Researchers at Aurora Rheumatology and Immunotherapy Center in Franklin, Wisconsin, are enrolling participants in a clinical trial evaluating the safety and effectiveness of an investigational drug to treat people with lupus.
“Lupus is a category of autoimmune diseases that primarily affect women of childbearing age, particularly women of color,” said rheumatologist Alvin Wells, MD, PhD, Advocate Aurora Research Institute’s principal investigator for the study. “As a progressive disease, lupus causes inflammation and tissue damage that can worsen over time, significantly impacting a person’s quality of life.”
Lupus affects approximately five out of every 100,000 people, and women are about nine times more likely than men to suffer from lupus, according to the U.S. Centers for Disease Control and Prevention. Symptoms include fatigue, skin rashes, and pain or swelling in the joints, often coming in flare-ups and then going into periods of remission. Lupus is typically managed with corticosteroids and immunosuppressive drugs.
“Despite advancements in lupus treatments, including recently approved biologic drugs, there is still a need for new drugs that can control the disease without as many unwanted side effects and without decreasing effectiveness over time,” said Laura Wrona, MSN, director of the Research Institute’s specialty clinical trials.
The clinical trial will assess the drug deucravacitinib in people with systemic lupus erythematosus, the most common type of lupus. Deucravacitinib is a novel tyrosine kinase 2 inhibitor, which is a type of targeted therapy known to help regulate an overactive immune system.
The study will randomly assign participants to receive either deucravacitinib or a placebo. The study is double-blinded, meaning neither the participant nor their doctor will know if the participant received deucravacitinib or a placebo, a method to prevent bias and ensure impartial study findings. Researchers plan to enroll approximately 490 participants in the study and will follow their progress for up to three years.
The clinical trial, “A phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of deucravacitinib in participants with active systemic lupus erythematosus (SLE) (POETYK SLE-1),” is sponsored by Bristol-Meyers Squibb Company, manufacturer of deucravacitinib.
Media contacts:
research.communications@aah.org
To learn more about our research, visit aah.org/research.