Dupixent is expected to gain a new indication for the treatment of prurigo nodularis to reach the phase 3 clinical endpoint

On October 22, 2021, Regeneron and Sanofi announced that dupilumab injection (dupilumab, English trade name Dupixent) is used in the treatment of adult patients with poorly controlled prurigo nodularis In the pivotal phase 3 clinical trial, the primary and all key secondary endpoints were met

Prurigo nodosa is a chronic type 2 inflammatory skin disease that causes intense chronic itching and skin lesions

Duplizumab is a fully human monoclonal antibody that inhibits the signal transduction of interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways

The specific key results of this phase 3 clinical trial are as follows:

The trial reached the 12th week primary endpoint.

In the 24th week, the number of patients in the duplizumab group with clinically significant pruritus relief was nearly three times that of the placebo group, 58% and 20%, respectively (p<0.

At week 24, nearly three times as many patients in the duplizumab group (45%) achieved smooth or almost smooth skin (p<0.

Patients in the Duplizumab group achieved significant improvements in health-related quality of life indicators, skin pain, and symptoms of anxiety and depression

The safety results of the trial are basically consistent with the known safety characteristics of Duplizumab in its approved indications

Reference materials:

[1] Dupixent® (Dupilumab) Is The First Biologic To Significantly Reduce Itch And Skin Lesions In Phase 3 Trial For Prurigo Nodularis, Demonstrating The Role Of Type 2 Inflammation In This Disease.

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