Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
Public ClinicalTrials.gov record NCT04410978. 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 population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
Study identification
- NCT ID
- NCT04410978
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 974 participants
Conditions and interventions
Conditions
Interventions
- Tolebrutinib Drug
- Teriflunomide 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 30, 2020 (Actual)
- Primary completion
- Jul 15, 2024 (Actual)
- Completion
- Jul 15, 2024 (Actual)
- Last update posted
- Jul 2, 2025
2020 – 2024
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama MS Center-Site Number:8400013 | Birmingham | Alabama | 35233 | — |
| University of San Francisco, Sandler Neurosciences Center-Site Number:8400137 | San Francisco | California | 94158 | — |
| University of Colorado-Site Number:8400012 | Aurora | Colorado | 80045 | — |
| Georgetown University Medical Center-Site Number:8400119 | Washington D.C. | District of Columbia | 20007 | — |
| Beth Israel Deaconess Medical Center-Site Number:8400064 | Fort Myers | Florida | 33919 | — |
| Axiom Clinical Research of Florida-Site Number:8400001 | Tampa | Florida | 33609-4052 | — |
| 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 | — |
| Tufts Medical Center-Site Number:8400072 | Boston | Massachusetts | 02111 | — |
| Michigan Institute For Neurological Disorders-Site Number:8400058 | Farmington Hills | Michigan | 48334 | — |
| The Memorial Hospital-Site Number:8400033 | Owosso | Michigan | 48867 | — |
| Sharlin Health & Neurology-Site Number:8400093 | Ozark | Missouri | 65721 | — |
| Missouri Baptist Medical Center-Site Number:8400019 | St Louis | Missouri | 63131 | — |
| Meridian Clinical Research, LLC-Site Number:8400005 | Raleigh | North Carolina | 27607 | — |
| Wake Forest University Baptist Medical Center-Site Number:8400116 | Winston-Salem | North Carolina | 27157 | — |
| The Ohio State University Wexner Medical Center-Site Number:8400150 | Columbus | Ohio | 43221 | — |
| Optimed Research, LTD-Site Number:8400147 | Columbus | Ohio | 43235 | — |
| Columbus Neuroscience-Site Number:8400010 | Westerville | Ohio | 40382 | — |
| Oklahoma Medical Research Foundation-Site Number:8400018 | Oklahoma City | Oklahoma | 73104 | — |
| Providence Multiple Sclerosis Center-Site Number:8400020 | Portland | Oregon | 97225 | — |
| University of Texas Southwestern Medical Center-Site Number:8400077 | Dallas | Texas | 75390 | — |
| Multiple Sclerosis Center, Swedish Neuroscience Institute-Site Number:8400121 | Seattle | Washington | 98122 | — |
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 156 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04410978, 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 NCT04410978 live on ClinicalTrials.gov.