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NCT06372145 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
A Phase 3 study of Relapsing Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, sponsored by Sanofi.
- Active
- Registry status
- Phase 3
- Development phase
- 2,500
- Enrollment target
- 20
- Study locations
NCT06372145 is a Phase 3 study of Relapsing Multiple Sclerosis and Secondary Progressive Multiple Sclerosis that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 2,500 participants, above the 2,061-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT06372145, a Phase 3 study of Relapsing Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,500 participants
- Enrollment target
- 20
- Study locations
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Teriflunomide
- DRUG Tolebrutinib
Study Locations (20)
Florida
- SFM Clinical Research, LLC- Site Number : 8400029 - Boca Raton
- University of Florida Health- Site Number : 8400159 - Gainesville
- Neurology Associates- Site Number : 8409902 - Maitland
- University of Miami- Site Number : 8400063 - Miami
- Aqualane Clinical Research- Site Number : 8400027 - Naples
- Axiom Clinical Research of Florida- Site Number : 8400001 - Tampa
- University of South Florida- Site Number : 8409905 - Tampa
California
- Collaborative Neuroscience Research- Site Number : 8400045 - Los Alamitos
- USC- Site Number : 8400143 - Los Angeles
- University of California San Diego Medical Center- Site Number : 8400101 - San Diego
- Regina Berkovich, MD, PhD- Site Number : 8400059 - West Hollywood
Alabama
- The University of Alabama at Birmingham- Site Number : 8400013 - Birmingham
- ~North Central Neurology Associates, PC- Site Number : 8400009 - Cullman
Colorado
- University of Colorado- Site Number : 8400012 - Denver
- Advanced Neurosciences Research- Site Number : 8400025 - Fort Collins
Illinois
- Consultants In Neurology- Site Number : 8409906 - Northbrook
- Springfield Clinic, LLP- Site Number : 8400071 - Springfield
Arizona
- Center for Neurology and Spine- Site Number : 8400089 - Phoenix
District of Columbia
- Georgetown University Medical Center- Site Number : 8400119 - Washington D.C.
Georgia
- Velocity Clinical Research- Site Number : 8409903 - Savannah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,500 participants |
| Start Date | 2024-04-16 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06372145
The ClinicalTrials.gov registry entry for NCT06372145 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 2,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,061-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (21% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06372145 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT06372145 about?
NCT06372145 is a clinical study titled "A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.". 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 (GEMIN...
What is the current status of trial NCT06372145?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,500 participants. The study started on 2024-04-16. Estimated completion is 2029-04-30.
What conditions does trial NCT06372145 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis.
What interventions are being tested in trial NCT06372145?
The interventions under investigation include: Placebo (DRUG), Teriflunomide (DRUG), Tolebrutinib (DRUG).
Who is sponsoring clinical trial NCT06372145?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06372145 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.