Welcome to the DARE-APS Study
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 antiphospholipid syndrome (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 on the surface of the immune cells that produce antiphospholipid antibodies (plasmablasts and 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 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 clinic visits will occur.
|Treatment Period||8 weeks||8 clinic visits with intravenous infusions given each week|
|Follow-up Period||Approximately 10 months||6 clinic visits over 10 months|