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Evaluating Frexalimab for Adults with Nonrelapsing Secondary Progressive Multiple Sclerosis

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

Phase 3 Interventional Sanofi · NCT06141486

This study is testing if a new medication called frexalimab can help adults with nonrelapsing secondary progressive multiple sclerosis slow down their disability progression.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment900 (estimated)
Ages18 Years to 60 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsocrelizumab, ofatumumab, ublituximab, rituximab, frexalimab
Locations338 sites (Birmingham, Alabama and 337 other locations)
Trial IDNCT06141486 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled study aimed at assessing the efficacy and safety of frexalimab in adults diagnosed with nonrelapsing secondary progressive multiple sclerosis (nrSPMS). Participants aged 18 to 60 will receive either the treatment or a placebo over a period of up to 36 months, with regular monitoring through scheduled visits. The study will conclude once a predetermined number of disability progression events are recorded, ensuring a thorough evaluation of the drug's impact on delaying disability progression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with a diagnosis of nonrelapsing secondary progressive multiple sclerosis and documented evidence of disability progression.

Not a fit: Patients who have experienced clinical relapses in the past 24 months or those who do not meet the specific inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly delay disability progression in patients with nonrelapsing secondary progressive multiple sclerosis.

How similar studies have performed: Other studies have shown promise in treating multiple sclerosis with similar approaches, but the specific efficacy of frexalimab in this context is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 337 other locations

+288 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Sclerosis
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.