Phase 3 LIBERTY-CUPID Study C Trial for Dupilumab Meets Primary, Secondary Endpoints for Chronic Spontaneous Urticaria

Regeneron Pharmaceuticals, Inc. and Sanofi announced today that the phase 3 LIBERTY-CUPID Study C trial for dupilumab (Dupixent) in chronic spontaneous urticaria (CSU) met its primary and secondary endpoints.¹

Researchers are assessing the efficacy and safety of dupilumab in patients with uncontrolled, biologic-naïve CSU receiving supplemental therapy with histamine-1 (H1) antihistamines.

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The phase 3 study enrolled a total of 151 children and adults with CSU. Patients were randomized to receive either dupilumab (n=74) or a placebo (n=77) in addition to an H1 antihistamine.

By week 24, investigators reported that 30% of patients treated with dupilumab achieved complete response, versus 18% of patients receiving the placebo.

They also reported a more significant reduction in itch achieved with dupilumab (8.64-point reduction) when compared with placebo (6.10-point reduction). Patients treated with dupilumab also experienced a more significant reduction in urticaria activity severity, measuring itch and hive symptoms, from baseline to week 24 (15.86-point reduction) versus placebo (11.21-point reduction).

Rates of treatment-emergent adverse events (53%) was equivalent for both the dupilumab and placebo groups, with adverse events such as accidental overdose, COVID-19 infection, and injection site reactions more common in the dupilumab treatment group.

These findings confirm data from the LIBERTY-CUPID Study A, in which dupilumab demonstrated nearly doubled reductions in measures of itch and urticaria versus standard of care alone.²

"Patients with uncontrolled chronic spontaneous urticaria experience debilitating itch and hives that appear without warning and disrupt their lives," said George Yancopoulos, MD, PhD, in a news release.¹ Yancopoulos is board co-chair, president, and chief scientific officer at Renegeron, as well as a principal investigator of dupilumab.

"With a nearly 50% reduction in itch and urticaria activity scores compared to placebo, these positive phase 3 results reaffirm the potential of Dupixent to bring relief and its well-established safety profile to those living with this chronic inflammatory skin disease," he said.

In October 2023, the US Food and Drug Administration (FDA) issued a Complete Response Letter for the supplemental Biologics License Application for dupilumab in this indication.³ Regeneron and Sanofi plan to submit these phase 3 data to the FDA by the end of 2024.

At present, Japan is the only country in which a regulatory body has reviewed and approved the safety and efficacy findings for dupilumab in CSU.⁴ If approved in the US, dupilumab would represent the first targeted therapy for CSU in 10 years.

"The positive pivotal data from this study reinforce the potential of Dupixent to offer a new treatment option for the many people suffering from chronic spontaneous urticaria who do not respond to standard-of-care antihistamines," said Dietmar Berger, MD, PhD, chief medical officer and global head of development at Sanofi.¹ "With clinically meaningful reductions in itch and hives for patients receiving Dupixent, we look forward to sharing these data with the FDA to bring Dupixent to patients with CSU in the US as soon as possible. With Dupixent now treating 1 million patients across seven approved indications, these new results underscore there are still many more patients that Dupixent can potentially benefit."

References

1. Dupixent (dupilumab) phase 3 trial confirms significant improvements in itch and hives for patients with chronic spontaneous urticaria (CSU). News release. BioSpace. September 11, 2024. Accessed September 11, 2024. https://www.biospace.com/press-releases/dupixent-dupilumab-phase-3-trial-confirms-significant-improvements-in-itch-and-hives-for-patients-with-chronic-spontaneous-urticaria-csu
2. Late-breaking phase 3 data at 2022 AAAAI Annual Meeting show Dupixent (dupilumab) significantly reduced itch and hives in patients with chronic spontaneous urticaria. News release. February 26, 2022. Accessed September 11, 2024. https://investor.regeneron.com/news-releases/news-release-details/late-breaking-phase-3-data-2022-aaaai-annual-meeting-show
3. Regeneron and Sanofi provide update on Dupixent (dupilumab) sBLA for chronic spontaneous urticaria. News release. Regeneron. October 20, 2023. Accessed September 11, 2024. https://www.biospace.com/press-releases/dupixent-dupilumab-phase-3-trial-confirms-significant-improvements-in-itch-and-hives-for-patients-with-chronic-spontaneous-urticaria-csu
4. Japan first in the world to approve Dupixent (dupilumab) for chronic spontaneous urticaria (CSU). News release. Regeneron. February 16, 2024. Accessed September 11, 2024. https://investor.regeneron.com/news-releases/news-release-details/japan-first-world-approve-dupixentr-dupilumab-chronic