The study (NCT02465437) is a randomized, double-blind and placebo-control trial, taking place at nine sites across the U.S., to evaluate Resunab’s efficacy, tolerability, safety and pharmacokinetics in up to 44 adults with systemic sclerosis. Drug efficacy is determined using the American College of Rheumatology’s Combined Response Index for diffuse cutaneous systemic sclerosis (CRISS), which measures such parameters as patient disability, skin and lung involvement, and patient and physician assessments of general health. Trial investigators will also study the drug’s mechanism of action and its effect on disease biomarkers.
Enrolled patients are randomly assigned to receive either Resunab (also called JBT-101) or placebo for 84 days, with a follow-up period of 28 days.
“We have long recognized the need for proven therapies for systemic sclerosis and were eager to participate in this clinical study of Resunab. Our hope is that treatment utilizing Resunab will lead to a reduction of inflammation and fibrosis without immunosuppression and without the need for patients to discontinue their other medications,” Robert Spiera, MD, director of the Vasculitis and Scleroderma Program at the Hospital for Special Surgery, Weill Cornell Medical College in New York City, said in a press release.
“We are very pleased to have completed patient enrollment ahead of schedule in this Phase 2 study in systemic sclerosis. These patients suffer from serious morbidity and have a significant need for new effective treatments, especially those that don’t suppress the immune system. We look forward to having the top-line data before the end of this year,” said Barbara White, chief medical officer of Corbus.
Researchers will also be collecting data on Resunab’s safety and efficacy as a systemic sclerosis treatment in the open-label extension phase of the study, White said.
That extension, which follows the close of the Phase 2 study, will give patients in both the control (placebo) and experimental group the option of receiving Resunab treatment.