A Phase 3 interventional study of Frexalimab and Placebo in Multiple Sclerosis, sponsored by Sanofi. Active, not recruiting at 311 sites in 27 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS 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 943 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.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Frexalimab IV administration
Drug: Frexalimab · Drug: MRI contrast-enhancing agents
Matching placebo
Drug: Placebo · Drug: MRI contrast-enhancing agents
SAR441344 Solution for IV infusion
Solution for IV infusion
IV, as per respective label
Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period
Defined as Increase from the baseline expanded disability status scale (EDSS) score of ≥1.0 point when the baseline is \<5.5, 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: Up to 36 months
Time to onset of composite cCDP confirmed over 3 months in the double-blind treatment period
Time frame: Up to 36 months
Time to onset of individual components of the composite, confirmed over 3-months or 6 months in the double-blind treatment period
increase from the baseline EDSS score of ≥1.0 point when the baseline is \<5.5, or ≥0.5 point when the baseline is ≥5.5
Time frame: Up to 36 months
Time to onset of confirmed disability improvement (CDI) in the double-blind treatment period
defined as decrease from the baseline EDSS score of ≥1.0 or ≥ 0.5 points when baseline is ≤5.5 or \>5.5 points, respectively, confirmed over 6 months.
Time frame: Up to 36 months
Number of new and/or enlarging T2hyperintense lesions per scan as detected by MRI, and number of new and/or enlarging T2-hyperintense lesions per scan as detected by MRI
defined as the sum of the individual number of new and/or enlarging T2-hyperintense lesions at all scheduled visits starting after baseline up to the end of double-blind treatment period
Time frame: Up to 36 months
Percent change in brain volume loss as detected by MRI scans at the end of double-blind treatment period compared to Month 6
Time frame: Up to 36 months
Change in cognitive function at the end of double-blind treatment period compared to baseline as assessed by symbol digit modalities test (SDMT)
Time frame: Baseline, Up to 36 months
Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time in the double-blind treatment period
Time frame: Baseline, Up to 36 months
Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time in the double-blind treatment period
Time frame: Baseline, Up to 36 months
Annualized relapse rate during the double-blind treatment period assessed by protocol defined adjudicated relapses
Time frame: Up to 36 months
Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation and AE of special interests (AESIs)
Time frame: Up to 36 months
Number of participants with potentially clinically significant abnormalities (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: Up to 36 months
Number of participants with antibody over time
Time frame: Up to 36 months
Change from baseline in serum Ig levels over time
Time frame: Up to 36 months
Change from baseline in plasma neurofilament light chain (NfL) levels over time in the double-blind treatment period
Time frame: Up to 36 months
Frexalimab plasma concentration over time in the double-blind treatment period
Time frame: Up to 36 months
Showing the first 100 of 311 sites across 27 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 May 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