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Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-study-of-frexalimab-sar441344-in-adults-c4ba81f9-dccd-48a4-a008-c27c9f6f3486 > Record changed: 2026-11-04 # Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis NCT06141486 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) Participants 943 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) Lead sponsor Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) Start date 2023-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) Number of sites 311 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## Title and summary **Summary** 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: \* This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. \* The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. \* If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Acronym** FREVIVA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Short title** Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Official title** A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## Dates **Completion date** 2028-03-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **First posted** 2023-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Registry last updated** 2026-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Primary completion date** 2028-03-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Start date** 2023-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## Size and sites **Actual participants** 943 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Participants** 943 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Number of sites** 311 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Lead sponsor** Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## Identifiers **Registry ID** NCT06141486 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **ClinicalTrials.gov ID** NCT06141486 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## Outcomes ### Primary outcomes 1. Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period Timeframe: Up to 36 months 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 ### Secondary outcomes 1. Time to onset of composite cCDP confirmed over 3 months in the double-blind treatment period Timeframe: Up to 36 months 2. Time to onset of individual components of the composite, confirmed over 3-months or 6 months in the double-blind treatment period Timeframe: Up to 36 months 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 3. Time to onset of confirmed disability improvement (CDI) in the double-blind treatment period Timeframe: Up to 36 months 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. 4. 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 Timeframe: Up to 36 months 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 5. Percent change in brain volume loss as detected by MRI scans at the end of double-blind treatment period compared to Month 6 Timeframe: Up to 36 months 6. Change in cognitive function at the end of double-blind treatment period compared to baseline as assessed by symbol digit modalities test (SDMT) Timeframe: Baseline, Up to 36 months 7. Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time in the double-blind treatment period Timeframe: Baseline, Up to 36 months 8. Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time in the double-blind treatment period Timeframe: Baseline, Up to 36 months 9. Annualized relapse rate during the double-blind treatment period assessed by protocol defined adjudicated relapses Timeframe: Up to 36 months 10. Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation and AE of special interests (AESIs) Timeframe: Up to 36 months 11. Number of participants with potentially clinically significant abnormalities (PCSAs) in laboratory tests, ECG, and vital signs during the study period Timeframe: Up to 36 months 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. 12. Number of participants with antibody over time Timeframe: Up to 36 months 13. Change from baseline in serum Ig levels over time Timeframe: Up to 36 months 14. Change from baseline in plasma neurofilament light chain (NfL) levels over time in the double-blind treatment period Timeframe: Up to 36 months 15. Frexalimab plasma concentration over time in the double-blind treatment period Timeframe: Up to 36 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** No ### Inclusion criteria - Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria. - Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee. - Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee. - Absence of clinical relapses for at least 24 months. - The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive. - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment. ### Exclusion 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 immunoglobulin levels (IgG and/or IgM) below the lower limits of normal (LLN) at Screening or a history of primary hypogammaglobulinemia. Patients with a history of secondary hypogammaglobulinemia induced by anti-C20 monoclonal antibodies (eg, ocrelizumab, ofatumumab, ublituximab, rituximab) may be considered for study inclusion provided their immunoglobulin levels are within the normal limits (WNL) at time of Screening. - 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 sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. - The participant was previously exposed to frexalimab. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## Sites - Alabama Neurology Associates- Site Number : 8400115Homewood, United States - Perseverance Research Center- Site Number : 8400138Scottsdale, United States - Imaging Endpoints- Site Number : 8400050Scottsdale, United States - Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134Berkeley, United States - University of California Irvine - School of Medicine- Site Number : 8400143Irvine, United States - University of California San Diego - La Jolla- Site Number : 8400095La Jolla, United States - Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184Los Angeles, United States - Hoag Memorial Hospital Presbyterian- Site Number : 8400031Newport Beach, United States - Stanford Neuroscience Health Center- Site Number : 8400120Palo Alto, United States - West Hollywood, United States - University of Colorado - Anschutz Medical Campus- Site Number : 8400001Aurora, United States - Advanced Neurology of Colorado- Site Number : 8400148Fort Collins, United States - Yale University School of Medicine- Site Number : 8400081New Haven, United States - Hartford Healthcare Medical Group- Site Number : 8400069Norwich, United States - MedStar Georgetown University Hospital- Site Number : 8400044Washington D.C., United States - Neurology of Central Florida- Site Number : 8400147Altamonte Springs, United States - MS & Neuromuscular Center of Excellence- Site Number : 8400015Clearwater, United States - Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054Gainesville, United States - Neurology Associates - Maitland- Site Number : 8400010Maitland, United States - Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060Orlando, United States - Axiom Clinical Research of Florida- Site Number : 8400049Tampa, United States - University of South Florida- Site Number : 8400013Tampa, United States - Palm Beach Neurology- Site Number : 8400105West Palm Beach, United States - Joi Life Wellness Group LLC- Site Number : 8400192Smyrna, United States - Rush University Medical Center- Site Number : 8400102Chicago, United States And 286 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## References ### Other registry identifiers (3) - 2023 - 2023-504359-29 - U1111-1280-7114 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06141486) ## Related records ### Drugs (1) - [Frexalimab](https://trialight.com/data/asset/frexalimab-1bb81466-d62a-41c9-8b80-76bdac85ccb3.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 --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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