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NCT04410978 · ClinicalTrials.gov registry record · Phase 3
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 974
- Enrollment target
NCT04410978: Completed Phase 3 study, sponsored by Sanofi.
NCT04410978 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 974 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04410978, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 974 participants
- Enrollment target
Study Summary
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
Primary Outcome
Multiple sclerosis (MS) relapse was defined as a monophasic, acute or subacute onset of new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Symptoms were attributable to MS, lasted for \>=24 hours with or without recovery, present at normal body temperature, and preceded by \>=30 days of clinical stability.
Interventions
- DRUG Teriflunomide
- DRUG Tolebrutinib
- DRUG Placebo to match Tolebrutinib
- DRUG Placebo to match Teriflunomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 974 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2024-07-15 |
| Phase | Phase 3 |
What the finished NCT04410978 record still lists
NCT04410978 is an interventional study that assigns participants to a tested intervention. The registered 974 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 4 interventions - of which Teriflunomide is the first listed.
NCT04410978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04410978 about?
NCT04410978 is a clinical study titled "Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)". 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 (Aubag...
What is the current status of trial NCT04410978?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 974 participants. The study started on 2020-06-30. Estimated completion is 2024-07-15.
What interventions are being tested in trial NCT04410978?
The interventions under investigation include: Teriflunomide (DRUG), Tolebrutinib (DRUG), Placebo to match Tolebrutinib (DRUG), Placebo to match Teriflunomide (DRUG).
Who is sponsoring clinical trial NCT04410978?
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 NCT04410978's enrollment target sits among peer trials
974 328th of 2000 higher than 1,672 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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