Since 2019, Dr. Knight and the APS Research Labs have been working with Dr. Doruk Erkan and his team at the Hospital for Special Surgery, APS ACTION, and researchers at both the National Institutes of Health and the Immune Tolerance Network to develop a first-of-its-kind clinical trial for individuals living with APS. We are thrilled to share that the trial is active, and we are currently recruiting patients to participate!
DARE-APS Study: We all know that new safe and effective treatments for APS are needed. In this research study, we will learn about the safety of the drug Darzalex® (daratumumab) in patients with APS and will also learn whether it reduces levels of the antiphospholipid antibodies that cause APS.
About the Study Drug: Daratumumab is an antibody that targets a protein called CD38, which is found on the surface of the immune cells that produce antiphospholipid antibodies (plasma cells). In APS, daratumumab may work by eliminating these antiphospholipid antibody-producing cells, thereby reducing damage to the body caused by antiphospholipid antibodies.
Daratumumab is currently approved by the U.S. Food and Drug Administration (FDA) to treat a blood cancer called multiple myeloma. However, it has not been tested in patients with APS and is therefore considered an experimental treatment in the DARE-APS study. There are a few case reports of daratumumab helping APS patients, but we need to study it more rigorously.
Participating in DARE-APS: Participation in DARE-APS will occur in two phases. During the treatment phase, participants will receive 8 weekly intravenous (IV) doses of daratumumab. The post-treatment follow-up phase will last an additional 10 months, during which 6 monitoring clinical visits will occur.
Eligibility: You may be eligible to participate in DARE-APS if you:
- Are between ages 18 and 70
- Have a diagnosis of APS
- Do not have lupus
- Have had certain problems associated with APS such as blood clots or pregnancy complications
Updates: We are looking for eligible individuals to participate starting in January 2024! We can only enroll a certain number of participants at a time, but we will keep a waitlist if there are many interested individuals.
Learn More: To learn more, visit the DARE-APS website.
Our site (University of Michigan in Ann Arbor, MI) and several others are actively recruiting for this study! If you think that you may be eligible and would like to be considered for participation, you may contact us: MichiganANSWERS@med.umich.edu or 734-647-3949.
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