Dupixent Phase 3 Trial Shows Major Itch and Hive Relief for Chronic Spontaneous Urticaria

TARRYTOWN, N.Y. and PARIS, Sept. 11, 2024—Regeneron Pharmaceuticals, Inc. and Sanofi have revealed successful outcomes from a Phase 3 trial (LIBERTY-CUPID Study C) for Dupixent (dupilumab) in patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) undergoing antihistamine treatment. CSU is a relentless skin condition causing unexpected and persistent hives and itch, significantly affecting the quality of life. The trial’s positive results echo those from Study A, the inaugural Phase 3 trial for Dupixent in this context. Earlier this year, Japan pioneered the approval and launch of Dupixent for adult and adolescent CSU patients based on Study A's findings.

“Patients with uncontrolled CSU endure extreme itch and sudden hives, severely disrupting their lives,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President, and Chief Scientific Officer at Regeneron. “Achieving nearly a 50% reduction in itch and urticaria scores compared to placebo, these Phase 3 results highlight Dupixent’s potential to alleviate this chronic inflammatory skin condition while maintaining a well-established safety profile."

The study included 151 participants, both children and adults, who were randomized to receive Dupixent (n=74) or placebo (n=77) in addition to standard-of-care H1 antihistamines. At the 24-week mark, efficacy outcomes for Dupixent compared to placebo were as follows:

- 30% of Dupixent-treated patients reported no urticaria (complete response) compared to 18% of those on placebo (p=0.02).

The safety profile for Dupixent was consistent with its known safety in approved dermatological uses. Treatment-emergent adverse events (AEs) were recorded at 53% for both Dupixent and placebo. More frequent AEs with Dupixent (≥5%) included injection site reactions (12% vs. 4%), accidental overdose (7% vs. 3%), and COVID-19 infections (8% vs. 5%).

Detailed trial results will be submitted to the U.S. Food and Drug Administration by the end of 2024 in response to a request for additional data for the supplemental biologics license application for Dupixent in CSU. These findings will also be presented at an upcoming medical meeting.

"The pivotal data underline Dupixent's potential as a new treatment for the many individuals suffering from CSU who do not respond to current antihistamines,” stated Dietmar Berger, M.D., Ph.D., Chief Medical Officer and Global Head of Development at Sanofi. “With notable reductions in itch and hives among patients taking Dupixent, we anticipate sharing these data with the FDA to expedite making Dupixent available to U.S. patients with CSU. With Dupixent now serving 1 million patients across seven approved indications, these results emphasize its potential to benefit more patients."

Globally, excluding Japan, Dupixent’s safety and efficacy for CSU have not been fully evaluated by any regulatory entity.

Chronic Spontaneous Urticaria (CSU) is a chronic inflammatory skin disorder partly driven by type 2 inflammation, resulting in sudden hives and persistent itch. Typically managed with H1 antihistamines, many patients find their condition remains uncontrolled, leaving them with few alternative treatments. These individuals continue to experience debilitating symptoms, significantly affecting their quality of life.

The LIBERTY-CUPID Phase 3 program investigating Dupixent in CSU includes Study A, Study B, and Study C. Study C, a randomized, double-blind, placebo-controlled trial, assessed Dupixent’s efficacy and safety as an add-on to antihistamines in 151 patients aged six and older with CSU unresponsive to antihistamines and not previously treated with omalizumab (biologic-naïve). 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's results led to Dupixent's approval in Japan for treating CSU in patients aged 12 and older whose condition is not managed with existing therapies. Findings from Study A and Study B were published in the Journal of Allergy and Clinical Immunology.

Dupixent, developed with Regeneron's proprietary VelocImmune technology, is a fully human monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, without being an immunosuppressant. The development program has demonstrated significant clinical benefits and reduced type 2 inflammation in Phase 3 trials, establishing IL-4 and IL-13 as central drivers of type 2 inflammation in multiple related diseases.

Dupixent has regulatory approvals in over 60 countries for various indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, CSU, and chronic obstructive pulmonary disease across different age groups. More than 1 million patients globally are treated with Dupixent.

Regeneron's VelocImmune technology uses a genetically engineered mouse platform with a humanized immune system to produce optimized fully human antibodies. Regeneron’s team has used this technology to create a significant number of FDA-approved or authorized monoclonal antibodies, including Dupixent.

Dupilumab is jointly developed by Regeneron and Sanofi. It has been studied in over 60 clinical trials involving more than 10,000 patients with various chronic diseases driven by type 2 inflammation. Beyond current approvals, Regeneron and Sanofi are exploring dupilumab in a variety of type 2 inflammation-driven conditions, including chronic pruritus of unknown origin and bullous pemphigoid, although these potential uses are still under clinical investigation.

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