Frequently Asked Questions

General Study Questions

Are there any possible benefits of being in the study?

Taking part in this study may or may not help to treat your IgG4-related disease. Your health could improve, stay the same, or get worse. However, the data we get from you during this study may help doctors learn more about the study drug and whether or not it provides benefit to patients with IgG4-related disease, and this may help future patients with IgG4-related disease.

Are there any possible risks from the study treatment?

All drugs have some risks, which may include things that could make you feel unwell, uncomfortable, or harm you. Your health will be closely monitored during the entire study. It is very important to tell the study doctor if you notice any changes in your health or if anything is bothering you.

Will it cost me anything to be in the study?

Taking part in this study will not cost you anything. You will not be charged for the study drug or any of the tests that are part of the study. The sponsor will not pay for doctor visits or other treatments or tests that are not part of this study.
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Prepaid travel arrangements and expense reimbursements are available. Expense reimbursements include meals, mileage, tolls, parking, and other study-related travel expenses.

How long will I be in the study?

The main study (Part A) lasts about 1year and 3 months (64 weeks). You may have the option to continue taking the active study drug at the end of your participation in Part A of the study by enrolling in the Part B, an open-label extension (OLE) study. The OLE lasts 1year.

Who is sponsoring the study?

Zenas BioPharma is sponsoring the study. They pay the study doctor and study site to run this study.

What if I decide to join the study and then change my mind?

Being in the study is completely voluntary. If you decide to join and then change your mind, you can leave the study at any time.
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If you leave the study early or if you stop taking the study drug early and decide to leave the study, the study doctor will ask you to complete one more visit, which may include a final health exam and lab tests, for your own safety.

What's the first step I should take?

If you are interested in learning more about the INDIGO study, click here.

Have Questions?

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