Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
Completed · Phase 3 · NCT04410978
Conditions: Relapsing Multiple Sclerosis
At a glance
- Research payments reported, 2025
- $405,160
- U.S. investigators named
- 19
- Sites paid
- 17
- Planned or actual enrollment
- 974
About the trial
- Sponsor
- Sanofi
- Tested
- Tolebrutinib (drug), Teriflunomide (drug), Placebo to match Tolebrutinib (drug), Placebo to match Teriflunomide (drug)
- Dates
- Started 2020-06-30; completion 2024-07-15
- Results posted
- Yes
Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites 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 $405,160 in research payments for this study in 2025 (50 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
- Khurram Bashir Neurology · Birmingham, AL
- Enrique Alvarez III, MD, PHD Neurology · Aurora, CO
- Faria S. Amjad, MD Neurology · Washington, DC
- Mark C. Cascione, M.D. Neurology · Clearwater, FL
- Derrick S. Robertson, M.D. Neurology · Tampa, FL
- Tung T. Wynn, M.D. Pediatric Hematology & Oncology · Gainesville, FL
- John M. Hemphill, M.D. Child Neurology · Savannah, GA
- Daniel R. Wynn, M.D. Neurology · Northbrook, IL
- Kristen J. Babinski, MD Neurology · Foxboro, MA
- Rany A. Aburashed, D.O Neurology · Owosso, MI
- Kenneth S. Sharlin, MD Neurology · Ozark, MO
- Emily P. Pharr, M.D. Neurology · Bozeman, MT
- John R. Scagnelli, M.D. Neurology · Raleigh, NC
- Aaron L. Boster, MD Neurology · Columbus, OH
- Tirisham V. Gyang, MD Neurology · Columbus, OH
- Gabriel Pardo, M.D. Neurology · Oklahoma City, OK
- Kyle E. Smoot, M.D. Neurology · Portland, OR
- Lauren M. Tardo Neurology · Dallas, TX
- Pavle Repovic, MD, PHD Neurology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Georgetown University Office of Tech Commercialization $82,973
- Providence St Vincent Medical Center, OR $69,471
- Velocity Clinical Research, Savannah $48,990
- Oklahoma Medical Research Foundation $46,959
- Consultants in Neurology, Ltd $43,291
- Swedish Medical Center, WA $24,240
- University of Alabama Hospital, AL $22,650
- Tufts Medical Center, MA $11,650
- The Ohio State University $10,492
- Sharlin Health and Neurology $10,350
- Wake Forest University Health Science $8,790
- University of Texas Southwestern $6,990
- $4,750
- Axiom Clinical Research of Florida $4,631
- Regents of the University of Colorado $4,172
- The Boster Center for Multiple Sclerosis $3,032
- University of South Florida $1,123
- Memorial Healthcare $606
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.