Dupixent® Phase 3 Trial Shows Major Itch and Hive Relief for CSU Patients

Regeneron Pharmaceuticals, Inc. and Sanofi have announced the success of their Dupixent® (dupilumab) confirmatory Phase 3 trial, known as LIBERTY-CUPID Study C, for the treatment of chronic spontaneous urticaria (CSU) in patients who have not previously been treated with biologics and who continue to experience symptoms despite taking antihistamines. CSU is a persistent skin condition characterized by sudden and severe hives and persistent itching, significantly impacting patients' quality of life. This latest trial builds on the positive results from Study A, the first Phase 3 trial of Dupixent for this indication.

The trial, which involved 151 participants, demonstrated that Dupixent significantly reduced itch severity and urticaria activity scores compared to a placebo. Patients in the Dupixent group saw a 50% reduction in these scores, with notable improvements in quality of life. Specifically, the trial showed an 8.64-point reduction in itch severity from baseline in the Dupixent group compared to a 6.10-point reduction in the placebo group. Additionally, there was a 15.86-point reduction in urticaria activity severity from baseline in the Dupixent group versus an 11.21-point reduction in the placebo group.

Importantly, 30% of patients treated with Dupixent reported complete relief from urticaria symptoms, compared to 18% in the placebo group. The safety profile of Dupixent remained consistent with its previously known properties, showing no significant adverse effects compared to the placebo. The most common side effects were injection site reactions, accidental overdose, and COVID-19 infections, occurring at slightly higher rates in the Dupixent group.

The positive outcomes from Study C support the case for regulatory resubmission in the U.S. by the end of 2024. If approved, Dupixent could become the first targeted therapy for CSU in over a decade. George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, emphasized the potential of Dupixent to provide substantial relief for patients suffering from this chronic inflammatory skin disease.

Dupixent was developed using Regeneron’s VelocImmune® technology, which utilizes a genetically engineered mouse platform to produce fully human antibodies. The drug inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, which are central to the type 2 inflammation seen in several related diseases. Dupixent has already been approved in over 60 countries for multiple indications, including atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis, among others.

The significance of this trial is underscored by the large number of people affected by CSU in the U.S., estimated to be over 300,000, who find their condition inadequately controlled by current antihistamine treatments. Dupixent's ability to offer a new treatment option could be transformative for these individuals.

The LIBERTY-CUPID Phase 3 program, which includes Study A, Study B, and Study C, evaluates Dupixent's efficacy and safety as an add-on therapy for CSU patients who do not respond to antihistamines alone. Study A has already led to the approval and launch of Dupixent in Japan for patients aged 12 years and older whose condition is not adequately controlled with existing therapies. Study B, which assessed Dupixent in patients unresponsive to both antihistamines and omalizumab, has also been published in the Journal of Allergy and Clinical Immunology.

Overall, the success of the LIBERTY-CUPID Study C trial marks a significant advancement in the treatment of chronic spontaneous urticaria and highlights Dupixent's potential to improve the lives of many patients suffering from this debilitating condition. The results are anticipated to pave the way for regulatory approval, making Dupixent a groundbreaking treatment option for those affected by CSU.

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