Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
Completed · Phase 3 · NCT04410991
Conditions: Relapsing Multiple Sclerosis
At a glance
- Research payments reported, 2025
- $248,091
- U.S. investigators named
- 14
- Sites paid
- 13
- Planned or actual enrollment
- 899
About the trial
- Sponsor
- Sanofi
- Tested
- Tolebrutinib (drug), Teriflunomide HMR1726 (drug), Placebo to match Tolebrutinib (drug), Placebo to match Teriflunomide (drug)
- Dates
- Started 2020-06-11; completion 2024-07-16
- 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 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 $248,091 in research payments for this study in 2025 (36 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
- Christopher C. Laganke, MD Neurology · Cullman, AL
- Wm D. Honeycutt, M.D. Specialist · Maitland, FL
- Derrick S. Robertson, M.D. Neurology · Tampa, FL
- Brian Steingo, MD Neurology · Boca Raton, FL
- Tung T. Wynn, M.D. Pediatric Hematology & Oncology · Gainesville, FL
- Ajay S. Gupta, MD Neurology · Fort Wayne, IN
- Jon D. Olson, MD Neurology · Baton Rouge, LA
- Corey Ford, MD Neurology · Albuquerque, NM
- Mark Gudesblatt, M.D. Neurology · Islip, NY
- Bijal K. Mehta, MD Neurology · Buffalo, NY
- Krupa S. Pandey, M.D. Neurology · Albany, NY
- Kenneth B. Pugar, D.O. Neurology · Centerville, OH
- Mary D. Hughes, MD Neurology · Greenville, SC
- Sibyl Wray, MD Neurology · Knoxville, TN
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Neurology Associates, PA $57,120
- Interspond LLC $51,943
- Infinity Clinical Research Sunrise $32,800
- Hackensack University Medical Center, NJ $28,336
- University of New Mexico $26,721
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical C $15,257
- Sibyl Wray MD Neurology PC $11,555
- Consultants in Neurology, Ltd $7,900
- Iu Health Neurology Fort Wayne $4,000
- NYU School of Medicine $3,600
- Delricht LLC $3,185
- University of South Florida $2,850
- 0000203566 North Central Neurology Assocs PC $2,825
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.