Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
Active, not recruiting · Phase 3 · NCT06141486
Conditions: Multiple Sclerosis
At a glance
- Research payments reported, 2025
- $4.9M
- U.S. investigators named
- 92
- Sites paid
- 96
- Planned or actual enrollment
- 943
About the trial
- Sponsor
- Sanofi
- Tested
- Frexalimab (drug), Placebo (drug), MRI contrast-enhancing agents (drug)
- Dates
- Started 2023-12-27; completion 2028-03-24
- Results posted
- Not yet
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first …
From ClinicalTrials.gov, last updated 2026-11-09. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Genzyme Corporation reported $4.9M in research payments for this study in 2025 (349 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
- Emily S. Riser, MD Specialist · Birmingham, AL
- Nida K. Laurin, M.D. Neurology · Scottsdale, AZ
- Suraj A. Muley, MD Neurology · Phoenix, AZ
- Michael V. Robers, M.D. Neurology · Phoenix, AZ
- Lori H. Travis, MD Neurology · Phoenix, AZ
- Regina R. Berkovich, MD Neurology · West Hollywood, CA
- Margaret E. Burnett, M.D. Neurology · Los Angeles, CA
- Joanna A. Cooper, M.D. Neurology · Berkeley, CA
- Benjamin M. Frishberg, M.D. Neurology · Carlsbad, CA
- Jennifer S. Graves, MD Neurology · San Diego, CA
- Annette M. Langer-gould, MD Neurology · Stanford, CA
- Christopher B. Lock, MD Neurology · Stanford, CA
- Michael Y. Sy, M.D. Neurology · Irvine, CA
- Enrique Alvarez III, MD, PHD Neurology · Aurora, CO
- Andrew D. Smith III, M.D. Neurology · Fort Collins, CO
- Erin Longbrake, MD Neurology · North Haven, CT
- Peter J. Mcallister, M.D. Neurology · Fairfield, CT
- Derek R. Smith, MD Neurology · Norwich, CT
- Faria S. Amjad, MD Neurology · Washington, DC
- Mitchell Wallin Neurology · Washington, DC
- Alicia V. Cabrera, MD Neurology · Altamonte Springs, FL
- Amparo Gutierrez, MD Physical Medicine & Rehabilitation (PM&R) · Orlando, FL
- Wm D. Honeycutt, M.D. Specialist · Maitland, FL
- Iris Marin Collazo, MD Neurology · Jacksonville, FL
- Kottil W. Rammohan, MD Neurology · Miami, FL
- Torge Rempe, M.D. Neurology · Gainesville, FL
- Derrick S. Robertson, M.D. Neurology · Tampa, FL
- Jean-raphael Schneider, M.D. Neurology · Clearwater, FL
- Brian Steingo, MD Neurology · Boca Raton, FL
- Paul K. Winner, D.O. Child Neurology · West Palm Beach, FL
- John M. Hemphill, M.D. Child Neurology · Savannah, GA
- Mitzi J. Williams, M.D. Neurology · Smyrna, GA
- Tracey A. Cho, MD Neurology · Iowa City, IA
- Veronica Cipriani Neurology · Chicago, IL
- Tiffani S. Franada, D.O. Neurology · Highland Park, IL
- Thomas J. Shoemaker, M.D. Neurology · Chicago, IL
- Daniel R. Wynn, M.D. Neurology · Northbrook, IL
- William L. Conte, M.D. Neurology · Merrillville, IN
- Sharon G. Lynch, M.D, Neurology · Kansas City, KS
- James M. Winkley II, M.D. Neurology · Lexington, KY
- Ariel O. Antezana Neurology · Alexandria, LA
- Bridget A. Bagert, MD Neurology · New Orleans, LA
- Jon D. Olson, MD Neurology · Baton Rouge, LA
- Kristen J. Babinski, MD Neurology · Foxboro, MA
- Roberto Bomprezzi, MD Neurology · Worcester, MA
- Deborah M. Green-laroche, MD Neurology · Boston, MA
- Joshua D. Katz, MD Neurology · Wellesley, MA
- Salvatore Q. Napoli, M.D. Neurology · Foxboro, MA
- Jacob A. Sloane, M.D., PH.D. Neurology · Boston, MA
- Scott D. Newsome, D.O. Neurology · Baltimore, MD
- Martin I. Belkin, D.O. Neurology · Farmington Hills, MI
- Mirela Cerghet, M.D., PH.D. Neurology · Detroit, MI
- Robert J. Pace, MD Neurology · Owosso, MI
- Herman Sullivan, MD Neurology · Grand Rapids, MI
- Esther L. Young, D.O. Neurology · Rochester Hills, MI
- Jonathan C. Calkwood, M.D. Neurology · Golden Valley, MN
- Brittani L. Conway, M.D. Neurology · Minneapolis, MN
- Jessica L. Stulc, MD Neurology · Golden Valley, MN
- Salim Chahin, MD Neurology · O Fallon, MO
- Kenneth S. Sharlin, MD Neurology · Ozark, MO
- Emily P. Pharr, M.D. Neurology · Bozeman, MT
- Matthew C. Carraro, M.D. Neurology · Charlotte, NC
- John R. Scagnelli, M.D. Neurology · Raleigh, NC
- Scott M. Belliston, D.O. Neurology · Fargo, ND
- Machteld E. Hillen, M.D. Neurology · Newark, NJ
- Mary Ann Picone, MD Neurology · Teaneck, NJ
- Corey Ford, MD Neurology · Albuquerque, NM
- Melissa Bloch, M.D. Neurology · Reno, NV
- Le H. Hua, M.D. Neurology · Las Vegas, NV
- Patricia Coyle, M.D. Neurology · East Setauket, NY
- Kathleen Munger, MD Neurology · Rochester, NY
- Bennett Myers, M.D. Neurology · Amherst, NY
- Claire S. Riley, M.D. Neurology · New York, NY
- Aaron L. Boster, MD Neurology · Columbus, OH
- Michelle C. Bowman, M.D. Neurology · Cincinnati, OH
- Lawrence P. Goldstick, MD Neurology · Dayton, OH
- Tirisham V. Gyang, MD Neurology · Columbus, OH
- Aram Zabeti, M.D. Neurology · Cincinnati, OH
- Gabriel Pardo, M.D. Neurology · Oklahoma City, OK
- Thomas P. Leist, M.D. Neurology · Philadelphia, PA
- Jikku Zachariah, D.O. Neurology · Reading, PA
- Steven M. Kreiger, O.D. Optometrists · Wakefield, RI
- Harold Moses, MD Neurology · Nashville, TN
- Sibyl Wray, MD Neurology · Knoxville, TN
- Annette F. Okai, MD Neurology · Plano, TX
- Adnan M. Subei, D.O. Neurology · Dallas, TX
- Michelle K. Betz, DO Neurology · Virginia Beach, VA
- Rahul H. Dave, M.D., PH.D. Neurology · Fairfax, VA
- Andrew J. Solomon, M.D. Neurology · Burlington, VT
- Kathryn T. Fong, M.D. Neurology · Edmonds, WA
- Ahmed Z. Obeidat, M.D., P.H.D Neurology · Milwaukee, WI
- Melanie D. Ward, M.D. Neurology · Morgantown, WV
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Alabama Neurology Associates PC $394,093
- Mount Sinai School of Medicine Psychiatry $208,821
- Medical College of Wisconsin Inc Att Department of Medicine Administrati Co Wendy Wozney Medical Col $191,304
- Regina Berkovich MD Phd $188,815
- Dragonfly Research LLC $164,968
- The University of Cincinnati Foundation $156,769
- The Ohio State University Ccicmass Spectrometry and Proteomi Facility $150,458
- Consultants in Neurology, Ltd $138,210
- University of South Florida $113,262
- Imaging Endpoints II Llc $109,338
- The Trustees of Columbia University the City of New York Co Clinical Trials Office $106,891
- Velocity Clinical Research Inc $105,601
- California PAcific Medical Ctr-Davies Campus Hosp, CA $99,770
- Yale University Sponsored Projects $93,569
- The Board of Trustees of the Lealan Stanford Junior University Stanford University $86,539
- Sanford Research $85,984
- Vanderbilt University Medical Center, TN $84,273
- Cleveland Clinic, OH $78,125
- Midwest Immunology Clinics PLLC $77,991
- University of Florida Contracts Grants $75,141
- Johns Hopkins University $72,574
- Profound Research Llc $68,729
- Ochsner Medical Center Acute, LA $63,232
- University of Massachusetts Medical School $62,093
- University of Vermont Medical Center $61,972
- Palm Beach Neurology Premiere Research Institute $60,670
- Dent Neurosciences Research Center Inc $54,947
- Neurology of Central Florida Research Center Llc $54,385
- The Ohio State University $54,171
- Riverhills Neuroscience $50,225
- Holy Name Medical Center $47,162
- Ronald Reagan UCLA Medical Center, CA $46,990
- Piedmont Healthcare PA $46,483
- Renown Regional Medical Center, NV $43,950
- Neurology Center of New England PC $42,665
- Mayo Clinic Jacksonville Corp $42,200
- University of Kansas Hospital $41,505
- University of California San Diegodispersements $41,469
- Tufts Medical Center, MA $40,542
- Glendale Neurological Associates PC $40,191
- Inova Loudoun Hospital, VA $40,000
- Regents of the University of Minnesota $39,342
- West Virginia University Lab $39,125
- Oklahoma Medical Research Foundation $38,145
- Board of Trustees of the Leland $36,204
- Georgetown University Office of Tech Commercialization $35,697
- Rush University Medical Center, IL $34,083
- Multicare Good Samaritan Hospital, WA $32,942
- Regents of the University of Colorado $30,804
- Swedish Medical Center, WA $29,800
- Methodist Hospitals Inc, IN $29,666
- Neurology Associates, PA $28,976
- Investigator Research Network Llc $27,998
- Beth Israel Deaconess Medical Center, MA $27,500
- Kaiser Foundation Hospital-Santa Clara, CA $27,085
- Mercy General Hospital, CA $26,796
- University of Florida Foundation Inc $26,635
- University of Maryland Baltimore Attn Sponsored Programs Accounting $26,371
- University of Miami Umiami Medicine Dermatology $26,045
- Minneapolis Clinic of Neurology, Ltd $26,037
- Boston Clinical Trials Llc $25,538
- Boster Research Center Llc $25,273
- Dartmouthhitchcock Clinic $24,214
- Holy Name Medical Center Found $23,925
- Thomas Jefferson University Attn Daisy Spruill $23,800
- Rutgers the State University of New Jersey $21,835
- Baptist Health Lexington, KY $19,300
- Sentara Medical Group $19,023
- Neurology Offices of South Florida $19,000
- Ms and Neuromuscular Center of Excellence $18,578
- Pennsylvania State University Attn Tressa Jilek Controllers Office Mc G230 $18,574
- Saturn Research Solutions Llc $18,538
- North Texas Institute of Neurology Headache $18,538
- Henry Ford Health Hospital, MI $18,484
- The University of Chicago Cardiology $18,400
- Savannah Neurology Specialists $16,800
- The Memorial Hospital Dba Memorial Healthcare $15,908
- Sharlin Health and Neurology $14,329
- Southern California Permanente Medical Group $14,200
- Uci Health-Orange, CA $13,273
- Delricht LLC $11,300
- Orlando Health, FL $11,140
- Neurology Consultants of Dallas PA $10,800
- Lake Huron Medical Center Op $10,800
- Hartford Hospital, CT $10,535
- Osf Heart of Mary Medical Center, IL $9,720
- Washington University $8,282
- The Research Foundation for The Station University of New York $8,200
- University of New Mexico $5,627
- Perseverance Research Center $5,098
- Keck Hospital of Usc, CA $3,950
- Wake Forest University Health Science $3,128
- Honorhealth Scottsdale Osborn Medical Center, AZ $1,500
- Ki Health PArtners Llc $1,500
- Sibyl Wray MD Neurology PC $980
- University of Iowa Hospital & Clinics, IA $975
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.