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NCT03996291 · ClinicalTrials.gov registry record · Phase 2
Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
NCT03996291: Completed Phase 2 study, sponsored by Sanofi.
NCT03996291 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 125 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03996291, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
Study Summary
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
Primary Outcome
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs
Interventions
- DRUG Tolebrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2019-09-23 |
| Est. Completion | 2024-11-26 |
| Phase | Phase 2 |
What the finished NCT03996291 record still lists
NCT03996291 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Tolebrutinib is the first listed.
NCT03996291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03996291 about?
NCT03996291 is a clinical study titled "Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis". 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
What is the current status of trial NCT03996291?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2019-09-23. Estimated completion is 2024-11-26.
What interventions are being tested in trial NCT03996291?
The interventions under investigation include: Tolebrutinib (DRUG).
Who is sponsoring clinical trial NCT03996291?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03996291's enrollment target sits among peer trials
125 558th of 2000 higher than 1,437 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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