Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
Public ClinicalTrials.gov record NCT04410991. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04410991
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 899 participants
Conditions and interventions
Conditions
Interventions
- Tolebrutinib Drug
- Teriflunomide HMR1726 Drug
- Placebo to match Tolebrutinib Drug
- Placebo to match Teriflunomide Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 11, 2020 (Actual)
- Primary completion
- Jul 16, 2024 (Actual)
- Completion
- Jul 16, 2024 (Actual)
- Last update posted
- Jul 2, 2025
2020 – 2024
United States locations
- U.S. sites
- 43
- U.S. states
- 27
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Central Neurology Associates, PC-Site Number:8400009 | Cullman | Alabama | 35058 | — |
| Center for Neurology and Spine-Site Number:8400089 | Phoenix | Arizona | 84018 | — |
| Arcadia Neurology Center-Site Number:8400070 | Arcadia | California | 91006 | — |
| Multiple Sclerosis Center of California-Site Number:8400135 | Newport Beach | California | 92663 | — |
| Harbor UCLA-Site Number:8400088 | Torrance | California | 90502 | — |
| Mountain Neurological Research Center, Inc.-Site Number:8400128 | Basalt | Colorado | 81621 | — |
| Advanced Neurosciences Research-Site Number:8400025 | Fort Collins | Colorado | 80528 | — |
| South Florida Neurology Associates-Site Number:8400029 | Boca Raton | Florida | 33487 | — |
| University of Florida Health-Site Number:8400159 | Gainesville | Florida | 32608 | — |
| Neurology Associates, PA-Site Number:8400004 | Maitland | Florida | 32761 | — |
| University of Miami-Site Number:8400063 | Miami | Florida | 33136 | — |
| Infinity Clinical Research-Site Number:8400008 | Sunrise | Florida | 33351 | — |
| University of South Florida-Site Number:8400006 | Tampa | Florida | 33612 | — |
| Meridian Clinical Research-Site Number:8400003 | Savannah | Georgia | 31406 | — |
| Consultants In Neurology-Site Number:8400011 | Northbrook | Illinois | 60062 | — |
| Prairie Education and Research Cooperative-Site Number:8400071 | Springfield | Illinois | 62701 | — |
| Fort Wayne Neurological Center-Site Number:8400039 | Fort Wayne | Indiana | 46804 | — |
| CHI Saint Joseph Medical Group Neurology-Site Number:8400110 | Lexington | Kentucky | 40509 | — |
| University of Kentucky-Site Number:8400106 | Lexington | Kentucky | 40536 | — |
| Norton Neurology MS Services-Site Number:8400127 | Louisville | Kentucky | 40207 | — |
| The NeuroMedical Center-Site Number:8400057 | Baton Rouge | Louisiana | 70810 | — |
| International Neurorehabilitation Institute-Site Number:8400034 | Lutherville-Timonium | Maryland | 21093 | — |
| Wayne State University-Site Number:8400046 | Detroit | Michigan | 48201 | — |
| Minneapolis Clinic of Neurology-Site Number:8400051 | Minneapolis | Minnesota | 55422 | — |
| Saint Luke's Hospital-Site Number:8400153 | Kansas City | Missouri | 64111 | — |
| West Omaha Family Physicians-Site Number:8400139 | Omaha | Nebraska | 68130 | — |
| University Of Nebraska-Site Number:8400129 | Omaha | Nebraska | 68198 | — |
| Hackensack University Hospital-Site Number:8400047 | Hackensack | New Jersey | 07601 | — |
| University of New Mexico-Site Number:8400032 | Albuquerque | New Mexico | 87131 | — |
| South Shore Neurologic Associates-Site Number:8400100 | Patchogue | New York | 11772 | — |
| Novant Health Multiple Sclerosis Care Center - South Park-Site Number:8400120 | Charlotte | North Carolina | 28210 | — |
| Meridian Clinical Research, LLC-Site Number:8400005 | Raleigh | North Carolina | 27607 | — |
| Sanford Brain & Spine Center-Site Number:8400126 | Fargo | North Dakota | 58103 | — |
| Dayton Center for Neurological Disorders-Site Number:8400081 | Centerville | Ohio | 45459 | — |
| Jefferson Neurology Associates-Site Number:8400016 | Philadelphia | Pennsylvania | 19107 | — |
| Premier Neurology-Site Number:8400069 | Greer | South Carolina | 29650 | — |
| Advanced Neuroscience Center-Site Number:8400035 | Franklin | Tennessee | 37064 | — |
| Sibyl Wray, MD, Neurology, PC-Site Number:8400007 | Knoxville | Tennessee | 37922 | — |
| Mt Olympus Medical Research-Site Number:8400163 | Katy | Texas | 77450 | — |
| Neurology Center of San Antonio-Site Number:8400036 | San Antonio | Texas | 78258 | — |
| Texas Institute for Neuroogical Disorders-Sherman-Site Number:8400151 | Sherman | Texas | 75092 | — |
| Neurological Associates-Site Number:8400097 | Richmond | Virginia | 23229 | — |
| Wheaton Franciscan Healthcare-Site Number:8400022 | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 143 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04410991, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 2, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04410991 live on ClinicalTrials.gov.