Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 974 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04410978
The ClinicalTrials.gov registry entry for NCT04410978 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 974 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Teriflunomide is the first listed.
NCT04410978 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.