Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)
Completed · Phase 3 · NCT04411641
Conditions: Non-relapsing Secondary Progressive Multiple Sclerosis
At a glance
- Research payments reported, 2025
- $435,234
- U.S. investigators named
- 26
- Sites paid
- 24
- Planned or actual enrollment
- 1,131
About the trial
- Sponsor
- Sanofi
- Tested
- Tolebrutinib (drug), Placebo to match Tolebrutinib (drug)
- Dates
- Started 2020-09-24; completion 2024-08-29
- Results posted
- Yes
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS Secondary Objective: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
From ClinicalTrials.gov, last updated 2025-07-02. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Genzyme Corporation reported $435,234 in research payments for this study in 2025 (91 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
- Lilyana Amezcua, M.D. Neurology · Los Angeles, CA
- Jennifer S. Graves, MD Neurology · San Diego, CA
- Yasir N. Jassam, MBCHB MRCPUK Neurology · Newport Beach, CA
- Enrique Alvarez III, MD, PHD Neurology · Aurora, CO
- Susan P. Anzalone, MD Neurology · Greenwood Village, CO
- Mark C. Cascione, M.D. Neurology · Clearwater, FL
- Wm D. Honeycutt, M.D. Specialist · Maitland, FL
- Derrick S. Robertson, M.D. Neurology · Tampa, FL
- Daniel R. Wynn, M.D. Neurology · Northbrook, IL
- Sharon G. Lynch, M.D, Neurology · Kansas City, KS
- Evanthia Bernitsas, MD Neurology · Detroit, MI
- Jessica L. Stulc, MD Neurology · Golden Valley, MN
- John R. Scagnelli, M.D. Neurology · Raleigh, NC
- Corey Ford, MD Neurology · Albuquerque, NM
- Carrie M. Hersh, D.O. Neurology · Las Vegas, NV
- Patricia Coyle, M.D. Neurology · East Setauket, NY
- Stephen C. Krieger, MD Neurology · New York, NY
- Krupa S. Pandey, M.D. Neurology · Albany, NY
- Hesham A. Abboud, M.D. Neurology · Cleveland, OH
- Aaron L. Boster, MD Neurology · Columbus, OH
- Robert J. Fox, MD Neurology · Cleveland, OH
- Lawrence P. Goldstick, MD Neurology · Dayton, OH
- Kyle E. Smoot, M.D. Neurology · Portland, OR
- Amit Bar-or Neurology · Philadelphia, PA
- Mary D. Hughes, MD Neurology · Greenville, SC
- Andrew J. Solomon, M.D. Neurology · Burlington, VT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Cleveland Clinic, OH $73,053
- University of New Mexico $51,815
- University of South Florida $37,750
- Providence St Vincent Medical Center, OR $35,765
- Mount Sinai School of Medicine Psychiatry $32,093
- University of California San Diegodispersements $24,074
- Minneapolis Clinic of Neurology, Ltd $19,780
- University of Kansas Medical Center Research Inst Inc $18,240
- Hospital of Univ of Pennsylvania, PA $18,207
- Univ. of Vermont - Fletcher Allen Health Care, VT $17,203
- $13,750
- The Research Foundation for The Station University of New York $12,606
- Hackensack University Medical Center, NJ $9,577
- Interspond LLC $8,000
- Regents of University of Colorado University of Colorado Denver $7,972
- Velocity Clinical Research, Savannah $7,602
- Consultants in Neurology, Ltd $7,200
- University of Cincinnati Physicians Company Llc $6,530
- Hoag Memorial Hospital Presbyterian $5,883
- Uh Cleveland Medical Center, OH $5,800
- Axiom Clinical Research of Florida $5,595
- Keck Hospital of Usc, CA $4,900
- Wayne State University $4,868
- Neurology Associates, PA $3,600
- The Boster Center for Multiple Sclerosis $3,372
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.