Participants:
Approximately 116 adults between 18-70 years of age
Check your eligibility now & get in touch with a study center
CHECK ELIGIBILITY
Are you between the ages of 18-70?
Have you been diagnosed with systemic lupus erythematosus (SLE) for at least 6 months?
What is SLE?
Systemic Lupus Erythematosus, often called lupus or SLE, is a long-lasting health condition that affects how your body's immune system works. Normally, your body's immune system protects you from illnesses, but in people with lupus, it gets confused and starts to attack the body's own healthy cells and tissues.
People with lupus may experience different symptoms, but some of the most common include pain, tiredness and aching or swollen joints. It's important to remember that lupus affects each person differently and symptoms can vary from mild to severe.
Doctors use various treatments to help manage lupus. The main goal of these treatments is to calm down the body's overactive defense system. This is often described as "suppressing the immune response."
To find out more visit the Lupus Foundation of America.
What is the study medication?
The study medication is still being tested, so it's not available for general use yet.
How does it work?
• Your immune system has a protein called CD40L.
• CD40L helps your body fight germs, but in autoimmune diseases, it can cause your immune system to attack your own body.
• The study drug attaches to CD40L, and this may help calm down your immune system and reduce attacks on your body.
What does this mean for you?
It could help limit your immune system's response against your own body. This might help reduce symptoms of your autoimmune disease.
Frequently Asked Questions
What can you expect during the study?
At your appointments, we'll do several checks to monitor your health:
- A physical exam, including checking your height, weight, and vital signs
- Assessments related to your lupus (SLE)
- An ECG test (a simple, painless test that checks your heart's electrical activity using electrodes placed on your skin)
- Blood and urine test
- Questionnaires about how you're feeling and how the treatment might be working
You'll receive the study medication or placebo in two ways:
- First treatment visit (about 6 hours): You'll get either the study medication or a placebo through an IV drip in your arm.
- Following treatment visits (about 2 hours each, every two weeks): You'll receive two small injections of either the study medication or placebo under the skin of your belly area.
What is a placebo?
A placebo looks like the medicine being tested and is also given in the same way as the medication that is being studied, but it does not have any medicine in it. During this study, you have a 1 in 2 chance (50%) of receiving the study medication or placebo.
Is there a cost to participate?
There is no cost to participate. All study-related exams, study-related medications and study-related medical care are provided. There is no insurance required to take part in this study. You may be compensated for time and travel.
Am I Eligible?
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 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.
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Version 1.0, 16Jan2025
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