Lone Star Neurology of San Antonio- Site Number : 8400036 San Antonio Texas 78258
University of Vermont - Larner College of Medicine- Site Number : 8400130 Burlington Vermont 05405
Neurological Associates- Site Number : 8400097 Richmond Virginia 23229

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 300 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06372145, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 12, 2026 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06372145 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →