Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Subjects With Prurigo Nodularis

This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity.

Chronic prurigo (CPG) is an independent chronic inflammatory skin disease characterized by chronic itching and multiple local or systemic prurigo lesions. Prurigo nodularis (PN) is the main subtype of CPG.

Inclusion Criteria:

• Able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form.
• 18 ≤ Age ≤ 75 years old.
• Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.

Exclusion Criteria:

• With drug-induced prurigo nodularis.
• With clinically significant diseases.
• With severe liver and kidney function damage at the screening.
• With malignant tumors within the first 5 years before the screening.
• Plan to undergo major surgical procedures during this study.