The first patient first visit (FPFV) has occurred for ITN’s REBOOT clinical trial. REBOOT is a clinical study that aims to evaluate the safety and effectiveness of belimumab and intravenous rituximab at inducing remission of primary membranous nephropathy (MN) compared to rituximab alone.
Primary MN is an autoimmune disease in which the body's own immune system causes damage to kidneys. This damage can cause the loss of too much protein in the urine, as well as reduced kidney function. Drugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by blocking inflammation and reducing the immune system's function. These drugs can have serious side effects and often do not cure the disease. There is a need for new treatments for MN that are better at improving the disease while reducing side effects.
In this study, researchers will evaluate if treatment with a combination of two different drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B cells. B cells are known to have a role in MN. Once these cells are removed, disease may become less active or even inactive. However, after stopping treatment, the body will make new B cells which may cause disease to become active again. Belimumab works by decreasing the new B cells produced by the body and, may even change the type of new B cells produced.
Neither rituximab nor belimumab is approved by the FDA to treat MN. Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis, and vasculitis. Belimumab is approved by the FDA to treat systemic lupus erythematosus.