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.
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.
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 65
- Have a diagnosis of APS
- Do not have lupus
- Have had certain problems associated with APS in the past 5 years such as blood clots or pregnancy complications
Learn More: To learn more, visit the DARE-APS website.
The study will hopefully begin recruiting participants in the first half of 2023.
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