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

Active, not recruiting · Phase 3 · NCT06372145

Conditions: Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis

At a glance

Research payments reported, 2025
$2.6M
U.S. investigators named
49
Sites paid
46
Planned or actual enrollment
2,500

About the trial

Sponsor
Sanofi
Tested
Tolebrutinib (drug), Placebo (drug), Teriflunomide (drug)
Dates
Started 2024-04-16; completion 2029-04-30
Results posted
Not yet

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

From ClinicalTrials.gov, last updated 2026-08-17. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Genzyme Corporation reported $2.6M in research payments for this study in 2025 (281 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • Interspond LLC $191,183
  • Boster Research Center Llc $188,325
  • Consultants in Neurology, Ltd $170,166
  • University of New Mexico $150,838
  • University of South Florida $150,119
  • Sibyl Wray MD Neurology PC $113,739
  • Minneapolis Clinic of Neurology, Ltd $101,809
  • The University of Cincinnati Foundation $79,501
  • Mount Sinai School of Medicine Psychiatry $79,371
  • Neurology Associates, PA $75,626
  • Delricht LLC $72,731
  • Georgetown University Office of Tech Commercialization $72,692
  • Arizona Neuroscience Research Llc $68,824
  • The Ohio State University $68,635
  • University of Kansas Medical Center Research Inst Inc $64,042
  • University of Miami Office of Research Administration O $55,166
  • Indiana University Health Inc $54,113
  • Providence St Vincent Medical Center, OR $54,023
  • University of Alabama Hospital, AL $53,917
  • Axiom Brain Health Llc $47,850
  • Cleveland Clinic, OH $47,040
  • Advanced Neurosciences Res LLC $46,501
  • The Research Foundation for The Station University of New York $45,790
  • Tufts Medical Center, MA $41,382
  • Wake Forest University Health Science $39,756
  • Aqualane Clinical Research Llc $38,578
  • The Memorial Hospital Dba Memorial Healthcare $36,660
  • Keck Hospital of Usc, CA $36,623
  • University of Vermont Medical Center $35,927
  • Mayo Clinic Mayo School of Cpd $35,060
  • Axiom Clinical Research of Florida $28,289
  • 0000203566 North Central Neurology Assocs PC $25,279
  • University of California San Diegodispersements $22,842
  • Norton Healthcare Inc $22,718
  • Wayne State University $22,271
  • University of Massachusetts School of Medicine $18,442
  • University of Kentucky Research Fo $17,372
  • Regents of the University of Colorado $16,898
  • Springfield Clinic LLP $16,143
  • Regina Berkovich MD Phd $16,069
  • Sfm Clinical Research Llc $13,861
  • Sharlin Health and Neurology $12,905
  • Glendale Neurological Associates PC $12,768
  • New York University NYU Grossman School of Medicine An Administrative Unit of New York University $12,720
  • Ochsner Medical Center Acute, LA $12,500
  • Henrico Doctors Neurology Associate Llc Neurological Associates $12,291

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.