Participants
Approximately 124 individuals
Check your eligibility now & get in touch with a study center
CHECK ELIGIBILITYCheck your eligibility now & get in touch with a study center
CHECK ELIGIBILITYCheck your eligibility now & get in touch with a study center
CHECK ELIGIBILITYCheck your eligibility now & get in touch with a study center
CHECK ELIGIBILITYCheck your eligibility now & get in touch with a study center
CHECK ELIGIBILITYWhat is IgG4-RD?
IgG4-related disease (IgG4-RD) is a rare condition where your immune system becomes overactive. This can cause swelling in different parts of your body, creating soft lumps that usually don't hurt. If not treated, the swelling can damage your organs and affect how well they work.
Most people with IgG4-RD are treated with medicines called steroids or other medications that help control the immune system's activity
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What is the investigational study drug and purpose of the study?
The investigational study drug, Rilzabrutinib, is a pill you take by mouth. It works by blocking a protein in your body called Bruton's Tyrosine Kinase (BTK), which is involved in the immune system response that causes inflammation in conditions like IgG4-RD.
The investigational study drug is still being tested, so it's not available for general use yet. You have a 1 in 2 chance (50%) of receiving the investigational study drug or placebo.
What can you expect during the study?
At your appointments, the following may be reviewed:
Physical exam
Review of medical information, vital signs, height, weight.
Imaging
Imaging of internal organs using a combination of the following: computed tomography (CT), magnetic resonance imaging (MRI), x-rays, positron emission tomography (PET) or ultrasound to identify organs affected and assess disease.
ECG (electrocardiogram)
Recording of the electrical activity of the heart over a short period of time, using electrodes placed on your skin.
Blood and urine tests
Questionnaires
Completed electronically onsite to better understand your experience with the disease.
Paper diary
Completed at home daily for medication compliance.
FAQs - frequently asked questions:
What is a placebo?
What is a placebo?
A placebo looks like the investigational study drug being tested and is also given in the same way, but it does not have any medicine in it.
Is there a cost to participate?
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.
Find a site near you
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 July 2025
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