The Phase 2 study (NCT03030118) seeks to identify individuals at high risk for developing lupus and treat them with an immune-modifying medication before they develop the disease. The overarching goal is to delay the onset of lupus, lessen its symptoms, and ultimately prevent it.
According to the Lupus Foundation of America, outcomes of this research potentially could have an impact on the estimated 1.5 million people in the U.S. who live with lupus, and also their healthy relatives who are affected disproportionately by the immune system disease.
These were the numbers in the minds of the team of researchers who decided to follow relatives of patients for eight years to see if they could find a way to identify those at-risk before the disease ever develops. The team was led by Judith James, MD, PhD, vice president of clinical affairs of OMRF.
“For some time, our lab has been interested in understanding the first things that go wrong in the body that lead to lupus. That fed into our work of trying to develop a better diagnostic test, as well as work in understanding how flares happen. Now we want to find ways to identify people at high risk so we can offer help before the damage starts,” said James, in a story on the OMRF website.
While studying relatives of lupus patients, James discovered that 89 percent of family members remained healthy, but 11 percent ended up developing the disease. Of those who did develop lupus, all displayed autoantibodies – inflammatory proteins that the body mistakenly releases against its own cells and tissues.
For this study, James and her team will test for these autoantibodies in blood samples and randomize subjects to a trial medication – hydroxychloroquine – or placebo.
The study is recruiting participants who are at risk of developing lupus. To be eligible to enroll in the trial, an individual must have a positive antinuclear antibodies (ANA) test, and at least one other lupus symptom. These might include skin rashes, joint pain, anemia, mouth sores, or sensitivity to sunlight.
“Even when patients come to the doctor and get all the best medicines we currently have, the disease still leads to deformities, shortened lifespans and things we just can’t fix. Now, we may have the ability to dial this back and prevent people from moving into full-blown lupus,” James added.
“This is a trial of enormous importance that could prove life-changing for everyone involved,” said Stephen Prescott, MD, president of OMRF. “This work is expansive, new and holds a great deal of hope. We are extremely proud of Dr. James’ brilliant work and excited for what lies ahead.”
To know more about the clinical trial and eligibility criteria, call (405) 271-7221 or email Virginia-Roberts@omrf.org.