HZNP-DAZ-303 (Sjogren's Syndrome) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called dazodalibep (the study drug) can improve symptoms for people who have Sjogren's Syndrome.
Sjogren's Syndrome
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with Sjogren's Syndrom
- Are not using a biologic medication or steroid to manage symptoms
- Do not have cancer or any chronic infection disease (e.g., HIV or Hepatitis C)
For more information, contact the study team at julianna.ethridge@duke.edu.
What is Involved?
If you choose to join this study, you will get a random assignment to 1 of 2 study groups. Depending on your assignment, you will either:
- Get the study drug; OR
- Get a placebo (inactive substance that has no drug in it)
You will have a 2-in-3 chance of being assigned to take the study drug and a 1-in-3 chance of being assigned to take a placebo.
The study drug targets receptors on T cells (immune cells in the blood) to block the activation of B cells. This drug mechanism is meant to decrease the overactivity of the immune system that is present in Sjogren's Syndrome.
The study drug and placebo are given as intravenous (IV) infusions. The infusions are once a month and participants will get the infusions in the study for up to 1 year.