The study drug, known as barzolvolimab (CDX-0159), is a monoclonal antibody given as an injection under the skin.
Antibodies are part of the body’s self-defense system. The immune system creates antibodies and sends them to stop a specific target, for example a virus or a germ.
Monoclonal antibodies are designed in a lab to bind to a specific target. In this study medication, they are designed to target mast cells.
Mast cells are a type of immune white blood cell that sends signals to other immune cells. When the other immune cells respond to the signal, they cause inflammation and damage.
In patients with EOE, mast cells are thought to play a role in the inflammation and damage to the esophagus (food pipe).
If barzolvolimab can stop mast cells in the esophagus (food pipe) from signaling, there may be less inflammation and damage in the esophagus.
The study drug is investigational, which means that it has not been approved by any regulatory agencies or healthcare authorities, and it can only be used in clinical research studies.
All patients will receive active drug during the study. Some patients may be randomly assigned to receive placebo for approximately 4 months of the medication period. You will have an equal chance of being assigned to the study drug or placebo for that time, but you will not know your assignment, and neither will the study doctor or study team, until the study is complete.
Investigational means the study drug is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like EvolvE.