A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. (NCT06372145)
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
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: The University of Alabama at Birmingham- Site Number : 8400013 — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (352 Sites)
Showing the first 25 of 352 sites.
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Relapsing Multiple Sclerosis
- A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS) — Fullerton, California
- A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone) — Cullman, Alabama
- Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis — Maitland, Florida
- Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2) — Phoenix, Arizona
- A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) — Birmingham, Alabama
Explore by condition: All Relapsing Multiple Sclerosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.