A Phase 3 interventional study of Frexalimab and Teriflunomide in Multiple Sclerosis, sponsored by Sanofi. Active, not recruiting at 382 sites in 41 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.
Study details include:
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 1,655 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
The participant must have at least 1 of the following prior to screening:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Participants will receive Frexalimab infusion and placebo tablet.
Drug: Frexalimab · Drug: Placebo tablet · Drug: MRI contrast-enhancing agents · Drug: Cholestyramine · Drug: Activated charcoal
Participants will receive teriflunomide tablet and placebo infusion.
Drug: Teriflunomide · Drug: Placebo infusion · Drug: MRI contrast-enhancing agents · Drug: Cholestyramine · Drug: Activated charcoal
SAR441344 Solution for IV infusion
Aubagio oral tablet
Solution for IV infusion
Oral tablet
IV, as per respective label
oral, 8 g 3 times daily for 11 days for accelerated elimination procedure (4 g 3 times daily for 11 days in case of intolerance). The teriflunomide local label should be followed.
oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.
Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses
ARR during the study period assessed by protocol-defined adjudicated relapses. This endpoint will be analyzed in the ITT population of each study using a negative binomial model with the total number of adjudicated relapses per participant occurring during the observation period as the response variable and with terms for treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, ≥4), and geographical region (US, non-US).
Time frame: Until Week 156
Time to onset of composite confirmed disability worsening (cCDW)
confirmed over 6 months as assessed by the composite of: * increase from the baseline expanded disability status scale (EDSS) score of ≥1.5 points when the baseline is 0, or ≥1.0 point when the baseline is 0.5 to 5.0, or ≥0.5 point when the baseline is ≥5.5, OR * increase of ≥20% from the baseline time in the 9-hole peg test (9HPT), OR * increase of ≥20% from the baseline time in the Timed 25-foot walk (T25FW) test
Time frame: Until Week 156
Time to onset of cCDW, confirmed over 3 months
Time frame: Until Week 156
Time to onset of individual components of the composite, confirmed over 3-months or 6-months
Time frame: Until Week 156
Time to onset of confirmed disability improvement (CDI)
defined as decrease from baseline EDSS score of ≥1.0 or ≥ 0.5 points when the baseline is ≥2 to ≤5.5 or \>5.5 points, respectively, confirmed over 6 months. No improvement possible for 0 to 1.5 points
Time frame: Until Week 156
Progression independent of relapse activity defined as the time to onset of 6-month cCDW
defined by either no prior relapse or an onset more than 90 days after the start date of the last adjudicated relapse
Time frame: Until Week 156
Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI
defined as the sum of the individual number of new and/or enlarging T2 lesions at all scheduled visits starting after baseline up to and including the EOS visit
Time frame: Until Week 156
Total number of new Gd-enhancing T1hyperintense lesions per scan as detected by MRI
defined as the sum of the individual number of new Gd enhancing T1-hyperintense lesions at all scheduled visits starting after baseline up to and including the EOS visit divided by the number of scans
Time frame: Until Week 156
Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6
Time frame: From Week 24 to Week 156
Change in cognitive function at the EOS compared to baseline as assessed by the symbol digit modalities test (SDMT)
Time frame: From baseline to Week 156
Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time
Time frame: From baseline to Week 156
Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time
Time frame: Until Week 156
Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs and safety scales during the study period
Time frame: Until Week 168
Number of participants with potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG and vital signs during the study period
12-lead ECG (electrocardiogram) will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.
Time frame: Until Week 168
Number of participants with antidrug (ADAs) over time
Time frame: Until Week 156
Change from baseline in plasma neurofilament light chain (NfL) levels over time
Time frame: Until Week 144
Frexalimab plasma concentration over time
Time frame: Until Week 144
Showing the first 100 of 382 sites across 41 countries.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi