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Phase III

Efficacy and safety study of frexalimab (SAR441344) in adults with nonrelapsing secondary progressive Multiple Sclerosis

  • Study HIC#:2000036443
  • Last Updated:07/25/2024

Is your MS progressing?

There are few effective treatment options available for people with non-relapsing, secondary progressive MS. Frexalimab is a monoclonal antibody that binds to and disrupts a protein called CD40L, which is found on certain white blood cells and is necessary for them to function. Frexalimab is being studied as a treatment for people with secondary progressive MS in a randomized, placebo controlled clinical trial (Freviva).

This is a Phase 3 trial, designed to see whether the investigational medicine works in this group of patients and whether it is safe. Participants will be randomly selected to receive placebo or the study drug; each participant has a 2 out of 3 chance of getting the active medication. Neither you nor your doctor will know which treatment you received until after the study is over. The study will provide study drug (a monthly infusion), blood testing and MRIs throughout the entire study, and study participation will last approximately 4.5 years.

  • Age18 years - 60 years
  • GenderBoth

Contact Us

For more information about this study, including how to volunteer, contact:

Dimitri Duvilaire

Help Us Discover!

You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

Trial Purpose and Description

Is your MS progressing?

There are few effective treatment options available for people with non-relapsing, secondary progressive MS. Frexalimab is a monoclonal antibody that binds to and disrupts a protein called CD40L, which is found on certain white blood cells and is necessary for them to function. Frexalimab is being studied as a treatment for people with secondary progressive MS in a randomized, placebo controlled clinical trial (Freviva).

This is a Phase 3 trial, designed to see whether the investigational medicine works in this group of patients and whether it is safe. Participants will be randomly selected to receive placebo or the study drug; each participant has a 2 out of 3 chance of getting the active medication. Neither you nor your doctor will know which treatment you received until after the study is over. The study will provide study drug (a monthly infusion), blood testing and MRIs throughout the entire study, and study participation will last approximately 4.5 years.

Eligibility Criteria

Are you eligible?


  • You are diagnosed with secondary progressive MS
  • Your MS is continuing to get worse, despite available treatment options


Principal Investigator

For more information about this study, including how to volunteer, contact: