Dupilumab meets primary endpoint in skin disease Phase III trial
pharmafile | July 29, 2021 | News story | |
Dupilumab has met its primary endpoint in a Phase III trial for patients with moderate-to-severe chronic spontaneous urticaria (CSU), an inflammatory skin disease.
Adding dupilumab (Dupixent) to standard-of-care antihistamines significantly reduced itch and hives for biologic-naïve patients, compared to those treated with antihistamines alone.
This is the fifth inflammatory disease that dupilumab has demonstrated positive trial results.
John Reed, Global Head of Research and Development at Sanofi, said: “The chronic nature of CSU, coupled with intense itch, causes both a physical and emotional burden on people who have not found an effective treatment.
“The success of this trial underscores the agility of our clinical operations team considering the pandemic conditions and underscores our ability to deliver on an aggressive timeline for addressing a significant unmet need for this patient population.”
George D Yancopoulos, President and Chief Scientific Officer at Regeneron, said: “This is the first Phase III trial to show that by targeting IL-4 and IL-13, Dupixent can address the debilitating symptoms of chronic spontaneous urticaria like persistent itch and hives when standard-of-care antihistamines cannot sufficiently control the disease.
“These data add to the increasing body of evidence that using Dupixent can reduce the disease burden of a diverse range of dermatologic, respiratory and gastrointestinal diseases.
“By early 2022 we look forward to reporting results from a second trial in patients who were unable to control their chronic spontaneous urticaria with another biologic medicine, as well other trial results in additional dermatologic diseases.”
CSU is a chronic inflammatory skin disease characterised by the sudden onset of hives on the skin and/or swelling deep under the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itch or burning sensation, which can be debilitating and significantly impact quality of life.
CSU is typically treated with antihistamines but for up to 50% of people living with CSU, their disease remains uncontrolled and treatment options are limited.