Dupixent Shows Promise in Phase 3 Trial for Chronic Spontaneous Urticaria
Key Insights
Dupixent met primary and key secondary endpoints in a Phase 3 trial for chronic spontaneous urticaria (CSU) patients uncontrolled on antihistamines.
The LIBERTY-CUPID Study C demonstrated a nearly 50% reduction in itch and urticaria activity scores compared to placebo.
Sanofi and Regeneron plan to resubmit data to the FDA, potentially making Dupixent the first targeted CSU therapy in a decade if approved.
SanofiView company profile and RegeneronView company profile's DupixentSearch drug (dupilumabSearch drug) has shown positive results in a Phase 3 trial, offering renewed hope for patients with chronic spontaneous urticariaSearch disease (CSU). The LIBERTY-CUPID Study C evaluated Dupixent in patients with uncontrolled CSU despite antihistamine treatment, confirming earlier findings and paving the way for a potential FDA resubmission.
The double-blind, placebo-controlled trial involved 151 patients aged six years and older who were biologic-naïve, meaning they had not previously been treated with omalizumabSearch drug. Participants received either DupixentSearch drug or a placebo in addition to standard-of-care antihistamines. The primary endpoint was the change from baseline in itch severity at 24 weeks, while a key secondary endpoint assessed changes in both itch and hives.
Significant Reduction in Itch and Hives
Results at 24 weeks demonstrated a significant reduction in both itch and urticaria activity in the DupixentSearch drug group. Patients treated with Dupixent experienced an 8.64-point reduction in itch severity compared to a 6.10-point reduction in the placebo group (p=0.02). Furthermore, there was a 15.86-point reduction in urticaria activity (itch and hive severity) with Dupixent, versus an 11.21-point reduction with placebo (p=0.02).
Notably, 30% of patients receiving DupixentSearch drug reported no urticaria, indicating a complete response, compared to only 18% in the placebo group (p=0.02).
Safety Profile Consistent with Previous Studies
The safety profile of DupixentSearch drug in this trial was consistent with its established safety record in approved dermatological indications. Treatment-emergent adverse events occurred in 53% of patients in both the Dupixent and placebo groups. The most common adverse events observed with Dupixent included injection site reactions (12% vs. 4% with placebo), accidental overdose (7% vs. 3%), and COVID-19 infection (8% vs. 5%).
Implications for CSU Treatment
These positive results reinforce the potential of DupixentSearch drug as a new treatment option for CSU patients who do not respond to standard antihistamine therapy. "The positive pivotal data from this study reinforce the potential of Dupixent to offer a new treatment option for the many people suffering from chronic spontaneous urticariaSearch disease who do not respond to standard-of-care antihistamines," said Dietmar Berger, M.D., Ph.D., chief medical officer and global head of development at SanofiView company profile.
With these data, SanofiView company profile and RegeneronView company profile plan to resubmit their application to the FDA, seeking approval for DupixentSearch drug in CSU. If approved, Dupixent would be the first targeted therapy for CSU in the US in a decade, offering a much-needed alternative for patients with this debilitating condition. Currently, Japan is the only country where Dupixent is approved for CSU.