Do you have relapsing MS (RMS) or non-relapsing MS (nrSPMS)? Click to find out more about the study.

Sanofi believes that everyone should have the opportunity to take part in clinical trials. It is important to include people who have been historically under-represented in clinical trials. Sanofi is committed to inclusivity in our studies.

If you are interested in learning more about these studies, we encourage you to complete a brief questionnaire to help determine if you may qualify to participate and be referred to a site recruiting in your area for further evaluation.

Learn more about MS

What is the investigational medication?

Frexalimab is a monoclonal antibody (mAb) that binds to and disrupts the activity of a protein found on the surface of certain white blood cells. This protein is called “CD40 ligand” (CD40L) and plays an important role in the part of the immune system that is responsible for the specific immune response to fight a pathogen (“germ”) that may cause sickness. Blocking CD40L can partly block this response including the ability to make antibodies to the pathogen “germ”. In patients with an autoimmune disease, like MS, the body’s immune system attacks brain tissue causing symptoms you experience, and lesions seen in special examinations such as magnetic resonance imaging (MRI). The study drug may help limit this abnormal immune response against brain tissue.

The investigational medication will be given every four weeks intravenously (IV).

Do you have relapsing MS (RMS)?

The purpose of this study is to compare the investigational medication to the standard of care in RMS, teriflunomide (daily dose), in reducing relapse frequency and in slowing the progression of disability in RMS and to assess its safety and tolerability.

1400Participants

39Approximate countries

Am I Eligible?

Study length
Approximately 47 months (4 years)
Number of study visits
Monthly infusions (which may be completed at home after 6 months), 14 study visits at the study site during the first year then quarterly visits

Study length
Approximately 58 months (4.5 years)
Number of study visits
Monthly infusions (which may be completed at home after 6 months), 14 study visits at the study site during the first year then quarterly visits
Chance of receiving placebo
You will have a 2 in 3 chances in receiving the investigational medication or a 1 in 3 chance of receiving a placebo

Do you have non-relapsing MS (nrSPMS)?

The purpose of this study is to compare the investigational medication to placebo in delaying disease progression and to assess its safety and tolerability.

858Participants

25Countries

Am I Eligible?

Terms to know

Double-blind

A trial where neither the patient or the site knows what the patient is receiving.

Placebo

A medication that looks like the investigational medication, but has no medication.

Double-dummy

The use of two different placebos to achieve blinding when the treatments being compared in a study are different. For example, when the investigational medication is an IV and the standard of care is a tablet.

Clinical Trial Q&A

Study FAQ

Is there a cost to participate?

Trial-related procedures and study medication will be provided at no cost. Home infusion may be made available. Additionally, transportation to the site may be provided.

What is expected during the study?

Participation in this study means that you agree to follow certain study rules. Your safety and the ability of the study to produce reliable new knowledge depend on it.

Provide truthful information about your medical condition(s) and drug(s) that you have been taking
Inform your study doctor before stopping or modifying your treatment(s) or before starting any new treatment(s)
Attend the scheduled visits and allow the tests or procedures to be performed, which include: physical exams, blood and urine testing, electrocardiograms, questionnaires, walking test, 9-hole peg tests, and MRIs
Follow your study doctor’s instructions regarding the study drug’s administration
Inform your study doctor or study staff, as soon as possible, of any side effects or health problems even if you do not think they are caused by the study drug

Can I speak with someone if I have questions?

Yes, after you complete the online questionnaire and give permission to be contacted, a study representative will contact with you. You can ask questions at any time, before deciding to participate and during study conduct.

Version 1.0, 27Mar2024
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