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NCT03889639 · ClinicalTrials.gov registry record · Phase 2
Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
NCT03889639: Completed Phase 2 study, sponsored by Sanofi.
NCT03889639 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 130 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
NCT03889639, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
Study Summary
Primary Objective: To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions. Secondary Objectives: * To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures. * To evaluate the safety and tolerability of SAR442168.
Primary Outcome
Number of new Gd-enhancing T1-hyperintense lesions was detected by brain MRI at the end of 12 weeks of SAR442168 treatment (i.e., at Week 12 for Cohort 1 participants and Week 16 for Cohort 2 participants). Data was planned to be collected and analyzed on pooled population of participants at each dose level of SAR442168 (either in Cohort 1 and 2) and pooled population of participants receiving placebo in Cohort 2 and was not planned to collected during placebo administration in Cohort 1 (Weeks 1
Interventions
- DRUG Placebo
- DRUG SAR442168
- DRUG Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2019-03-29 |
| Est. Completion | 2020-01-02 |
| Phase | Phase 2 |
What the finished NCT03889639 record still lists
NCT03889639 is an interventional study that assigns participants to a tested intervention. The registered 130 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 3 interventions - of which Placebo is the first listed.
NCT03889639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03889639 about?
NCT03889639 is a clinical study titled "Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis". Primary Objective: To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions. Secondary Objectives: * To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures. * To evaluate the safety and tolerability of SAR442168.
What is the current status of trial NCT03889639?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2019-03-29. Estimated completion is 2020-01-02.
What interventions are being tested in trial NCT03889639?
The interventions under investigation include: Placebo (DRUG), SAR442168 (DRUG), Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI) (DRUG).
Who is sponsoring clinical trial NCT03889639?
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 NCT03889639's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 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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