FREVIVA: Efficacy and Safety Study of Frexalimab (SAR441344) in Adults with Nonrelapsing Secondary Progressive Multiple Sclerosis (FREVIVA)

Clinical Trial Title

A Phase 3 randomized, double-blind, efficacy and safety study comparing SAR441344 to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis

National Clinical Trial Number:

NCT06141486

Contact Information

Becca McWilliams

Clinical Trial Protocol Description:

The main objective of this study is to assess the efficacy and safety of frexalimab* compared to the efficacy and safety of a placebo in delaying disability progression in nrSPMS. This will be evaluated by the assessment of your functioning, to be confirmed after a 6-month interval, and it will be measured by the assessment of the disability status, or changes in walking, or changes in manual dexterity. It will also be assessed by imaging of your brain by MRI, which shows disease activity of MS.

*The study evaluates an investigational drug frexalimab for the treatment of nrSPMS. Frexalimab is not approved by the U.S. Food and Drug Administration (FDA) for use in patients who have MS and is considered an investigational new drug.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
  • Have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
  • Have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.
  • Have had absence of clinical relapses for at least 24 months.
  • 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.

You will be excluded from the study if any of the following criteria apply to you:

  • Have a history of infection or may be at risk for infection.
  • Have the presence of psychiatric disturbance or substance abuse.
  • Have a 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.
  • Have a history or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN).
  • Have 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.
  • Have 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.
  • Have been previously exposed to frexalimab.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Thomas Shoemaker, MD

Becca McWilliams

Clinical Trial Location

Rush University Medical Center

Location

Rush University Medical Center

1620 W Harrison St
Chicago, IL 60612

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