Press release
Dupixent® (dupilumab) Phase 3 Trial Confirms Significant Improvements in Itch and Hives for Patients with Chronic Spontaneous Urticaria (CSU)
Confirming the results of Study A, this second pivotal trial in biologic-naïve patients met primary and key secondary endpoints, showing treatment with
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Confirming the results of Study A, this second pivotal trial in biologic-naïve patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores compared to placebo More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines Data will support regulatory resubmission in the U.S. by year-end; if approved, Dupixent would be the first targeted therapy for CSU in a decade TARRYTOWN, N.Y. and PARIS, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a Dupixent® (dupilumab) confirmatory Phase 3 trial (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving background therapy with antihistamines. CSU is a chronic skin condition that causes sudden and debilitating hives and persistent itch, which can impact quality of life. This positive trial confirms results from Study A, the first Phase 3 trial of Dupixent in this setting. Earlier this year, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on the results from Study A. “Patients with uncontrolled chronic spontaneous urticaria experience debilitating itch and hives that appear without warning and disrupt their lives,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “With a nearly 50% reduction in itch and urticaria activity scores compared to placebo, these positive Phase 3 results reaffirm the potential of Dupixent to bring relief and its well-established safety profile to those living with this chronic inflammatory skin disease.” Study C enrolled 151 children and adults who were randomized to receive Dupixent (n=74) or placebo (n=77) added to standard-of-care histamine-1 (H1) antihistamines. At 24 weeks, efficacy among patients receiving Dupixent compared to placebo was as follows: 8.64-point reduction in itch severity from baseline with Dupixent versus a 6.10-point reduction with placebo (p=0.02).15.86-point reduction in urticaria activity (itch and hive) severity from baseline with Dupixent ve...