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

PARIS, France and TARRYTOWN, NY, USA I September 11, 2024 I A phase 3 study of Dupixent (dupilumab), specifically the LIBERTY-CUPID Study C, has shown promising results for treating patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) who were also receiving antihistamine therapy. CSU is a persistent skin condition characterized by sudden hives and an ongoing itch that drastically affects the quality of life. This study's positive outcome corroborates findings from Study A, the initial phase 3 trial for Dupixent in this medical context. Earlier this year, Japan became the first country to approve and launch Dupixent for treating CSU in both adults and adolescents, based on Study A’s results.

According to Dietmar Berger, M.D., Ph.D., Chief Medical Officer and Global Head of Development at Sanofi, these pivotal results underscore Dupixent's potential to serve as a new treatment avenue for individuals suffering from chronic spontaneous urticaria who do not respond to traditional antihistamines. Dr. Berger noted that Dupixent has already been used to treat one million patients across seven approved indications, and these new findings highlight its potential to benefit even more patients.

Study C involved 151 participants, both children and adults, who were randomized to either receive Dupixent (74 participants) or a placebo (77 participants) in addition to their standard antihistamine therapy. After 24 weeks, the efficacy of Dupixent compared to the placebo showed significant results. Notably, 30% of those treated with Dupixent reported no urticaria symptoms (complete response), compared to 18% of the placebo group. The safety outcomes were generally consistent with the known safety profile of Dupixent in other dermatological uses, with 53% of both the Dupixent and placebo groups experiencing treatment-emergent adverse events (AEs). Common AEs observed with Dupixent included injection site reactions, accidental overdose, and COVID-19 infections.

Detailed findings from this study will be submitted to the US Food and Drug Administration (FDA) as part of the supplemental biologics application for Dupixent in CSU. These findings are also expected to be presented at an upcoming medical conference.

George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President, and Chief Scientific Officer at Regeneron, highlighted the debilitating nature of uncontrolled CSU, which causes random hives and itching, severely impacting patients' lives. He emphasized that the phase 3 results reinforce Dupixent's potential to offer significant relief and maintain a strong safety profile for those affected by this chronic skin disease.

Outside of Japan, Dupixent's safety and efficacy for CSU have not been fully evaluated by any regulatory authority. CSU is a chronic inflammatory skin condition driven by type-2 inflammation, which triggers sudden hives and persistent itching. Despite treatment with H1 antihistamines, many patients continue to suffer from uncontrolled symptoms, leaving them with limited alternative treatment options and significantly impacting their quality of life.

The LIBERTY-CUPID Phase 3 study program, investigating Dupixent in CSU, includes Studies A, B, and C. Study C, a randomized, double-blind, placebo-controlled trial, evaluated the efficacy and safety of Dupixent added to standard antihistamine therapy in 151 patients aged six and older who remained symptomatic despite antihistamine use and had not previously been treated with omalizumab. The primary endpoint was the change in itch severity at 24 weeks, and a key secondary endpoint was the change in itch and hives at 24 weeks.

Study A was instrumental in securing Dupixent's approval in Japan for treating CSU in individuals aged 12 and older whose symptoms are inadequately controlled by existing therapies. Results from both Study A and Study B were published in The Journal of Allergy and Clinical Immunology.

Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of interleukin-4 (IL4) and interleukin-13 (IL13) pathways. It is not an immunosuppressant. Dupixent has demonstrated significant clinical benefits and a reduction in type-2 inflammation in phase 3 studies, showing that IL4 and IL13 are central drivers of type-2 inflammation in various diseases. Currently, Dupixent has regulatory approvals in over 60 countries for several indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, CSU, and chronic obstructive pulmonary disease.

Dupilumab is being co-developed by Sanofi and Regeneron under a global collaboration agreement. To date, Dupilumab has been studied in over 60 clinical trials involving more than 10,000 patients with various chronic type-2 inflammatory diseases. In addition to its currently approved uses, Dupilumab is being investigated in phase 3 studies for a range of diseases driven by type-2 inflammation or other allergic processes, including chronic pruritus of unknown origin and bullous pemphigoid. These potential uses are still under clinical investigation and have not yet received full regulatory evaluation.

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