Sanofi and Regeneron announce data from second positive Phase III trial showing dupilumab leads to significant improvements in patients with prurigo nodularis

First RCT reported significantly reduced itch and skin lesions. In second trial vs placebo, more than 3 times as many patients on dupilumab experienced clinical reduction in itch from baseline, attained clear/almost clear skin & had lower rates of skin infections after 24-weeks.

SPS commentary:

The companies intend to begin international regulatory filing for dupilumab during the first half of 2022 for the treatment of prurigo nodularis (PN), an underdiagnosed and misunderstood disease, which currently has no approved systemic treatments. Dupilumab inhibits the signalling interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, which are the central drivers of the type 2 inflammation that cause the hallmark symptoms of PN: unbearably itchy, burning and stinging skin, and dozens of thick skin lesions covering the body.

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