LIBERTY-CUPID Study C Confirms Benefit of Dupilumab in Biologic-Naive CSU

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Data from the LIBERTY-CUPID Study C offer confirmation of the benefits of dupilumab (Dupixent) for reducing itch and disease activity among patients with uncontrolled chronic spontaneous urticaria (CSU).

One of 3 phase 3 trials in the LIBERTY-CUPID program, topline results from LIBERTY-CUPID Study C confirm findings of LIBERTY-CUPID Study A, which was used as the basis for approval of dupilumab in CSU patients aged 12 years in older in Japan. According to Sanofi, detailed results of the study will be provided to the US Food and Drug Administration by year-end in response to agency’s request for additional data to be included in the Supplemental Biologics License Application (sBLA) for dupilumab in CSU.¹

“The positive pivotal data from this study reinforce the potential of [dupilumab] to offer a new treatment option for the many people suffering from chronic spontaneous urticaria who do not respond to standard-of-care antihistamines," 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 [dupilumab], we look forward to sharing these data with the FDA to bring [dupilumab] to patients with CSU in the US as soon as possible. With [dupilumab] now treating 1 million patients across seven approved indications, these new results underscore there are still many more patients that [dupilumab] can potentially benefit.”

Boasting several approvals for dermatological conditions dating back to 2017, dupilumab is developed and marketed through a partnership by Sanofi and Regeneron. Using data from LIBERTY-CUPID Study A and B, Sanofi and Regeneron filed for an sBLA for dupilumab to treat adult patients aged 12 years and older with CSU not adequately controlled with standard of care antihistamine treatment in March 2023. The initial target action date for the FDA decisions October 2023.^2,3

On October 20, 2023, Sanofi and Regeneron announced the receipt of a Complete Response Letter requesting additional efficacy data to support a potential approval to treat CSU. In their announcements, the companies referenced an already ongoing trial they intended to use in support of the application.³

Topline data from Study C indicated use of dupilumab met primary and key secondary endpoints for treatment of patients with uncontrolled, biologic-naïve CSU receiving background therapy with antihistamine. Among an overall population of 151 patients, use of dupilumab was associated 8.64-point reduction in itch severity from baseline to week 24 relative to a 6.10-point reduction observed with placebo (P = .02).¹

Analysis of key secondary endpoints suggested use of dupilumab was associated with a 15.86-point reduction in urticaria activity severity from baseline to week 24 relative to an 11.21-point reduction observed with placebo (P = .02). The release from Sanofi also highlighted 30% of dupilumab-treated patients achieved complete response compared to just 18% of the placebo group (P = .02).¹

According to the release, safety results were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. Adverse events in the trial observed among 5% or more of dupilumab-treated patients compared to placebo-treated patients included injection site reactions (12% vs 4%), accidental overdose (7% vs 3%), and COVID-19 infection (8% vs 5%).¹

“Patients with uncontrolled chronic spontaneous urticaria experience debilitating itch and hives that appear without warning and disrupt their lives," said George D. Yancopoulos, MD, PhD, board co-chair, president, and chief scientific officer at Regeneron.¹ "With a nearly 50% reduction in itch and urticaria activity scores compared to placebo, these positive phase 3 results reaffirm the potential of [dupilumab] to bring relief and its well-established safety profile to those living with this chronic inflammatory skin disease.”

References:

1. Sanofi. Press release: Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU. Sanofi. September 11, 2024. Accessed September 15, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-11-05-05-00-2944239.
2. Kunzmann K. Regeneron, Sanofi receive CRL for add-on dupilumab sbla for chronic spontaneous urticaria. HCP Live. October 25, 2023. Accessed September 15, 2024. https://www.hcplive.com/view/fda-dupilumab-chronic-spontaneous-urticaria.
3. Office of the Commissioner. FDA approves New Eczema Drug Dupixent. U.S. Food and Drug Administration. March 28, 2017. Accessed September 15, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-eczema-drug-dupixent.