Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
Public ClinicalTrials.gov record NCT03996291. 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
Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To determine the long-term safety and tolerability of SAR442168 in RMS participants Secondary Objective: To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods
Study identification
- NCT ID
- NCT03996291
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 125 participants
Conditions and interventions
Conditions
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
- Sep 23, 2019 (Actual)
- Primary completion
- Nov 26, 2024 (Actual)
- Completion
- Nov 26, 2024 (Actual)
- Last update posted
- Oct 23, 2025
2019 – 2024
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Central Neurology Associates, PC Site Number : 8400005 | Cullman | Alabama | 35058 | — |
| Neurology Associates, PA Site Number : 8400002 | Maitland | Florida | 32761 | — |
| University of South Florida Site Number : 8400009 | Tampa | Florida | 33612 | — |
| Velocity Clinical Research Site Number : 8400007 | Savannah | Georgia | 31406 | — |
| Consultants In Neurology Site Number : 8400001 | Northbrook | Illinois | 60062 | — |
| UC Health, LLC Site Number : 8400008 | Dayton | Ohio | 45417 | — |
| MDH Research LLC Site Number : 8400006 | Westerville | Ohio | 43081 | — |
| Neurology PC Site Number : 8400003 | Knoxville | Tennessee | 37922 | — |
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 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03996291, 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 Oct 23, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03996291 live on ClinicalTrials.gov.