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Tiger, Multiple Sclerosis (MS) Patient

Do you have non-relapsing MS (nrSPMS)?

We are seeking participants between the ages of 18 and 60 who have been diagnosed with Secondary Progressive Multiple Sclerosis (SPMS) for a clinical trial.


If you are interested in learning more about this study, 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.

What is the investigational medication?

This clinical trial is using an investigational medication, which means it is not yet approved in Australia to treat Secondary Progressive Multiple Sclerosis, and can only be used in research studies like this one.  It 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). 

This study is testing the investigational medication to see if it is effective in limiting the abnormal immune response against brain tissue.  The investigational medication will be given every four weeks intravenously (IV).

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    Study length
    Approximately 58 months (4.5 years)
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    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 a visit every 3 months for the following years.  

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    Chance of receiving placebo

    You will have a 2 in 3 chances of 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
Double-blind

A trial where neither the participant or the site knows whether the participant is receiving the investigational medication or placebo.   

Terms
to
know

Placebo

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

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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.  You may be reimbursed for any reasonable travel, parking, meals and other costs associated with the research project visit.  

What is expected during the study?

Participation in this study means that you agree to the following to ensure your safety and the ability of the study to produce reliable new knowledge.  You can choose to stop participating in the study at any time.  

  • Provide 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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