Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

Keymed Biosciences Co.Ltd200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Prurigo Nodularis

Interventions

StapokibartBIOLOGICAL

Stapokibart Injection

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Hospital of China Medical University

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

Proportion of subjects with ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at week 24

The Worst Itch Numerical Rating Scale (WI-NR) is a patient-reported outcome (PRO) consisting of individual items with scores ranging from 0 ("no itching") to 10 ("the most severe itching imaginable"). Subjects are required to use this scale to rate the severity of their most severe itching in the past 24 hours.

Time frame: Up to week 24

Secondary Outcomes

Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN stage (IGA-CNPG S) at week 24

IGA-CNPG-S stands for Investigator Global Assessment of Chronic Nodular Prurigo - Severity scale, a clinical tool used to rate the overall severity of chronic nodular prurigo (CNPG) by evaluating lesion number, size, and inflammation.

Time frame: Up to week 24

Change from the baseline in the WI-NRS at each other visit

Time frame: Up to week 24

Proportion of subjects with Investigator's Global Assessment score of 0 or 1 for PN Activity (IGA-CNPG A) at each visit

A clinician-assessed scale to evaluate the overall appearance of lesions in chronic nodular prurigo

Time frame: Up to week 24

Change from baseline in Dermatology Life Quality Index (DLQI) score at each visit

A patient-reported questionnaire measuring the impact of skin disorders on daily life and quality of life.

Time frame: Up to week 24

Change from baseline in Skin Pain NRS at each visit

A numerical rating scale for patients to self-assess the intensity of skin pain.

Time frame: Up to week 24

Data from ClinicalTrials.gov

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