CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 974 enrolled
Drug / intervention
Tolebrutinib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04410978
NCT04410978Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis

Sanofi·interventional·Posted Jun 1, 2020·Updated Jul 2, 2025

In Brief

A Phase 3 clinical trial evaluating Tolebrutinib, Teriflunomide, and 2 other interventions for Relapsing Multiple Sclerosis. Completed, enrolled 974 participants across 179 sites in 24 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesAustria, Belarus, Bulgaria, Canada, China, Czechia, Denmark, Estonia, Finland, Germany, Hong Kong, Italy, Japan, Lithuania, Mexico, Poland, Romania, Russia, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 1, 2020
Enrollment StartJun 30, 2020
Primary CompletionJul 15, 2024
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 6.1 years ago

Interventions

Tolebrutinibdrug

Pharmaceutical form: Tablet Route of administration: Oral

Teriflunomidedrug

Pharmaceutical form: Tablet Route of administration: Oral

Placebo to match Tolebrutinibdrug

Pharmaceutical form: Tablet Route of administration: Oral

Placebo to match Teriflunomidedrug

Pharmaceutical form: Tablet Route of administration: Oral