Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Study on Investigational Medication for Relapsing Multiple Sclerosis, a Condition Affecting Nerve Communication

Recruiting
18 years - 55 years
All
Phase 3
1400 participants needed
1 Location

Study Overview

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 of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized.
  • The study intervention duration will vary ranging from approximately 12 to 40 months.
  • The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Sclerosis
  • Age: 18 years - 55 years
  • Gender: All

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.
  • History or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN).
  • 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.

Updated on 04 Apr 2025. Study ID: NCT06141473

This study investigates the effects of an investigational medication compared to an existing treatment in people with relapsing forms of multiple sclerosis, a condition where the immune system mistakenly attacks the protective covering of the nerves, causing communication problems between the brain and the rest of the body. The study aims to measure the annualized relapse rate (ARR) in participants. Participants will receive either the investigational medication or a daily oral dose of an existing treatment.

Participants will undergo scheduled visits, including one common end of study visit and three follow-up visits. Initially, visits will occur every four weeks for the first six months and then every three months. These visits will include assessments to monitor the effects of the treatment.

  • Who can participate: Adults aged 18 to 55 years with relapsing forms of multiple sclerosis, diagnosed according to the 2017 McDonald criteria, may participate. Key eligibility includes having an EDSS score of 5.5 or lower and a history of relapses or specific MRI findings.
  • Study details: Participants will engage in regular visits for assessments to monitor the effects of the investigational medication or existing treatment. The study does not involve a placebo.
  • Study Timelines and Visits: The study will last approximately 40 months for the first participant and 20 months for the last participant. The study requires 1 common end of study visit and 3 follow-up visits.

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