Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

Phase 3Active Not RecruitingNCT06424470

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 improved by ≥ 4 points from baseline on the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 of treatment.

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

Data from ClinicalTrials.gov

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