Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
Completed · Phase 3 · NCT04458051
Conditions: Primary Progressive Multiple Sclerosis
At a glance
- Research payments reported, 2025
- $905,220
- U.S. investigators named
- 35
- Sites paid
- 38
- Planned or actual enrollment
- 767
About the trial
- Sponsor
- Sanofi
- Tested
- Tolebrutinib (drug), Placebo (drug)
- Dates
- Started 2020-08-13; completion 2025-11-14
- Results posted
- Not yet
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: 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 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168
From ClinicalTrials.gov, last updated 2026-01-07. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Genzyme Corporation reported $905,220 in research payments for this study in 2025 (188 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
- Todd D. Levine, MD Neurology · Phoenix, AZ
- Lilyana Amezcua, M.D. Neurology · Los Angeles, CA
- Regina R. Berkovich, MD Neurology · West Hollywood, CA
- Jennifer S. Graves, MD Neurology · San Diego, CA
- Omid Omidvar, M.D. Neurology · Los Alamitos, CA
- M. L. Purino, M.D. Neurology · Arcadia, CA
- Susan P. Anzalone, MD Neurology · Greenwood Village, CO
- Wm D. Honeycutt, M.D. Specialist · Maitland, FL
- Torge Rempe, M.D. Neurology · Gainesville, FL
- Derrick S. Robertson, M.D. Neurology · Tampa, FL
- Jean-raphael Schneider, M.D. Neurology · Clearwater, FL
- Jagannadha R. Avasarala, MD, PHD Neurology · Lexington, KY
- Bridget A. Bagert, MD Neurology · New Orleans, LA
- Roberto Bomprezzi, MD Neurology · Worcester, MA
- Rany A. Aburashed, D.O Neurology · Owosso, MI
- Martin I. Belkin, D.O. Neurology · Farmington Hills, MI
- Evanthia Bernitsas, MD Neurology · Detroit, MI
- Brian M. Keegan, M.D. Neurology · Rochester, MN
- Kenneth S. Sharlin, MD Neurology · Ozark, MO
- Emily P. Pharr, M.D. Neurology · Bozeman, MT
- Matthew C. Carraro, M.D. Neurology · Charlotte, NC
- Rana K. Zabad, MD Neurology · Omaha, NE
- Corey Ford, MD Neurology · Albuquerque, NM
- Melissa Bloch, M.D. Neurology · Reno, NV
- Patricia Coyle, M.D. Neurology · East Setauket, NY
- Stephen C. Krieger, MD Neurology · New York, NY
- Bijal K. Mehta, MD Neurology · Buffalo, NY
- Krupa S. Pandey, M.D. Neurology · Albany, NY
- Aaron L. Boster, MD Neurology · Columbus, OH
- Robert J. Fox, MD Neurology · Cleveland, OH
- Tirisham V. Gyang, MD Neurology · Columbus, OH
- Thomas P. Leist, M.D. Neurology · Philadelphia, PA
- Ann D. Bass, M.D. Neurology · San Antonio, TX
- Staley A. Brod, M.D. Neurology · Milwaukee, WI
- Bhupendra O. Khatri, M.D. Neurology · Milwaukee, WI
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- The Ohio State Univ Found $137,891
- University of California San Diegodispersements $73,245
- University of Florida Contracts Grants $60,256
- Mount Sinai School of Medicine Psychiatry $60,041
- Mayo Clinic Mayo School of Cpd $59,814
- Ochsner Medical Center Acute, LA $44,644
- Boster Research Center Llc $42,965
- University of Massachusetts School of Medicine $42,573
- Sharlin Health and Neurology $34,324
- Memorial Healthcare $28,815
- University of New Mexico $27,996
- Cleveland Clinic, OH $26,771
- Hackensack University Medical Center, NJ $22,550
- Regina Berkovich MD Phd $21,350
- University of Kentucky Research Fo $21,000
- University of South Florida $20,262
- The Ohio State University $19,961
- Neurology Associates, PA $19,393
- The Board of Regents of the University of Nebraska $19,181
- Mayo Clinic $16,449
- Sc3 Research Group $14,729
- Keck Hospital of Usc, CA $13,469
- Honorhealth Scottsdale Osborn Medical Center, AZ $11,462
- Ms and Neuromuscular Center of Excellence $8,833
- Sheth MD PA Lone Star Neurology of San Antonio $7,946
- Medical College of Wisconsin Inc Attn Donald Basel $7,600
- Jefferson Health Nephrology $6,250
- The Research Found of the State University of New York $5,150
- Wheaton Franciscan Healthcare Southeast Wisconsin Inc $4,800
- Interspond LLC $4,450
- Wayne State University $4,248
- Collaborative Neuroscience Research $4,075
- Renown Regional Medical Center, NV $3,200
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical C $3,000
- Wake Forest University Health Science $2,290
- $2,250
- Forsyth Memorial Hospital Inc $1,128
- Presbyterian Hospital, Dba Novant Health Presbyt $650
- Glendale Neurological Associates PC $210
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.