TUH researchers entering last stage of lupus study

The FDA approved the study for its third and final stage, which is now underway.

Researchers at Temple University Hospital have already started screening patients for the third phase of its clinical trial to develop a new lupus treatment.

The autoimmune disease occurs when the body’s immune system cannot tell the difference between healthy and invasive cells. This means the immune system attacks healthy cells, which can cause a whole host of issues from extreme fatigue and hair loss to light sensitivity and ulcers in the mouth or nose. The disease can be fatal.

Dr. Roberto Caricchio, an associate professor of medicine is the principal investigator and study doctor for the trials being conducted at TUH. Other trials for the same study are being conducted across the country.

“We are looking for 10 to 20 patients who have moderate to severe symptoms,” Caricchio said. “We’re screening one patient on Monday … and she could start getting the medication as soon as the Monday after the screening.”

Caricchio said that because the second phase of the trial went so well, it could be on the “fast-track” for approval from the Food and Drug Administration.

“If phase three is as good as phase two, it will take less time to get final approval,” he said. “This is a very promising time for lupus patients.”

If approved, the medication Caricchio is testing will only be the fifth one approved by the FDA, he said. The last time a medication was approved to treat lupus was in 2011, and before that, nothing had been approved since 1955.

“As a new method, this is the fifth [one approved],” Caricchio said. “That’s why I wanted to participate, to give people in Philadelphia the medication, because no other institution or hospital [in the area] is doing this right now.”

Temple was selected as one of the locations for the study, funded by AstraZeneca, an international pharmaceutical company. According to its study record on ClinicalTrials.gov, the study is also being conducted in different laboratories in the United States and also in countries like Argentina, Israel, South Korea, New Zealand, Ukraine and the United Kingdom.

Caricchio said the study is a “double-blind,” meaning neither the patients nor the people conducting the study know whether the patients are taking the new medication or a “placebo,” which has no medical effect. This will be used to compare the data collected from both groups impartially.

The patients will take the new medication on top of any additional treatments they are receiving for lupus for about 14 months, Caricchio said. The doctors will follow up with the patients for an additional three months until the medication has completely left their system. After that, the double-blind is over, and patients who took the medication will have the option to continue taking it for another two years.

To select participants in the trial, Caricchio said the researchers will need to “pinpoint” patients.

“One of the criteria is the disease has to be active but not responding to the available treatment,” he said.

Caricchio added the laboratory had to go through intense certification in order to be approved to conduct the trial.

“We need to be able to understand how to diagnose and we need to be able to understand how the patient fits the criteria,” he said. “The site needs to have labs that can take care of the samples in a particular way.”

Julie Christie can be reached at julie.christie@temple.edu.

Brianna Cicero contributed reporting.

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