This represents the first biologic to show positive phase 3 results in prurigo nodularis.
Sanofi and Regeneron announced today that the monoclonal antibody dupilumab had met its primary and all key secondary endpoints during a pivotal phase 3 of the PRIME2 trial, which investigated the efficacy of the biologic in adults with prurigo nodularis inadequately controlled on topical prescription therapies or when therapies were not advisable.
The PRIME2 trial addressed the effects that uncontrolled prurigo nodularis had on the quality-of-life of patients, including intense, chronic itch and skin lesions. Currently, there are no approved systemic treatments for the inflammatory skin disease.
Prurigo nodularis represents the third dermatological disease in which dupilumab had shown significant improvements in itch, the other 2 being atopic dermatitis and chronic spontaneous urticaria.
The new data highlights dupilumab as the first biologic to show positive phase 3 results in prurigo nodularis.
Data from the PRIME2 trial showed that 37% of all patients with uncontrolled prurigo nodularis who had received dupilumab experienced a clinically meaningful reduction in itch from baseline compared to 22% of placebo patients 12 weeks into the study.
Additionally, nearly 3 times as many dupilumab treated patients experienced a clinically meaningful reduction in itch from baseline at 24 weeks, with 58% of dupilumab patients reporting improvements compared to 20% of placebo patients.
The safety results of the trial were consistent with known safety profiles of dupilumab in other approved indications. This marked the 6th disease in a phase 3 trial for dupilumab that reinforced the established safety profile of the biologic.
In the statement, members of Sanofi and Regeneron noted that the data reinforced the impact of targeting interleukin-4 (IL-4) and IL-13 to address itch and skin lesions in affected patients.
“We are encouraged that patients in this trial experienced a significant reduction in itch and skin lesions, especially given that prior to enrollment nearly all patients had severe itch and nearly 40% had 100 or more nodules covering their body,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi.
“We are committed to continuing to leverage the robust Dupixent clinical program to transform the understanding of the science behind a number of type 2 inflammatory diseases and look forward to presenting the full results at a future medical congress.”
Currently, the potential use of dupilumab for the treatment of prurigo nodularis is currently under clinical development. The safety and efficacy of the biologic regarding this particular inflammatory disease have not been fully evaluated by any regulatory authority.