A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation — From baseline until the End of study approximately 4 years per participant
- Number of Participants with Potentially clinically significant abnormalities (PCSAs) — From baseline until the End of study approximately 4 years per participant
Potentially clinically significant abnormalities (PCSAs) determined by laboratory tests, electrocardiogram (ECG), or vital signs and safety findings on MRI during the study period.
Trial sites (352)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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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 Japan