Aurora St. Luke’s Medical Center in Milwaukee has joined an international clinical trial studying an experimental treatment for adults and adolescents living with a chronic inflammatory disorder of the tube that connects the throat and stomach.
The study will evaluate the safety and effectiveness of the investigational drug CC-93538 in people with eosinophilic esophagitis (EoE), an allergic disorder that causes repeated episodes of tissue swelling in the esophagus.
“For people with EoE, the inflammation in the esophagus is often caused by an immune response to an unknown allergen,” said gastroenterologist Tarun Sharma, MD, Advocate Aurora Research Institute’s principal investigator for the study. “The result is an unsettling condition known as dysphagia, or difficulty swallowing. Dysphagia increases the possibility that food may become lodged in the esophagus, requiring endoscopy to remove it.”
Allergists and gastroenterologists are reporting increased incidence of EoE, according to the American Academy of Allergy Asthma & Immunology. EoE is typically managed with dietary changes.
“There have been many advances in the use of specialized biological and antibody therapies for other allergic conditions, and providing similar targeted therapies for EoE will fulfill an unmet need and provide an improved quality of life for these patients,” said Advocate Aurora allergist and clinical immunologist Monica Vasudev, MD.
The study drug CC-93538 is a monoclonal antibody. Monoclonal antibodies are a type of biologic drug made in a laboratory. They are designed to stop the body’s own immune system from reacting to the allergen.
“Sometimes the body’s immune system can overreact to a foreign substance by attracting too many inflammatory cells to the area, which causes problematic amounts of swelling or scarring,” Dr. Sharma said. “In patients with EoE, biopsies on endoscopy reveal an overabundance of a type of white blood cell called eosinophils.”
CC-93538 is being studied to see if it can block interleukin-13 (IL-13), a natural substance produced by the immune system.
Researchers will randomly assign participants to receive either CC-93538 or a placebo. The study is double-blinded, meaning neither the participant nor their doctor will know if the participant received CC-93538 or a placebo, a method to prevent bias and ensure impartial study findings. Researchers will follow participants for up to four years.
Researchers plan to enroll 399 participants, including adolescents, in the study at more than 200 sites around the world. EoE can develop in people of all ages, with adolescents comprising 10% of all patients.
“With no cure and an increasing number of people being diagnosed with EoE, there is a clear unmet need for new potential treatments,” said Laura Wrona, MSN, director of specialty clinical trials research. “Advocate Aurora Research Institute is proud to participate in this clinical trial that could potentially help some of our youngest future patients.”
The clinical trial, titled “A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent participants with eosinophilic esophagitis,” is sponsored by Celgene, manufacturer of CC-93538.
To learn more about Advocate Aurora’s research, visit aah.org/research.