Phase 3 Trial on Dupilumab for Chronic Spontaneous Urticaria Stopped

Dupilumab did not reach statistical significance in interim analysis despite numeric improvements being observed across key endpoints.

An announcement by Regeneron Pharmaceuticals and Sanofi provided developments from an ongoing phase 3 trial on dupilumab for the management of chronic spontaneous urticaria.

The phase 3 trial, titled LIBERTY-CUPID, has been stopped due to futility, as dupilumab did not reach statistical significance in interim analysis despite numeric improvements being observed across key endpoints.

The trial had assessed dupilumab added to antihistamines in patients refractory to omalizumab at 24 weeks. Positive numerical trends in reducing itch and hive, which were the primary endpoints, were observed.

Additionally, the safety data were generally consistent with the known safety profiled of dupilumab in approved indications.

The LIBERTY-CUPID program was initiated in 2020 with an accelerated direct-to-phase 3 strategy. Primary and all key secondary endpoints at 24 weeks were observed in the previously reported phase 3 trial, which evaluated a different group of patients who were biologic-naïve.

Detailed results from the first trial will be presented at the AAAAI Annual Meeting later this month, and the companies expect to share results from the second trial in a scientific forum.

"Chronic spontaneous urticaria is a very complex disease, and these data add to the body of evidence assessing the underlying drivers of disease burden, including the potential role of interleukin-4 and interleukin-13," said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer at Regeneron. "While Dupixent did not show a significant benefit in the most difficult-to-treat patients who remain refractory to all approved medicines, we are carefully assessing the potential role of Dupixent in CSU based on the success of the first Phase 3 trial in biologic-naïve patients, where Dupixent nearly doubled the reduction in itch and urticaria activity."