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

Investigating the Effect of an Investigational Medication on a Form of Multiple Sclerosis Where Symptoms Come and Go

Recruiting
18 years - 55 years
All
Phase 3
1400 participants needed
17 Locations

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 13 Jan 2025. Study ID: NCT06141473

This study investigates the effect of an investigational medication compared to a daily oral dose of another treatment in people with relapsing forms of multiple sclerosis (MS). Multiple sclerosis is a condition where the immune system attacks the protective covering of nerves, which can lead to various physical and mental symptoms. The study aims to measure the annualized relapse rate, which refers to how often relapses occur over a year.

Participants will undergo scheduled visits that include a common end of study visit and follow-up visits. Initially, visits will occur every 4 weeks for the first 6 months, then every 3 months thereafter. The study will involve taking either the investigational medication or a daily oral dose of another treatment. A placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine, may also be used.

  • Who can participate: Adults aged 18 to 55 years with relapsing forms of multiple sclerosis can participate. They must have an EDSS score of 5.5 or lower and meet specific relapse or MRI criteria.
  • Study Details: Participants will take either the investigational medication or a daily oral dose of another treatment. A placebo may be used, which is an inactive substance that looks like the investigational medication but contains no medicine.
  • Study Visits: The study requires 4 visits.

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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