The A.M.IgA. Study is evaluating whether mezagitamab, an investigational medication not approved for clinical use, can help slow down the progression of IgA nephropathy (IgAN) by reducing how much of the defective IgA protein is produced in the body.
Study participation will last up to 110 weeks and includes up to 26 visits. The study includes a 22-week treatment period followed by an 82-week follow-up period. Those who qualify will be randomly assigned (like flipping a coin) to receive either the investigational medication or a placebo (a substance that looks like the investigational medication but contains no active ingredients), along with standard-of-care therapy. Two out of every 3 participants will receive the investigational medication, and 1 out of 3 will receive the placebo.
Participants can expect regular visits to help monitor their health throughout the study. During these visits, the team may ask health and medication questions, check vital signs such as blood pressure and heart rate, collect blood and urine samples, perform physical exams, and complete other study-related tests.
During the 22-week treatment period, participants will receive subcutaneous (under the skin) injections for a total of 16 doses. Participants will then enter an 82-week follow-up period.
