Dupixent Phase 3 Data Show Meaningful Gains for Chronic Spontaneous Urticaria
New Phase 3 results for Dupixent (dupilumab) point to clear benefits for people living with chronic spontaneous urticaria (CSU). In this confirmatory study—building on an earlier trial—patients on Dupixent saw nearly a 50% drop in both itch and overall urticaria activity scores compared with those on placebo. For a condition defined by unpredictable hives and persistent itch, that kind of reduction matters day to day, night to night.
CSU affects more than 300,000 people in the U.S., and many don’t get adequate relief from standard antihistamines. These data are expected to support a regulatory resubmission in the United States. If approved, Dupixent would offer a targeted option for CSU—an area that hasn’t seen a truly new treatment approach in about a decade.
How the Trial Was Run and What It Measured
The pivotal data come from LIBERTY-CUPID Study C, which enrolled 151 adults who had not previously received a biologic. Participants continued background antihistamines and were randomized to Dupixent or placebo. After 24 weeks, Dupixent consistently outperformed placebo across prespecified measures of itch and urticaria severity—scores that track the frequency and intensity of hives and the burden of itch over time.
What Patients Experienced
Compared with their starting levels, patients on Dupixent reported an 8.64-point reduction in itch severity, versus a 6.10-point reduction on placebo. On overall urticaria activity, the Dupixent group improved by 15.86 points, compared with 11.21 points for placebo. Notably, 30% of patients receiving Dupixent reported complete relief from urticaria symptoms, versus 18% among those on placebo. Put simply: more patients felt clear, and those who improved tended to improve more.
Safety Findings Lined Up with What’s Already Known
Safety results were consistent with Dupixent’s established profile in its approved uses. Adverse events occurred in 53% of patients in both the Dupixent and placebo groups, suggesting a similar overall rate of side effects. Injection-site reactions were more common with Dupixent, and there were reports of COVID-19 infections in the Dupixent group. Taken together, the safety data support continued evaluation and potential use of Dupixent in CSU, alongside careful discussion between patients and clinicians.
Why This Matters for Patients
These findings reinforce Dupixent’s potential to ease the constant itch and recurrent hives that define CSU—symptoms that can derail sleep, work, and daily life. George D. Yancopoulos, M.D., Ph.D., co-Chair and Chief Scientific Officer at Regeneron, underscored that the results strengthen confidence in Dupixent’s ability to improve care for this difficult condition. The core message is straightforward: more control, fewer symptoms, and a chance to feel like yourself again.
Dietmar Berger, M.D., Ph.D., Chief Medical Officer at Sanofi, highlighted plans to move quickly on the U.S. regulatory front, aiming to bring this option to patients sooner if cleared. With more than one million people already treated with Dupixent across approved indications, the CSU data signal an opportunity to expand its reach to those still searching for relief.
About the Research Program and What’s Next
The LIBERTY-CUPID program comprises multiple studies assessing Dupixent’s efficacy and safety in chronic spontaneous urticaria. Detailed results from this Phase 3 trial will be submitted to the U.S. Food and Drug Administration and are expected to be featured at upcoming medical meetings. The goal is simple: show the full picture of benefit and risk so patients and physicians can make informed choices.
Frequently Asked Questions
1. What is Dupixent used for?
Dupixent is used across several approved indications, including asthma and atopic dermatitis, and it’s being studied as a targeted therapy for chronic spontaneous urticaria.
2. How does Dupixent work?
Dupixent is a monoclonal antibody that blocks signaling of interleukin-4 and interleukin-13—key drivers of type 2 inflammation—which can help reduce itch and hive activity.
3. What were the main outcomes of the Phase 3 trial?
Patients on Dupixent achieved nearly a 50% improvement in itch and urticaria activity scores versus placebo, with a 30% rate of complete symptom relief compared with 18% on placebo.
4. What is the expected regulatory timeline for Dupixent?
The trial results will be submitted to the FDA, with hopes of securing approval by the end of the year, pending the agency’s review.
5. What safety information should I know about Dupixent?
Overall adverse event rates were similar between Dupixent and placebo. Injection-site reactions were more common with Dupixent, and COVID-19 infections were reported. Talk with your healthcare provider about risks and benefits and whether this option fits your situation.
