Participate in Research at CU Anschutz

The purpose of this study is to test different doses of the study drug, Imvotamab, to see if it is safe and can be tolerated to treat people with moderate to severe rheumatoid arthritis (RA). Imvotamab is a new type of antibody, which is a protein made in the laboratory. Antibodies are a part of the immune system that identify and attach to specific foreign things like bacteria or viruses. In this case, imvotamab targets two different cell types. One of these targets is CD20, found on the surface of the cells that trigger the body to think that the tissues are foreign (B cells). The other target is CD3, which is present on a different group of immune cells (T cells). Imvotamab brings these two cell types together and allows the immune cells in your body to kill the B cells. Lowering the number of B cells in the body may reduce the severity of RA.

Screening period (6 weeks): During this period, you will have screening tests and procedures done to see if you meet the requirements to be in this research study. The initial screening tests are planned to be done on a single day and may take a total of approximately 2-4 hours. Study Treatment Period (4 weeks): This study will use a drug called Imvotamab. If you are eligible to enter the study, you will enter the Study Treatment period and will be randomly assigned to receive either the study drug (Imvotamab) or placebo. The study drug or placebo will be given once a week for four weeks and given through a vein (also called intravenous [IV] administration). Safety Follow Up Period (48 weeks): There will be six follow up visits at approximately 5, 6, 12, 24, 36, and 52 weeks after your first dose of study drug or placebo. You will be asked to return to the clinic for these visits to perform safety assessments. The study team will determine how you are doing, and you will be asked if you have started any new therapies. These visits will continue until the end of the study, or until you withdraw consent.