A phase 3 trial evaluating dupilumab in patients with chronic spontaneous urticaria (CSU) refractory to omalizumab has been stopped due to futility, according to a press release issued by Regeneron and Sanofi.

Study B of the randomized, double-blind, placebo-controlled CUPID trial (ClinicalTrials.gov Identifier: NCT04180488) evaluated the efficacy and safety of dupilumab in 83 patients with CSU who remained symptomatic despite standard of care treatment and were intolerant or incomplete responders to omalizumab. Patients were randomly assigned to receive dupilumab or placebo every 2 weeks, in addition to antihistamines, during the 24-week treatment period. 

The coprimary endpoints were the change from baseline in itch (measured by the weekly itch severity score) and the change from baseline in itch and hives (measured by the weekly urticaria activity score) at 24 weeks.

Results showed that treatment with dupilumab demonstrated positive numerical trends in reducing itch and hives; however, it failed to meet statistical significance during an interim analysis conducted by an independent review committee. The safety of dupilumab was found to be generally consistent with its known profile for its approved indications.

“While [dupilumab] 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 [dupilumab] in CSU based on the success of the first phase 3 trial in biologic-naïve patients, where [dupilumab] nearly doubled the reduction in itch and urticaria activity,” said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer at Regeneron. 

Findings from Study A of the CUPID trial showed that treatment with dupilumab was associated with significantly reduced itch and hives in biologic-naïve patients with moderate to severe CSU when compared with antihistamines alone. The Companies plan to continue investigating dupilumab in this patient population.

“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,” added Yancopoulos.

Dupilumab is currently marketed under the brand name Dupixent® and is approved for the treatment of moderate to severe atopic dermatitis in patients 6 years of age and older; for maintenance treatment of severe asthma in patients 12 years of age and older; and for chronic rhinosinusitis with nasal polyps in patients 18 years of age and older.


Regeneron and Sanofi provide update on ongoing Dupixent® (dupilumab) chronic spontaneous urticaria phase 3 program. News release. Regeneron Pharmaceuticals, Inc. Accessed February 18, 2022. https://www.prnewswire.com/news-releases/regeneron-and-sanofi-provide-update-on-ongoing-dupixent-dupilumab-chronic-spontaneous-urticaria-phase-3-program-301485426.html.