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Evaluating Frexalimab for Relapsing Multiple Sclerosis

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

Phase 3 Interventional Sanofi · NCT06141473

This study is testing a new drug called frexalimab to see if it works better than teriflunomide for adults with relapsing multiple sclerosis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1600 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsfrexalimab
Locations384 sites (Birmingham, Alabama and 383 other locations)
Trial IDNCT06141473 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of frexalimab compared to teriflunomide in adults with relapsing forms of multiple sclerosis. Participants aged 18 to 55 will be monitored for their annualized relapse rate over a variable duration of 12 to 40 months. The study includes regular follow-up visits and MRI assessments to track disease progression and treatment response. The trial will involve both active treatments and placebo controls to ensure robust data collection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 diagnosed with relapsing forms of multiple sclerosis who meet specific inclusion criteria.

Not a fit: Patients with primary progressive multiple sclerosis or those with significant risk factors for infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce relapse rates in patients with relapsing multiple sclerosis.

How similar studies have performed: Previous studies have shown promise in using similar monoclonal antibody approaches for treating multiple sclerosis, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 383 other locations

+334 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 2026-06-09 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.