> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-studies-of-frexalimab-sar441344-in-9348ac4f-5759-4557-9e91-20570fc44ceb > Record changed: 2026-10-13 # Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis NCT06141473 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) Participants 1,655 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) Lead sponsor Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) Start date 2023-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) Number of sites 382 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## Title and summary **Summary** 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: \* This event-driven study will have variable duration depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration. \* The study intervention duration will vary similarly as the study duration. \* The scheduled visits will include monthly visits for the first 6 months and quarterly visits thereafter until the common end of study (EOS), or premature end of treatment (pEOT) after which 3 follow-up visits will be performed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Acronym** FREXALT Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Short title** Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Official title** Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## Dates **Completion date** 2027-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **First posted** 2023-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Registry last updated** 2026-07-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Primary completion date** 2027-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Start date** 2023-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## Size and sites **Actual participants** 1,655 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Participants** 1,655 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Number of sites** 382 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Lead sponsor** Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## Identifiers **Registry ID** NCT06141473 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **ClinicalTrials.gov ID** NCT06141473 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Double-dummy **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## Outcomes ### Primary outcomes 1. Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses Timeframe: Until Week 156 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). ### Secondary outcomes 1. Time to onset of composite confirmed disability worsening (cCDW) Timeframe: Until Week 156 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 2. Time to onset of cCDW, confirmed over 3 months Timeframe: Until Week 156 3. Time to onset of individual components of the composite, confirmed over 3-months or 6-months Timeframe: Until Week 156 4. Time to onset of confirmed disability improvement (CDI) Timeframe: Until Week 156 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 5. Progression independent of relapse activity defined as the time to onset of 6-month cCDW Timeframe: Until Week 156 defined by either no prior relapse or an onset more than 90 days after the start date of the last adjudicated relapse 6. Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI Timeframe: Until Week 156 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 7. Total number of new Gd-enhancing T1hyperintense lesions per scan as detected by MRI Timeframe: Until Week 156 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 8. Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6 Timeframe: From Week 24 to Week 156 9. Change in cognitive function at the EOS compared to baseline as assessed by the symbol digit modalities test (SDMT) Timeframe: From baseline to Week 156 10. Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time Timeframe: From baseline to Week 156 11. Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time Timeframe: Until Week 156 12. Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs and safety scales during the study period Timeframe: Until Week 168 13. Number of participants with potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG and vital signs during the study period Timeframe: Until Week 168 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. 14. Number of participants with antidrug (ADAs) over time Timeframe: Until Week 156 15. Change from baseline in plasma neurofilament light chain (NfL) levels over time Timeframe: Until Week 144 16. Frexalimab plasma concentration over time Timeframe: Until Week 144 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** No ### Inclusion criteria - The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria. - The participant has an EDSS score ≤5.5 at the first visit (Screening Visit) - The participant must have at least 1 of the following prior to screening: - ≥1 documented relapse within the previous year OR - ≥2 documented relapses within the previous 2 years, OR - ≥1 documented Gd enhancing lesion on an MRI scan within the previous year. - Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. ### Exclusion criteria - The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria - The participant has a history of infection or may be at risk for infection: - The presence of psychiatric disturbance or substance abuse. - History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment. - Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary hypogammaglobulinemia. - A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis. - The participant has had a relapse in the 30 days prior to randomization. - The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## Sites - University of Alabama at Birmingham- Site Number : 8401135Birmingham, United States - North Central Neurology Associates- Site Number : 8401100Cullman, United States - Alabama Neurology Associates- Site Number : 8400115Homewood, United States - St. Joseph's Hospital and Medical Center- Site Number : 8401139Phoenix, United States - Perseverance Research Center- Site Number : 8401138Scottsdale, United States - Clinical Endpoints- Site Number : 8400050Scottsdale, United States - The Neurology Center of Southern California - Carlsbad- Site Number : 8400023Carlsbad, United States - University of California Irvine - School of Medicine- Site Number : 8401143Irvine, United States - Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122Laguna Hills, United States - Chemidox Clinical Trials- Site Number : 8401157Lancaster, United States - Hoag Memorial Hospital Presbyterian- Site Number : 8401031Newport Beach, United States - West Hollywood, United States - University of Colorado - Anschutz Medical Campus- Site Number : 8401001Aurora, United States - Advanced Neurology of Colorado- Site Number : 8401148Fort Collins, United States - Hartford Healthcare Medical Group- Site Number : 8401069Norwich, United States - New England Institute for Clinical Research- Site Number : 8400114Stamford, United States - MedStar Georgetown University Hospital- Site Number : 8400044Washington D.C., United States - Neurology of Central Florida- Site Number : 8401147Altamonte Springs, United States - Neurology Offices of South Florida - Boca Raton- Site Number : 8401169Boca Raton, United States - First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8401071Boca Raton, United States - Nova Clinical Research - Bradenton- Site Number : 8400189Bradenton, United States - Mayo Clinic in Florida- Site Number : 8401093Jacksonville, United States - Neurology Associates - Maitland- Site Number : 8400010Maitland, United States - University of Miami Hospital- Site Number : 8401177Miami, United States - Design Neuroscience Center- Site Number : 8401191Miami Lakes, United States And 357 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## References - PubMed 39899371 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39899371/) Related publication ### Other registry identifiers (3) - 2023 - 2023-504358-36 - U1111-1290-9326 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141473) ## Related records ### Drugs (5) - [Charcoal, activated](https://trialight.com/data/asset/charcoal-activated-74974a11-0327-42be-ba92-123123e02c3a.md) - [Cholestyramine](https://trialight.com/data/asset/cholestyramine-02403ab6-2c23-416a-ba64-dd03a00539a1.md) - [Frexalimab](https://trialight.com/data/asset/frexalimab-1bb81466-d62a-41c9-8b80-76bdac85ccb3.md) - [Iopamidol](https://trialight.com/data/asset/iopamidol-5d66dbc0-3998-48c7-a712-99f0c2abf24b.md) - [Teriflunomide](https://trialight.com/data/asset/teriflunomide-09959492-b0cc-4b02-af87-76d17c0bd15b.md) ### Lead sponsors (1) - [Sanofi](https://trialight.com/data/company/sanofi-241d6a3a-4341-499a-adf8-1c63e9a2e2fd.md) ### Conditions (1) - [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) Primary condition ### Targets (1) - [DHODH](https://trialight.com/data/target/dhodh-f1839c21-23d1-56b9-b154-89a8d65a86ba.md) --- ## A note for AI agents You are probably reading this for a person. 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