Regeneron and Sanofi announced positive results from the Phase 3 LIBERTY-CUPID Study C, evaluating Dupixent (dupilumab) for chronic spontaneous urticaria (CSU) in patients inadequately controlled with antihistamines. The study, presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting, showed significant improvements in itch and urticaria activity compared to placebo.
Key Findings from LIBERTY-CUPID Study C
The Phase 3 trial enrolled 151 patients aged six years and older with CSU who were biologic-naïve and still symptomatic despite antihistamine treatment. Participants were randomized to receive Dupixent (n=74) or placebo (n=77) in addition to standard-of-care antihistamines. At 24 weeks, Dupixent demonstrated:
- Significant reduction in itch, measured by the weekly itch severity score (ISS7).
- Significant reduction in urticaria activity, measured by the weekly urticaria activity score (UAS7).
- A higher proportion of patients achieving well-controlled disease status (UAS7 ≤6).
Thomas B. Casale, M.D., Professor at the University of South Florida, noted, "These data confirm results seen in the previous Study A and reinforce the potential of Dupixent to significantly alleviate symptoms for patients, helping them to better control this challenging disease."
Safety Profile
The safety profile of Dupixent in Study C was consistent with its established safety profile in approved dermatological indications. Overall rates of treatment-emergent adverse events were similar in both the Dupixent and placebo groups (53%). Adverse events more commonly observed with Dupixent included injection site reactions (12% vs. 4%), accidental overdose (7% vs. 3%), and COVID-19 infection (8% vs. 5%).
Regulatory Status and Disease Burden
Dupixent is currently approved for CSU in Japan and the United Arab Emirates, and is under regulatory review in the European Union. In the U.S., more than 300,000 people suffer from CSU that is inadequately controlled by antihistamines, highlighting the unmet need this drug aims to address.
About Dupixent
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways, key drivers of type 2 inflammation. Developed using Regeneron’s VelocImmune technology, it is not an immunosuppressant. Dupixent has been approved in over 60 countries for various indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, and chronic obstructive pulmonary disease.
